journal of the american college of dentists · 2018-10-09 · eric k. curtis, dds kent w. fletcher...

Journal of the

American Collegeof Dentists

Taking a Product from Concept

to Market

Summer 2006Volume 73Number 2

A publication promoting excellence, ethics, professionalism,and leadership in dentistry

The Journal of the American College ofDentists (ISSN 0002-7979) is publishedquarterly by the American College ofDentists, Inc., 839J Quince OrchardBoulevard, Gaithersburg, MD 20878-1614.Periodicals postage paid at Gaithersburg,MD. Copyright 2006 by the AmericanCollege of Dentists.

Postmaster–Send address changes to:Managing EditorJournal of the American College of Dentists839J Quince Orchard BoulevardGaithersburg, MD 20878-1614

The 2006 subscription rate for members of the American College of Dentists is $30,and is included in the annual membershipdues. The 2006 subscription rate for non-members in the US, Canada and Mexico is $40. All other countries are $60. Foreignoptional air mail service is an additional$10. Single copy orders are $10.

All claims for undelivered/not receivedissues must be made within 90 days. Ifclaim is made after this time period, it willnot be honored.

While every effort is made by the publishersand the Editorial Board to see that no inaccurate or misleading opinions or state-ments appear in the Journal, they wish tomake it clear that the opinions expressed in the article, correspondence, etc. hereinare the responsibility of the contributor.Accordingly, the publishers and the EditorialBoard and their respective employees andofficers accept no liability whatsoever forthe consequences of any such inaccurate or misleading opinion or statement.

For bibliographic references, the Journalis abbreviated J Am Col Dent and should be followed by the year, volume, numberand page. The reference for this issue is:J Am Col Dent 2006; 73(2): 1-58

Publication Member of the American Association of Dental Editors

Mission

T he Journal of the American College of Dentists shall identify and place before the Fellows, the profession, and other parties of interest those issues that affect dentistry and oral health. All readers should be challenged by the

Journal to remain informed, inquire actively, and participate in the formulation of public policy and personal leadership to advance the purposes and objectives of the College. The Journal is not a political vehicle and does not intentionally promotespecific views at the expense of others. The views and opinions expressed herein donot necessarily represent those of the American College of Dentists or its Fellows.

Objectives of the American College of Dentists

T HE AMERICAN COLLEGE OF DENTISTS, in order to promote the highest ideals in health care, advance the standards and efficiency of dentistry, develop goodhuman relations and understanding, and extend the benefits of dental health

to the greatest number, declares and adopts the following principles and ideals as ways and means for the attainment of these goals.

A. To urge the extension and improvement of measures for the control and prevention of oral disorders;

B. To encourage qualified persons to consider a career in dentistry so that dentalhealth services will be available to all, and to urge broad preparation for such a career at all educational levels;

C. To encourage graduate studies and continuing educational efforts by dentists and auxiliaries;

D. To encourage, stimulate and promote research;E. To improve the public understanding and appreciation of oral health service

and its importance to the optimum health of the patient;F. To encourage the free exchange of ideas and experiences in the interest of better

service to the patient;G. To cooperate with other groups for the advancement of interprofessional

relationships in the interest of the public;H. To make visible to professional persons the extent of their responsibilities to

the community as well as to the field of health service and to urge the acceptanceof them;

I. To encourage individuals to further these objectives, and to recognize meritoriousachievements and the potential for contributions to dental science, art, education,literature, human relations or other areas which contribute to human welfare—by conferring Fellowship in the College on those persons properly selected for such honor.

Journal of the

American Collegeof Dentists

aade

EditorDavid W. Chambers, EdM, MBA, PhD

Managing EditorStephen A. Ralls, DDS, EdD, MSD

Editorial BoardMaxwell H. Anderson, DDS, MS, MEDBruce J. Baum, DDS, PhDNorman Becker, DMDD. Gregory Chadwick, DDSJames R. Cole II, DDSEric K. Curtis, DDSKent W. FletcherBruce S. Graham, DDSFrank C. Grammar, DDS, PhDSteven A. Gold, DDSDonna Hurowitz, DDSFrank J. Miranda, DDS, MEd, MBALaura Neumann, DDSJohn O’Keefe, DDSIan Paisley, DDSDon Patthoff, DDS

Design & ProductionAnnette Krammer, Forty-two Pacific, Inc.

Correspondence relating to the Journalshould be addressed to: Managing EditorJournal of the American College of Dentists839J Quince Orchard BoulevardGaithersburg, MD 20878-1614

Business office of the Journal of theAmerican College of Dentists:Tel. (301) 977-3223Fax. (301) 977-3330

OfficersMarcia A. Boyd, PresidentH. Raymond Klein, President-electJohn M. Scarola, Vice PresidentMax M. Martin, TreasurerB. Charles Kerkhove, Jr., Past President

RegentsThomas F. Winkler III, Regency 1Charles D. Dietrich, Regency 2J. Calvin McCulloh, Regency 3Robert L. Wanker, Regency 4W. Scott Waugh, Regency 5Patricia L. Blanton, Regency 6Paul M. Johnson, Regency 7Thomas Wickliffe, Regency 8

Product Development to Practice10 From the Laboratory to the Operatory

Linda C. Niessen, DMD, MPH, FACD

14 Is This Idea Worth Anything? Mechanics of Technology TransferJ. Max Goodson, DDS, PhD

18 Development of the Curvex Toothbrush Stephen D. Harada, DDS

21 Challenges to the Introduction of New Technologies to Dental PracticeMichael L. Barnett, DDS

26 Clinical Trials and Oral Care R&DRobert W. Gerlach, DDS, MPH

32 The Dental Enterprise: Its Transition from Xenodontic to Biodontic DentistryEdward F. Rossomando, DDS, PhD, MS

Issues in Dental Ethics35 Why Our Ethics Curricula Don’t Work

Charles N. Bertolami, DDS, DMedSc, FACD

Study: Medical Visits for Dental Problems47 Adult Patient Visits to Physicians for Dental Problems

Leonard A. Cohen, DDS, MPH, MS, and P. Ann Cotten, DPA, CPA

Departments

2 From the EditorCornpone

4 Readers RespondLetters to the Editor

7 Forum: The Good NameSteve Chan, DDS, FACD

53 LeadershipMentoring

Cover Photograph: ©2006 Andrei Tchernov, iStockphoto.

Cornpone OpinionsIn the 1890s, Mark Twain published amagazine article “Corn-pone Opinions.”The title comes from an imagined childorator friend of Clemens’s youth whoholds, “You tell me whar a man gits hiscorn pone, en I’ll tell you what his ’pinions is.” In Twain’s words, “A man is not independent, and cannot affordviews which might interfere with hisbread and butter. If he would prosper, he must train with the majority; in matters of larger moment, like politicsand religion, he must think and feelwith the bulk of his neighbors, or sufferdamage in his social standing and in his business prosperities.”

Twain ran through examples such ashoop skirts, tastes in literature, religion,and politics to demonstrate that themass of humanity drifts in and out ofviews about what is proper with little or no formal thought. “It may be,” hesays, “that such an [original, rational]opinion has been born somewhere, atsome time or other, but I suppose it gotaway before they could catch it and stuffit and put it in the museum.” In a

be unworkable. Such conformity is indispensable to the insurance industrythat now pays for half the dental bill in America.

Twain anticipated by a good fiftyyears Abraham Maslow’s hierarchy ofneeds. This psychologist demonstratedthat we first worry about survival, thensecurity. If these are in hand, we directour concern to being recognized as a valued member of various groups. Thatbecomes, as Twain remarked, the basisfor the fourth level of needs—self-esteem.Self-actualization, the highest level, iswhere original systems of thoughtthrive. This theory helps explain whynon-patients, whose lives are dominatedby getting by, generally view dentistry interms of survival (pain relief) and whyso many patients are motivated at thefunctional level of care. The general rise in prosperity and security in thiscountry has also recently released abacklog avalanche of demand for goodappearance (acceptance and self-esteem).Few patients ever make it to the preventive,systematic pro-health, self-actualizationlevel. Or as Twain remarked, “I am persuaded that a coldly-thought-out andindependent verdict…is a most rarething—if it ever existed.”

Nowhere is the power of belongingto a community more clear than withregard to ethics. The number of originalmoral and religious thinkers is so small

2

2006 Volume 73, Number 2

Editorial

From the Editor

Commercialism in Dentistry and Its Victims

majestic sweep of his arm, he brushes allindividual intelligence into the dust bin:“Broadly speaking, there are none butcorn-pone opinions. And broadly speaking,corn-pone stands for self-approval. Self-approval is acquired mainly fromthe approval of other people. The resultis conformity.” Of course, Twain washaving his fun at our expense; are wereally to believe that everything is basedon “corn?”

I can see that some of you have gradually assumed a defensive posture in anticipation of Chambers beating you over the head with some dead guyconcerning EBD, professional codes with“don’t criticize” clauses, and the tensionbetween monopolies and access. Not I!Basically, Twain was right; at least hewas on the money.

A pretty strong case can be made thatmedicine and dentistry are vigorouslyignoring EBM and EBD. Practitioners areweighing what works in their officesand is approved by their colleagues onone hand and comparing it to what academic researchers are saying. Twainwould have predicted the outcome ofthat one in a minute. I do have somemisgivings about routine extraction ofasymptomatic third molars, consideringcaries as a treatment opportunity ratherthan a disease process, and standingorders for bitewings. I also wonder why dentists push whitening and notnicotine patches. But professional opinion is the source of the standard ofcare. And if standards did not exist, thenotion of a functioning profession would

that we can name them. I wouldn’t giveyou any odds on success if you wanted toconvince me to behave as you do byattaching my ideas. It is much moreprobable that what passes for rationalthought about the important things inlife comes in the form of rationalizationsof positions that have already been takenfor other reasons—often for the sake of fitting in with a valued group such as one’s parents or colleagues. Ethicsprograms in dental schools that talkabout what one ought to do witherbefore the lessons young practitionersmaster by watching the first dentist theyassociate with. We must have homilieson what is best in the profession. But theprofession generates the homilies; thehomilies do not make the profession.

Having walked so far in the goodcompanionship of Mark Twain, I, forone, must part company for the rest ofthe journey. Samuel Clemens spent hislife obsessing about both finding and losing his identity by playing to publicopinion. He invented the humorousfront of Mark Twain, but he was alsoTom Sawyer—the guy who made akilling in the whitewash business, ranan insider trading scheme in bible versesto impress his girlfriend, and staged hisown death so he could listen to the orations at his funeral. Dentistry is well stocked with individuals who are working through similar struggles byshowing their cases on the CE circuitand becoming the president of everyorganization that will have them.

3

Journal of the American College of Dentists

Editorial

Like Clemens, some in dentistrytoday are trapped inside a false dichotomy—self-determination or interference, control or surrender, conformity or having a few original ideas. Really, wecan have it both ways. We can choose,support, and create communities thatvalue intelligent, reasoned progress thatis open and not privately selfish. We can conform by fostering intelligent discussion. If conforming to professionalnorms means being prepared to discussthe reasons for doing something andsupporting a common ethical set of values, we can have our cornpone andeat it too. Surely somebody else musthave been thinking this way; dentistryhas come a long way since SamuelClemens’ time, and it wasn’t onlybecause of conformity.

David W. Chambers, EdM, MBA, PhD, FACDEditor

Ethics programs in dental schools that talk about what one ought to do wither before the lessons young practitioners master by watching the first dentist they associate with.

Dear Managing Editor:

Through your office, I would like to compliment the Editor of the College onthe winter 2005, volume 72, number 4(“Standards”) edition of the Journal ofthe American College of Dentists.

I have been anxiously awaiting anissue of the Journal that focused on standards. I found it even more excitingwhen it appeared that standards werebeing co-joined by some authors withevidence-based dental practice initiatives.The two subjects were sometimes discussed as being partners in a symbiotic relationship that would ultimately benefit patients and have apositive effect on treatment outcomes.But appearances can be deceiving, andon final reading of the “standards” edition, I found that the marriage ofstandards and evidence-based dentalpractice were two issues that the sevencontributing authors could or would not find time or reason to connect.

Each of the contributing authors isrecognized as an authority on at leastone of the issues, and each is a significantstakeholder in promoting opinions andobservations of his or her profession,school, company, or organization. As aresult, the “standards” issue fails to provide a blueprint for the developmentof a scientifically-based method of

patient treatment and treatment planningcentered on mutually agreed clinicalstandards. There was no attempt atcross-fertilization between authors anddifferent disciplines.

Dr. Chambers seems to point to thisconclusion in his editorial, “How shoulddentists practice?” He offers yet anotherguidepost or opinion in his landmark #8 “outcomes-based practice,” wherein retrospective analysis of multiple practiceoutcomes would and should providevaluable insights into the developmentof proven treatment decisions for theoffices where the care was provided. (I purposely use the words “would” and“should” because Dr. Chambers impliesin his editorial that, as professionals, we studiously avoid words and phrasesthat seem to force compliance.)

On balance, Dr. Debora Matthews’article, “What is a clinical pathway?” seemsto come closest to satisfying my thirst for a process of integrating standards ofcare with best science in patient treatmentand outcomes analysis. I suggest that the clinical pathways approach to thedevelopment of patient care algorithmsis only deficient in that it ignores theimportance of developing individualpatient health indices against which thepathways algorithms would be applied.

I can wholeheartedly agree that thedevelopment of any sort of practiceguidelines that were developed for application on a population basis arebound to be found inappropriate forsome individuals in individual practices.Not being able to respond to the healthprofile and idiosyncrasies of individual

patients is apparently a fatal flaw thathas kept practice guidelines developmentat a standstill. As Dr. Armitage pointsout, “When it comes to standards, onesize does not fit all.”

The answer seems obvious: developand use a universal program that measures each patient’s health profile or wellness index. Do that and a majorimpediment to progress in this area of standards and practice guidelinesdevelopment will have been overcome.

In Dr. Ellek’s article, “The ADA’sPractice Parameters,” she points out that“the parameters have served the needsof practicing dentists for fifteen years.And they describe a range of treatmentoptions that dentists will want to considerin combination with particular clinicalconditions and patient preferences.” The ADA cautions us that “the parame-ters not be used out of the context ofindividual professional judgment.”

I served in the ADA House of Delegatesduring the years when the PracticeParameters were being developed andadopted, and I was disheartened by theabsence of “prescriptive direction” todentists to embrace the parameters as a first step in formulating a universallanguage in treatment planning and aglossary of terms in patient care. As aresult, the Practice Parameters becameoptional considerations for dentists,

4


Readers Respond

Letters to the Editor

and I fear that most dentists would notrecognize the value of the parameters in their everyday practices or practicesof the future. I do not remember everreceiving a list of the ADA’s PracticeParameters. Neither would many dentistsappreciate the benefit of weaving diagnostic codes (SNODENT) andPractice Parameters.

So the development of standards and practice guidelines languishes inthat dark hole of indecision. Who willstand up and use his or her bully-pulpitto influence member dentists to placetheir professional egos aside and toadopt scientifically proven and legitimately developed standards andpractice guidelines?

The Journal of the AmericanCollege of Dentists, along with mostother journals, has an obligation andmission to teach. The ACD Journalhas a long-standing commitment toidentifying and promoting ethics in dentistry. I can think of no better waythan for the ACD to identify the benefitsthat are potential in patient care andtreatment outcomes should standardsand practice guidelines be developed and promulgated while the individualpatient’s health profile is a primary concern.

Lawrence J, Singer, DDS, FACDWallingford, CT

Dear Dr. Chambers,

It is with great pleasure that I respond to the wonderful paper by Dr. KennethJones in the fall 2005 issue of theJournal of the American College ofDentists. I agree with so much of whatDr. Jones so passionately professes. Dr.Jones correctly points out many of theflaws of the Medicaid system that makeit so difficult for dentists to participate,especially the administrative burden and low reimbursement rates. I wouldsuggest that dentists in Ohio take thecourse of dentists in many other states—assist in developing a lawsuit against thestate Medicaid agency to improve feesand reduce administrative burdens. This has been successful in many states,and we hope it will work here in Floridawhere I live.

Dr. Jones clearly recognizes that the problem of access to dental care inthe U.S. is complex. It is really a societalissue of immense magnitude and multiplicity of causes. Dentists alone willnot fix the problem. While I can concurwith Dr. Jones’ suggestion that maybeone solution is to require all dentists to see Medicaid patients, I think thenumbers of underserved patients andthe geographic misdistribution of dentists would make it unlikely that thisis a sufficient response. We need more innovative solutions, more prevention,more education, more responsible parents and patients, better workforcemodels, etc. We need the profession tofight for these things, not resist them.

(A summary of dental education’s position can be found in Haden, N.K., et al., Improving the oral health status ofall Americans: Roles and responsibilitiesof academic dental institutions. Reportof the ADEA President’s Commission.Journal of Dental Education 2993, 67(5), 563-583.)

I also agree that we need to improvethe ethics education and commitment of our parishioners and students. Manyof us in dental education and practicewould applaud Dr. Jones’ suggestion thatdental schools make better efforts to“find those prospective students that are not only bright and talented, buthave the ethical commitment to make adifference from day one. We need lessemphasis on who has the class with thehighest GPA and a little more on whoseclass remains true to the personal state-ment that said ‘I want to help people.’”

However, I also believe that ethicseducation in dental school can show students model behaviors and actionsthat will improve their approaches toaccess to care issues. I think one wonder-ful teaching model is the participation of members of the American College of Dentists in predoctoral ethics and professional curricula in our schools.Students want to hear from the “wet fingered practitioners” that they havebeen fully involved in care for the poor

5


Readers Respond

and underserved. I also applaud therecent efforts of the American DentalAssociation to initiate a review of theCode of Professional Conduct andPrinciples of Ethics with a partial focuson access issues. This should be of assistance to all practicing dentists indealing with access dilemmas.

My only concern is with Dr. Jones’suggestion that students from poor anddisadvantaged backgrounds may notreturn to their roots. This misperceptionmust be corrected, even if one of Dr.Jones’ sources is “more than one educator.” I would direct readers to arecent publication—Sullivan, L. et al.Missing persons: Minorities in thehealth professions. The SullivanCommission, Washington, DC. 2004. The data and summary on page 24 seem to rebut and refute the fear thatindividuals from underprivileged back-grounds fail to assist those communitiesfrom which they arise.

Thanks to Ken Jones and others who understand and passionatelybelieve that professionalism is morethan being called “Doctor.” Instead, it is“knowing that I have done my best tofulfill my obligation to my profession, tomy family upbringing, to my patients,and to a society that says that what I domatters.” This attitude makes me proudto be a member of this profession.

Sincerely,Frank Catalanotto, DMD, FACDGainesville, FL

Author’s ResponseThank you, Dr. Catalanotto, for readingand understanding my wet-fingeredviewpoint. Your cited reference to the2004 Report of the Sullivan Commissionon Diversity in the Healthcare Workforceseems impressive. However, I believe myeyes and ears out here in the everydaypractice of dentistry. Both as a dentistand as an attorney, I have faith in myown observations and discussions, and I know that one can interpret statisticsand studies in many different ways. In fact, it happens every day, as expertwitnesses arrive at diametricallyopposed opinions on the exact samecase facts. It would be interesting to readfollow-ups that determine each one ofthese individual senior’s actual practiceaccess parameters, two, five, and twentyyears down the road from graduation.Are their promised “I’m going to’s” anydifferent from their eventual “I did’s?” Ilook forward to a more long-term studyon this subject and to seeing how thestatistics compare with the individualpractice realities. Until then, we’ll justhave to “agree to disagree.”

Kenneth D. Jones, Jr., DDS, JDMansfield, Ohio

6


Readers Respond

…professionalism is morethan being called “Doctor.”Instead, it is “knowing that I have done my best to fulfill my obligation to myprofession, to my familyupbringing, to my patients,and to a society that saysthat what I do matters.”This attitude makes meproud to be a member ofthis profession.

Steve Chan, DDS, FACD Mercedes. McDonald’s. Tiffany.Each is only a name. But as abrand, the name now brings a

host of associations—and a reputation.The principles of branding apply not onlyto the commercial world, but to dentalpractices and professional associations.There are fundamental behaviors thatdrive choice in the marketplace. Brandingtips choice in favor of the brand.

Branding is not advertising, nor marketing, nor commercialism.Branding is a continuous exercise to create and maintain a specific image inthe marketplace.

When an early craftsman placed hisdistinctive mark on the underside of thevessel he created he made a declarationto the marketplace: “I made this.” His signature made a declaration to themarketplace. The act was just one elementto differentiate his work from others inthe market. The craftsman’s intent wasto create a greater value beyond othersimilar works in the market. Those who would consume the work sought agreater value beyond merely possessingthe object.

When a name is the first that oneassociates with a product or service, it is a brand. Kleenex is a facial tissue.Hallmark makes greeting cards. Yet, notall facial tissues are Kleenex, nor are allcards a Hallmark. Those who choose the brand expect more value.

When the vessel from that potterbecame the coveted “maker” in the market, the craftsman’s good namebecame the brand. In dentistry, whenpatients refer others, a doctor’s name

becomes a brand. Current patients of apractice received something they valuedmore than just the filling or crown.

Fundamental behaviors drive consumption. Behaviors that drive consumption of name brands over othersin the same business are the same forFortune 1000 companies as well as dentalpractices. Brands alter the balance ofchoice. In highly competitive markets,brands can sustain a competitive edge.

• Brands differentiate—and they target.

• Brands beckon—and they promise.

• Brands are intellectual properties—yet you cannot touch, taste, smell,feel, or hear them.

• Brands satisfy—beyond touch, taste,smell, feel, and hearing.

• Brands command value—and theycommand loyalty.

• Brands create emotional responses—and they inspire apostles.

A rose is a rose is a rose, but a brandseparates. The Apple iPod is not thefastest MP3 player, nor has the mostcapacity, or the most features, but it’s themost recognized and the market leader.Is it just the advertising?

7


The Good Name

Forum

Dr. Chan is a Past President of the Northern CaliforniaSection of ACD and practicesin Fremont, California.

Consider: In an experiment, subjectswere asked how much they would payfor a pair of good quality diamond earrings. A second group was asked how much they would pay for the sameearrings, but were told they are fromTiffany. A third group was asked whatthey would pay for the earrings, butwere told they are from Wal-Mart. Theaverage price for unbranded earringswas $550. With Tiffany branding, theaverage price subjects were willing topay increased to $873. The increase wasonly due to the addition of the name,Tiffany. With the Wal-Mart name, theprice expectation fell to $81, a decline of85% from the unbranded earrings anddecline of 91% from the Tiffany-brandedearrings. Why was there a willingness topay a premium for the same product?The money is just a marker, a measure,of how much they valued what theywere willing to consume.

Branding is not just advertising. It’smore than a logo or slogan. It is morethan a list of product features. Effectivebranding typically does not need to profess their virtues to the market. Self-proclaiming superlatives simply donot persuade the consumer of the merits of the brand. The strategies of brandingare subtle. The object of branding shiftsthe point of reference to the consumer.Brands induce the consumer to tell the story.

Branding is more than introducingproducts or services in the market andjust seeing “what sticks.” It is a deliberatedissection of the market. It is an array oftactical choices to achieve an impressionin the market. It is a series of consciousdecisions on where a company wants toposition itself in the market. Brandingstrategies create an emotional bond.

How do consumers choose a dentist?A filling is a filling is a filling. Yet, patientstypically do not have expertise to evaluatewhat they purchase. Branding is theimpression of the service, not the physical“filling.” When a soccer mom professesto other team moms: “My kid goes to Dr. Widget,” Dr. Widget’s name hasbecome a de facto brand.

When a person identifies himself or herself as a patient of Dr. Widget, heor she expresses a quasi-membershipwith that practice. The law of exclusivityapplies here. When something is perceivedto be desirable yet limited in access, thedrive is to want to be a part of those elite few.

Branding of goods is typically judgedby tangible attributes. Goods can bephysically compared. Services, in contrast,are typically judged by intangible qualities. In the case of practices, theylook to other environmental cues suchas professionalism, the staff, and theappearance of the office, the ease of performance, confidence. The cues mayor may not correlate with the soundnessof the service just purchased.

Judging goods are more often con-ducted using search qualities as opposedto services where experience qualitiesare determinates in judging services.Search qualities enable the consumer to evaluate features prior to purchasewhereas experience qualities are judgedafter some trial or consumption.

Consider the Yellow Pages. In anycategory, here is a market microcosm tocompare competitors. In the YellowPages, ads tend to be a lure as an initial point of contact. Ads are used to differentiate themselves among competitors. In contrast, brands useadvertising as another tool to affirm theidentity of the brand. Inconsistentimagery undermines the brand strength.

Some practices adopt a fictitiousname to impart an institutional or mainstream identity. Brands are morethan just a name. Indeed, names aloneare not brands. A brand imbues a namewith strong perceptions and emotions.Contrived names are perceived by theconsumer as contrived. Generic-soundingnames become perceived as generic. Arisk of adopting institutional soundingnames may impart impersonal institu-tional imagery to the consumer.

Dental practice branding is largelypersonality driven. Every personality isunique. Every character of the practice isan extension of the dentist’s personality.Every conscious choice of featuresimparts some character of the dentist.From business card design to office color palette to the manner of engagingpatients the consumer draws impressionsabout the practice.

Yet it is not just an array of features.It is the consumer’s perception of gettingmore than his or her money’s worth.Advertising a list of features such assleep dentistry, cosmetics, and digitalradiography may create an episodicbuzz, but do these features tip the scalesof choice? Does that choice recur? Is

8


Forum

this entire array uniquely characteristicor do others in the market offer thesame things?

Are the features of value to the consumer where they are willing to pay more for it? Does the consumptionmerely satisfy or does it delight? Doesthe consumer perceive they are buying a service which is premium amongother practices available to them? Doesconsumption create bonds of loyalty? Do they want to repeat the experiences?

Effective branding is revealed.Effective branding is often minimalist.The message should permeate through-out the organization with every touchpoint. People draw conclusions andmake choices from watching. The objectis to induce the targeted end user to singthe praises of the brand.

In developing a positioning statementfor the brand, a conscious design maps out:1. A description of the targeted consumer.2. Identify the frame of reference.

What does the end user get from consuming the brand? Who are relevant competitors (brands thatclaim to serve the same goal)?

3. Identify the point of difference, i.e.why consuming the brand is superior to alternatives. What are the concrete functional benefits? What are theabstract emotional benefits?

4. What is the supporting evidence forclaims related to the frame of refer-ence and point of difference, i.e.,what are the reasons to believe inthis company?The principles of excellence, ethics,

and professionalism are intimatelylinked to branding in dentistry as in thecommercial world. Whenever there ishuman performance, there are flawsand faux pas. Beyond differences inopinion or taste, a brand’s promise of

what it delivers is tested when there aremistakes. A brand’s promise is its bondwith the consumer.

How a brand behaves in the face ofchallenge reveals more about a brandthan its declarations to the market.Consider the examples of an event thatchallenged a maker’s reputation. Tylenolresponded to contaminated productswith an unprecedented scale of productrecall and industry-changing packaging.Contrast the effect of Ford’s and FirestoneTire’s responses to incidents of tireblowouts on Ford Explorers. Whenwords are inconsistent with behaviors,the brand’s image is in conflict. Thewhole world is watching.

Fortune 1000 companies spend millions designing, cultivating, and protecting their brands. They expendthese resources for a more predictableoutcome in the marketplace. The returnon this investment of time is proportionalto the detail taken in the design. Brandingis not a series of random acts.

In the marketing wars, just believingyou have a great product is naive. A successful brand continuously works atsustaining its position and its relation-ship with the consumer. The object is to“brand” the brand in the minds of thetarget consumers.

The object of becoming a brand isprimary recognition in any specific market. It is not just constructing a better widget; it is the sum of actions tosustain your “good name.” At the end of the day, in dentistry, and indeed, in professional associations, you havebecome a brand, when those who consume your wares do so solelybecause of your “good name.” ■

9


Forum

Branding is not advertising,nor marketing, nor commercialism. Branding is a continuous exercise to create and maintain a specific image in the marketplace.

Linda C. Niessen, DMD, MPH, FACD

AbstractThe market for dental technology is expected to continue its growth, but tochange in direction toward products based on biology. As the dental industryconsiders potential new technologies, itmust consider the following components in the development process: patent protection of concepts, the clinical relevance of innovations, an overall business plan, the regulatory environment,manufacturing issues, testing required bythe Food and Drug Administration, andmarketing. The theory of diffusion of innovations proposed by Everett Rogerscan be used to predict characteristics oftechnologies that will diffuse quickly andthose users who will adopt innovationsquickly or reluctantly.

In 2004, the U.S. spent $1.9 trillion onhealth care, 16% of the GDP (Smith etal., 2006). The market for dental care

rose to $80 billion, an increase of 6%over 2003. It is estimated that about 70%of the U.S. population sees a dentist in agiven year. The aging of the population,increased demand for esthetic dentalservices, and retention of natural teethare thought to be contributing to thegrowth of the dental care market.

Growth of the dental care market isalso being fueled by new products andtechnologies that make dental care morecomfortable for the patient and moreefficient for dental professionals.Innovation is critical to the success of amodern dental manufacturer. In 1995,DENTSPLY International’s sales were$572 million. In 2005, DENTSPLY’s saleshad grown to $1.7 billion. However, the1995 product portfolio represented a littleover half of the products sold in 2005.The new products came from acquisitions,new product development, and licensingagreements. New product developmentis critical to both the growth of dentalpractices and the dental industry.

This paper will provide an overviewof the dental industry and discuss howmanufacturers work with dental profes-sionals, scientists, and inventors to bringnew dental products and technologies to dentistry.

Dental Market OverviewThe global dental supply and equipmentmarket is estimated to be $13 billion, ofwhich equipment accounts for $2 billionand dental consumable supplies accountfor the remaining $11 billion. The U.S.,

Europe (Germany is the largest marketin Europe), and Japan are the threelargest dental markets. Figure 1 showsthe dental markets by continent as a piechart. Dental market growth rates forthe next five years are estimated to be5% to 6% with some variability based ona country’s economic growth.

Industry growth drives vary by thestage of development in each country. An aging population, the retention ofnatural teeth, and the increased patientexpectation of esthetic dentistry are serving to fuel the dental market indeveloped countries such as the U.S. In the developing world, the rising standard of living and large unmet needare driving demand for dental care.

The provision of dental care hasevolved during the past century fromone of extraction in the early twentiethcentury, to repair by the middle of thecentury, to prevention and estheticsrecently. The twenty-first century willsee the fruits of the molecular biologyrevolution bring new and emergingtechnologies to dentistry. These tech-nologies have the ability to redefine how dental care is provided, how oraldiseases are prevented, and how oralhealth is improved.

New salivary diagnostic tests for oralcancer or caries risk factors are being

10


From the Laboratory to the Operatory

Product Development to Practice

Dr. Niessen is Vice Presidentfor Clinical Education,DENTSPLY International, andClinical Professor, BaylorCollege of Dentistry, TexasA&M Health Science Center,Dallas, TX 75246.

developed. Genomics and proteomics are leading to new tests for caries andperiodontal diseases. Salivary DNA testsare already commonly used in lawenforcement. Microbiologic indicatorsare being developed for causative bacterialagents in caries and periodontal disease.“Smart” materials are being developed torepair lost tooth structure or preventtooth structure from being lost initially.

Advancements in imaging technologiesare changing how we diagnose and treatoral diseases. CT scans are improvingimplant placement and making the procedure even less invasive. Diagnosingcaries using radiographs may become a technique of the past as electricalimpedance improves our ability to diagnose caries at earlier stages prior tohard tissue loss. Ultrasound may be usedfor caries and calculus detection. Futurepreventive trends may include newmethods to remineralize or strengthenteeth, novel delivery systems for fluoridesand other remineralizing solutions,modifications to the disease-causing bacteria, and vaccines against caries andperiodontal disease. How will these newtechnologies reach the dental operatory?

New Product Development ProcessNew product development requires a collaboration with scientists and inventors(who conceive the idea), academiciansand clinicians (who conduct the clinicaltrials on the product), manufacturers(who make the product), and distributors(who distribute/sell the product).

New product ideas can be generatedby individuals working on their own,within a university, or in industry. Anacademic-based scientist and the parentuniversity may partner with a manufac-turer to bring a new product to market.For example, Dr. Max Goodson’s effortsto identify a locally administered antibi-otic agent led to the development ofActisite® fibers.

Many dental manufacturers investsignificant resources in internal researchand development teams that generatenew product ideas. New product ideasand technology can also be acquired by a company or can be licensed fromuniversities or another company.

New ideas (intellectual property)require patent protection. Once a newidea that has relevance to dentistry isidentified, a patent search is conducted.For a company to invest in a new idea or technology, a critical component inthe evaluation of the idea is the patentprotection surrounding it. Bringing anew product to market requires a considerable investment, after the purchase or license of the technology.

Patent protection enables a company torecoup the initial investment needed tobring the product to market withoutother companies immediately enteringthe marketplace with the same or similar “me too” product.

Clinical relevance is another criticalcomponent of the idea and technologyevaluation. Does the idea meet a clinicalor patient need? Does it solve a clinicalproblem? What does it replace? Does itmake the delivery of dental care easieror more efficient for the patient or dental team? Is the potential technologyor product easy to incorporate into adental operatory or dental laboratory? Is it easy to learn the new technology?

Once clinical relevance is determined,a business plan is developed. The mar-keting team will identify the market size.In other words, who will buy the productand what will they be willing to pay forthe product? What does the productcompete with? The manufacturing teamwill evaluate the cost to manufacture

11



Figure 1. Percent share of the global dental market by continent and country.

Europe31.8%

Other5.5%Asia

5.4%Latin

America3.6%

Japan15.5%

U.S.38.2%

the product. Are raw materials readilyavailable? Can existing manufacturingfacilities be used to make the product?Do manufacturing facilities have to bemodified? Does the product require anyspecific handling such as refrigerationduring shipping and storage?

The R&D team will determine theregulatory path for the program and thecosts of any clinical trials necessary tobring the product to market. Is the product a drug, device, or combination?Like voting in Chicago, consultation withthe FDA should occur early and often.

The costs to develop and manufacturethe product are then weighed againstthe revenues that will be generated bythe sales of the product. These costs versus revenues determine the return oninvestment to the company for this newproduct. It is important to recognize thatthe costs associated with developing andlaunching a product must be expendedprior to any revenue generation.Occasionally, unforeseen expenses as aresult of delays in the product launchthat were not calculated in the originalreturn on investment estimates do occur.

As part of this evaluation process, theR&D team will conduct internal testingto validate the initial claims made by theinventor. Professional testing for safetyand effectiveness will be conducted.Clinical trials will be conducted underFDA guidelines. The product type (drug,device, biologic, or combination) willdetermine the clinical trial requirements.Most dental devices are approved by theFDA under the 510K process which takesadvantage of research already conductedon similar products already approved for the market. If a similar (predicate)product does not exist, an NDA (NewDevice Application), with more extensivetesting requirements, will be requiredprior to the clinical trials.

Clinical trials are usually conductedunder contract to a university, with acontract research organization (CRO), or in-house. The National Institute ofDental and Craniofacial Research recentlyfunded four large Practice Based ResearchNetworks that may serve as potentialsites for dental industry clinical trials.

The costs of clinical trials are animportant component of the new productdevelopment process. Experienced clinicalscientists are critical to the conduct ofthe clinical trials. University-based clini-cians provide this pool of experiencedinvestigators, because they understandthe importance of patient informed consent, compliance with the clinicalprotocol, and completing the trial in thetime frame outlined.

End-user testing or field testing willoccur to assist the marketing departmentsin identifying the relevant benefits andfeatures of the new product. After theproduct is launched, post-market surveil-lance occurs to ensure that the product is performing as expected.

Technology TransferJust because one builds a better mouse-trap, such as a nickel-titanium rotaryendodontic file or a zirconia material for crowns and bridges, does not meandental professionals will use it. Adoptinga new product or technology varies bydental professional. The most commontheory on technology transfer is Rogers’(1995) “diffusion of innovation theory.”Rogers identifies five types of innovationadopters, based on how quickly theyincorporate new technologies:• Innovators (venturesome)• Early Adopters (respectable)• Early Majority (deliberate)• Late Majority (skeptical)• Laggards (traditional)

Innovators are the first to adopt a newtechnology. If you are driving a hybridcar, consider yourself an innovator. Ifyou have an 8-track tape player or Beta

12



The future of dental industry will move from primarily a device businessto one based more on pharmaceutical and biologics principles.

video camera in your closet, you couldbe an innovator or an early adopter.Since patient care requires consistent,reliable performance from the productsor techniques, most dental professionalstend to be more deliberate in their adop-tion of new products and fall into theearly majority category. Table 1 lists thedifferences between the early adoptersand the early majority. Those who arenot interested in change can fall into thelate majority or laggard categories.

Malcolm Gladwell, in his book The Tipping Point (2000), describedhow ideas diffuse through society using the theory of social epidemics. He identified the “role of the few”—theconnectors, mavens, and salesmen andsaleswomen who serve as the messengerswho bring the message of the new ideaor technique to dental professionals.This role is often filled by the clinician or educator who provides continuingeducation programs and teaches dentalprofessionals about new techniques andproducts, or the well respected specialistin a community that the general dentistslook to for advice.

The “stickiness factor” refers to howsalient the message is or how it connectswith patients or dental professionals.Digital radiography immediately con-nected with (was not sticky for) dentalprofessionals who were comfortablewith computers and could not wait toget rid of the messy developing chemicalsin the dental office. The “power of context” refers to the sensitivity of themessage or the transmission of an ideain various settings. For example, duringthe advent of the HIV epidemic inAmerica, one dentist was reported tohave transmitted HIV/AIDS to a patient.Within a very short time, patientsexpected (and demanded) their dentalprofessionals to wear gloves during dental procedures to ensure that they

did not transmit HIV to patients. The fear of being infected by HIV/AIDS from one’s dentist served as a powerfulcontext in which to transmit this newidea of wearing gloves during every dental procedure.

Roger Clarke (www.anu.edu.au/people.roger.clarke/sos/inndiff.html)summarizes the characteristic of innova-tions identified by Rogers (1995) thatenable them to become readily adoptedby society. If the new product or ideaprovided a relative advantage (performedbetter than the current product or technique), it would be more readilyadopted. An innovation has a betterchance of being adopted if it satisfiesthese criteria: • It is compatible or consistent with

existing values, experiences, or needs.• It is easier to use (or less complex)

than existing products or techniques.• Its results can be observed. • It can be tried on a limited basis.

Some clinicians have hypothesizedthat the characteristics of dental innova-tions that enable easy adoption are those that: • Save the dental professional time and

enable them to make more money.• Are demanded by patients.• Ensure compliance with medical-

legal considerations.Whatever the reasons for adopting

innovations, it is clear that as the dentalindustry introduces new products andtechnology to dentistry, an understandingof the theories of technology transfer willassist in the adoption of these new ideas.

SummaryStephen Jay Gould wrote, “Obsolescenceis a fate devoutly to be wished for, lestscience stagnant and die” (1989, p. 347).Given the innovations that we see entering the dental marketplace today,oral health science is very much alive andwell. New science and technology willhelp achieve the movement of dentistryfrom a primarily surgical discipline toone that is medically and surgically oriented and practiced. Industry supportis needed to provide products to achievethis type of dental practice. The future of the dental industry will move from primarily a device business to one basedmore on pharmaceutical and biologicsprinciples. The characteristics of dentalprofessionals must be understood tofacilitate adoption of any new technology.■

ReferencesGladwell, M. (2000). The tipping point.Little, Brown, Co: Boston.Gould, S. J. (1989). Wonderful life: theBurgess Shale and the nature of history.W. W. Norton: New York.Rogers, E. M. (1995). Diffusion of innova-tions (4th Ed.). New York: The Free Press.Smith, C. S., Cowan, C., Heffler, S., Catlin,A., & the National Health Accounts Team(2006). National health spending in 2004:recent slowdown led by prescription drugspending. Health Affairs, 25 (1), 186-196.

13



Table 1. Differences between early adopters and early majority.

Early Adopters

Technology focusedRevolutionary changeVisionary usersWilling to take risksWilling to experimentTend to communicate across disciplines

Early Majority

Not technology focusedEvolutionary changePragmatic usersRisk averseProven applicationsTend to communicate within disciplines

J. Max Goodson, DDS, PhD

AbstractThe path from a proven scientific idea to a commercially viable product is seldomeasy. It often requires ten or more yearsand millions of dollars. The essential elements include a creative concept thathas been proven sound, identification of the commercial applicability of the concept, and financing and management of the development process.

Every year, scientists working inoral health research generatethousands of excellent new ideas.

Most contribute to theory building; someare practical innovations that other scientists put to use to accelerate theresearch enterprise; a few have potentialfor application in healthcare delivery.These are product concepts—the break-through ideas behind a technology thatmay improve oral health. The stories ofideas in the laboratory making theirdeveloper famous, and perhaps financiallyblessed, are known. What is less wellunderstood is the hard path from conceptto viable product and the challenges thatleave so many good ideas unrealized.

For a concept to travel to successfulcommercialization, it must meet threecriteria: 1) it has to work, not only incontrolled situations, but generally orpractically; 2) it has to be of substantialeconomic advantage to those other than the researcher; and 3) the manyformalized steps between conceptionand development must be successfullynegotiated.

A Good IdeaResearch is hard work. A breakthroughidea with commercial applicationsrequires something more. Creativity is aprecious blend of novelty and usefulness.Novelty can strike in the laboratory, butnot in the normal way science is done.Observation, especially the knack of seeing something new in what otherssee in traditional ways is one source. For example, Horace Wells saw nitrousoxide used as a party pastime drug by

the upper middle class and wonderedwhy it could not be used with the sameeffects but for different purposes. Pasteur’sfamous, but usually misquoted, remark is also to the point: “chance favors the prepared mind” (he actually saidchance favors only the prepared mind).Einstein’s very fully mylenated brain wasmore powerful than others and struckthe theories of relativity by a processthat might be called “pure creativity.” For most of use, serendipity is a morerealistic goal. The fortuitous pairing of luck and awareness that promotedFleming to discover penicillin is a well-known example. Logical reasoning,working with predictable consequencesover a range of situations, is yet anotherpath to good ideas. It certainly workedfor Crick in the case of triplet DNA. Yetanother source is noting relationships,often consciously using analogy torearrange things, as Mendeleyev didwith the periodic tables.

Whether by these or other meansnovel ideas are generated, they must stillmeet the test of usefulness in order toqualify as creative. They must predictablysolve a problem that someone else caresabout. That kind of insight is more likely

14


Is This Idea Worth Anything? Mechanics of Technology Transfer


Dr. Goodson is Director ofClinical Research at theForsyth Insititute in Boston. He may be contacted [email protected]. This paper was developedfrom his presentation at anAmerican Association forDental Research symposium,“From ‘R’ to ‘D’: The ABCs of product development,”March 2006.

to come at the edges where science andpractice rub against each other than it isto be found in the lab.

Commercial ViabilityOther people have to be able to makemoney off the researcher’s good idea if it is to go anywhere. Someone else must by able to turn more of a profit inprototyping, developing, protecting,financing, manufacturing, marketing,and distributing the new idea than theydo with their current line in order toswitch their interest to it. Because theidea is unproven, a premium is usuallyexpected. Sometimes a single firmassumes responsibility for all these functions and needs only make a largeprofit on the aggregate. If developmentof the idea is distributed across severalentities, each will expect to make a profit. It is a virtual certainty that thetypical researcher is incapable of substituting his or her expertise for thatof others in the development-to-marketprocess, so the idea is still-born unless it offers enough profit potential to othersto attract their attention.

The same logic applies to end users.Dentists, physicians, or others whomight use the products flowing from agood idea can be counted on to applytheir own personal profit logic to anyinnovation. It is natural for scientists tothink in terms of effectiveness of patienthealth outcomes. While practitioners areaware of these metrics, they are also sensitive to ease of use, training, requiredchanges in other parts of the practiceroutine, and their own opportunity forfinancial reward. Sometimes, as in

Block Drug’s failure to engage dentists inprescribing nicotine patches or in bikersrejection of motorcycle helmets, effectiveproducts fail to match the users’ self-concept. The dental market is unusual in several respects. Many dentists seethemselves as very inventive and preferpersonal work-arounds. They are slow to innovate, depending heavily on professional word of mouth. They alsobuy almost everything they use in theiroffices on their personal credit cards.That means big-ticket changes and innovations spill over to other aspects of the practice and are in direct competi-tion with the family vacation.

Commercializing a Research IdeaNow that the path that a good idea musttravel to become a commercially viableproduct has been established, attentioncan turn to the process that transforms a concept into a product.

The first step (omitted at great risk) isthe initial reality check. Is the trip worthtaking? Here are some of the questionsthe researcher might want to ponder:• When fully commercialized, will the

product generate sufficient revenueto be self-sustaining in the market?Normally $10-20 million would be a safe ante. If you want a large company to sell it, we are talking $50 million and up.

• Will the fully commercialized productmake a difference to people? Is it better and more likely to generateprofit for others than what is available

15



Creativity is a preciousblend of novelty and usefulness.

now? Is it safe from being overrun in a short period by other developingtechnology?

• Can one handle the competitive pressures of commercial life? Thesewill include financial uncertainty,peer attacks, potential lawsuits, job loss, etc.

• Is it worth it personally? Can thisbecome the most important thing in one’s life (rather than a dream)that one is prepared to spend ten ormore years to achieve?If the responses to this very challeng-

ing reality check are convincinglypositive, the first and concrete step is to protect one’s opportunity to developthe idea. It is an absolute requirementthat intellectual property be protected,because that is all one has at this point—an idea. A patent allows the inventor tostake a claim to the potential value thatmay arise out of the idea. A patient is awarrant from the government providinga right to prevent others (if one has thefunds to procure legal services) fromusing an invention for some specifiedperiod of time, in essence the right to amonopoly for a time. It also converts theidea into a marketable entity, allowingone to sell or license it. In exchange forthe exclusive use of an idea, the inventormust publicly and formally disclose the secrets of the invention. Patent applications can be denied if the inventorfails to demonstrate that the idea isnovel and useful (the two criteria of creativity discussed above) and that theinvention is nonobvious. The cost ofobtaining a patent normally exceeds$10,000, and substantially exceeds thissum if international patents are obtained.

An alternative approach is to securea provisional patent. The so-called“patent pending status” is simpler andless expensive. Costing less than $100

for some very simple forms, the extent of disclosure is minimal. Although theprovisional patent establishes a filingdate and serves to some degree as adeterrent to competitors, the maximumlength of protection provided by thisapproach is one year.

As soon as the topic of “owning anidea that has commercial value” comesup, it is necessary to inquire aboutwhether and how that ownership mightbe divided. There are two issues: 1) doesthe individual who first articulates anovel and useful idea have an opportunityto own it outright and completely, and 2) once ownership of an idea has beenestablished, can it be sold or divided?

Individuals who work alone andreceive no support from other interestsmight be to able argue that their ideasare their own. But the many American scientists who are employees of researchor commercial organizations will be governed by conditions in their terms ofemployment as to what proportion ofintellectual property is theirs and howthe organization may or may not help in developing a concept for market.Employees of the federal government are bound by similar and very restrictiveterms. Currently, there is an ongoingdebate as to whether employees of theNational Institutes of Health should be allowed to profit from commercialspin-offs of their tax-supported work.

Universities are especially affected by these issues because they focus onpure research and are funded, throughtuition, state support, and private andfederal grants and contracts, for knowl-edge creation and transmission throughteaching and publication. In 1980, theUnited States government laid down the basic framework that governs thestructure of commercializing researchideas flowing from federal funding. Thisis known as the Bayh-Dole Act, and thebasic reasoning is that it is good forAmerica when promising ideas are

16



Other people have to be able to make money off the researcher’s goodidea if it is to go anywhere.

sped to commercial application and thatuniversities are in a better position to dothis than the government. Universitiesare expected to develop research innova-tions arising from federal funding. Manyuniversities have established offices forthis purpose, and a typical arrangementis that the scientist receives one-third ofthe resulting revenue stream (sometimesnet of development costs), while theremainder is plowed back into research.On occasion, a university may determinethat an innovation lacks commercialpotential, in which case the innovatormay be offered the entire ownership ofthe innovation.

Prior to enactment of Bayh-Dole, theaverage annual number of universitypatents on research was approximatelytwo hundred; in 2003, the number hasswelled to almost five thousand. In thatyear, $41 million were invested inresearch sponsorship. At the same timethere were four hundred thirty-two startup companies associated with thistype of activity, over eight thousandpatent applications, and just over fourthousand patents issued from relatedactivity. This costs out at about $10 millioninvested per patent issued.

Intellectual property has most of thesame characteristics as does real property.It can be bought and sold, divided,bequeathed, and even rented out for use. The latter is called licensing, and as with rental agreements, conditionscan be attached to licensing the use ofintellectual property. They may be exclusive or non-exclusive and can belimited to certain uses, certain markets,and specific time periods. They mayeven contain clauses requiring the partner to develop the product within aspecific period of time or relinquishinterests. Licensing arrangements may

be sold for a lump sum or for future royalties. Although intellectual property,unlike real property, is not taxable, it is subject to governmental restrictions onuse and requires substantial investmentto bring out its potential value.

The normal means by which aresearcher’s good idea, protected asintellectual capital, is commercialized isby selling and licensing portions of it tothose who ensure its development.

Commercialization costs money.Some of the alternative approaches to capitalization include university development, starting one’s own business,and working with industry partners,including consultants, stockholders, collaborators, and contractors. Thosewho generate ideas will face a trade-offbetween control and economic return.Moving toward established commercialfirms for product development will tendto compromise what inventors regard as the purity of their ideas. Retainingindependence requires large infusions ofcash that may diminish future earningsand force eventual loss of control oreven of the company. Venture-capitalfunders are normally interested in short-term payback, may require theinnovator to put up a large initial invest-ment (often bigger than one’s house),and may insist on further protections oftheir funds through testing, licenses, oremployment of experts.

The Food and Drug Administrationregulates drugs, devices, medical equip-ment, and so forth prior to and duringmarketing. The filing for FDA approvalalone can be expensive and time-con-suming. Phase I and II trials will berequired for any novel idea in order toestablish safety, efficacy, and dosage-response relationships. Prior to marketing,novel products must undergo a Phase IIIclinical trial, normally consuming threeto five years and costing hundreds ofthousands to millions of dollars.

Innovators who come from the academic ranks must also weigh the culture clash they are about to experi-ence. Academic tradition emphasizes the values of abstract ideas, inquiry, long time horizons, open work and publication, and societal good. By contrast, in commercial developmentthese values take the form of concreteproducts, goal-directed development,short horizons, confidentiality, and corporate profit in industry.

Decisions about these fundamentalvalues and the path most appropriate fordeveloping an idea must be worked outin the innovator’s mind before acceptingpartners. They are the bedrock for thecontracts that must be negotiated. Awell-negotiated contract is fair to all parties; it must consider the partnershipbased on the differing needs each bringsto the table. It is natural for the personwith the idea to overestimate the rewardsof the idea while underestimating bothits cost and time to development.Normally the researcher with the goodidea is at a disadvantage, even followingthorough preparation. Scientists negoti-ate few such contracts over a lifetime.

The road from a good idea to a usefulproduct in the hands of dentists is difficult. The work necessary to ensuresound science, commercial viability, protection of creative interests, and regulatory compliance is substantial.Fortunately for the dental profession,there are those individuals and organiza-tions prepared and qualified to makethat journey. ■

17



Stephen D. Harada, DDS

AbstractThis is a first-hand narrative of the steps in developing a new toothbrush from concept through initial marketing. Thedesign seeks to provide the softest bristlesconsistent with effective plaque removal.Patent protection, incremental design andtesting, and accurate market analysis havebeen essential steps in the process.

From the middle of 1998 to the endof 2003, the Curvex toothbrushand its derivatives, were developed

to offer an innovative manual toothbrushwith a bristle array that would not onlygeometrically fit the most difficult areasof the mouth to clean, but also try to use the softest bristle filaments in theindustry range of “soft” toothbrusheswithout a loss of plaque removal efficacy.The industry standard for a “soft” toothbrush is a .007 mil diameter bristlefilament (most commonly used), to ahigh of .008 mil diameter, (also the startof the “medium” range) to a .006 mildiameter filament (the softest of therange). From the onset, it was recognizedthat there were three main considerations:1) the softer the bristle, the more likelyto encounter bristle deformation whenbrushing in the customary to and fromotion; 2) a softer bristle must achievean adequate level of plaque removal; and3) if a softer bristle could be successfullyintegrated in toothbrush head design,there could be benefits to the gingivalhealth of the user. The Curvex was theresult of these efforts.

The head of the toothbrush wouldincorporate a tapering bristle array ateach end of a larger planar mid-sectiongroup of bristles. The mid-section planararray would serve to clean the most easily reached areas (i.e., buccal surfacesof teeth). The tapering end groups atboth ends would result in an innovativegeometric fit for closer contact with thelingual anterior curve of the upper and

lower arches. When brushing in theusual to and fro motion, the end groupsof bristles would support the larger mid-section group of bristles to reducebristle “splaying” when brushing in thelongitudinal to and fro direction andallow use of a softer .006 mil diameterfilament and still maintain adequateplaque removal efficacy.

To complement this unique bristlearray, a convex head was devised. Thiswould not only allow the toothbrush toreach further back on the palate (whenbrushing the lingual of upper molars) by curving away from the roof of themouth, but also allow the end groups ofbristles to engage behind any terminalmolar with ease. This configurationwould also avoid hitting the mandiblewhen reaching the lingual surfaces oflower molars.

The neck and handle were reversedcurved, as opposed to most conventionaltoothbrushes, to allow a reach furtherback without hitting the tips of theupper and lower anterior teeth.

Initial Development and TestingThe first prototypes were made by modifying commercially available tooth-brushes to our specifications and design.These prototypes were provided to a limited number of dental professionalsfor evaluation. This took place over a

18


Development of the Curvex Toothbrush


Dr. Harada is President andFounder of Ergonomic DentalTechnologies, Inc. (EDT).www.edit-curvex.com

three- to six-month period. The firstreports from dental professionals werevery encouraging.

Patent CounselFollowing preliminary design work, theservices of a patent counsel were sought.This was the single most important stepin the entire project, and remains sotoday. The intense collaboration betweeninventor and counsel cannot be overemphasized. One must engage the services of the absolute best—not the best that can be afforded, but the best. A poorly drafted patent is no better thannone at all.

After counsel was engaged andreviewed the design, a patent search ofprior designs, or, as it is called, “prior art”was done to verify originality or inven-tive novelty. The inventor and counselthen reviewed all materials to determineif there was enough novelty to proceedwith a patent application and how to word it. For us, this entire process involved three to four months. To protectintellectual property, all feasible variationsto the basic concept should be appliedfor. This also allows for future productdifferentiation. The application processcan and does take years, but is crucial toprotect the invention. Once submitted,the United States Patent Office does itsown search; in my case, prior art datingfrom as far back as the 1860s was citedand had to be addressed.

As it was felt that the oral hygienedevice market was expanding worldwide,international patents would be sought

in Europe and Asia. These involved separate applications on the part of thepatent counsel. It should be emphasizedthat there are no guarantees of successeven if a United States patent has beenissued. Japan, as a world economicpower, was of primary interest andimportance even though it was knownthat their patent procedures were verydifficult. It was determined that due tothe differing nature of marketing in foreign countries, I would pursue a retailposition in Japan, although it is very difficult for most American companies to penetrate the Japanese packaged-goods market.

At the same time production wasbeing initiated, patent counsel wasinvolved in various trademark searches.This had to be done not only for the U.S., but also individually for any othercountry in which sales might result.Each country had to be searched, andthen a trademark filed for. The Curvexname was in fact the result of no lessthan eight searches internationally anddomestically. Following consultationwith the FDA, and prior to any sales,requirements for registration were met.

Proof of Concept/AdditionalTestingAfter further trials to determine optimumdimensions for strength, aesthetics,ergonomic engineering and potentialcommercial engineering, design engineerswere recruited to construct computerassisted drawings (CAD) with which to

19



One must engage the services of the absolutebest—not the best that can be afforded, but thebest. A poorly draftedpatent is no better thannone at all.

create a mold for additional tests. A rubber mold was created that could produce fifty samples of the toothbrush,sans bristling. These in turn were bristled by another source.

It had been previously decided thatthe fifty toothbrush samples would besent to selected members of the dentalprofession, and if a 75% positive responsewas received I would proceed to the next step. These trials extended over asix-month to one-year period. This goalwas met.

ManufacturingA decision was made to manufactureentirely in the continental United States,as opposed to out-sourcing or assemblyof components in the U.S. The manufac-turer was selected and large capacitymolds were fabricated for commercialproduction. Even though costs werehigher, it was also decided to use the bestmaterials that would lend themselvestoward ease of recyclibility.

Marketing and DistributionIt was decided that for the United States,I would approach the dental professionalmarket. Data showed that over 20% ofAmericans received toothbrushes fromtheir dentist, and that 80% of allAmericans use a manual toothbrush.Additionally, it was felt that the dentalhealthcare professionals would be mostappreciative and receptive to an innova-

tive product that was not just a “me too”copy or variation of existing designs.

In making the decision to marketCurvex in the United States first to thedental profession, in fact to colleagues, Ifelt the need for a valid clinical study, notjust a “focus group” evaluation. To thisend a clinical study was done comparingplaque removal of the Curvex with its.006 mil diameter filament with theOral-B Indicator, which uses a .008 mildiameter filament. This was conductedat the University of the Pacific, Arthur A.Dugoni School of Dentistry DentalHygiene Program, under the auspices ofthe Department of Periodontics. TheCurvex was found to remove plaque aseffectively as the Indicator. These resultswere presented at the IADR/AADR meetingin March 2005. ADA Certification wasalso sought for Curvex and achieved.

Currently Curvex is sold to the dental professional market throughmajor American dental distributors.Institutional sales have been achievedand the domestic retail market is in theplanning stages. Internationally, Curvexis sold retail in Japan’s largest GSM. ■

20



Michael L. Barnett, DDS

AbstractDespite promising breakthroughs in basicbiomedical science, the pace at whichinnovative and disruptive new technologiesare developed and introduced into dentalpractice lags behind that of medicine. This is largely a result of resource issues,both financial and human, as well as determinants in the marketplace. For example, the cost of developing a new drugor technology for dentistry and bringing itto market is often disproportionably highrelative to the size of the dental market,thereby making it commercially unfeasibleto pursue development. When a new technology is commercialized, its successfulintroduction can be facilitated by researchthat makes a compelling case for effectiveuse. As our understanding of mechanismsof disease pathogenesis progresses, identifying compounds and technologieswith applicability to both oral and systemicdiseases could change the economics ofdental product development and lead toadditional innovative advances in our field.

In 1997, in a guest editorial in theJournal of Dental Research entitled“Molecular approaches to oral

therapeutics: Dentistry in the next millennium?” I discussed, perhaps with abit of naïve optimism, what I envisionedas a future change in the paradigm ofdental treatment. At that time, I spoke of the evolution of a mechanical/surgical paradigm to a pharmaceutical/regenerative one. Implicit in this viewwas the expectation that a steady streamof discoveries would be commercializedleading to significant innovations in themanagement of oral diseases. Clearly,this has not been occurring at the rate at which it may have been envisioned,and certainly nowhere near the speed at which new technologies have beenintroduced in medicine.

Why has this been the case? I believethat part of the answer, at least, can befound in a consideration of three aspectsof the technology transfer process: thediscovery phase (in which basic discov-eries are made with potential applicationto clinical practice), the development/commercialization phase (a major effortin which the practicality of the discoveriesis determined and the necessary formu-lation and preclinical and clinical studiesare conducted), and the applicationphase (in which new technologies areintegrated into routine clinical practice).

Some would limit the definition oftechnology transfer to the first two phases; that is, they define it as themechanism by which research discoveriesare transferred from the academicresearch lab to companies in order for

them to be developed and commercialized.However, if clinicians or consumers cannot be convinced to use the newproducts, all that has come before willhave been futile. This paper will considersome of the issues that may facilitate orinhibit the development and introductionof truly innovative new products to dental practice. In this paper, my frameof reference will be primarily that ofdrug development, whether prescriptionor over-the-counter. I should note at theoutset that opinions expressed are solelymy own, and may not reflect the opinionsor experiences of others in the oral carepharmaceutical industry.

The Discovery PhaseWith regard to discovery, it is importantto note that most of the basic biomedicalresearch relevant to dentistry is conductedin academic institutions. There is relativelylittle basic dental research conducted by

21


Challenges to the Introduction of New Technologies to Dental Practice


Dr. Barnett is an independentconsultant in the oral careproducts industry and ClinicalProfessor of Periodontics atthe School of Dental Medicine,State University of New Yorkat Buffalo. He was formerlySenior Director of Dental Affairsand Technology Developmentat Warner-Lambert (later Pfizer)Consumer Health Products. He may be contacted [email protected]. This paperis based in part on a talk theauthor presented at a sympo-sium, “The impact of researchon the future of dentistry,”held at the University ofRochester, May 21, 2002.

industry. So it is reasonable to assumethat the pace of discovery will be signifi-cantly impacted by the availability ofadequate resources in the schools, bothhuman and financial. The vast majorityof basic research in dentistry is fundedby the National Institute of Dental andCraniofacial Research (NIDCR). Considertwo numbers: 389 and 7.4. If the score of a game were 389 to 7.4, there wouldbe no question about which side won.However, in this case the score is $389million to $7.4 billion. Put another way,$389 million is approximately the annualfiscal year 2006 NIDCR budget covering avariety of activities, only some of whichinclude basic research, while $7.4 billionis the approximate annual budget fordrug discovery, research, and developmentfrom only one pharmaceutical company.(See www.nidcr.nih.gov/NewsAndReports/ReportsPresentation/DirectorReportJanuary2006.htm and www.pfizer.com/pfizer/are/investors_reports/index.jsp.)Given this great disparity in financialresources alone, it is not surprising thata disparity exists between advances inmedicine and those in dentistry.

The question is often asked, whydoesn’t the dental industry support significant research and development(R&D) spending for basic research? Theanswer is found in the dynamics of themarketplace, in particular, the level ofanticipated sales compared to the cost ofdeveloping and launching a truly newproduct, especially a drug product. Thedental market, especially that portionthat does not involve over-the-counterproducts, is relatively small, and the cost of developing and commercializingnew chemical entities and other new

technologies is rather large. Therefore,the economics preclude widespreadinvestment by large established companiesin products that would have sales whichcould be considered quite modest bylarge company standards. Thus, eventhough a pharmaceutical company that markets oral care products mightspend $7 billion annually on R&D, theallocation of resources will depend upon the relative size of the market forprescription drug products for systemicdiseases and that, say, for over-the-counteroral care products. As an example, in acompany with total annual sales ofapproximately $50 billion, oral careproducts may constitute only about $1billion of the total and, as a result, beallocated a commensurate (relativelysmall) share of R&D funds.

In addition to adequate funding,there is a need for an adequate numberof talented, active investigators in bothbasic and clinical areas. With regard tonew technology development, a signifi-cant driver has been the encouragementof an entrepreneurial mindset amongacademic investigators largely as a resultof the Bayh-Dole Act of 1980. This actallowed the patenting of discoveriesfunded by federal grants and contracts,and enabled the research institutionsand inventors to share in the proceedsfrom their inventions. Academicianshave discovered that the licensing oftechnologies and the establishment ofstart-up companies to leverage these can be lucrative, and universities havediscovered that significant income canbe derived from research findings ontheir campuses and have established aninfrastructure to foster relationshipsleading to commercialization. To givesome idea of the magnitude of theincome that can accrue to a university,in fiscal year 2001 the number one institution, Columbia University, earned

22



The dental market, especially that portion that does not involve over-the-counter products, isrelatively small, and the cost of developing and commercializing new chemical entities and other new technologies is rather large.

approximately $129.9 million from thelicensing of technologies. Given the new entrepreneurial spirit developing inacademia, this should have the potentialto be a more powerful force driving the discovery of new clinically relevanttechnologies in the years to come.

However, in recent years, it has been increasingly challenging to attracttalented dental scientists to pursue academic careers that will allow them tomaximize their scientific development.Economic considerations are clearly afactor in that the majority of studentsgraduate with considerable debt and,faced with the choice between a lucrative private practice or an academic career,will generally choose the former. This isespecially true in an environment wherefaculty shortages often preclude the lux-ury of sufficient time for research toallow one to be competitive in the questfor funds and where federal funding ofresearch through such agencies as NIH/NIDCR is being effectively reduced bycompeting budget priorities in Congress.

The Development/CommercializationPhase What has to occur between that “eureka”moment in the laboratory and the availability in the marketplace of a product based on a new discovery? Aheadline in the New York Times severalyears ago proclaimed, “Despite billionsfor discoveries, pipeline of drugs is farfrom full.” The gist of this article wasthat while intuition suggests that theapplication of new knowledge andenhanced methods (exemplified, forexample, by advances in genomics andproteomics and by the use of combinato-rial chemistry to create and evaluatenew compounds) should dramaticallyfacilitate the rate of new drug discovery,in fact many of the “traditional” consid-erations, such as drug toxicity and theability to successfully produce and formulate a drug product for human

use, remain rate-limiting steps. Theprocess of developing and commercializ-ing a new drug or technology is quiteexpensive and lengthy, taking approxi-mately ten or more years. In fact, it hasbeen estimated that only one of everytwo hundred fifty drugs that enter preclinical testing is ultimately approvedby the FDA. Moreover, a recent studyfrom Tufts University estimates that theaverage total cost of developing a new prescription drug is upwards of $800million after the cost of failures andother costs are factored in. (See http://csdd.tufts.edu/NewsEvents/RecentNews.asp?newsid=6.)

In the case of dental technologies,this figure can be a bit misleading, sinceoftentimes a product is developed not bya major pharmaceutical company but bya new, start-up company financed withventure capital or working in partnershipwith a larger company. In such cases,the actual cost may be only tens of millions of dollars, but the odds of success may decrease because there isoften only one egg in the basket. Themajor players in the dental productsworld are consumer products companiesthat rarely pursue compounds or productsrequiring an NDA (New Drug/DeviceApplication) but that modify existingproducts or develop new therapeuticproducts that are governed by an OTCMonograph. (Notable exceptions are successful products that have been marketed under an NDA such as triclosan-containing dentifrices and chlorhexidine-containing mouth rinses.)

What does it take to get venture capitalists or large corporations willingto take on a new technology? At a minimum, the technology should

provide some breakthrough in the management of a disease or offer clearadvantages over existing treatment ordiagnostic methods, and it should bepatent protected. The latter is a key consideration as any company investingconsiderable sums to commercialize adiscovery will need to have exclusivityover a reasonable period of time.However, innovativeness and intellectualproperty protection are, in themselves,not sufficient. As noted above, companiesare also interested in the size of theprospective market for a new product. In the case of dentistry, the potentialmarkets are small compared to many forpharmaceutical products. For example,the entire U.S. dentifrice market in 2005was $2.5 billion, which was dividedamong a number of different companies,while blockbuster drugs might havesales of several billion dollars each.Additionally, since the cost of developingand launching new products is consider-able, decisions regarding whether topursue products, especially consumerproducts, are often made by companiesnot on the basis of projected needs ordemographics, but rather on the basis of focus group results and the size of anexisting market, in order to provide someassurance that the product is likely to bea success. So it is clear that a variety ofhurdles must be surmounted in order for the development/commercializationstage to be successfully navigated.

The Application PhaseFinally, in considering therapeutic products that are used in dental practice,what does it take for a product that hasreceived FDA approval to be accepted forwidespread use in dental practice? Or, toput it another way, what are some of thechallenges to accomplishing this? Why isit that products that are initially success-

23



ful to some degree are unable to sustaina significant market presence and eventually are discontinued? As I pointedout in a 2002 Journal of Dental Researcheditorial, “Decisions, decisions,” thereseems to be two issues involved. Sincethese are often very new technologiesand may represent new approaches to disease management, that is, thepharmaceutical/regenerative ratherthan the mechanical/surgical, manydentists may not be up-to-date with thepathogenic mechanisms of disease onwhich these new technologies are basedand therefore do not feel comfortableadopting them for their patients. This isnot to be construed as a criticism of thepracticing dentist since it is very difficultfor any of us to keep current with everynew scientific advance. Therefore, theeffective introduction of a new technologyshould incorporate some aspect of education and preparation of dentalpractitioners by the company.

In addition, product claims and supporting data should provide a com-pelling argument for utilizing a product,especially in this age of evidence-basedpractice. Unfortunately, the clinical datasupporting product launches may notalways be the most compelling. This can result from the fact that studies submitted to demonstrate a product’seffectiveness generally use the mostinclusive patient populations and results

are generally expressed as means of thepatient groups studied. To use as anexample a site-specific treatment forperiodontitis, it is possible that this canunderestimate a product’s true potential.This happens because the distribution ofseverely involved and lesser involvedsites cause the differences between thenew technology and controls to not beoverly impressive (often in the range oftenths of millimeters when expressed as group means) because results in therelatively few more severely involvedsites are “diluted out” by shallower sites.Despite this, it is likely that the new tech-nology could have greater effectivenessin certain subsets of patients or sites.Thus, information concerning specificpatient populations for which the tech-nology would be especially indicated andthe proper place for incorporating thetechnology in the course of therapywould not only be more persuasive butalso result in a higher probability of successful outcomes when the product is actually employed in practice. The paradox is that while studies providingsuch information could be instrumentalin helping to assure the ultimate successof the product, there are frequently costand time inhibitions which precludetheir being conducted prior to productlaunch. As a result, potentially effectiveproducts can be commercial failuresbecause practitioners are not providedenough information to help ensure clearly beneficial therapeutic outcomes.While the statistical significance of study results is usually presented, theclinical significance is often not adequately addressed.

24



The process of developingand commercializing a new drug or technology isquite expensive and lengthy,taking approximately ten or more years. In fact, it has been estimated that only one of every twohundred and fifty drugs that enter preclinical testing is ultimatelyapproved by the FDA.

ConclusionIt is clear, therefore, that there are anumber of significant challenges to beovercome in the development and marketing of truly innovative productsin dentistry. Nevertheless, while the challenges discussed in this paper havebeen largely related to drug products, itshould be recognized that, in fact, therehave been significant advances in dentalpractice over the years, particularly inthe areas of materials, devices, and diagnostics. Some examples are thedevelopment of new composite restorativematerials, the widespread use of dentalimplants, and the introduction of digitalradiography and, more recently, conebeam radiographic techniques. In addition, there are always ongoingefforts to develop and commercializenew products with a number of smallcompanies working on innovativeapproaches to the development of newtherapies and diagnostics, for example,biomimetic materials for regeneratingtooth and bone, novel therapies and preventive agents for dental caries,chemotherapeutic approaches to treatingperiodontitis, saliva-based diagnostics,and methods for early detection of dentalcaries and oral mucosal lesions. Also,larger, more established consumer prod-uct companies are constantly developingnew products to satisfy consumer needs.

However, the pace at which newtechnologies and quantum leaps areintroduced into dental practice lagsbehind that of medicine, largely as aresult of resource issues, both financialand human, as well as determinants inthe market place. Perhaps in addition to the “usual suspects,” we should lookoutside the dental research communityfor potential therapies. As noted, thehigh cost of bringing new chemical

entities through the FDA process, coupledwith the relatively small size of the dental market, is a considerable barrierto the development of technologies,especially new drugs or drug-based combination products. However, tech-nologies with potential applicability todentistry are sometimes being investigatedfor other, wider indications by companieswhich have not considered dental applications. Given that a large percentageof the cost of developing new chemicalentities is in the preclinical phase ofdevelopment, the cost of conducting clinical studies for dental diseases can bea comparatively modest incremental costover and above studies for the primaryindication. Of course, the flip side to thisis to identify applications of productsdeveloped for dentistry to other diseases,and seek ways to facilitate their develop-ment for the additional indications. This would be a means of easing thefinancial burden of developing dentalproducts as the overall potential marketfor all indications could potentially justify the development costs. Finally, as a professional community we need to be informed about the scientificrationale, indications, and evidence-basefor new technologies in order to best utilize new advances and assure theirultimate success. ■

25



The major players in thedental products world are consumer productscompanies that rarely pursue compounds or products requiring an NDAbut, rather, modify existingproducts or develop newtherapeutic products thatare governed by an OTCMonograph.

Robert W. Gerlach, DDS, MPH

AbstractThe introduction of hydrogen peroxidewhitening strips in 2000 has contributed to new paradigms for treatment andexpanded interest in tooth whitening.Clinical trials played a prominent role inthe whitening strip research and develop-ment process. Four case studies from the whitening strip development programare used to review the fundamentals ofclinical trials design, conduct, analysis, and interpretation as part of new productdevelopment in oral care.

“Do you have any ‘clinicals’?”This is perhaps the mostcommon question from

clinicians, researchers, reporters, andeven consumers when a new product orservice is introduced to dentistry.

Clinical trials play a prominent rolein research and development (R&D)leading to these innovative oral careproducts and treatments. Critical elementsin the design, conduct, analysis, andinterpretation of clinical trials aredescribed, with reference to new productdevelopment in oral care. The case studies were part of R&D for hydrogenperoxide whitening strips. Introduced in 2000, this so-called “easy-to-use” tooth whitening system represented asignificant departure from contemporarytreatment (Gerlach, 2000). Four examplesearly in that program typify the strengthsand limitations associated with clinicaltrials and new dental product develop-ment and how oral care R&D differsfrom the classic pharmaceutical model.

Clinical trials are a class of prospec-tive, designed medical studies. Eligibility,treatment, and evaluation may be closelycontrolled via specific entrance criteria,prescribed usage, calibration, or otherfactors. Human studies typically follownonclinical research in order to confirmor refute findings from bench experi-ments or patient observation. In classicdrug development, clinical research iscategorized in phases, where phase I isearly safety testing among healthy vol-

unteers to assess drug pharmacokineticsand pharmacodynamics, phase II is initial efficacy testing in a populationsuffering from the disease or condition ofinterest, and phase III is the broad scaleclinical safety and efficacy testing usedby regulators for approval and labeling.

New pharmaceutical developmenthas often focused on the “blockbuster”approach—R&D in pursuit of the rare billion dollar proposition—a virtualunknown in oral care. With little promise of the return on investment that enables lengthy development, there has been relatively little new drugdevelopment in dentistry. Over the past twenty years, fewer than a dozendentistry-specific drugs have gained U.S.Food and Drug Administration (FDA)approval. Only one area, locally deliveredantimicrobials for periodontitis, has atleast three new drug approvals and noneof these could readily be classified as a“blockbuster.” Instead, oral care R&D has more typically focused on FDA“monograph” actives (such as fluoridesfor caries, where safety and efficacywere previously established), devices(such as implants, toothbrushes, andrestorative materials that may leverage a preexisting or “predicate” deviceapproval), and increasingly, cosmeticssuch as the hydrogen peroxide gel on

26


Clinical Trials and Oral Care R&D


Dr. Gerlach is a research scientist at The Procter &Gamble Company, Mason, OH.He may be contacted [email protected]

whitening strips. Unlike new drug development, clinical trials are not typically required as part of R&D formonograph actives, devices, or cosmetics,so most clinical research is voluntary.

Types of Studies Used in TestingNew ProductsThe randomized controlled trial (RCT) is generally thought to represent thegold standard test of efficacy and safetyin biomedical research. Participants inan RCT receive either the experimentalproduct or technique of interest (theunknown) or a control product or technique (the known). In oral care, mostcontrolled clinical trials are sponsored by industry as part of the lengthy R&Dprocess leading to a new product. In general, these industry-sponsored clinical trials are undertaken to 1) aid in development and decision making(for example, which product iteration to advance for safety, efficacy or costpurposes); 2) address explicit or implicitregulatory or credentialing requirements(recommended or mandated by govern-ment, professional associations, orreviewing bodies); or 3) support market-ing, claims, or communications (directlyor indirectly to consumers, professionals,or reviewing organizations).

Four early studies with different controls are used to characterize thedesign, conduct, analysis, and interpreta-tion of oral care clinical trials and theunique contributions of this research tonew product development.

The Proof of Concept Study–The Basis for InterestA fourteen-day study was conducted to assess clinical response with an exper-imental hydrogen peroxide whiteningstrip. Thirty-six healthy adults were randomly assigned to the experimentalstrip or three other professional, tray-based products at different peroxideconcentrations. Results for all four systems showed significant (p < 0.001)whitening relative to baseline, with nosignificant (p > 0.56) differences betweenthe experimental strips and the lowestconcentration professional whiteningtray (Gerlach, Gibb, & Sagel, 2000).

With monograph actives, devices,and cosmetics, first clinical research inoral care often begins with “proof ofconcept” to assess potential activity relative to baseline, historical controls,or head-to-head comparisons. The firstcomparative clinical trial evaluated anearly whitening strip formulation versusa professional tray-based carbamide peroxide system. The tray control wasselected because of limited clinical trialsevidence under different usage conditions,market share, and personal experience.The design simply paired the experimen-tal whitening strips at twice the peroxideconcentration and half the contact timeversus the daytime tray system. Twohigher peroxide concentration tray systems from the same manufacturerwere selected as additional controls.

27



Although large multi-centerRCTs provide additionalcomplexity in recruitment,training, standardization,and analysis, these trialsare somewhat uncommonin dentistry.

Prior to this clinical trial, there were anumber of unknowns associated withthe new-to-the-world strips. While stripsrelied on conventional oxidative chem-istry, there was no efficacy precedentwith low levels of total peroxide used for short periods (custom trays were typically filled with large volumes of geland then worn overnight). There was no assurance that individuals could andwould reapply strips twice daily over afew weeks, and safety with the uncon-ventional strip delivery was generallylimited to a few case studies or uncon-trolled clinical trials. The objectiveinstrumental method (digital imaging)was largely untested, and clinicalresponse with the controls (daytime tray use at rising concentrations) wasunknown. Failure at this early stagecould have been attributed to inadequaciesassociated with the experimental strip,the method, the benchmark controls, ora number of other factors associatedwith study design, conduct and analysis.

Experts have long cautioned interpretation of RCTs that show non-inferiority (Burns & Elswick). Even with controls, clinical outcomes such asthose seen in this first whitening stripcomparative trial may be readily misinterpreted, as variability, samplesize, and other factors may contribute to between-group differences or lackthereof. Absence of significant between-group differences did not mean thegroups were necessarily equivalent. Theuse of two additional control groups,while contributing to overall complexity,aided in study interpretation, since theperoxide concentration effect seen withthe professional tray systems suggested

adequate measurement sensitivity in this clinical trial to detect a treatmenteffect. While the primary comparison(experimental whitening strip to lowestconcentration professional tray) wasmultivariable in nature, the experimentalstrips had approximately twice the peroxide concentration for half the timecompared to the tray. Since concentra-tion and time empirically contributed to whitening, outcomes from this firstRCT made sense. We interpreted the outcomes to mean that whitening stripscould provide a whitening benefit withless time and lower total peroxide thancontemporary professional tray systems,and planned further research.

The Placebo-Controlled Trial–Causal Efficacy and SafetyA randomized, double-blind, placebo-controlled clinical trial with fifty-sevenadults evaluated response after two weeksstrip daily use and six months post-treatment. Results demonstrated that the peroxide strip group experienced significant (p < 0.0001) initial colorimprovement relative to baseline andplacebo, with most of the whitening sustained over six months. Tooth sensitivity and oral irritation, the mostcommon adverse events during strip use, resolved and there were no newtreatment-related adverse events duringthe post-treatment period (Gerlach, Gibb, & Sagel, 2002).

Clinical research commonly involvescomparisons to a negative control, suchas untreated, inactive therapy, or in thiscircumstance, placebo. Placebos play acritical role in R&D, since this is the onlynegative control that allows for thedirect assumption of causality. The useof controls, one of the cornerstones ofthe RCT, helps blind evaluation and aidsin study interpretation. Randomization,the other cornerstone of the RCT, limitsintroduction of unknown bias. Adverseevents are collected in a standard manner

irrespective of causality. Test products aredispensed in common blinded packagingwith unique subject numbers. Data aregenerally recorded electronically, andevaluability is determined after data final-ization, but prior to treatment unblinding.

The research also demonstrates theimportant contribution of methods tothe RCT. Whitening strip clinicalresearch started with no preconceptionof product efficacy or safety. One impor-tant early research objective was toobjectively measure clinical response in order to guide formulation, since variables relating to materials, concen-tration, thickness, retention, andmanufacturing could all be manipulated,and any of these could impact favorablyor unfavorably on clinical responses. Toassure unbiased evaluation during theformulation phase, early whitening stripclinical trials used a novel, instrumentalevaluation of whitening via standardizeddigital images of tooth surfaces to assesscolor change over time. The digital imaging method offered appreciableadvantages over the contemporaryapproach (shading), which has historicallyyielded ambiguous results for variousoral care products. Images were collectedblind to treatment assignment, time, and study design, using endpoints thathave been shown to be relevant to self-perception of tooth color. Safety was assessed using pharmaceutical standard practices from interview andclinical examination to ascertain signsand symptoms that may possibly beassociated with treatment.

Results from the placebo-controlledtrial were consistent with the earlierproof of concept study. Despite differencesrelating to sites, populations, and time,two-week use of whitening strips yieldedsimilar color improvement. Comparisonsto placebo helped confirmed that a

28



durable whitening effect, with 70-80% of initial color improvement, was still evident after six months. The methodalso demonstrated a serendipitous finding—age was inversely related to whiteningresponse. Like other experiments, clinicaltrials offer the opportunity for discovery.In this study, younger subjects experi-enced more whitening during thetwo-week treatment period. Whetherthis unanticipated outcome was attributed to chance or some biologicalor behavioral factors was unknown.

Clinical-trials experts have long recognized the ethical and practical limitations associated with placebo-controlled trials (Lasagna, 1979). Exceptfor some medical evaluation, there maybe little in return for the study volunteerwho is randomly assigned to the placebo.In oral care RCTs, subjects are often compensated for participation in placebo-controlled studies, and such compensationcould impact recruitment, compliance,or other factors. It can be difficult toidentify volunteers for placebo-controlledtesting and limit dropout from a lengthyclinical trial. When treatment effect isnotable (such as the visible whiteningseen when peroxide is delivered using a tray or strip barrier), subjects andresearchers may discern treatmentassignment despite blinding. Perhapssurprisingly, placebos may necessitatespecific R&D, since these may be difficultto formulate and use may contribute tomeasurable clinical response.

Alternatives to placebos include dose-ranging studies or comparisons to anactive therapy or positive control. Studieswithout experimental controls may makecomparisons to baseline or historicaldata from other studies. These studiesprovide less evidence of safety and efficacy compared to controlled trials, socaution should be used in interpretingoutcomes from such uncontrolledresearch. Despite these limitations,

placebo-controlled trials play an important role in R&D with respect toformulation, safety and other factors. Weinterpreted the findings of this placebo-controlled trial to indicate that it was the peroxide on strips led to measurableinitial and sustained whitening withoutpersistent side effects, and that agemight contribute to response.

The Positive Control—ExtendedEvidence of Efficacy and Safety A randomized clinical trial evaluatedwhitening safety and efficacy in thirtyadolescents who completed orthodontia.Subjects were assigned to whiteningstrips or an overnight professional tray-based whitening system, and archeswere each treated sequentially for fourcontinuous weeks. Results for eachgroup exhibited significant (p < 0.0001)mean color improvement by arch atWeek 2, and increasing through Week 4.Groups did not differ on whitening afterfour weeks, and the adverse event profilewas generally similar in occurrence andseverity to earlier research in adults(Donly & Gerlach, 2002).

The first adolescent study was undertaken after the discovery in theplacebo-controlled RCT of a statisticalrelationship between decreasing age andincreasing tooth whitening. Treatmentfollowed institutional review, parentalconsent, and child assent. This was apositive controlled study, as the experi-mental strip to the professional traysystem used in the original proof of con-cept study, with the latter used overnightaccording to convention. Arches weretreated separately over a four week period to limit use, and clinical responsewas carefully monitored throughout overeight weeks. Results demonstrated theviability of strip or tray tooth whitening

in this age group. Measured whiteningamong children exceeded that seen inprevious studies among adults, withoutuntoward safety findings.

In recent years, the pharmaceuticalresearch community has recognized theneed for RCTs in children (Caldwell,Murphy, Butow, & Craig, 2004). Thesestudies pose specific challenges withrespect to ethics, conduct, and interpre-tation, and are rarely indicated as part of new adult drug marketing plans, somost use in that age class comes in theabsence of RCT evidence. To spur childtesting, U.S. drug approval now incorpo-rates limited marketing incentives forRCTs in children. There are no similarincentives for monograph, device, orcosmetics research, and at the time ofthis testing, virtually no high quality evidence on tooth whitening practices in children existed. Use by children waspossible, so clinical research was con-ducted to assess safety and efficacy ofwhitening strips among this population.The first RCT evaluated children after

29



Over the past twenty years, fewer than a dozendentistry-specific drugshave gained U.S. Food and Drug Administration(FDA) approval.

completion of orthodontics where estheticsmay be of particular personal concern.

This first adolescent strip RCT wasfollowed by other studies involving presumptively “vulnerable” populations,including the elderly, xerostomics, andothers. Such research provided importantevidence of safety. Other safety evidencecame from RCTs involving extendedusage, up to twice daily use over a six-month period among individuals withtetracycline-associated tooth stain, andlong-term post-treatment follow-up.Such research can be controversial, asthere are disincentives to test “outside ofthe norm.” If an untoward outcomewere observed under extraordinaryusage conditions, an extraneous popula-tion, or extended monitoring, thenadverse findings could impact R&D andmarketing plans. Because whiteningstrips represented a new-to-the-worldapproach to treatment, numerous RCTswere conducted to evaluate extended useand post-treatment monitoring relativeto active controls and placebo. While thecomposite research now represents thelargest body of controlled testing in thisage group, the first RCT involved thirtyadolescents, and individually, fifty-sixhours of strip use—four hundred andforty-eight hours of tray use. We inter-preted the first adolescent study todemonstrate the viability of tooth whiten-ing among younger age groups, withpotentially better efficacy and comparableside effects to those seen in adults.

Integrated Research—ExpandingClinical Trials EvidenceAn integrated analysis was conducted onthirteen whitening-strip clinical trials.The research involved six hundred sevensubjects, ranging from ten to seventy-four years of age. In the pooled sample,twice-daily use of whitening strips resultedin significant (p < 0.0001) whitening(color or shade), with age and starting

tooth color significantly (p < 0.0001)impacting on whitening response. Safetyfindings were unremarkable (Gerlach &Zhou, 2001).

This integrated analysis has been apart of longer-term R&D, even contribut-ing to marketing decisions. One discoveryin meta-analysis was the effect of ageand starting tooth color on whiteningclinical response. While contemporaryresearch had typically enrolled thirty- to forty-year-olds with certain startingtooth shades, the larger sample size inthe meta-analysis and the broader popu-lation allowed for assessment of responseamong younger individuals. Resultsdemonstrated that meaningful whiteningcould be achieved among younger agegroups with mild discoloration.

The composite research providedimportant evidence of safety. Althoughindividual RCTs showed no meaningfulsafety findings in the absolute or relativeto controls, sample size in any singletrial was relatively small. The integratedanalysis of thirteen reported clinical trials involved over six hundred subjectsassigned to whitening strips over four-teen to twenty-four days. Increasedsample size provides important evidenceof safety, especially with respect touncommon events. Sample sizes of threehundred or more are generally thoughtto be needed to detect infrequent eventswith some certainty (less than 1% occurrence). In pharmaceutical R&D,multi-center studies are often conductedas part of phase IV, where such post-marketing studies have a role inincreasing sample size and promotingprofessional experience. Although large multi-center RCTs provide additional complexity in recruitment,training, standardization, and analysis,

30



Clinical-trials experts havelong recognized the ethicaland practical limitationsassociated with placebo-controlled trials. Except forsome medical evaluation,there may be little in returnfor the study volunteer who is randomly assigned to the placebo.

these trials are somewhat uncommon in dentistry.

Dentistry has seen considerablerecent interest in cross-study integrationvia a meta-analysis of multiple clinicaltrials, and systematic review (a criticalintegration of the available research,particularly RCTs) (Ismail & Bader,2004). The resulting integrated evidence,which generally increases study power(discrimination), may provide the highest evidence of efficacy and safety.In this regard, integrated analysis mayserve as an alternative to multi-centertesting for the purposes of safety assess-ment. Care must be taken with suchresearch, particularly when the integratedanalysis is limited to the published litera-ture, as with the first meta-analysis onwhitening strips. Publication bias maylimit the quality of available evidencefrom RCTs. Three types of outcomes areparticularly vulnerable to publicationbias: trade secrets, no effect or negativefindings, and repetitive trials. The role of integrated analysis and systematicreview in oral care R&D is uncertain, asthe approach is relatively new, and thereare few examples of such assessmentduring R&D (versus afterwards). Forwhitening strips, the integrated analysisdemonstrated efficacy and safety across abroad population and different conditionsof use, with age and color contributing toclinical response. These findings con-tributed to marketing targeting a youngerdemographic group, a group that contin-ues to be at the forefront of whiteningstrip use, and a primary participant insubsequent whitening-strip RCTs.

Summary Monograph actives, devices, and cosmetics—along with foods or new techniques—carry little to no requirement for clinicaltesting, and in fact, most of the thousandsof oral care products and many techniqueshave never been subject to rigorous

evaluation via clinical trials. In contrast,the clinical development program withwhitening strips has been particularlycomplex in number and scope, with clinical research contributing a varietyof discoveries and six variants (approxi-mately one per year) since the originalsystem in 2000, along with extensive scientific exchange. Whitening-stripRCTs have been conducted in collabora-tion with various academic and contractresearch groups within and outside theU.S. The clinical program remainsincomplete, particularly in the area ofpractice-based research, which hasgained in interest in recent years(Philstrom & Tabak, 2005). In-officestudies, which are commonplace in dermatology, urology, orthopedics, andother medical disciplines, are relativelyrare in dentistry. The multi-center, multi-examiner, practice-based approachconflicts with some of the basic premisesof RCTs on standardization and analysis,while combination treatment, concomi-tant medications, fees, ethical issues, and other factors make such researchdifficult to plan, conduct, and interpret.Nonetheless, such research is believed tohelp model clinical practice experienceand promote technology transfer fromRCTs to contemporary practice. Furtherresearch may be indicated to extendwhitening-strip RCT findings to the practice environment.

Whitening strips continues to be amarket leader and demonstrable businesssuccess. The clinical trials program leading to this novel product has beenunusually comprehensive, with respectto the number and types of RCTs. Inhindsight, it is not easy to state whethermarket success enabled comprehensiveclinical testing or whether the clinicaltesting resulted in the evident marketsuccess. ■

ReferencesBurns, D.R., & Elswick, R.K. (2001).Equivalence testing with dental clinical trials. Journal of Dental Research, 80,1513-1517.Caldwell, P.H.Y., Murphy, S. B., Butow, P.N.,& Craig, J. C. (2004) Clinical trials in chil-dren. Lancet, 364, 803-811.Donly, K.J., & Gerlach, R.W. (2002). Clinical trials on the use of whiteningstrips in children and adolescents. GeneralDentistry, 50, 242-245.Gerlach, R. W. (2000). Shifting paradigmsin whitening: Introduction of a novel systemfor vital tooth bleaching. Compendium ofContinuing Education in Dentistry, 29(Supplement), S4-S9.Gerlach, R. W., Gibb, R. D., & Sagel, P. A:(2000). A randomized clinical trial comparinga novel 5.3% hydrogen peroxide bleachingstrip to 10%, 15% and 20% carbamide peroxide tray-based bleaching systems.Compendium of Continuing Education inDentistry, 21 (Supplement), S22-S28.Gerlach, R. W., Gibb, R. D., & Sagel, P. A.(2002) Initial color change and color retention with a hydrogen peroxide bleaching strip. American Journal ofDentistry, 15, 3-7. Gerlach, R. W., & Zhou, X. (2001).Vitalbleaching with whitening strips: summaryof clinical research on effectiveness andtolerability. Journal of ContemporaryDental Practice, 2, 1-16.Ismail, A. I., & Bader, J. D. (2004). Evidence-based dentistry in clinical practice. Journalof the American Dental Association, 135,78-83. Lasagna, L. (1979). Placebos and controlledtrials under attack. European Journal ofClinical Pharmacology, 15, 373-374.Philstrom, B. L. & Tabak, L. (2005) TheNational Institute of Dental andCraniofacial Research: research for thepracticing dentist. Journal of the AmericanDental Association, 136, 728-37.

31



Edward F. Rossomando, DDS, PhD, MS

AbstractThroughout the twentieth century, dentistryadvanced through the science of betterinert reparative materials and their relatedtechniques. Although the diffusion of consequent discoveries has been slow, the twenty-first century will be marked bya biologically grounded approach to oralhealth care. This transformation from a“xenodontic” to a biodontic model will beassisted by the cooperation of the entiredental enterprise and by students who arewell prepared in the biological sciences.

When patients visit a dentaloffice, they expect a diagnosisand resolution of the problem.

They expect to leave the office with their problems solved completely, withminimum physical and psychologicaldiscomfort, and at a reasonable cost. The success of a dentist in providing oralhealth care quickly, completely, painlessly,and at a reasonable cost requires the collaborative effort of what can bereferred to as the dental enterprise. Inthe United States, the dental enterpriseincludes the dental industry, dentalschools, dental provider associations andorganizations, and a number of dentalgovernment agencies. It is through coop-eration in this enterprise that dentistryis able to provide oral health care to theAmerican people. The necessity for cooperation among the components ofthis enterprise cannot be overemphasized,since good oral health is vital to thequality of life of each citizen. Similarly,the good oral health of citizens is vital toour nation’s economy. In addition, main-taining the oral health of our armedforces is an absolute for national defense.

During the twentieth century, thedental enterprise cooperated on develop-ing methods, techniques, and materialsfor the repair and restoration of losttooth structure and for the replacementof lost teeth. For most of that century,repair, restoration, and replacement (the3Rs of dental practice) were accomplishedusing metals of various types (gold andamalgam), plastics (acrylics), ceramics,and rubber for dentures. These materialsare nonbiological, or foreign to the body,

and because the Greek word for foreignis xeno, I will refer to the practice of dentistry during this period as the practice of xenodontic dentistry.

Xenodontic DentistryThe components of the dental enterprisecooperated in the development of xen-odontic dentistry during the twentiethcentury. Dental schools taught it, thedental industry manufactured and distributed products for it to function,and dentists used these products to provide care to patients. The NationalInstitute of Dental and CraniofacialResearch (NIDCR), the research compo-nent of the dental enterprise, providedfinancial support for research, whichdeveloped new and improved products,equipment, and procedures to enhancexenodontic dentistry. In addition, theNIDCR funded clinical trials and programsto train the next generation of scientistsand teachers for our dental schools.

During the second half of the twenti-eth century, a series of discoveries frombasic science laboratories suggested thatthe era of xenodontic dentistry mightend. One of the first papers to supportthis was in 1953 when the structure ofDNA, the hereditary material of life, was

32


The Dental Enterprise: Its Transition from Xenodonticto Biodontic Dentistry


Dr. Rossomando teaches atthe School of Dental Medicine,University of Connecticut. He may be contacted [email protected].

elucidated (Watson & Crick). Additionalsupport came about fifty years laterwhen the sequence of the humangenome was published in 2000(National Institutes of Health, 2000;Venter et al., 2001).

As this milestone was reached, manyin the dental enterprise began to envisiona new era in dentistry: one in whichxeno-materials were replaced by bio-basedmaterials to repair and restore toothstructure and replace teeth lost to disease.I will refer to the practice of dentistryduring this as the practice of biodonticdentistry. The introduction of bio-basedmaterials into dentistry was more diffi-cult than anticipated. Some segments of the dental enterprise were so investedin xenodontic dentistry, that the introduction of biodontic dentistrywould be disruptive, in that it wouldrequire displacing elements supportiveof xenodontic dentistry.

The Dental Enterprise andTechnologies Mapping the sequence of the humangenome, though a milestone for the scientific establishment, appears to havehad little or no effect on the dentalindustry, dental education, or dentalpractices. To understand why it did notresult in the mobilization or unificationof these components of the dental enterprise, it is helpful to appreciate thedifference between revolutionary andevolutionary innovations.

A clear example of a revolutionaryinnovation is the flight of the Wright

brothers’ 1903 Flyer, an event that ush-ered in a new industry. This innovationwas accepted so rapidly that in fewerthan one hundred years, that originalflight of about forty yards at Kitty Hawkevolved into a spacecraft, a flight thatbrought us hundreds of thousands ofmiles into space. One reason this innova-tion was accepted so readily and evolvedso rapidly was that it was revolutionary.There was no preexisting aviation enterprise; therefore, acceptance of theWright Flyer did not require the displace-ment of a preexisting form of flight. Theacceptance of an innovation becomesmore difficult if it must displace an existing enterprise.

Did mapping the sequence of thehuman genome represent a revolutionaryevent? And did its acceptance by the dental enterprise require the displace-ment of preexisting manufacturing,educational, and oral health deliveryactivities? Not necessarily. Although it istrue that this event represented what is,without argument, the first step in whatwill eventually become biodontic dentalpractices, and the displacement of xenodontic dental practices, the acceptance of this innovation should bedescribed as an evolutionary step, one of many the dental enterprise took asthe twentieth century was traversed.

Like any evolutionary step, adaptationwill be required of the dental enterprise.Manufacturers must recognize the needto adjust their products and educators

33



Mapping the sequence of the human genome,though a milestone for thescientific establishment,appears to have had littleor no effect on the dentalindustry, dental education,or dental practices.

must redo their curricula. As a result ofthe transition from xenodontic tobiodontic dentistry, dental offices willnot have to change the services they provide in any drastic way. Their respon-sibility will remain to repair, restore, andreplace teeth and tooth structure lost todisease. What will change is how they dothis. Instead of using xenodontic materialslike metals, plastics, and ceramics, theywill use biodontic materials like thosederived from stem cells or other biologi-cally obtained materials. Ease of use,opportunities for greater success, andenhanced patient satisfaction will drivethe transition from xenodontic tobiodontic dental practice.

Transition from a Xenodontic toBiodontic Dental Practice Most evolutionary changes take time.The amount of time depends on what is evolving. In the case of mammals, evolution can take many generations. Inthe case of bacteria or viruses, changescan occur in one generation. Based on historical trends of acceptance time forinnovations in dentistry, the transitionfrom xenodontic to biodontic dentalpractices might be expected to take several generations. This would be trueif not for one critical factor: the intellec-tual level of the students entering dentalschools today. Today’s dental studentsare not only more “cyber savvy” thanprevious generations, but they enter dental school with a better biologicalbackground than before, and they aretaught more biological science in dentalschool than ever before. As a result, theuse of biodontic products for repair,restoration, and replacement is moreacceptable to them than the use of xenodontic products.

Fortunately, there are those in thedental enterprise who have recognizedthis change. Several schools have alreadyaltered their curricula to increase the

number of basic science hours. Somedental manufacturers have acquiredbiotech start-ups, recognizing that theneed for biodontic materials will increaseas soon as these students graduate.Some manufacturers, recognizing therapid rate of change, have joined withdental schools in ventures that promotethe use of new biodontic products andequipment by the students.

For example, at the University ofConnecticut School of Dental Medicine,the dental students in the Connecticutchapter of the Biodontic Society have setup an interest group for exploring theuse of new equipment and products.With the support of the dental school’sadministration and dental companies,these students have acquired space andsolicited products and equipment to betested. In addition, student chapters ofthe Biodontic Society are being formedat other dental schools with the expectation that Product Evaluation and Research Laboratories (PERLs) willbe formed.

Given the role of dental students as agents of change and the support ofall components of the dental enterprise,it should come as no surprise that thetransition from xenodontic to biodonticdental practice may take less than one generation. ■

References National Institutes of Health (2000).“Working draft” of human genomeannounced at White House. The NIHRecord [serial on-line]. Accessed athttp://www.nih.gov/news/NIH-record/08_08_2000/story03.htm. Venter, J. C., Adams, M. D., Myers, E. W.,et al. (2001). The sequence of the humangenome. Science, 291, 1304-1351.Watson, J. D., & Crick, F. H. C. (1953). Astructure for deoxyribose nucleic acid.Nature, 171, 737-738.

34



Today’s dental students are not only more “cybersavvy” than previous generations, but they enterdental school with a betterbiological background than before, and they aretaught more biological science in dental schoolthan ever before. As aresult, the use of biodonticproducts for repair, restoration, and replace-ment is more acceptable to them than the use of xenodontic products.

Charles N. Bertolami, DDS, DMedSc,FACD

AbstractThe impact our ethics curricula have onstudents seems marginal at best. Studentstake the ethics courses we offer and passthe tests we give, but no one’s behaviorchanges as a result. We fundamentally seeourselves teaching about ethics, which isslightly different than teaching ethics—and expecting behavior to change as aresult of what is taught. The premise ofthis article is that our ethics courses areinadequate in content and form to theextent that they do not cultivate an intro-spective orientation to professional life. In some cases, they amount to little morethan a study of various state dental practice acts or the Code of Ethics of theAmerican Dental Association. Three specific weaknesses are identified in a typical ethics curriculum: 1) failure to recognize that more education is not theanswer to everything; 2) ethics is boring;and 3) course content is qualitatively inadequate because it does not foster anintrospective basis for true behavioralchange. A fourth element, an innovation, is directed to this third weakness andentails implementing a precurriculum veryearly in the dental educational experienceto address the disconnect between knowledge and action.

Why Our Ethics Curricula Don’t Work Issues in DentalEthicsAmerican Society for Dental Ethics

Associate EditorsDavid T. Ozar, PhDJames T. Rule, DDS, MS

Editorial BoardPhyllis L. Beemsterboer, RDH, EdHMuriel J. Bebeau, PhDLarry Jenson, DDSBruce N. Peltier, PhD, MBADonald E. Patthoff, Jr., DDSGerald R. Winslow, PhDPamela Zarkowski, RDH, JD

Correspondence relating to the Dental Ethics section of the Journal of the American College of Dentistsshould be addressed to: PEDNETc/o Center for EthicsLoyola University of Chicago6525 North Sheridan RoadChicago, IL 60627e-mail: [email protected]

No one has ever done the rightthing because of taking anethics course in dental school.

Can I prove this with scientific certainty?No, but the impact our courses have onstudents seems marginal, as is surely evident to anyone who has spent muchtime in dental schools or dealing withdental students. Cheating is common, asany dental educator or administratorcan attest. At the very least, if our ethicscurricula were working, wouldn’t suchdishonesty be relatively uncommon? Asit is, our students take the ethics courseswe offer and pass the tests we give, butno one’s behavior changes as a result.Unfortunately, most educators seem justfine with that. After all, it’s unimaginablethat after an outbreak of cheating, weshould call our ethics professors toaccount for their failing.

We fundamentally see ourselvesteaching about ethics, which is slightlydifferent from teaching ethics—in thesense of expecting behavior to change as a result of what is taught. But in professional education, is it all thatunreasonable to expect ethics curriculato positively and beneficially influencethe behavioral choices students andpractitioners actually make in life? Whenit comes to ethics, I doubt the disparitycould be greater between what we teachin professional schools and what thepublic thinks we teach. The selectionprocess for admitting future doctors todental or medical school combined with

35


Issues in Dental Ethics

Dr. Bertolami is Professor andDean, School of Dentistry, Univer-sity of California, San Francisco.He may be contacted [email protected] paper is the 2005 winnerof the Journalism Prize inExcellence, Ethics, andProfessionalism of theAmerican College of Dentistsand the American Associationof Dental Editors. The essayappeared in the April 2004issue of the Journal of DentalEducation and appears by permission of the AmericanAssociation for DentalEducation.

some special wisdom purportedlyimparted somewhere along the way isjust assumed to guarantee graduates whohold themselves to a higher standard.Higher at least than what might beexpected from some alternative educa-tional process: one driven, for instance,by the purely bottom line mentality ofmarket-driven capitalism. An example of the latter might be one in whichapplicants bid on open slots, with theseat going to the highest bidder; or inwhich professors augment income byagreeing to grade only selected students’tests or to write only selected studentsletters of recommendation based onadditional personal financial considera-tion (Easterbrook, 2002; MacWilliams,2001). Thankfully, in the United Statessuch abuses are uncommon; neverthe-less, the public might still be surprisedby the minimal consideration given toethics as an admissions criterion, despiteavailability of some rather creativeapproaches to discerning this most elusive of attributes (Galdwell, 2002).This difference between perception andreality is all too evident in periodic callsfor increasing exposure of students tocourses on ethics, usually right aftersome public disclosure of wrongdoing bya practitioner captures the attention ofthe media and then fosters a demand foraction. The negligent death or injury ofa patient, misconduct of a financial orsexual nature, or simply the suspicionthat practitioners are placing their owninterests ahead of the people they’re supposed to be serving, all lead todemands for something to be done: foruniversities to do a better job inculcatingethical values in the minds of students.

The scenario is by no means uniqueto professional education, just starkerbecause the standards are higher andthe failings more obvious. When scaledup to the societal level, we end up withan all too familiar litany of malfeasanceand scandal. Examples abound: collusion

between corporate leaders and theaccounting firms that were supposed tobe auditing them; university researchscientists fabricating data in order topublish papers for promotion and tenure;theft of donated money by leaders ofcharitable organizations; egregious misbehavior by priests; presidentialimpeachments with attendant under-mining of public confidence in electedofficials and in government; greed driving collapse of the savings and loanindustry—all examples of systemic corruption, corruption by professionals,that enhanced understanding of theprinciples of ethics is supposed, somehow,to correct. If only it were that easy.

To make the argument more force-fully: when a dentist is caught inwrongdoing and his or her license isrevoked, he or she is usually entered intoa “diversion” program to be rehabilitated.This typically involves referring the dentist to the local dental school for re-education. But, what are we in theschools supposed to do with them?Enroll them in a continuing educationcourse and then test them on the defini-tion of the word “beneficence”? No one’sbehavior changes as a result. The mis-take is that it’s just assumed that theguilty can be slotted into some preexist-ing and suitably convincing curriculumon good behavior. While the term “re-education” is sometimes used as ahumorous euphemism for coercive persuasion, in this context, the differencebetween knowing the answers to questions on a test and assimilating themeaning of those answers into one’sprofessional and personal identity is crucial. State dental boards, dental asso-ciations, legislatures, and the universitiesthemselves should know better. It justdoesn’t work that way, but we pretend itdoes (which is an ethical issue in itself).Oxford philosopher and ethicist Simon

36



The difference betweenknowing the answers toquestions on a test andassimilating the meaning ofthose answers into one’sprofessional and personalidentity is crucial.

Blackburn makes this point when heparaphrases Aristotle: “It takes educationand practice [emphasis added] in orderto become virtuous. It does not just happen, like growing taller or hairier…[and] education is a matter of drawingout a ‘latent’ potential, at least in thebest people” (Blackburn, 2001). Alain deBotton underscores the notion thatthings don’t just happen with an analogythat compares living without thinkingsystematically to practicing “an activitylike pottery or shoemaking without following or even knowing of technicalprocedures. One would never imaginethat a good pot or shoe could result fromintuition alone; why then assume thatthe more complex task of directing one’slife could be undertaken without anysustained reflection on premises orgoals?… Perhaps because we don’tbelieve that directing our lives is in factcomplicated. Certain difficult activitieslook very difficult from the outside,while other, equally difficult activitieslook very easy. Arriving at sound viewson how to live falls into the second category, making a pot or a shoe intothe first” (deBotton, 2000).

Is any of this appropriate matter fordiscussion during the education of oneentering a health profession? I contendthat it is. For one thing, according to former Harvard president Derek Bok,“most of the sources that transmit moralstandards have declined in importance.Churches, families, and local communitiesno longer seem to have the influencethey once enjoyed in a simpler, morerural society. While no one can be certainthat ethical standards have declined as aresult, most people seem to think thatthey have, and this belief in itself canerode trust and spread suspicion in waysthat sap the willingness to behavemorally toward others” (Bok, 1976). Itdoes seem that universities and profes-sional schools have a role to play.

My premise is that our ethics coursesare inadequate in content and form tothe extent that they do not cultivate anintrospective orientation to professionallife. In some cases they amount to littlemore than a study of various state dentalpractice acts or the Code of Ethics of theAmerican Dental Association; or, evenworse, they offer a set of abstractions:formal definitions for terms like justice,respect, responsibility, caring, virtue,trustworthiness, beneficence or thememorizing of such desiccated notionsas “the four components of a moral life.”Students catch on fast. They realize thatthe assumption underlying these defini-tions is unstated—namely, that theyalready buy into the behaviors that thedefinitions describe, that all they reallyneed is catchier phraseology to cementtheir commitment to good behavior.While such information should certainlybe included somewhere in the dentalcurriculum, it is just that, information—nothing potentially life-altering or, moreto the point, potentially convincing.While the ethics courses do succeed intelling students what our expectations of them are, that’s about all they do.Knowing our expectations is all that’sneeded to pass the test. What the coursesfail to address is the one question every-one really wants the answer to: Why?Why be good? Why be ethical? Only theanswers to those questions have anyhope of convincing anyone to actuallydo anything differently. Our prevailingethical curricula pretend that everyonealready knows and accepts the answers,so we can move on, having laid the flimsiest of foundations. The result? Noone is convinced of anything; lives andbehaviors do not change, and only themost ruminating of students is likely topose the questions, “Why should I do

what you say is the right thing? Whyshould I be even remotely interested inany of this?” At their best, our ethics curricula offer sputteringly apoplecticanswers. At their worst, they offer onlysilence. The courses make assumptionsabout what students know and whatthey value, but such assumptions maynot be grounded in reality and therebyrender much of the ethics curriculumincoherent to increasing numbers of students.

This article considers three specificweaknesses in a typical ethics curriculumas a starting point for creative thinkingabout ways to improve. It also proposesone innovation to help remediate students(and I argue that all students requiresuch remediation) not only to makeethics intelligible, but with the sincereaim of positively influencing behaviorboth in dental school and beyond.

The weaknesses are: 1) failure to recognize that more education is not theanswer to everything; 2) ethics is boring;and 3) course content is qualitativelyinadequate because it does not foster anintrospective basis for true behavioralchange. A fourth element, an innovation,is directed to this third weakness andentails implementing a precurriculumvery early in the dental educationalexperience to address the disconnectbetween knowledge and action. By veryearly, I mean at the beginning of the first year and possibly, under certain circumstances, even before formalmatriculation into dental school. By precurriculum, I mean prior to under-taking our current set of ethics courses.

Weakness One: Failure toAcknowledge the Limits ofEducation Yale psychologist Robert Sternberg(2002) argues that we act as if there areno social problems for which more orbetter education isn’t the answer. He

37



asserts that the value of education is soconvincing that it is sometimes the onlysolution considered, and he points to theendemic belief that education is offeredas the answer to virtually every problem.By way of illustration he gives the caseof one South American country thatappointed in the 1980s a minister for thedevelopment of intelligence, believingthat higher intelligence would, some-how, create better, more humane people.It strikes us oddly discordant that thereare some problems—perhaps the mostimportant problems—for which moreeducation, more knowledge is not theanswer. Here’s a sobering fact: of the one hundred fifty people convicted atthe Nuremberg war crimes tribunalsthat followed World War II, twenty werephysicians (No author, 1997)—presumablyintelligent and educated people. Amongthe Nuremberg war criminals, it is doubtful that any single profession wasas well represented as medicine, unlesstwenty-two convicted SS officers arecounted as all sharing a “profession.”Whatever benefits go along withincreased intelligence, says Sternberg,wisdom is not one of them. Further, ifwisdom is defined in terms of seeing theworld as it truly is and acting on thataccurate vision, then a key insight follows:it is ethics and wisdom that go hand inhand, not intelligence and wisdom. Healso points out that focusing exclusivelyon the development of academic skillsmay actually take away from the kindsof activities that could help studentsdevelop wisdom. Nowhere is this truerthan in professional education. While“increased academic skills may be necessary for many kinds of success,”Sternberg asserts, “they are not sufficient.Students need something more.” In thelong run, success in practice depends on

acquiring the kind of practical wisdomSternberg refers to. Yet this is seldom discussed let alone formally taught inprofessional school. In fact, Bok asserts,“Professional schools have never shownmuch interest in providing lectures onmoral conduct or surveys of ethical theory. Many of them have simplyignored moral education altogether”(1997). This is especially unfortunateinasmuch as “higher education occupiessuch strategic ground from which tomake a contribution,” says Bok. “Everybusinessman and lawyer, every publicservant and doctor will pass through our colleges, and most will attend ourprofessional schools as well. If othersources of ethical values have declined ininfluence, educators have a responsibilityto contribute in any way they can to themoral development of their students.”

Knowledge-based ethics coursesaccomplish little by way of ensuringexemplary conduct because there is anenormous disconnect between knowingwhat’s right and doing it, betweenunderstanding the principles of ethics atan intellectual level and applying themin daily life. Simply put, people do notnecessarily do wrong because they do notknow what is right. There is somethingmuch deeper than simple knowledge atthe root of ethical behavior.

Weakness Two: Ethics Is Boring As to the courses we give, most ethicalprinciples are simply too abstract, dry,and off-putting to have any practicaleffect. In a word, they’re boring. Theycapture neither a student’s attention norinterest, much less make any differencein real life. Thomas Merton saw no valueto a person struggling to obtain virtue in the abstract, that is, as a quality forwhich a person has no direct experience.Such a person, he observed, will neverprefer virtue to the corresponding vicethat, by comparison, will inevitablyseem the more lively, inviting, and excit-ing (Merton, 1993). The difference

between living ethically and studyingethics is the difference between playing asport and reading the rulebook.

Furthermore, “poor instruction canharm any class. But it is devastating to a course on ethics, for it confirms theprejudices of those students and facultywho suspect that moral reasoning isinherently inconclusive and that courseson moral issues will soon become vehicles for transmitting the private prej-udices of the instructor” (Bok, 1997).Ethics courses taught by dentists canrapidly degenerate to moralizing inpreachy little sermonettes or, even worse,to a self-indulgent self-righteousnessreminiscent of Adam Smith’s famousobservation that “virtue is more to befeared than vice, for its excesses are notsubject to the constraint of conscience.”But even when taught by professionalethicists, such curricula can prove grindingly dull, recounting only variousethical theories ad seriatim—empiricism,epicureanism, logical positivism, materi-alism, rationalism, skepticism, stoicism,utilitarianism, whatever—and again canfail to deliver. “To the extent that thesecourses are simply surveys of ethical theory,” writes Bok, “they…do little tohelp the student cope with the practicalmoral dilemmas he may encounter inhis own life” (Bok, 1997). Such ethicscourses do not help students capture theexciting vision of “who I could be”; hecontinues, they do not “help studentsclarify their moral aspirations…to definetheir identity and to establish the level of integrity at which they will lead theirprofessional lives.” “Many individualswho are disposed to act morally,” hesays, “will often fail to do so becausethey are simply unaware of the ethicalproblems that lie hidden in the situationsthey confront. Others will not discover amoral problem until they have gotten toodeeply enmeshed to extricate themselves.”Bok concludes that “students [need to]

38



become more alert in discovering themoral issues that arise in their own lives,”but, even when they do, that knowledgehas to somehow change behavior.

Weakness Three: QualitativeInadequacy Something more is needed than learningabout dental practice acts, codes ofethics, and various historical ethical theories. Something different is needed,something that helps students identifytheir core belief structure—possibly modifying those beliefs in light of a newlearning experience—and then recon-necting the student’s central machineryfor action with that set of beliefs, newlydiscovered and embraced as his or herown. This entails personalizing the curriculum: making it honest and intro-spective, and coming before formaldental ethics courses. Thus, an innova-tive precurriculum in ethics must bepersonalized; it must be honest; and itmust be appropriately sequenced.

Difficulty in making the transitionbetween theory and practice is a problemwe are very well acquainted with in professional education: between under-standing the principles of, say, physiologyand applying that knowledge in a practical clinical setting. The same goesfor ethics. Recognizing when you’re atan ethical decision point and then actingin accord with what you’ve learned—giving life to the abstract—must be one ofthe goals of a curriculum in professionalethics. How to make this happen is the question.

An Innovation: An IntrospectivePrecurriculum If the problem lies in the disconnectbetween theory and practice, then whatmay be missing is a preamble, offeringantecedent—even remedial—ways ofthinking with the aim of making subse-quent formal courses in ethics moreintelligible and more relevant, lettingstudents decide for themselves whether

what they have been taught fits withtheir own personal conception of an ethical life, a moral life, a good life.Before formal ethics courses can makemuch sense, students have to come toterms with who they really are, whatthey really want, and what they reallybelieve and why. The personal odysseyby which a student successfully negotiates the arduous path toward professional school does not encouragefacing such questions. Instead, theyfloat—reading the signs of the times and circumstances, responding to thepressures and preferences emanatingfrom parents, peers, and professors.They certainly know how they are supposed to act, what they are supposedto say, and what they are supposed tobelieve. This is especially evident on the day candidates are interviewed foradmission. Even in the case-based problem-solving scenarios offered in our ethics courses, students clearly knowthe answers we’re looking for. But,whether they really buy into any of thebehaviors that the answers speak to wedon’t really know, nor—if the truth istold—do they. The question seldom entersthe consciousness of most professionalschool students. This is not surprising.They have been so focused on succeedingin a highly competitive environment togain admission that serious introspectionis a luxury that just never arises, or evenworse, is interpreted as a sign of weak-ness. Yet such introspection—coming toterms with one’s own true feelings andbeliefs—is essential. It is the foundationfor long-term compatibility with one’schosen occupation and for happiness inprofessional and personal life.

The premise of the precurriculum is that courses on professional ethics,even very well done and engaging ones,are effective in explaining to us what

it means to be good, but much less effective in convincing us to be good,that is, to act on that understanding.What does it take to act? What kind ofintellectual matter can we present to students that, were their brains to marinate in it for a period of time, wouldlead to positive changes in action? Theanswer is: matter that provokes mean-ingful introspection so that students arecontinually incubating insights that theyhave discerned for themselves. This issomething currently missing from dentaleducation, maybe because we just presumestudents are naturally introspective. Ifthey are, nothing in the dental curriculumpromotes that orientation.

Apart from the decline in influenceof the traditional vehicles for transmittingmoral standards in our society, consider-ing such matters before embarking onthe formal study of professional ethicshas added importance in light of theincreasing diversity of society and theprofessions. An increasingly diversesocial, cultural, ethnic, racial, and gendercomposition of the professions meansthat students do not necessarily shareany single cultural heritage or beliefstructure. Finding common groundbetween students and faculty, indeedbetween groups of students themselves,is not easy. Counterintuitively, theincreasing diversity of the people who

39



“It takes education andpractice in order to becomevirtuous. It does not justhappen, like growing talleror hairier…[and] educationis a matter of drawing out a ‘latent’ potential, at leastin the best people”

populate professional schools makes the discussion about core ethical issueseasier. Why? Because each person mustultimately devise his or her own personalsynthesis anyway, possibly borrowingfrom many disparate sources and coming up with what works for him orher, while at the same time achievingcompatibility with the lofty aspirations ofthe profession. If nothing else, diversitycan breed openness to new views anddifferent ways of thinking—necessary ifthey are ever going to learn to think for themselves.

Students do not usually enter profes-sional school expecting to reconstructfor themselves a whole new way ofthinking and behaving. It’s hard for allof us. As Blackburn observes, “Any mod-erately sober reflection on human lifeand human societies suggests that weare creatures easily swayed, constantlyinfected by the opinions of others, lackingcritical self understanding, easily grippedby fantastical hopes and ambitions. Ourcapacity for self-government [which, by

the way, is what professional Codes ofEthics are all about] is spasmodic, andeven while we preen ourselves on ourcritical and independent, free and rationaldecisions, we are the slaves of fashionand opinion and social and culturalforces of which we are ignorant. Itwould often be good, and no signal ofdisrespect to ourselves, if those whoknow better could rescue us from ourworst follies” (Blackburn, 2001).

Therefore, no one should be particu-larly surprised if students do not feel upto the task. This is where students canbenefit from some help in formalizing aschema for introspection that can serveas a preamble to professional life. Onethat does not teach values, ethics, ormorality per se, but provides an approachand a syntax for students to both beginthinking about these things for them-selves and to want to do so. When wouldsuch a curriculum be undertaken andwhat would be its content? The “when”question is the easier of the two: veryearly, certainly during the first year, possibly as an intensive several-day experience during orientation week,hence a precurriculum. If necessary, itcould also occur as a self-study experi-ence in the summer before professionalschool begins, the so-called golden peri-od between the letter of acceptance andactual matriculation, when students arethinking most idealistically and whenthey might actually do the assignment.In any case, it must occur before theinevitable bonding as a class that ourlockstep dental curriculum imposes, and before the maladaptive cynicismthat sometimes sets in when students’collective identity as a class congeals.

The premise of a precurriculum isthat professional school students arefundamentally idealistic, or they werewhen first attracted to the health professions. That idealism bespeaks aspark of introspection to begin with. Thisresidual idealism has to be captured,

cultivated, and maintained. As Bokwrites, “We should be willing to assumethat most students will have sufficientdesire to live a moral life that they willprofit from instruction that helps themto become more alert to ethical issues,and to apply their moral values morecarefully and rigorously to the ethicaldilemmas they encounter in their professional lives” (Bok, 1997).

Such a precurriculum would almostcertainly necessitate curricular materials(de Mello, 1995) that by current standardswould be unconventional, at least untilappropriate adaptations could be devised.But the content itself would be aimed atthree central tenets that, though rifewith my own personal opinions, are atleast worth discussing.

Doing Well, Doing Good Dental students admittedly want to dowell, in the financial and material sense;but they also want to do good, in thesense of serving others, adhering to theidealism that motivated them to becomedoctors in the first place. Is it possible todo well in all the ways so valued by amaterialistic society, while at the sametime not giving up on a life of altruism?This first central idea of the precurriculumsays that there is no intrinsic conflictbetween doing well and doing good,between personal material benefit andhelping meet the needs of other people.In fact, when things work right, thesetwo aspects of personal behavior can bemutually reinforcing, reflective of a lifein overall balance. It also assumes thatwe must be completely honest with ourselves and with others. Fundamentalto such honesty is a recognition andacceptance of our own secret motives.This is essential for professional do-gooders, which includes doctors. To paraphrase Thomas Merton, the desire

40



Knowledge-based ethicscourses accomplish little byway of ensuring exemplaryconduct because there is an enormous disconnectbetween knowing what’sright and doing it, betweenunderstanding the principlesof ethics at an intellectuallevel and applying them in daily life.

for virtue is frustrated in many people ofgood will by the distaste they instinctivelyfeel for the false virtues of those who are supposed to be good but who do notlive up to their own stated ideals. He contends that persistent wrongdoersactually have a very keen eye for falsevirtues and a very exacting idea of whatvirtue should be in a good person. Ifindividuals who are supposed to be goodonly “see a ‘virtue’ which is effectivelyless vital and less interesting than theirown vices, they will conclude that virtuehas no meaning, and they will cling towhat they have although they hate it”(de Mello, 1995). The same point ismade more directly by Blackburn, whoinsists that we “confront what reallybothers people about the subject.”Namely, “the many causes [students]have to fear that ethical claims are akind of sham” (Blackburn, 2001)—thatis, that even we the professors don’t really believe what we’re teaching.

In the health professions the senti-ment is commonly expressed that thepatient’s welfare always comes first, thatthe patient’s needs must come before theneeds of the practitioner. This is a noblesentiment; it is also untrue. No seriouseffort at fostering ethical behavior inprofessional practice can be based on aprinciple, however hallowed, that is onits face, false. Physicians and dentists donot place the patient’s welfare beforetheir own. The platitude that they do sois only passably credible to the extentthat the patient’s and the practitioner’sinterests are not usually in conflict. Onthose occasions when the patient’s andthe practitioner’s interests do conflict,each person—patient as well as practi-tioner—can be reliably counted on toplace themselves first (as most conspicu-ously displayed in all malpracticelitigation). Practitioners do indeed oftenplace the patient’s welfare above theirown convenience, but this is a differentthing entirely. The purpose of much ofthe educational, social, cultural, and

economic environment that society hascreated around health care is to preventconflicts between the welfare of thedeliverer and the welfare of the recipientof care from ever arising. It sounds dis-cordant to doctors and patients alike, buteach person is either overtly or secretlypursuing their own interests. Society has shrewdly concocted an arrangementwherein most health professionals areaccorded highly privileged lives andthus, by helping others, help themselves—most of the time. This unspoken socialcontract between health care providersand the public simply reflects the impor-tance society places on its own health.The precurriculum proposed in this article acknowledges that there is nothingwrong with individuals (including doctors) pursuing their own enlightenedself-interest. The trick is to structure professional practice (and one’s entirelife) in a way that allows one’s own bestinterests to be pursued while concomi-tantly furthering the interests of othersand of society and to learn to recognizeand avoid situations in which one’s ownbest interests and those of others are inconflict. In other words, dental educatorsneed to help students learn how to maxi-mize win/win situations while minimizingwin/lose situations that inevitably deteriorate toward lose/lose scenarios inwhich both patient and provider lose.

Being Bad—Being Blind The second central idea is “being bad—being blind.” The essence is that peoplewho engage in unethical conduct do sonot because they actually want to bebad, but because they choose to be blind.In other words, the fundamental error ofthe criminal (or the unethical practition-er) is that they misconstrue where theirown true interests lie. Once one acceptsthat there is nothing wrong with pursu-ing one’s own best interests, it becomes

important to know what, exactly, thoseinterests are. What appears to be in one’sself-interest over the short term can bemanifestly disastrous over the longer term.

As Blackburn notes, clearly recogniz-ing one’s true interests is not all thateasy, after all, when considering what“is required for a life of reason or a life oftrue flourishing, we will find people areperfectly ready to settle for a good fake”(Blackburn, 2001). Many forces cloudthe issue, aiming to get us to think and act in particular ways: to make usproductive, controllable, a good citizen,and a hard worker. The message is oftensubliminal but is powerful nonetheless,exerting hidden influence and frequentlycoming from the people in our lives we trust the most—parents, teachers,friends, spouses, pastors—people whoreally do have our best interests at heartbut who can themselves be deluded. Not to mention others who do not necessarily have our interests at heart:corporate advertisers and the media, for instance. Blackburn describes theproblem of “thinking poisoned by anenveloping climate of ideas, many ofwhich may not even [be] conscious. Forwe may not be aware of our ideas. Anidea in this sense is a tendency to acceptroutes of thought and feeling that wemay not recognize in ourselves, or evenbe able to articulate. Yet such dispositionsrule the social and political world”(Blackburn, 2001). Hidden influencesaffect everyone in society, including students entering dental school. The difference is that we are trying to getdental students to adopt a code of behav-ior that is higher than the societal norm,a task made impossible if we never talkabout those influences and their effectson decision making.

41



Meekly accepting others’ decisions—call it a Code of Ethics—is precisely whatwe faculty devoutly hope students willdo. But the point is that there can be noethical decision-making if students haveno experience making decisions forthemselves, weighing the evidence forthemselves, and drawing their own con-clusions—inventing for themselvesprinciples they can live by with comfortand confidence. This entails questioningeveryone and everything, including ourown most cherished and firmly heldbeliefs, developing the attitude that suchbeliefs, however revered, are always heldonly contingently. Are our beliefs basedon what others have told us and that wehave mindlessly accepted without closeexamination, or have we questionedwhat we have been told? Have we discov-ered for ourselves what we genuinelyhold to be true, what we actually believe,not what we say we believe in order tokeep peace with everyone else? Are dentalstudents ever stimulated to considertheir attachments, their beliefs, andtheir fears? Typically students considertheir beliefs to be what makes them whothey are: their fears, what keeps themsafe, their attachments, what makes lifeexciting—in a nutshell, what got theminto dental school in the first place (deMello, 1995). But, conscious and formalconsideration of these deeply held andpersonal qualities can expose them asdecisive filters of the incoming stream ofreality upon which the student is makinglife decisions: a highly filtered view thatcan engender biases, prejudices, andmost importantly, misconstrual of one’sown true interests.

Allied to the matter of blindness and the misconstrual of one’s own bestinterest is the misery factor. Unethicalpeople are extremely unhappy. They arenot unhappy because they are unethical;

rather, they are unethical because theyare unhappy. They conceive of one oranother unethical act as a means ofovercoming their misery—a seeminglysmall price to pay for achieving happi-ness. They have given up seeking a curefor their unhappiness; what they want isrelief: “a good fake.” True criminals are acase in point. They want what someoneelse has. Why? It is a question I ask students during my ethics lectures. Ipose the question: What do you want inlife? We then play the game of “FiveWhys.” Whatever they say they want, Iask why?—doing so five consecutivetimes. Before the fifth why, the answeralmost always ends up being “because Iwant to be happy.” In this sense they—all of us—are not all that different fromthe criminal; we all want the same thing:to be happy. Only our means differ.Happiness and ethics are inseparable.Moreover, ethical practice is just a part of an ethical life, and an ethical life isjust a part of a broader, healthier, andmore robust experience of life itself.

Beyond the matter of ethics (and aspart of it), misery is also worth talkingabout in professional education becauseit may manifest not only in unethicalbehavior but also in other maladaptiveschemas. Dentists in particular have awell-known reputation for a high inci-dence of suicide. Why is this neverdiscussed in dental school? Whether it’strue is arguable; nevertheless, even ifdentists and physicians have no higherrate of suicide (or depression, anxiety,anger, addiction, divorce, etc.) than thepopulation in general, what kind ofaccomplishment is that? How is it thateducated people with impressive creden-tials, degrees, and titles who have nearcertitude of financial security, prestige,and recognition—all things we’ve beentold to work toward—are not protectedfrom the same hazards that attend thelives of others who, in most ways, are

much worse off? These questions are seldom asked in professional school andare therefore never answered. A cycle ofmaladaptive behavior can begin longbefore professional school. It can persistand, significantly, be rewarded in dentalschool and practice. But it culminateseventually in a feeling of being trapped:a feeling that engenders unhappinessand counterproductive behaviors both inprofessional practice and in life. When itdoes, it can lead in turn to unethicalactivity—activities the practitioner, in adelusional fog, is convinced will bringhappiness. The tragedy of such behavioris that the doctor, desensitized, living “a good fake,” no longer sees life the way it truly is (or can be).

Trained to Be Bad The third central idea of a possible pre-curriculum is honestly acknowledgingand confronting the truth that in theprofessions we are almost trained to bebad. Professional people can be uniquelyvulnerable—unintentionally trained to be unethical. People who go to dental,medical, law school, etc. are accustomedto competing to get what they want.Competition entails winners and losers.Professionals are at the top of a highlycompetitive pyramid and have becomeacclimated to (even acquired a taste for)being the winner. Professionals such asdentists are equally accustomed to seeinga lot of losers along the way and becomehardened to the notion that there arealways going to be losers. Unfortunately,the stance that “what I want is what’sright” easily becomes “what’s right iswhatever I want.” As stated earlier, thereis nothing wrong with pursuing one’sown best interest. Knowing one’s ownlegitimate needs, pursuing them, evenaggressively, is fine provided what wewant is really in our best interest andbalanced by the legitimate needs of others.You winning does not mean I have tolose. In fact, from a purely pragmaticperspective, to construct a life wherein42



you consistently win, often at the cost of others, is to create for yourself anintrinsically unstable situation, like thesuccessful mobster who is fabulouslywealthy but installs bars on the windowsof his home and is afraid to go outside.Or, as expressed by Harvard Law ProfessorMary Ann Glendon, “people remember,and they get back—with interest”(Glendon, 1994).

Most of us make the assumption thatmost people are honest most of the time.This is almost certainly true. But it’s alsotrue that most people are dishonestsome of the time. Herein lies a conflict.There is throughout professional educa-tion a subtle, almost subliminal, andunjustifiable assumption that profession-als are honest and ethical all of the time;in other words, people like us never dowrong. We know it isn’t true, but we pretend it is, and we teach our ethicscourses as if it’s simply a lack of knowledge that leads professionals to wrongdoing. Based on this false foun-dation, the rest of our ethics curriculabecome a house of cards. The truth is we are exactly the kind of people whocommit unethical acts. We could not possibly be better trained, cultivated, andrewarded for doing so. Any assumptionthat academic credentials or high testscores immunize us against wrongdoingis imaginary and dangerous.

Why are highly intelligent peoplealmost uniquely vulnerable to certainkinds of mistakes and wrongdoing?Perhaps because the intrinsically subjec-tive nature of our own intellects causesus to overvalue what we know and toundervalue what everyone else knows.Down deep, we think we’re smarter thanothers—even in the face of evidence tothe contrary (Sternberg, 2002).

Perhaps the most important aspectof a precurriculum would be to help

students understand that there are noreal gurus. No one can teach you anythingwhen it comes to learning the truth ofan ethical life. Whatever you learn, youhave to teach yourself. Regrettably, thelanguage of good behavior can soundterribly clichéd. “Professors are oftenreluctant even to talk about this subject,”says Bok, “it is so easy to seem censoriousor banal” (Bok, 1997). It is why, despiteSternberg’s urging that we teach wisdomas part of an academic curriculum(2002), Herman Hesse’s Govinda assertsthat “wisdom is not communicable. The wisdom which a wise man tries tocommunicate always sounds foolish.Knowledge can be communicated, butnot wisdom. One can find it, live it, befortified by it, do wonders through it, butone cannot communicate and teach it”(Hesse, 1957). Whatever the body of wisdom that informs one’s life, it cannotbe procured in a package. Mentors andguides can help point the way—the purpose of the precurriculum—but in the last analysis, the discoveries have tobe the student’s alone. Thus, this is notabout teaching values; rather, it is aboutencouraging each student to develop hisor her own values while understandingmultiple points of view and consideringeven his or her most firmly held beliefsin a strictly contingent way, open alwaysto change in the face of new evidence.

Regarding the exact structure of sucha course, I envisage an approach similarto one used at the University of California,San Francisco (UCSF) for the past fouryears. This one-quarter, one-hour perweek course titled “Leadership andValues” is for all practical purposes identical in content to the precurriculumdescribed in this article with its focus onthe three central ideas discussed hereand with emphasis on the student’sattachments, beliefs, and fears. It is,however, somewhat different in form,inasmuch as the present course is an

elective not a requirement (and thereforeconsists of students self-selected on thebasis of their own preexisting interest inthe subject matter). It has been open toall students regardless of year, ratherthan coming at the very beginning ofdental school. But, like the proposed precurriculum, the format is small-group,seminar-style. Some years a waiting listof more than fifty students has been generated—more than could be accom-modated, reflecting a high level ofinterest among students when thecourse content became known amongstudents generally. Specified readings aredistributed to students prior to class, andtwo students self-identify as discussionleaders for that session. Classes consistof a brief oral introduction by theinstructor to frame the kinds of questionsaddressed by the readings, followed byboth student-led and instructor-led dis-cussion. Classes conclude with generalscenarios that are quite likely to arise inthe life of a dental student before the

43



Ethics courses taught bydentists can rapidly degen-erate to moralizing inpreachy little sermonettesor, even worse, to a self-indulgent, self-right-eousness reminiscent ofAdam Smith’s famousobservation that “virtue is more to be feared thanvice, for its excesses are not subject to the constraint of conscience.”

next class session. Most predictable arethose scenarios that involve anxiety,depression, or anger and the misconstrualof one’s own true interests under thesway of these highly charged emotionalstates. The subsequent class sessionincludes a discussion of these actualevents during the intervening weekbefore moving on to new material. Thereare no examinations or assignmentsapart from the readings and participationin discussion. The content of the proposedprecurriculum would be the same, butadapted and possibly intensified by amore concentrated experience duringorientation week or, conceivably, as aself-study program prior to beginningdental school.

Do I think implementation of such acurriculum would really work, that is,would it influence behavior? I do, at leastfor some students, and over time. Why?Because the intent of the precurriculumis not to provide information; rather it isto cultivate a beneficial way of thinking,one to which the student will becomehabituated if it is reinforced throughoutthe dental school experience. The intentis not to teach the student to see every-one and everything in the light of anoppressing morality, but rather to seeeveryone and everything in the light oftheir own true interests. To place them-selves at the center of the universe,which everyone does anyway, but to do so consciously and from the honestperspective of their own well-orderedlife. Seeing the world in this way willpromote professional standards if wereally do believe that living an ethical lifeis not only best for the world, but bestfor us. Further, the potential impact ofsuch a precurriculum has to be assessedwith the understanding that attaining

an ethical life does not occur overnight.It is literally a whole-life project, occurringin fits and starts, two steps forward, onestep back. It requires that students andpractitioners, who do on occasion fail to do the right thing, learn from theexperience. This can only happen afterthe event, when the dust settles, providedthey are introspective enough to perceivethe occurrence as a failing in the firstplace; a failing having an ethical dimen-sion; and a failing that offers anopportunity for behaving differentlynext time—an opportunity for growth.

How will continual reinforcementoccur? It presumes faculty memberscapable of modeling a “reflective practi-tioner” mode of introspection andaccustomed to exercising critical appraisalin their own lives. Having faculty membersundergo a precurriculum experiencethemselves could be an important facultydevelopment activity. There is someanecdotal evidence that such retreat-format experiences can make a differ-ence in people’s lives (de Mello, 1995).But even if well-run faculty developmentretreats are not possible, it would still bea big help if faculty could simply under-stand that when it comes to teaching,there is a difference between the infor-mation they give to students and theinformation they give off to students(Postman, 1994); that the content ofwhat we teach is one thing, but the form in which we teach it is another

(Bertolami, 2001; O’Donnell, 1998); andthat “the content of a lesson may be theleast important part about learning”(Postman, 1986). All of this is expressedmost succinctly by the great nineteenth-century educational theorist John Deweywho said, “The greatest of all pedagogicalfallacies is the notion that a personlearns only what he is studying at thetime. Collateral learning in the way offormation of enduring attitudes…may be and often is more important [thanthe intended content of what is taught”(Postman, 1986). At the very least, sensitivity to these issues may help prevent faculty from unintentionallyundoing whatever is accomplished forstudents through a precurriculum.

Such an approach could create a climate of opinion within dental schoolswhere introspection could be discussedwithout embarrassment as an importantpart of one’s professional education: aclimate that helps students understandthat it isn’t enough just to do the rightthing, that what is also required is towant to do the right thing. The differenceis as subtle as it is immense. The effectcould be to re-sensitize students and faculty to the truth that some problemsfor which we as a profession do not nowhave answers are, at their root, ethical innature. It involves perceiving subtletiesthat, upon reflection, become glaringtruths that students would never detectwithout a more introspective approachto professional life.

By way of example, in dentistry, our failure to see certain problems asfundamentally ethical in nature frustratesattempts at workable solutions. Theshortage of faculty in dental schools(and all public sector careers) might bea case in point. This problem is almostnever cast in an ethical light, but it couldbe: we still act in universities as if enteringa profession is a noble calling for which

44



Students do not usually enter professional schoolexpecting to reconstructfor themselves a whole new way of thinking and behaving.It’s hard for all of us.

some sacrifice is expected. The problemis that society as a whole has moved on.“The Victorian ideal of a life devoted toduty, or a calling,” says Blackburn, “issubstantially lost to us. So a greater proportion of our moral energy goes toprotecting claims against each other”(Blackburn, 2001). No one feels thischange more directly than dentists inpractice who see first-hand how theworld works and what it values. Thus,the usual argument runs something like this: students have high debts andpractitioners make a lot of money—depending on the specialty, perhapsthree times what a typical faculty member earns (Lindauer et al., 2003).Therefore, dental graduates are justifiedin avoiding faculty jobs in favor of practice in order to do the right thing bypaying off their debts. But consider analternative view, one that recognizesthat as a profession, dentistry is accordedan extraordinary degree of self-governanceon the grounds that it is party to a binding social contract based on serviceto the public.

Has dentistry delivered on its part of the bargain? The Surgeon General’sreport on oral health in America offersrather dramatic evidence of a positivecorrelation between a population’s percapita income and the number of dentists in a community (No author,2000). In other words, dentists havegone where the money is, establishingisolated conclaves of what O’Neil callsfreestanding suburban bungalow practices (futurehealth.ucsf.edu/from_the_ director_1003.html).

They have avoided practicing in bothrural areas and the inner city just as theyhave avoided faculty positions or publicsector careers. Many dentists also refusepatients on public assistance, patientsunder the age of three, patients over the age of eighty, patients with seriousillnesses, or patients who are in nursinghomes. If dentists distributed themselvesmore equitably among all different types

of communities (and accepted all kindsof patients) as required by dentistry’ssocial contract (the basis of its autono-my), the net income of dentists, thoughstill high, would not be as high as it is.In this light, the problem is not only thatfaculty salaries are too low; it is also thatprivate practice incomes are too high—achieved at the social cost of taking careof only those who can pay, but not thosewho need care and are unable to pay. Inother words, market-based capitalismrules. Were we to extrapolate this principle to academic life, we would beback to the notion of selling seats in dental schools to the highest bidders and offering letters of recommendationat a price. Under those circumstances,the problem of paying faculty enough to compete with private practice woulddissolve overnight.

Have dental educators themselvescontributed to the problem of studentdebt by failing to control costs and byencouraging everyone and anyone toassume however much debt is needed topay for their education? Do faculty concernthemselves with the compromises thenew dentist will make in order to relievethe fiscal burden we’ve talked them intotaking on? Have faculty been fixatedobsessively on maintaining outmodedteaching technologies that continue tomake dental education among the mostexpensive in the university? Do statedental licensing boards insist on testingstudents on technical procedures havinglittle relevance to contemporary practiceand that require faculty to teach studentsnot what they need to know but whatthey need to pass—and at enormousexpense? Do dental license examinersargue that only live patient examinationsprove competence, but at the same time excuse themselves from periodic re-examination under the same terms? Allthese questions have an ethical dimension.

It’s been said that the only Zen youfind on mountaintops is the Zen youbring up there with you (Pirsig, 1984).Correspondingly, the only ethics studentsgenerally find in professional school isthe ethics they bring in with them. Ourearliest childhood notions of doing rightby others can hold us in astonishinglygood stead throughout life. But for professional school students who willroutinely have the life and welfare ofother human beings in their hands,wouldn’t a more mature and consciousunderstanding of one’s own code of lifeand behavior, including the beliefs under-pinning them, constitute a worthwhilegoal? Isn’t an important opportunity lost for the professions by not helpingstudents deliberate such matters forthemselves in a very practical way?

Perhaps in the process studentscould discover an approach to livingthey can subscribe to not only intellectu-ally but also at the deepest emotionallevels—an approach that is continuallymodified or reinforced by facultythroughout the clinical experience ofdental school. Something that castsethics in a vibrant and positive lightrather than obsessing over what one isnot supposed to do—a continuing project,robust and person-building.

Perhaps a professional ethicist wouldargue that the content of the precurricu-lum discussed in this article isn’t reallyethics at all; it is actually a course onintrospection. I concede the point.However, cultivating as a matter of habitthe thought patterns such a curriculumcould foster is badly needed in profes-sional education, whatever it is called. It does involve taking risks, but the

45



objective is simply to become as sensitiveto the ethical environment as we havebecome of the physical environment.“We know that we depend upon [thephysical environment], that it is fragile,and that we have the power to ruin it,thereby ruining our own lives,” saysBlackburn. “Perhaps fewer of us are sensitive to what we might call themoral or ethical environment. This isthe surrounding climate of ideas abouthow to live. It determines what we findacceptable or unacceptable, admirable or contemptible. It determines our conception of when things are goingwell and when things are going badly. It determines our conception of what isdue to us, and what is due from us, as we relate to others. It shapes our emotional responses, determining whatis a cause of pride or shame, or anger or gratitude, or what can be forgivenand what cannot. It gives us our standards— our standards of behavior. In the eyes of some thinkers…it shapesour very identities” (Blackburn, 2001).This seems something worth takingsome risks for. ■

ReferencesBertolami, C. N. (2001). Rationalizing thedental curriculum in light of current dis-ease prevalence and patient demand fortreatment — content and form. Journal ofDental Education, 65, 725-735. Blackburn, S. (2001). Being good: A shortintroduction to ethics. Oxford: OxfordUniversity Press. Bok, D. C. (1976).Can ethics be taught?Change, 26-30. de Botton, A. (2000). The consolations ofphilosophy. New York: Pantheon Books. de Mello, A. The way to love. New York:Image Doubleday. Easterbrook, M. (2002). In Colombia,decades of graft cripple a university.Chronicle of Higher Educucation, August 2.

Gladwell, M. (2002). The tipping point:how little things can make a big difference.Boston: Little Brown. Glendon, M. A. (1994). Legal ethics: Worldsin collision. First Things, 21-27. Hesse H. (1957). Siddhartha. New York:New Directions. Lindauer, S. J., Peck, S. L., Tufekci, E.,Coffey, T., & Best, A. M. (2003). The crisisin orthodontic education: Goals and per-ceptions. American Journal of Orthodonticand Dentofacial Orthopedics, 124, 480-487. MacWilliams, B. (2001). Corruption, conflict,and budget cuts afflict academe in formerSoviet Republics: Few universities have the resources or the will to reform.Chronicle of Higher Education, December 14. Merton, T. (1993). Thoughts in solitude.Boston: Shambhala. No author (1997). The Nazi doctors andNuremberg: Some moral lessons revisited.Annals of Internal Medicine, 127, 307-308. No author (2000). Oral health in America: A report of the Surgeon General. Rockville,MD: U.S. Department of Health and HumanServices, National Institute of Dental andCraniofacial Research, National Institutesof Health. O’Donnell, J. J. (1998) Avatars of theword: From papyrus to cyberspace.Cambridge: Harvard University Press. Pirsig, R. M. (1984) Zen and the art ofmotorcycle maintenance: An inquiry intovalues. New York: Bantam Books. Postman, N. (1986). Amusing ourselves todeath: Public discourse in the age of showbusiness. New York: Penguin Books.Postman, N. (1994). The disappearance ofchildhood. New York: Vintage Books. Sternberg, R. J. (2002). It’s not what youknow, but how you use it: Teaching for wisdom. Chronicle of Higher Education,June 28.

46



Dental students admittedlywant to do well, in the financial and material sense; but they also want to do good, in the sense ofserving others, adhering tothe idealism that motivatedthem to become doctors in the first place.

Leonard A. Cohen, DDS, MPH, MS, and P. Ann Cotten, DPA, CPA

AbstractBackground and Objectives: Mostphysicians lack substantive training in dentistry and are usually not capable ofproviding definitive dental care. Therefore,physician offices are generally not themost appropriate site for the managementof most dental problems. This study was conducted to examine the rate withwhich patients visit physician offices forthe treatment of dental problems and theirsatisfaction with the treatment received.

Methods: Data on dental related problemswere collected through a random telephonesurvey of English-speaking Maryland residents over the age of 20. A randomdigit dial methodology was used to generatethe sampling frame. A total of 811 interviews were conducted. The overallsurvey has a margin of error of +/- 3.44%at the 95% confidence level.

Results: 5.6% of respondents reportedseeing a physician for a dental problemduring the prior year. Almost 80% reportedbeing satisfied with the treatment received,while 36.4% reported needing follow-upcare with a dentist for treatment of the sameproblem. Respondents expressing greatersatisfaction with their visit to the physicianwere less likely to report needing to see adentist for follow-up care (p<.05).

Conclusions: Additional studies are neededto assess the quality and appropriateness ofphysician management of dental problems.

Orofacial pain represents a significant public health problemaffecting approximately 39

million adults during any six-monthperiod in the United States (Lipton, Ship,& Larach-Robinson, 1993). Dental problems in general may result in dayslost from work and school, as well as bed rest days (National Center for HealthStatistics, 1996), and may significantly diminish the quality of life and disruptthe activities of daily living until resolved(Rosenberg, Kaplan, Senie, & Badner,1988; Kressin, Spiro, Bosse, Gracia, &Kazis, 1996). While seeking professionaldental services to address oral healthproblems may be an ordinary occurrencefor most persons, for some individualshaving access to dental care is anythingbut usual. Individuals without access to dentists in private practice are dispro-portionately poor and of minoritybackgrounds. In general, these groupsexperience greater frequency and severityof oral disease, and most frequently face cost and other barriers to access(National Institute of Dental Research,1987; Green, Person, Crowther, Frison,Shipp, Lee, & Martin, 2003; Manski,Moeller, & Maas, 2001; Brown, Wall, &Lazar, 2002; U.S. Department of Healthand Human Services, 2000; Stewart,Ortega, Dausey, & Rosenheck, 2002).

Individuals who lack access to private practice or community dentalservices may utilize hospital emergencydepartments (EDs) (Lewis, Lynch, &Johnston, 2003; Burt, & Schappert,2004; Graham, Webb, & Seale, 2000;Waldrop, Ho, & Reed, 2000; Cohen,

Manski, Magder, & Mullins, 2002) orphysician offices (Burt, & Schappert,2004; Riley, Gilbert, & Heft, 1999; Cohen,Manski, Magder, & Mullins, 2003) asalternative sources for the managementof toothaches and related conditions.During the period 1997-2000, dentalproblems represented 0.7% of all ED visits (Lewis, Lynch, & Johnston, 2003).During a similar period (1999-2000),dental-related problems accounted forapproximately 0.3% of all physicianoffice visits (Burt, & Schappert, 2004).

Unfortunately, EDs and physicianoffices are generally not the most appro-priate site for the management of mostdental problems. Many EDs do not generally provide dental services, andtherefore, are usually not capable of providing definitive dental care. Thesame is generally true of physicians,most of whom lack substantive trainingin dentistry. When definitive treatment isnot available, patients may have to returnfor re-treatment of the same condition(Pennycook, Makower, Brewer, Moulton,& Crawford, 1993; Burgess, Byers, &

47


Adult Patient Visits to Physicians for Dental Problems

Study: Medical Visits for Dental Problems

Dr. Cohen is Professor,Department of Health Promotionand Policy, University ofMaryland Dental School. Hemay be contacted at [email protected].

Dr. Cotten is Director,Schaefer Center for PublicPolicy, University of Baltimore,She may be contacted at [email protected].

The authors wish to acknowl-edge Christopher Scalchunes forassistance with data analysis.

Dworkin, 1990). Thus, although the use of EDs and physician offices for the treatment of dental problems is well documented, major gaps in our under-standing of these treatment patternsremain. “Oral Health in America: A Reportof the Surgeon General” commented onthe lack of data on physician-based servicesfor oral and craniofacial conditions (U.S. Department of Health and HumanServices, 2000). Furthermore, few, if any,studies have examined patient satisfactionwith the treatment received in physicians’offices for dental problems nor the needfor follow-up care by a dentist. The current study was undertaken to explorethese issues.

MethodsData for this research project were collected via telephone surveys withMaryland residents over the age of twentyconducted from November 27 throughDecember 16, 2004. Questions related todental problems were part of a largergeneral population survey. The sampleof potential respondents was generatedusing random digit dialing techniques.The sample was selected from all of theblocks of potential working phone num-bers in Maryland drawn from all listedand unlisted phone numbers, excludingcell phones. A total of eight hundredeleven people were interviewed. Theoverall survey has a margin of error of ±3.44% at the 95% confidence level.

The question about the source of thedental problem was unprompted andopen-ended. Reponses were later recodedinto appropriate categories to facilitate

analysis. The analysis contained in thisreport only reflects the responses ofthose individuals who responded to thequestions about dental problems.Statistics are calculated on the numberof respondents to each question. Pearsonchi-square was used to test for significance,when appropriate, except when cell sizewas less than five where a Fisher’s ExactTest was used. Where necessary, responsecategories were collapsed due to smallcell size. The research protocol wasreviewed by the University of MarylandBaltimore Office for Research Studiesand judged exempt from IRB review.

ResultsAmong all survey respondents, 5.6%(45/803) reported that they had seen aphysician or a medical doctor other thana dentist for a dental-related problemduring the prior twelve months. Table 1presents the demographic compositionof those respondents with dental-relatedmedical visits. The majority of theserespondents were female (71.1%) andWhite (69.8%). The largest percentagepossessed a graduate or professionaleducation (29.5%), were in the $50,000-$100,00 income range (32.4%), andwere in the age range 46-64 years of age(46.7%). Table 2 presents the percentageof all respondents who visited a medicalprovider for a dental-related problem by demographic characteristics. No statistically significant differences werenoted in the rate of visits to physiciansfor dental problems based on the respon-dent’s demographic background.

Respondents with dental-relatedphysician visits were asked to describethe nature of their dental problem. Themost frequent problem mentioned was“toothache” (26.7%). A surprisinglylarge percentage of the respondents(26.7%) reported that they did not knowor were not sure of the nature of theirdental problem. Next most frequently,“jaw joint pain,” was mentioned by 13.3%

48



Table 1.Demographic Compositions of Respondents with Dental-Related Medical Visits (%)

Medical Visits (n=45)

Gender: Male . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28.9Female . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71.1

Race: White, non-Hispanic . . . . . . . . . . . . . . . . . . . . . 69.8Black, non-Hispanic. . . . . . . . . . . . . . . . . . . . . . 20.9Hispanic . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.3Other . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7.0

Education: <High School . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.3High School/GED. . . . . . . . . . . . . . . . . . . . . . . . 27.3Some College/Technical School . . . . . . . . . . . . 20.5College. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20.5Graduate/Professional Education . . . . . . . . . . . 29.5

Income: <$25,000 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27.0$25,000–$50,000 . . . . . . . . . . . . . . . . . . . . . . . 29.7$50,000–$100,000. . . . . . . . . . . . . . . . . . . . . . . 32.4>$100,000 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10.8

Age: 21-30 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8.931-45 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24.446-64 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46.7>64. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20.0

of the respondents followed by “otherproblem” (8.9%), “painful oral sores”(6.7%), “face/cheek pain” (6.7%), “gingival problems” (6.7%), and “burning mouth” (4.4%).

Respondents with dental-problem-related physician visits next were askedto describe their level of satisfaction withthe treatment or advice they were given(Table 3). Only 20.4% indicated thatthey were somewhat/very dissatisfied,while 79.6% reported that they weresomewhat/very satisfied with the treat-ment received. Respondent level ofsatisfaction was not related to gender,education, or age. However, there was adefinite trend toward Whites reportinghigher levels of satisfaction (somewhat/very satisfied 89.7%) than Blacks (somewhat/very satisfied 57.1%, p=.07).Another trend showed satisfactionappearing to be related to respondentincome with individuals reporting annualincomes less than $25,000 expressing ahigher level of satisfaction (somewhat/very satisfied 100%) compared to indi-viduals earning greater that $25,000(somewhat/very satisfied 70.4%, p=.07).

Slightly more than one-third (36.4%)of the respondents who saw a physicianor medical doctor for a dental problemreported that following their visit to the physician they had to see a dentistfor treatment of the same problem.Respondents who expressed no need forfollow-up with a dentist were more likelyto report being satisfied with the visit tothe physician (92.9% versus 64.3%,p<.05) (Table 3). The natures of therespondents’ dental problems were notrelated to the need for follow-up with adentist. A comparison of the demographiccharacteristics of these respondentsrevealed no association with respondentgender, education, or income. Blacks,however, exhibited a trend toward being

49



Table 2.Percentage of Respondents Who Visited a Medical Provider for a Dental Problem by Demographic Characteristics

No Dental Visits Dental Visits

Overall: .........................................................................5.6 ...........................94.4

Gender: Male ................................................................4.7 ...........................95.3Female.............................................................6.1 ...........................93.9

Race: White, non-Hispanic .......................................5.4 ...........................94.6Black, non-Hispanic ........................................5.0 ...........................95.0Hispanic...........................................................6.3 ...........................93.7Other................................................................8.6 ...........................91.4

Education: <High School ...................................................2.5 ...........................97.5High School/GED ............................................5.7 ...........................94.3Some College/Technical School .....................4.1 ...........................95.9College ............................................................4.9 ...........................95.1Graduate/Professional Education...................9.2 ...........................90.8

Income: <$25,000..........................................................7.0 ...........................93.0$25,000 - $50,000 ..........................................6.8 ...........................93.2$50,000 - $100,000 .........................................4.9 ...........................95.1>$100,00..........................................................3.0 ...........................97.0

Age: 21-30 ...............................................................6.0 ...........................94.031-45 ...............................................................5.2 ...........................94.846-64 ...............................................................6.2 ...........................93.8>64...................................................................4.9 ...........................95.1

Table 3.Percentage of Respondents With a Dental-Related Visit to a Physician Who Were Satisfied With the Visit by Demographic Characteristics and Need for Dental Follow-up

Somewhat/ Somewhat/ Very Satisfied Very Dissatisfied

Overall: .............................................................79.6 ...........................20.4

Gender: Male.....................................................83.3 ...........................16.7Female .................................................76.0 ...........................24.0

Race: White, non-Hispanic............................89.7 ...........................10.3Black, non-Hispanic .............................57.1 ...........................42.9

Education: High School or less..............................84.6 ...........................15.4Some College or more.........................76.7 ...........................23.3

Income: <$25,000 ............................................100.0 .............................0.0>$25,000 ..............................................70.4 ...........................29.6

Age: 21-45....................................................73.3 ...........................26.7>45 .......................................................82.1 ...........................17.9

Need for Dental Yes .......................................................64.3 ...........................35.7Followup:* No ........................................................92.9 .............................7.1

*p<.05

more likely to report needing a follow-upvisit with a dentist for their problemthan did Whites (71.4% versus 26.7%,p=.07). Finally, younger respondents(ages 21-45) were significantly morelikely to report needing a follow-up visitwith a dentist than were those over theage of 45 (53.3% versus 21.4%, p<.05).

DiscussionThis study had several limitations.Although the survey sample was drawnfrom all potential working phone num-bers in Maryland, people without atelephone and people who only use cellphones were excluded from the samplepopulation. In addition, the relativelysmall sample size limited the ability toexplore demographic correlates of visitsto physicians for dental problems,patient satisfaction with the servicesreceived, as well as the need for follow-upcare with a dentist. As such, the statisticalanalyses examining these relationshipsshould be interpreted with caution. The study does, however, present newfindings documenting the frequency ofdental-problem-related patient visits to physicians as well as previously unreported overall findings concerningpatient satisfaction and need for follow-upservices from a dentist.

In the United States during 1995,there were approximately seven hundredmillion total patient visits to physicianoffices which represented 81% of allambulatory visits (Schappert, 1997).This figure had increased to eight hundred ninety million visits by 2002(Woodwell & Cherry, 2004), with visitsfor dental-related problems representingapproximately 0.3% of all physicianoffice visits (Burt & Schappert, 2004). In the present study, approximately 5.6%of the respondents reported that they

had visited a physician for a dental problem during the prior twelve months.This compares to the much largerapproximately 40% of the U. S. populationthat visits a dentist during the year(Manski, Moeller, & Maas, 2001). Datafrom the 1989 National Health InterviewStudy (NHIS) indicated that 21.8% ofindividuals over the age of seventeen inthe U.S. civilian population experiencedorofacial pain symptoms over a six-monthperiod (Lipton, Ship, & Larach-Robinson,1993). Although the findings from theNHIS survey obviously are not directlycomparable to the present study, theysuggest that approximately 10% of individuals suffering from acute dentalsymptoms may seek assistance from aphysician for their dental problem. As wasthe case in the NHIS study, toothachesrepresented the most frequently citedproblem among Maryland respondents(26.7% versus 12.2% in NHIS). Also similar to the findings in the NHIS study, where females experienced thehighest prevalence of orofacial pain,females in the present study were mostlikely to report visiting a physician for dental problems.

There were no statistically significantdifferences in the rate of visits to physiciansbased on the respondent’s demographicbackground. An association might havebeen expected because, as previouslymentioned, the poor and minoritiesexperience a higher level of oral disease(Green, Person, Crowther, Frison, Shipp,Lee, & Martin, 2003; Manski, Moeller, &Maas, 2001; Brown, Wall, & Lazar, 2002),and frequently face cost and other accessbarriers (National Institute of DentalResearch, 1987; U.S. Department ofHealth and Human Services, 2000;Stewart, Ortega, Dausey, & Rosenheck,2002). Differences in physician utilizationassociated with respondent race andincome may have been obfuscated bythe small sample size. Nevertheless, ageneral comparison of the frequency ofvisits to physicians for dental problems

with that of visits to dentists in general(U.S. Department of Health and HumanServices, 2000) revealed, as would beexpected, a much lower rate of visits forall demographic groups, but a similarpattern as regards higher visit rates forfemales, those better educated, and thenon-elderly. However, unlike the generalpattern of dental services utilization,Hispanics as compared to Whites, andthose with lower incomes as comparedto those with higher incomes, exhibitedhigher rates of visits to physicians fordental problems. Inasmuch as incomeand education are generally directly correlated, the paradox of a seeminglyhigher rate of visits to physicians byrespondents with both greater educationand low income was unexpected.

Over three-quarters of the respondents(79.6%) reported satisfaction with thetreatment they had received. Althoughno comparative studies are available,empirically this level of satisfactionappears quite high. The trend suggestingthat Whites were more satisfied thanBlacks with the care received is consistentwith national data reflecting patient satisfaction. However, the trend showinglower income individuals to be more satisfied than higher income individualscontradicts national reports (U.S. Depart-ment of Health and Human Services,2004). Patient satisfaction with treatmentis closely associated with the patient’sperception of the quality of the doctor-patient relationship (Speedling & Rose,1985; Mataki, 2000; Kress & Shulman,1997). Inasmuch as the quality of therelationship has been linked with thequality of the communication betweenthe physician and patient (Mellor &Milgrom, 1995; Newsome & Wright,1999), it appears that these patientswere generally approving of their communications with their physicians.

50



Approximately one-third of therespondents sought follow-up care fortheir dental problem from a dentist following their physician visit. Thus, itappears that approximately two-thirds of the respondents may have receivedeffective treatment for their problem orthe problem resolved itself. It might havebeen expected that respondents seekingfollow-up would have disproportionatelyrepresented patients presenting withtoothaches, since these individuals mightbe thought to be most likely to need theservices of a dentist to achieve resolutionof their dental problem (Pennycook,Makower, Brewer, Moulton, & Crawford,1993; Burgess, Byers, & Dworkin, 1990).This, however, was not the case. Thehigher rates of dentist follow-up experi-enced by Black respondents appear to be consistent with national data thatreflect greater dental morbidity andhigher toothache rates among Blacks(U.S. Department of Health and HumanServices, 2000). As might be expected,respondents seeking follow-up care weremore likely to have been dissatisfiedwith the care received from their physician. This dissatisfaction may have resulted from the fact that theirexpectations for obtaining relief for their dental problem were not met(Newsome & Wright, 1999).

Although physicians can providecare for dental problems, they often are not capable of providing definitivetreatment. As such, physician offices are not generally considered the mostappropriate setting for the treatment ofdental problems. Most physicians havereceived only minimal training in themanagement of dental-related problems(Pennycook, Makower, Brewer, Moulton,& Crawford, 1993; Burgess, Byers, &Dworkin, 1990). Nevertheless, therespondents in the present study wereoverwhelmingly satisfied with the carethey received. Several authors have provided guidance to physicians in the

management of dental problems (Comer,Caughman, Fitchie, & Gilbert, 1989;Clark, Album, & Lloyd, 1995; Pyle &Terezhalmy, 1995; Venugopal, Kulkarni,Neruker, & Patnekar, 1998; Drum, Chen,& Duffy, 1998). In recognition of thisneed, the General Medical ServicesCommittee of the British MedicalAssociation published guidelines on themanagement of dental problems(General Medical Services Committee,1994). Guidelines have been shown toassist physicians in dealing with dentalproblems in the hospital emergency roomsetting (Ma, Lindsell, Jauch, & Pancioli,2004). Further studies are needed toassess the quality and appropriateness of physician’s management of dentalproblems. ■

REFERENCESBaker, B. (1987). Emergency dental treatmentfor the family physician. Canadian FamilyPhysician, 33, 1521-1524.Brown, L. J., Wall, T. P., & Lazar, V. (2002).Trends in caries among adults 18 to 45years old. Journal of the American DentalAssociation, 133, 827-834.Burgess, J., Byers, M. R., Dworkin, S. F.(1990). Pain of dental and intraoral origin.In J. J. Bonica (Ed.), The management ofpain, 1. Philadelphia, PA: Lea and Febiger.Burt, C. W., & Schappert, S. M. (2004).Ambulatory care visits to physician offices,hospital outpatient departments, and emergency departments: United States,1999-2000. National Center for HealthStatistics. Vital Health Stat, 13, 157. Clark, M. M., Album, M. M., & Lloyd, R.W.(1995). Medical care of the dental patient.American Family Physician, 52, 1126-1132.Cohen, L. A., Manski, R. J., Magder, L. S.,& Mullins, C. D. (2002). Dental visits tohospital emergency departments by adultsreceiving Medicaid: Assessing their use.Journal of the American DentalAssociation, 133, 715-724.Cohen, L. A., Manski, R. J., Magder, L. S.,& Mullins, C. D. (2003). A Medicaid popu-lation’s use of physicians’ offices for dentalproblems. Journal of the American PublicHealth Association, 93, 1297-1301.

Comer, R. W., Caughman, W. F., Fitchie, J. G., & Gilbert, B. O. (1989). Dental emergencies, management by the primarycare physician. Postgraduate Medicine, 85,63-66, 69-70, 77.Drum, M. A., Chen, D. W., & Duffy, R. E.(1998). Filling the gap: Equity and access to oral health services for minorities andthe underserved. Family Medicine, 30, 206-209.General Medical Services Committee(1994). Patients presenting with dentalproblems. London: British MedicalAssociation.Graham, D. B., Webb, M. D., & Seale, N. S. (2000). Pediatric emergency room visits for nontraumatic dental disease.American Academy of Pediatric Dentistry,22, 134-140.Green, B. L., Person, S., Crowther, M.,Frison, S., Shipp, M., Lee, P., & Martin, M. (2003). Demographic and geographicvariations of oral health among AfricanAmericans. Community Dental Health, 20,117-122.Kress, G., & Shulman, J. D. (1997).Consumer satisfaction with dental care:Where have we been, where are wegoing? Journal of the American College ofDentists, 64, 9-15.Kressin, N., Spiro, A., Bosse, R., Gracia, R.,& Kazis, L. (1996).Assessing oral healthquality of life: Findings from the normativeaging study. Medical Care, 34, 416-427. Lewis, C., Lynch, H., Johnston, B. (2003).Dental complaints in emergency depart-ments: A national perspective. Annals ofEmergency Medicine, 42, 93-99.Lipton, J. A., Ship, J. A., & Larach-Robinson, D. (1993). Estimated prevalenceand distribution of reported orofacial painin the United States. Journal of theAmerican Dental Association, 124, 115-121.Ma, M., Lindsell, C. J., Jauch, E. C., &Pancioli, A. M. (2004). Effect of educationand guidelines for treatment of uncompli-cated dental pain on patient and providerbehavior. Annals of Emergency Medicine,44, 323-329. Manski, R.J., Moeller, J. F., & Maas, W. R.(2001). Dental services: An analysis of utilization over 20 years. Journal of theAmerican Dental Association, 132, 655-664.

51



Mataki, S. (2000). Patient-dentist relation-ship. Journal of Medical Dental Sciences,47, 209-214.Mellor, A., & Milgrom, P. (1995). Dentists’attitudes toward frustrating visits:Relationship to satisfaction and malprac-tice complaints. Community Dentistry andOral Epidemiology, 23, 15-19.National Center for Health Statistics(1996). Current estimates from theNational Health Interview Survey, 1996.Series 10, no. 200. Hyattsville, MD: U.S.Public Health Service; 1996.National Institute of Dental Research(1987). Oral health of United States adults:The national survey of oral health in U.S.employed adults and seniors 1985-1986.National findings. NIH Publication No. 87-2868. Washington, DC: U.S. GovernmentPrinting Office.Newsome, P. R. H., & Wright, G. H. (1999).A review of patient satisfaction: 2. Dentalpatient satisfaction: An appraisal of recentliterature. British Dental Journal, 186, 166-170.Pennycook, A., Makower, R., Brewer, A.,Moulton, C., & Crawford, R. (1993). The management of dental problems pre-senting to an accident and emergencydepartment. Journal of the Royal Societyof Medicine, 86, 702-703. Pyle, M. A., & Terezhalmy, G. T. (1995). Oral disease in the geriatric patient: Thephysician’s role. Cleveland Clinic Journal of Medicine, 62, 218-226.Riley, J. L., Gilbert, G. H., & Heft, M. W.(1999). Health care utilization by olderadults in response to painful orofacialsymptoms. Pain, 81, 67-75.Rosenberg, D., Kaplan, S., Senie, R., &Badner, V. (1988). Relationship among dental functional status, clinical dentalmeasures, and generic health measures.Journal of Dental Education, 52, 653-657.Schappert, S. M. (1997). Ambulatory care visits to physician offices, hospitaloutpatient departments, and emergencydepartments: United States, 1995. NationalCenter for Health Statistics. Vital HealthStat, 13, 129. Speedling, E. J., & Rose, D. N. (1985).Building an effective doctor-patient relationship: From patient satisfaction topatient participation. Social Science inMedicine, 21, 115-120.

Stewart, D. C. L., Ortega, A. N., Dausey, D.,& Rosenheck, R. (2002). Oral health and useof dental services among Hispanics. Journalof Public Health Dentistry, 62, 84-91.U.S. Department of Health and HumanServices (2000). Oral health in America: Areport of the Surgeon General. Rockville,MD: U.S. Department of Health and HumanServices, National Institute of Dental andCraniofacial Research, National Institutesof Health, 2000.U.S. Department of Health and HumanServices (2004). National healthcare dis-parities report. Agency for HealthcareResearch and Quality, Rockville, MD. AHQRPublication No. 05-0014.

Venugopal, T., Kulkarni, V. S., Neruker, R.A.,& Patnekar, P. N. (1998). Role of pediatricianin dental caries. Indian Journal of Pediatrics,65, 85-88. Waldrop, R. D., Ho, B., & Reed, S. (2000).Increasing frequency of dental patients inthe urban ED. American Journal ofEmergency Medicine, 18, 687-689.Woodwell, D. A., & Cherry, D. K. (2004).National ambulatory medical care survey:2002 summary. Advanced data from vitaland health statistics; no 346. Hyattsville,MD: National Center for Health Statistics.

52



Technical Glossary

Editor’s note: In an effort to make research papers that contain technical concepts more“user friendly,” the Journal will attach a technical glossary to those paperswhere it seems useful.

The Margin of Error is X%.

Wherever surveys are conducted there is an opportunity for error. When it isreported that 60% of individuals surveyedfavor this policy or that, the actual proportion might be a bit higher or a bit lower. It is customary for public pollsters and the media to simply state a percentage error— x%, ± y.

The actual situation is a bit more compli-cated that this. First, the margin of errorstatement is understood as shorthand for the statement, “If you say that theaverage response was x%, with a marginof error of y% you will be correct aboutz% of the time.” It is convention to set y at 95%.

There is a simple formula for calculatingthis value, and it depends on threethings: 1) how large the sample is, 2)whether the proportions tend to be closeto 50:50 or at extreme values (such as5% versus 95%), and 3) how confidentone wants to be.

Larger samples produce smaller errorranges. Suppose a sample of four individ-ual was evenly split between two

alternatives. The reported probabilitywould be .50 ± .49. That is a huge marginof error and not much help. If the samplesize is increased to 20 (keeping the pro-portion at .50), the margin or error dropsto 22%. With sample sizes of 150, theerror is 8%; and with a sample of 1000,the error rate drops to less than 1%.

This example was based on an assumptionthat the proportion favoring a statementis roughly equal to the proportion takingthe opposite view. When the proportionsare unequal (almost all in favor or almostall opposed), the error range decreases.Using the sample sizes of 4, 20, 150, and1000, the error on a 95% versus 5% splitwould be 21%, 10%, 3%, and almostnothing. Of course the errors are not symmetrical, despite the tradition to treatthem as such. A proportion of 95% with a 10% plus error rate is nonsense. If situations such as this arise, there aresophisticated methods for getting aroundthe problem. In practical terms, it isunwise to use this kind of data for making decisions.

If one can live with greater than 95% certainty in making claims about surveyresults, the error ranges can be shortened.At a 90% chance of reporting a correctvalue, the error range is only 75% aswide. If more confidence is desired, say99%, the error ranges are about halfagain as large.

David W. Chambers, EdM, MBA, PhD, FACD Let me begin with a story. In a place

called Ithaca, some three thousandyears ago, a lad named Telemachus

came of age while his father was absent.In the process of becoming a young man he had help and he had detractors.Most simply ignored him in their owneagerness to get ahead. A few felt virtuousand lectured him about what they mighthave done themselves if they had beenas good as their word. There were somewho sought his economic harm andspread rumors to damage his reputation.This latter group knew that the daywould soon come when Telemachuswould be old enough to challenge them.There was also an old family friend who showed the boy what it meant to be strong, wise, and virtuous. WhenOdysseus, the boy’s father, returned from the Trojan wars, the careers of thedetractors were terminated violently.History failed to record the names ofthose who ignored or lectured Telemachus—which is really all they deserve. Homernamed the detractors who stood in theway in his epic Odyssey, but they are notrecalled fondly today. Only the moremature man who showed the young boyhow to become a king is rememberedthrough the ages. His name was Mentor,and he alone touched the future.

This is a contemporaneous story,and every professional today has anopportunity to make the timeless choice.Many will be too busy with their ownaffairs to give much thought to how theyoung men and women coming intodentistry will matter. Some will preach

at them a little and expect that schoolsor parents should do their duties. Therewill always be a handful who badmouththe coming generations as being under-trained and improperly respectful oftraditional values. These are the oneswho will fight their younger colleaguesfor the future of the profession—and thesmart money is always on youth. Thereare also dentists who encourage, workwith, guide, nurture, reveal secrets to,earn the privilege of scolding, and want to see the success of their juniorcolleagues. Perhaps they share a fewpatients when new dentists move totown, introduce them at professionalmeetings, answer a question late oneevening about a difficult case, or suggesta trustworthy accountant. The olderpractitioners may not know all thenewest materials or pharmacology, butthey can teach a level of quality that isfar above the standard of care. Theywant the new guy or gal in town to succeed because he or she will thusblend the best of the emerging disciplineof dentistry with the deep traditions ofprofessionalism that cannot be learnedfrom a few years in dental school or a CE course. These dentists who touchthe future are called mentors.

What and Why of MentoringMentoring is a long-term relationshipthat permits the professional growth ofboth an experienced individual and a

53


Mentoring

Leadership

junior colleague. The bond matters, butits purpose is not social; both parties areexpected to be transformed. And theprocess takes place in a professional context—it is for a purpose that colleagueswould approve. Johnson and Riles capture the essence of the relationship:“Mentors provide protégés with knowl-edge, advice, counsel, support, andopportunity in the protégé’s pursuit offull membership in a particular profession.Mentoring is an act of generativity—aprocess of bringing into existence andpassing on a professional legacy.” Someadditional characteristics that help identify true mentoring include voluntaryengagement (in both directions), mutu-ality, reflection, regular and prolonged(but generally informal) interaction,empowerment and development of both parties, absolute individuality andcustomization, and absence of a curricu-lum or generic path to be followed.

As valuable as a quick appearancebefore students might be, teaching is notmentoring. Teaching aims to provideknowledge and the instructor is assuredprotection from being changed by his or her students. CE gurus are seldommistaken for mentors; if dental schoolfaculty members are mentioned in this way, it is always because of a relationship that existed outside of thelecture hall. Coaching, often used as asynonym, differs from mentoringbecause the goal is group performance,not individual development. Personal

trainers come closest to mentors, butthey engage in hopes of financial returnand seldom share a common professionalidentification with those they train.Consultants are also unlikely to be confused with mentors.

Research has shown that protégéscan expect to benefit from mentoring inthe following ways: accelerated careermobility, improved professional identity,greater professional competence,increased career satisfaction, morefinancial success, greater acceptancewithin the profession, and decreasedcareer and life stress. They are also morelikely to become mentors themselves.The mutuality of mentoring is supportedin research demonstrating internal satisfaction and fulfillment, enhancedcreativity and professional synergy,career and personal rejuvenation, devel-opment of a loyal support base, esteemfrom peers, and the pleasure of shapingthe future of the profession for mentors.Mentoring is professionally sanctionedbecause it leads to greater productivityand competence, enhanced commitmentto the profession, and early identificationand development of future leaders.

How Mentoring WorksOn the Greek island of Cos, just milesfrom present-day Turkey, two schools ofmedicine flourished in the fifth centuryB.C. At one end of the island, the CnidianSchool believed that medicine involvedidentifying and treating diseases.Patients were the medium in which disease manifested itself, and patientswere treated only in a secondary sense.

54


Leadership

There will always be ahandful who badmouth thecoming generations asbeing under-trained andimproperly respectful of traditional values. Theseare the ones who will fighttheir younger colleaguesfor the future of the profession—and the smartmoney is always on youth.

At the other end of the island, those inthe Hippocratic School argued that thejob of the healer is to assist in reestab-lishing the natural balances in patientsthat allow them to heal themselves.

Understanding this fundamental difference in the approach to a helpingprofession is critical to getting a grip on mentoring. Cnidians and theirdescendents prefer an approach basedon telling others what to do—very rational, very arms-length and uninvolved.Those in the Hippocratic tradition understand what it means to say thatmentoring is based on establishing arelationship in which others can grow.In fact, the Hippocratic Oath containsthe sentence, “If any son of my colleaguewill come to me I will teach him theArt.” These words should cause some onthe CE circuit to blush.

The essence of mentoring is capturedin the Irish saying, “It doesn’t matter howtall your father is, you have to do yourown growing.” Mentoring is creating the conditions that support maximalprofessional growth. On that basis, wecan develop some of the approaches togood mentoring. Knowing the answersand being persuasive will not appear on the list.

Matching UpMentors are almost never one’s boss;that is a complicating dual relationship.Spontaneous pairings of mentors andprotégés work better than assigned pairings. The protégé must recognize a

blend of competence, power, openness,and safety in the mentor. The mentormust be perceived to have already takenthe journal that the protégé proposes, or at least to have taken parts of it. Buthe or she must also be a good travelingcompanion, demonstrating warmth,good listening skills, trustworthiness,interpersonal sensitivity, respect for values, and even humor. From the mentor’s side, an ideal protégé haspotential that can be developed. They area promising investment in the future ofthe profession. The mentor must be ableto say with conviction, “The professionwill be better when I retire if I work withthis young man or women than if I workwith others or if I work with none.” Notethat the investment is in the profession;when mentors seek to clone themselves,mentoring becomes hideous.

The early stages of a mentoring relationship should include explorationand discussion. One of the best meansfor determining compatibility is to talkabout dreams. Without significant over-lap in a common future, the mentoringproject will come unraveled. If there isharmony at this level, the means forrealizing these dreams should be dis-cussed. How often the meetings shouldtake place and where, what each partyshould do, which topics are on the tableand which are not, how progress will bemeasured, a mutual commitment tohonesty and candor, and an expectationto work at the project for about four orfive years should all be part of the con-versation. Although mentoring is alwayscustom work, it is inviting unnecessary

surprises not to have these frank discus-sions up front. If either party finds thistoo awkward, ending before startingmight be the wise move. Research hasshown that parties feel more comfortablein mentor-protégé relationships that areof the same sex or ethnic mix but theyare not necessarily more effective. The critical determinant of a good relationship is squaring the expectationsat the outset.

The Protégé’s Journey Anyone who has ever been a parent, orperhaps taught in a residency program,understands the delicate balance requiredto support another’s growth. Some ofthe required skills are discussed below.

Acceptance and support are essential.A mentor helps the protégé articulate his or her dream and then blesses it. The support should be unconditional.That doesn’t mean that the protégé ispraised for every action, including thegoofs and vapid moves. It does meanthat through it all the protégé can count on the mentor to attentive andaffirming of his or her younger colleagueas a person. Mentors who know theirprotégés well can acknowledge fears andfailures while preserving the person and their promise.

Sponsor the protégé. Be seen withthem at important events and withimportant people. Recommend them tothose who can help and open doors forthem. Broadcast their triumphs. Give

55


Leadership

them important assignments in the profession. Guide them to the resourcesthey need. Point out which prizes areworth pursuing and show them whocan be trusted and who might not betrustworthy—and teach them how todetermine these things for themselves.

Protégés, especially as they begin tohit their stride, deserve to be challenged.By matching challenges to the level ofthe protégé’s competence, mentors guidedevelopment. It is a gradual process thatmay call for a scaffolding of safety fromtime to time. Challenges should bematched with high expectations forexcellence. Protégés should not have toguess what constitutes excellence,whether excellence is expected of them,or whether their mentor believes theyare capable of achieving excellence.

Mentors should model the behaviorsprotégés need to learn. They can demon-strate both dental and interpersonalaccomplishment. They should also gobeyond and reveal the complexity andbalance they have achieved in their ownlives. A single-dimension mentor isquickly recognized as shallow and has to resort to “do as I say and not as I do.”It helps if protégés can hear reflectionsfrom the mentor on why they are doingthe things they do, what the critical cuesare to monitor, what counts as success,and even that all outcomes may not be successful but each provides anopportunity to learn.

There is a difference between judging(seldom helpful) and providing feedback(very necessary). In the first case, one isexpressing a personal point of view; inthe second, information is provided thatwill help the protégé perform better infuture. Feedback involves calling attentionto gaps in performance outcomes andstandards and invites a discussion of howthis cam about. Occasionally, a mentorwill misunderstand the importance ofimmediately, clearly, and forcefully con-fronting career-damaging, unprofessional,or destructive habits on the part of theprotégé. “That is personal,” they say tothemselves. Wrong; the mentor-protégérelationship sanctioned by a professionalgroup makes questionable personalbehavior a central concern. There is no part of mentoring that is moreimportant than challenging a protégé tobuild sound values.

It is important that mentors knowwhen to disclose personal informationabout themselves and when that is inappropriate. The test is whether theself-discloser helps the protégé. Someindividuals abuse the mentor-protégérelationship by using the younger colleague as a forced audience. The mentor is most valuable when they disclose personal examples of their coping with issues rather than theirmastery of circumstances.

Some mentors are naturals at reflective narration; many are not. Theskill involves weaving little stories that contains observations about theprotégé’s behavior and the context inwhich they occur. It is a way of making

situations meaningful. A mentor mightsay, for example, “I noticed that you heldyour counsel in the board meeting whenforeign licensure was being discussed. I can remember a few years ago whenyou would have been at the microphoneevery five minutes presenting logicalarguments that no one wanted to hear. I think you are showing some maturity inknowing that this issue has already beendecided and there’s no point in collectingenemies.” There is no finer gift that aperson with wisdom and perspective can give a young colleague than to putcomplex and novel insights into wordswhich can be taken home to ponder.

Managing the RelationshipMentoring relationships are complex;they do not always run true. Of course,they require time, and one of the vulnerabilities to which any process thatunfolds over four or five years is subjectis loss of interest or inconsistency inmeetings and follow-through, especiallyon the part of the busy mentor.

But it is the emotional aspects ofmanaging a relationship that are typicallymost challenging. On occasion, romanticor sexual or pathological involvementsdevelop in mentor-protégé relationships,just as they do in other close pairings. It even happens that mentors areaccused of these when they are quiteinnocent of everything except the needto document unusual behavior and seekoutside professional help at the earliest

56


Leadership

The older practitionersmay not know all thenewest materials or pharmacology, but theycan teach a level of quality that is far abovethe standard of care.

warnings. When the protégé fails conspicuously or commits some self-defeating or unethical gaff, the mentorsuffers guilt by association.

Some degree of idealization is to beexpected in the healthiest of processes. It is best to expect it, but not commenton it. It is also to be expected that thementor will grow initially to a verystrong power position with respect tothe protégé. Again, this can be expected,but should be recognized tacitly andnothing more. Emotional attachmentand friendship, on the other hand arenormal and healthy. If the mentor is not joyous over the protégé’s accomplish-ments and if a mutual frankness andinterest in small details of each other’spersonal life fail to emerge, it is a warningthat the relationship is souring.

One of the sayings engraved at theDelphic oracle in ancient Greece is generally translated as “know yourself.”A preferred translation would be “knowyour place.” Mentoring is not for every-one. The essential trait is self-awarenessor authenticity, in the sense that mentor-ing only makes sense as a naturalextension of who one really is. If indulgedin as a form of ego aggrandizement, itwill spill failure and perhaps disgrace.Mentors must be able to “walk the talk.”Their actions, their descriptions, andtheir motives must all be congruent.When they say, “I believe you will makea difference to the profession some dayand I am willing to work with you onthat,” they had better mean it all the way through.

Concluding the Relationships The mentoring relationship is like an airplane trip. It must come to an end, it ishoped, just at and not before its plannedtime. There is a built-in mechanism inmentoring that brings most of them toconclusion in four or five years. It happensbecause the protégé grows faster thenthe mentor and because their worldchanges around them. A longer relation-ship should be viewed as suspicious ofpathology. The goal of mentoring is tocreate a peer, not a dependent.

It is unfortunate when successfulmentor-protégé relationships just driftapart. They should be celebrated. A dinner or other formal occasion wouldbe nice. The mentor should summarizethe accomplishments of the protégé—agrand reflective narrative—and shouldofficially recognize the colleague as afully-fledged peer. The former protégéshould say thank you. At that point theprofession will stand higher than it didpreviously. That is worth celebrating.

A SuggestionPerhaps the American College of Dentistscan take a leadership role in supportingmentors among its Fellows who willinfuse the values of the College into theyoung men and women entering theprofession. We know the value of thisactivity; we know how to do it; and noone could do it better.

Here is how it might work. InterestedSections would ask schools in their areas to provide the names of graduateswith the highest potential for future leadership and would recruit fromamong Fellows those willing to considerbecoming mentors. Perhaps the youngmen and women could be invited to aSection dinner meeting to facilitate possible pairings.

The Central Office would provide amanual for mentors, outlining the goalsof mentoring, suggestions such as thosethat appear in this essay, and suggestedactivities. Examples might include visitsto each others’ offices, sponsorship atCollege meetings, attending professionalmeetings together, and an occasionalbreakfast or lunch. Each activity wouldcarry a predetermined point value.

As Fellows accumulate points for theirwork, they would receive recognitionfrom the College, culminating at somepoint in awarding of a pen of recognitionand confirming of the formal designation“Mentor of the College.” In the meantimethe professional would have beenenriched and there would be a cadre ofemerging leaders from which to recruitnew Fellows to the College. ■

57


Leadership

The mentor must be ableto say with conviction,“the profession will bebetter when I retire if Iwork with this young man or women.”

Recommended Reading

Summaries are available for the threerecommended readings marked byasterisks. Each is about eight pageslong and conveys both the tone andcontent of the original source throughextensive quotations. These summariesare designed for busy readers whowant the essence of these references infifteen minutes rather than five hours.Summaries are available from theACD Executive Offices in Gaithersburg.A donation to the ACD Foundation of$15 is suggested for the set of summarieson generations; a donation of $50would bring you summaries for all the2006 leadership topics.

Brounstein, Marty (2000). Coaching & Mentoring forDummies.*New York: Wiley. ISBN 0-7645-5223-6;328 pages; about $20.

Coaching is defined as the sum of all the skills that develop others; mentoringis the one of these that focuses on self-development of others. Shift frommanager as a doer to manager as a coach.Full of practical ideas, this book is easyto follow—it is essentially a fat outline.

W. Brad Johnson and Charles R. Riley.(2004).The Elements of Mentoring.*New York: Palgrave Macmillan. ISBN 1-4039-6401-7; 146 pages; about $22.

Mentoring is a multi-year relationshipdesigned to promote professionalgrowth, for both the protégé and thementor. The book is modeled on Strunkand White’s classic, The Elements ofStyle, that has taught generations of students to write clearly. Each of thefifty-seven “elements” of mentoring isprefaced with a short case, followed bytwo or three pages of narrative and threeto six actionable recommendations.Johnson teaches at the U.S. NavalAcademy and Johns Hopkins University;Ridley teaches at Indiana University andworks as a consultant. The book is short,clear, and rich. It would make a nice gift.

Zachary, Lois J. (2000).The Mentor’s Guide:Facilitating Effective LearningRelationships.*San Francisco: Jossey-Bass. ISBN 0-7879-4742-3; 197 pages; about $25.

Mentoring is defined with a twist—to becentered on personal learning of thementee, with a specific nod toward thepersonal growth of the mentor. Filledwith lots of “nice sounding words” andworksheets, the text seldom goes beyondthe surface. Perhaps this is intended as aworkbook for a course. The author is aconsultant and trainer, specializing inleadership development and coaching.

58


Leadership

American College of Dentists839J Quince Orchard BoulevardGaithersburg, MD 20878-1614

Periodicals PostagePAID

at Gaithersburg, MD

journal of the american college of dentists · 2018-10-09 · eric k. curtis, dds kent w. fletcher...

Documents