Anti-gingivitis effect of a dentifricecontaining bioactive glass(NovaMin

s

) particulateTai BJ, Bian Z, Jiang H, Greenspan DC, Zhong J, Clark AE, Du MQ. Anti-gingivitiseffect of a dentifrice containing bioactive glass (NovaMin

s

) particulate. J ClinPeriodontol 2006; 33: 8691. doi: 10.1111/j.1600-051X.2005.00876.x. r BlackwellMunksgaard 2006.

AbstractBackground: The objective of this pilot clinical trial was to evaluate the anti-gingivitis and anti-plaque effects of a dentifrice containing bioactive glass(NovaMin

s

) compared with a placebo control dentifrice in a 6 weeks clinical study.

Methods: The study design was a randomized, double-blinded, controlled clinicaltrial. One hundred volunteers took part in the study and were matched for plaque index(PLI), gingival bleeding index (GBI), age and gender. The protocol was reviewed andapproved by the Ethical Committee of the University. The subjects received asupragingival prophylaxis to remove all plaque, calculus and extrinsic stain. Followingthe baseline examination, subjects were instructed to brush with their assigneddentifrice and toothbrush. The PLI and GBI were determined for the baseline and 6weeks. The data were analysed using a repeated-measures ANOVA conducted on the twodependent measures to compare the effect between the test and control group.

Results: Ninety-five subjects finished the study. The results showed that the PLI(baseline5 1.54, 6 weeks5 1.29) and GBI (baseline5 1.14, 6 weeks5 0.47) weresignificantly reduced, respectively, over the 6 weeks period in the test group (po0.001for each measure). There was a 58.8% reduction in gingival bleeding and a 16.4%reduction in plaque growth. There was no difference of the PLI (baseline5 1.60, 6weeks5 1.57) and GBI (baseline5 1.18, 6-week5 1.02) over the 6 week period in thecontrol group.

Conclusion: This study demonstrated that a dentifrice containing NovaMins

significantly improves oral health as measured by a reduction in gingival bleeding andreduction in supragingival plaque compared with a negative dentifrice over the 6weeks study period.

Key words: anti-gingivitis, anti-plaque,bioactive glass.

Accepted for publication 24 October 2005

Maintenance of gingival health is criti-cal in preventing gingivitis and its pro-gression into periodontal disease. Arecent survey of periodontal healthreported that as many as 62% of theadult population in the United Statessuffers from gingivitis as determinedby gingival bleeding (Brown et al.1996). A similar study conducted inthe United Kingdom reported that over70% of adults had visible plaque onexamination (Morris et al. 2002).The control of plaque in the main-

tenance of gingival health has been well

established in the literature (Axelsson &Lindhe 1981, Cobb 1996). The role ofplaque-associated bacteria in the devel-opment of gingivitis has also been stu-died extensively (Smulow et al. 1983,Dahlen et al. 1992, Marsh 1992,McNabb et al. 1992). Smulow et al.(1983) demonstrated that professionalplaque control had a significant influ-ence on subgingival bacterial levels.McNabb et al. (1992) and Hellstrom etal. (1996) showed that rigorous self-performed plaque control over long per-iods of time reduced the levels and

composition of subgingival bacteriaand reduced the frequency of deepperiodontal pockets.Owing to the established relationship

between bacteria, plaque and gingivitis,a major focus in the treatment of gingi-vitis in recent years has been thedevelopment and use of various anti-microbial therapies. Chlorhexidine (Cla-vero et al. 2003, Santos et al. 2004),triclosan/co-polymer (Rosling et al.1997, Nogeira-Filho et al. 2000, Volpeet al. 2002, Cullinan et al. 2003) andhexetidine (Sharma et al. 2003) have all

Bao Jun Tai1, Zhuan Bian1,Han Jiang1, David C. Greenspan2,Jipin Zhong2, Arthur E. Clark3

and Min Quan Du1,4

1School of Stomatology, Wuhan University,

Wuhan, China; 2NovaMin Technology Inc.,

Alachua, FL, USA; 3College of Dentistry,

University of Florida, Gainesville, FL, USA;4Key Laboratory of Oral Biomedical

Engineering, Wuhan University, Ministry of

Education, Wuhan, China

J Clin Periodontol 2006; 33: 8691 doi: 10.1111/j.1600-051X.2005.00876.x Copyright r Blackwell Munksgaard 2006

86

been shown to reduce plaque and gingi-vitis in various clinical studies. Essentialoil-containing mouthrinses have alsodemonstrated reductions in plaque andgingivitis in clinical studies (Lush et al.1974, Charles et al. 2004, Sharma et al.2004). Many of these clinical studieshave demonstrated improvements inindices of gingival health, which havebeen ascribed to the anti-microbial prop-erties of the various compounds. Rosl-ing et al. (1997) showed an effect of atriclosan-containing dentifrice on thenumber of subgingival microbiota overa 3-year period, although these effectswere limited to only a few of the speciesevaluated. In a short-term clinical study,Adams et al. (2003) showed a significantreduction in the viability of plaquebacteria in a triclosan/zinc formulationcompared with a triclosan/polymer tooth-paste containing no zinc. In a review ofclinical data for two chemotherapeuticmouthwashes, Santos (2003) concludedthat studies demonstrated a clinical ben-efit in reducing plaque and gingivitis andresulted in a lowering of the total micro-bial flora without changing the microbialcomposition of supragingival plaque.There has also been a significant body

of in vitro research that has demon-strated anti-microbial properties of thesecompounds. In a study comparing theanti-microbial efficacy of a triclosan/zinc dentifrice, Finney et al. (2003)found a broad spectrum of anti-micro-bial activity against a mixed biofilm.Shapiro et al. (2002) demonstrated asignificant reduction in microbial loadfor 12 different mouthrinse products in amixed biofilm model.Bioactive glasses (NovaMin

s

, Nova-Min Technology, Alachua, FL, USA)have been used in bone and tissueregeneration for over 15 years (Wilsonet al. 1993, Lovelace et al. 1998).Recently, anti-microbial propertiesinherent in these materials have beendescribed (Stoor et al. 1998, Allan et al.2001, 2002). One of these compositionshas recently been formulated into adentifrice and has demonstrated stronganti-microbial behaviour in vitro(Greenspan et al. 2004). While the exactmechanisms of the anti-microbial activ-ity have not yet been fully established, itis likely that the high rate of ionicrelease and local changes in oral pHseem to play a major role.This double-blind, placebo-con-

trolled, pilot clinical study was designedto test the hypothesis that the anti-microbial effects of NovaMin

s

shown

in vitro when incorporated into a dailyuse dentifrice could improve the indicesof gingival health in a general popula-tion with no periodontitis.

Material and Methods

The study was a randomized, double-blind, parallel group clinical trial com-paring experimental dentifrice with anactive NovaMin

s

to a placebo formula-tion. The protocol for the study wasreviewed and approved by the MedicalEthical Committee of Wuhan University.All volunteers provided written informedconsent for participation in the study.The study was conducted and monitoredin accordance with the guidelines forGood Clinical Practice. Two hundredvolunteers from the local populationwere recruited for the study through localadvertising and clinical patients from theclinics at Wuhan University. One hun-dred qualified volunteers were acceptedinto the study.The inclusion criteria required patients

to be at least 18 years of age, in goodgeneral health, with a minimum of 20scorable teeth, no visible signs ofuntreated caries and in good generalhealth. Exclusion criteria includedpatients who received antibiotics oranti-inflammatory therapy within 14days of the baseline examination orwere on long-term antibiotic or anti-inflammatory therapy, patients who hadperiodontal pockets in excess of 4mm,no partial dentures or clinically unaccep-table restorations or bridges, pregnant orlactating women and patients with remo-vable dentures (partial or full).Sample size calculations were based

on detecting a difference of 0.3 in plaquescore between the test group and thecontrol group using a two-tailed signifi-cance level of 5% with a 90% power.The Silness and Loe plaque index (PLI)was used in this study (Silness & Loe1964). An average plaque score wascalculated for each patient by summingthe individual plaque scores for eachtooth and dividing by the total numberof sites scored for each subject. From theindividual scores, mean group PLI scoreswere calculated. Gingival bleeding index(GBI, Ainamo & Bay 1975) was calcu-lated for all teeth of each subject bysumming the individual GBI scores anddividing that sum by the number of sitesgraded for each subject. These measure-ments were conducted at baseline andat 6-week recall visits. A two by two

(treatment: test material, placebo) bytwo (time period: baseline, 6 weeks)repeated-measures ANOVA analysis wasconducted on two dependent measures,PLI and GBI. Means and SDs from theseanalyses are reported. Statistical analysisof the data was performed using SPSSVersion 10 (SPSS, Chicago, IL, USA).A complete clinical oral assessment

was carried out including measurementof PLI and GBI at baseline and after6 weeks. The assessments included themesial, buccal, distal and lingualsurfaces for plaque after using a pla-que-disclosing treatment (Chrom-O-Reddisclosing solution, Germiphene, Brant-ford, ON, Canada) and mesio-buccal,buccal and disto-lingual surfaces forgingival bleeding, which were recorded30 s after running a probe along thegingival margin. A single examiner per-formed all clinical measurements for theclinical study. There was no calibrationof the examiner prior to the study.Screening prior to acceptance into thestudy was conducted for each subject.Complete medical and dental historywas reviewed, and examination of theoral mucosa, teeth and periodontiumwas performed.Patients accepted into the study

returned for a baseline examination.Patients were told not to perform anyoral hygiene (including chewing gum)for 8 h prior to the baseline and 6 weeksexamination. Patients were assessed forplaque using the PLI and gingival inflam-mation using GBI, as well as for oralsoft-tissue status. Following the assess-ments, all subjects received a supragingi-val prophylaxis and polishing to removeplaque, calculus and extrinsic stain.After prophylaxis, patients were

instructed on the proper brushing tech-nique and were given either the testdentifrice (non-aqueous toothpaste con-taining 5% NovaMin

s

) or a placeboformulation (non-aqueous toothpastewithout NovaMin

s

) along with a diaryto record product usage and daily oralhygiene activities. The abrasivity ofboth dentifrices were similar: the rela-tive dentin abrasivity (RDA) of theactive was 130 7.3, and the RDA ofthe placebo was 114 5.8 (data on fileat NovaMin Technology Inc., Alachua,FL, USA). The test and control denti-frices were dispensed to subjects by adental assistant not involved in thestudy. The two products were also simi-lar in terms of their taste, texture andcolour. All products were packaged inplain white tubes (50 g each) labelled

Anti-gingivitis effect of a dentifrice 87

only with lot numbers to insure properblinding of the product from the patientsand an examiner. Subjects were alsogiven a soft bristled toothbrush to useduring the clinical study. Subjects wereassigned to one of the toothpastes usinga computer-generated randomizationnumbering scheme. Subjects were askedto refrain from all other unassignedforms of oral hygiene, including non-study toothbrushes or toothpastes, dentalfloss, chewing gum or oral rinses duringthe study. At 6 weeks, subjects wererecalled and gingival index and PLIwere evaluated. At the conclusion ofthe study, all study materials werereturned to the study director.

Results

A total of 200 students were screenedand 100 subjects were enrolled, with 50subjects per product group. A total of 95patients completed the study. All diariesto record product usage and daily oralhygiene activities were retreived, andinformation violating rules of the studywere not found. Five subjects did notcomplete the study because of personalor medical reasons unrelated to the useof study toothpastes. No adverse eventswere recorded or observed during thestudy. The demographic data for thesubjects completing the study are shownin Table 1.Table 2 shows the mean values and

SDs of the PLI for all subjects whocompleted the study. The differencesbetween the test group and the controlgroup at baseline were not statisticallysignificant. The PLI was reduced

significantly (po0.05) in the test groupafter 6 weeks of product use. The reduc-tion in the test group was 16.4%. Therewere no statistically significant differ-ences in the PLI of the control groupbetween baseline and 6-week measure-ments (p40.05). At the 6-week timeperiod, the reduction in PLI in the testgroup was significantly greater(po0.025) compared with that in thecontrol group (Fig. 1).Table 3 shows the mean and SDs for

the GBI data for all subjects who com-pleted the study. The differencesbetween the test group and the controlgroup at baseline were not statisticallysignificant. The GBI was significantlyreduced in the test group comparedwith the baseline after 6 weeks of pro-duct use (po0.001). The reduction inGBI in the test group after 6 weeks was

58.8%. There were no statistically sig-nificant differences between the baselineand 6-week data for the placebo tooth-paste group (p40.05). Comparison ofthe two groups at the 6-week time pointshowed significantly greater reduction inGBI for the test group compared with thecontrol group (po0.001) (Fig. 2).

Discussion

The purpose of this pilot clinical studywas to evaluate the effect of a newbioactive glass-containing dentifrice onthe gingival health of an adult popula-tion with moderate gingivitis. The mate-rial was incorporated into a non-aqueousdentifrice formulation without fluorideand contained 5% by weight of thebioactive glass. The results demonstrateda significant reduction in GBI (58.8%)over a 6-week period of twice daily use,and a statistically significant reduction inPLI (16.4%) over that same period. Inboth cases, there was a statistically sig-nificant difference in both the PLI(po0.025) and GBI (po0.001) betweenthe NovaMin

s

test group and the controlgroup at the 6-week time point.The lack of any appreciable reduc-

tion in either the PLI or GBI in thecontrol group in this study was some-what surprising. Many previous tooth-

Table 1. Demographic data of the subjects

Test group Control group

n 47 48Female 22 25Male 25 23Age (mean) 34.5 38.6Standard deviation 8.8 10.1

Table 2. Effects on plaque index (PLI) at twotime periods (means and standard deviations)

Testgroup

Controlgroup

Subjects 47 48Baseline 1.54 (0.34) 1.60 (0.37)6 weeks 1.29 (0.40) 1.57 (0.41)Mean difference(baseline6 weeks)

0.25 (0.08) 0.03 (0.09)

Baseline6 weeks po0.001 p40.05

00.20.40.60.8

11.21.41.61.8

Baseline 6 weeksTime Period

Plaq

ue In

dex

(PLI)

Test Material Placebo

Toothpaste Effects on Plaque Index

Fig. 1. Results of the plaque index (PLI)measurements at baseline and 6 weeks.There was no statistical difference betweengroups at baseline, and the test group hadsignificantly lower PLI at 6 weeks comparedwith the control group (po0.001). Therewas also a significant decrease in PLI ofthe test group at 6 weeks compared withbaseline (po0.001), while there was nosignificant decrease in PLI for the controlgroup between baseline and 6 weeks. Theerror bars represent the standard error of themean.

Table 3. Effects on gingival bleeding (GBI) attwo time periods (means and standard devia-tions)

Testgroup

Controlgroup

Subjects 47 48Baseline 1.14 (0.79) 1.18 (0.71)6 weeks 0.47 (0.36) 1.02 (0.56)Mean difference(baseline6 weeks)

0.67 (0.15) 0.16 (0.15)

Baseline6 weeks po0.001 p40.05

Toothpaste Effects on Gingival Bleeding

0

0.2

0.4

0.6

0.8

1

1.2

1.4

Baseline 6 weeksTime Period

Gin

giva

l Ble

edin

g (G

BI)

Test Material Placebo

Fig. 2. Results of the gingival bleedingindex (GBI) measurements at baseline and6 weeks. There was no statistical differencebetween groups at baseline, and the testgroup had significantly lower GBI comparedwith the control group at 6 weeks(po0.001). There was also a significantdecrease in GBI of the test group at 6 weekscompared with baseline (po0.001), whilethere was no significant decrease in GBI forthe control group between baseline and 6weeks. The error bars represent the standarderror of the mean.

88 Tai et al.

brushing studies looking at gingivalhealth and plaque reduction have shownsignificant treatment effects in the con-trol groups (Owens et al. 1997, Heas-man et al. 1999, McCracken et al. 2000).These effects have been attributed to thewell-known Hawthorne effect. This phe-nomenon was first described by Mayo(1933) and is related to the fact thatparticipants in a study will improve theirperformance regardless of any change incondition. In the current clinical study, itwas expected that there would have beensome improvement in the indices of thecontrol group because of this effect, but itwas not seen, even though all patientsreceived the same toothbrushing instruc-tions at the baseline examination.While the mechanical control of den-

tal plaque has been clearly shown toretard the advance of gingivitis andperiodontal disease (Axelsson & Lindhe1981, Wilson et al. 1987). Axelsson &Lindhe (1981) reported that non-com-pliant patients exhibited signs of recur-rent disease processes. Owing to theinconsistency of simple mechanical con-trol of plaque accumulation, a numberof chemotherapeutic agents have beenincorporated into home use products tocontrol plaque and gingivitis. These agentshave generally been incorporated intoeither mouthrinses or toothpastes. Themain action of these agents has beenfocused on their anti-microbial action.There have been a number of active

ingredients incorporated into variousdentifrices. Triclosan/co-polymer denti-frices with or without zinc citrate havebeen studied extensively for their anti-plaque and anti-gingivitis effectiveness.Tricolsan is a phenolic agent comprisedof bisphenol and a non-ionic germicide(DeVizio & Davies 2004). Lindhe et al.(1993) reported on the results of a6-month clinical trial comparing a tri-closan/co-polymer dentifrice with afluoride-containing dentifrice and foundthat the triclosan group had more plaquereduction and resolution of gingivitisthan the regular fluoride dentifricegroup. Studies including long-term clin-ical trials (Rosling et al. 1997), short-term experimental gingivitis models(Nogeira-Filho et al. 2000) and short-term randomized clinical studies (Volpeet al. 2002) have demonstrated signifi-cant reductions in plaque and gingivitisfrom about 20% to as high as 60%.Stannous fluoride has also been incor-

porated into various dentifrice composi-tions. Stannous fluoride is a broadspectrum anti-microbial agent. There

were a number of clinical studies con-ducted in the 1990s demonstrating theclinical efficacy of the material in theprevention and reduction of gingivitis.Perlich showed that a stabilized, 0.454%stannous fluoride dentifrice was superiorto a NaF control in reducing gingivalbleeding and gingival index, but not inplaque reduction of plaque (Perlich et al.1995). In a 9-month comparative clin-ical study using both stannous fluoridedentifrices and mouthrinses in combina-tion, Mengel et al. (1996) demonstratedstatistically significant reductions in gin-gival and plaque indices for an amine/stannous fluoride regimen over NaFcontrols. In a clinical study comparinga stabilized stannous fluoride dentifricewith a triclosan/co-polymer dentifrice,McClanahan showed significant efficacyin the reduction of both gingivitis andgingival bleeding as well as statisticallygreater reductions in those parameterscompared with the triclosan/co-polymerdentifrice (McClanahan et al. 1997).However, tooth staining and formula-tion challenges prevented wide accep-tance of the material.More recently, Archila et al. (2004)

compared a stabilized stannous fluoride/sodium hexamethaphosphate dentifricewith a triclosan-containing dentifrice asa control and found that the experimen-tal group had statistically significantlyless gingivitis and less bleeding than thecontrol group. Mankodi et al. (2005)published work on a 6-month clinicaltrial with a stabilized 0.454% stannousfluoride/sodium hexametaphosphatedentifrice and showed a 21.7% reduc-tion in gingivitis, 57.1% reduction inGBIs and 6.9% less plaque versus afluoride dentifrice.Early clinical studies using 0.2%

chlorhexedine mouthrinses demon-strated an anti-plaque/anti-gingivitiseffectiveness of chlorhexidine as anadjunct to normal daily oral hygiene(Loe et al. 1976, Lang et al. 1982).However, undesirable side effectsincluding tooth staining and alterationof taste perception led to the use oflower concentrations of the anti-micro-bial agent. Charles et al. (2004) andothers have demonstrated in clinicalstudies that reducing the concentrationof chlorhexidine to 0.12% while effec-tive at reducing plaque and gingivitisstill resulted in tooth staining and calcu-lus deposition in the group using thechlorhexidine mouthrinse.Essential oil mouthrinses have also

been shown to possess some effective-

ness against plaque and gingivitis. Astudy comparing a 0.12% chlorhexidinemouthrinse (Peridex

s

, Zila Technical,Phoenix, AZ, USA) with an essentialoil mouthrinse (Listerine

s

, Pfizer, NewYork, NY, USA) showed comparablereductions in both plaque (21.6% and18.8%, respectively) and gingival index(18% and 14%, respectively). Sharma etal. (2004) showed that an essential oilmouthrinse in conjunction with regularbrushing and flossing provided a signif-icant reduction in plaque and gingivitisover brushing and flossing alone.Although bioactive glasses have been

used in bone regenerative surgeries forover 15 years, it is only recently that theinherent anti-microbial properties ofthese materials have been studied. Stooret al. (1998) first published results ofexposure of planktonic organismsknown to be involved in the progressionof gingivitis and periodontitis to parti-culate bioactive glass compositions. Inthese studies, it was found that exposureof a 40% solution of bioactive glass tothe cultures for 10min. resulted in a 3log reduction in Actinobacillus actino-mycetemcomitans and total loss of via-bility of the organism with a 60min.exposure. Similar results were found inPorphyromonas gingivalis. Actinomycesnaeslundii lost total viability in a10min. exposure to the bioactive glassas did Streptococus mutans. Allan et al.(2001), using particulates of bioactiveglass (designated 45S5 Bioglass

s

,USBiomaterials Corp., Alachua, FL,USA) with a size range from 300 to500mm, showed an antibacterial effectagainst S. mutans, S. sanguis, P. gingi-valis, Furobacterium nucleatum, A.actinomycetemcomitans and Prevotellaintermedia with a 1-h exposure to theparticulates. The percentage kill rangedfrom 51% against S. mutans to 100%kill of P. intermedia. Allan ascribedmuch of the effect of the bacterial killto an increase in pH of the bioactiveglass in solution, although it appearsthat the release of large quantities ofcalcium from the bioactive glass mightalso play a role in the observed beha-viour towards the microbes. Allan et al.(2001) also studied this compositionagainst mixed species biofilms derivedfrom human saliva and found that theviability of the biofilms exposed tothe bioactive glass was significantlyreduced compared with biofilmsexposed to a bio-inert glass. One of theauthors recently showed that fine parti-culate bioactive glass (NovaMin

s

)

Anti-gingivitis effect of a dentifrice 89

incorporated into a non-aqueous denti-frice was able to reduce the viability ofplanktonic bacterial cultures of S.mutans, F. nucleatum, A. naeslundiiand S. sanguis. A 2-min. exposure to a1:3 dilution of both 3% and 10% bioac-tive glass-containing dentifrice reducedthe viability of these organisms by 4.5log against F. nucleatum to total loss ofviability of the S. sanguis culture.A study conducted to determine the

inflammatory properties of these 5mmbioactive glass particulates was under-taken by Rectenwald et al. (2002), usinga mouse intra-peritoneal model toactivate macrophage activity. Theresults of this study showed that thebioactive glass particles actually attenu-ated the pro-inflammatory responseagainst an endotoxin challenge. Theresults showed an up-regulation of inter-leukin (IL)-6 without a concomitantincrease in either IL-1b or IL-10.The study included a toxic shock modelthat showed an attenuation of serumlevels of tumour necrosis factor(TNF)-a of 60% in animals dosed withthe bioactive glass particulates com-pared with controls. In a clinical studyevaluating the anti-inflammatory effectsof bioactive glass bone graft materialplaced in periodontal defects, Han et al.(2002) found that crevicular elastaseproduction in crevicular fluid was sig-nificantly lower in bioactive glass-grafted sites compared with root planingand debridement sites. The authors con-cluded that the lower elastase levelswere an indication of less tissue destruc-tion and lower inflammation at the sites.In the current clinical study, there

were statistically significant reductionsin both the PLI (16%) and GBI (58%).The abrasivity of both the test andcontrol toothpastes used in this studywas similar, and well within the accep-table range for daily-use dentifrices. Ifthe results presented in this study weresolely due to the mechanical removal ofplaque, then one would have expectedthere to be no differences between theactive toothpaste and the control tooth-paste. The fact that there was a 16.5%reduction in PLI and an even greaterpercentage reduction in GBI forthe active toothpaste suggests that theaction was more than just mecha-nical. Eberhard et al. (2004) recentlypublished the results of an experimentalgingivitis clinical study using a slurry ofbioactive glass particulates. While hedid not see any significant reductionsin microbial activity as a result of the

application of the bioactive glass parti-culate, there was an attenuation of theclinical signs of inflammation, and therewas a reduction in the measured IL-1b,although no significance was given.Recently, Xu et al. (2004) reviewed theproperties of triclosan-containing denti-frices and ascribed at least some of thebenefit of reduction of gingivitis of thecompound to anti-inflammatory properties.In the current study, a prophylaxis

was performed after baseline measure-ments to bring the plaque levels to auniformly low state, ideally close tozero. The results after the 6-week eva-luation showed a complete re-growth ofplaque in the control group to baselinelevels before prophylaxis. In the experi-mental group there was statistically lessplaque at 6 weeks than at baseline,although the GBI was substantiallyreduced (on a percentage of baseline)when compared with the PLI. Thisdifference in the overall changes in theindices further suggests that there mightbe some anti-inflammatory componentto the experimental formulation that isresponsible for the reduction in GBIcompared with the plaque reduction.The results of the current study

demonstrated a significant reductionin gingivitis in a relatively short periodof time. There were no adverse eventsreported with the use of the material.To our knowledge, this is the first timethat a dentifrice that does not containantibiotics and/or fluoride has beenshown to have a therapeutic effect ongingival health. Further clinical studiesare required to determine the long-termeffectiveness of this new compound.Additional studies should also be under-taken to determine if there will beany build-up of microbial resistance,and whether the reductions seen in thebleeding index in this study are due to amodification of the plaque compositioneither in amount or species of bacteria,or merely a reduction in the overallplaque level. While plaque presencehas almost universally been associatedwith the development of gingivitis, itmay be that plaque can exist without theprogression of the disease.

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Address:

Min Quan Du

Key Laboratory of Oral Biomedical Engineering

Wuhan University

Ministry of Education

65 Luoyu Road, Wuhan, 430079

China

E-mail: duminquan@hotmail.com

Clinical Relevance Statement

The control of plaque in the main-tenance of gingival health has beenwell established. Rigorous self-per-formed plaque control over long per-iods of time is known to reduce thelevels and composition of the sub-

gingival bacteria. The relationshipbetween bacteria, plaque and gingi-vitis in recent years has led to a focuson anti-microbial therapies for thetreatment of gingivitis and perio-dontitis. This paper introduces theclinician to a compound that has

been used in bone and tissue regen-eration, and that possesses inherentanti-microbial properties that mayprove useful in the treatment of gin-givitis.

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