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189Indian Journal of Clinical Practice, Vol. 21, No. 4, September 2010

ORIGINAL STUDY

he color of the teeth is determined by a

combination of the intrinsic color and the

presence of any extrinsic stains that may

form on the teeth.1 Discoloration of the teeth is

a common dental complaint in most populations.

Several treatment options are available to enhance thecolor of the teeth; these include whitening toothpaste,

professional cleaning to remove stain, bleaching agents,

bleaching strips, bleaching pen, bleaching gel and laser

bleaching.2,3As teeth whitening has become a routine

dental procedure, its quantification and efficacy have

been recognized and are of great concern in esthetic

dentistry. Te color of teeth varies from individual

to individual. Some have lighter shades of teeth than

others naturally, while others have darker shades. Signs

of discoloration include yellow, discolored, stained

or dark spotted teeth. Causes for teeth discolorationvary; consumption of certain types of food and drink

such as coffee, tea and red wine can stain teeth. Foods

that normally change color when exposed to air such

as cherries, pomegranates and blueberries can also

contribute to teeth discoloration. Unhealthy habits

like smoking or chewing tobacco can also stain the

teeth. Poor dental hygiene, which is represented by

inadequate flossing and brushing, is another cause forteeth discoloration. High fluoride content - present in

drinking water of some areas and in some oral hygiene

products such as mouthwashes - can cause staining of

the teeth, producing a mottled appearance. In children,

antibiotics such as tetracycline and doxycycline may

lead to intrinsic discoloration of the teeth.

Certain medical therapies such as radiation and

chemotherapy for cancer treatment tend to affect both

the enamel and the dentin layers and can be responsible

for teeth discoloration. Also, certain dental procedures

such as amalgam restorations that contain silver mayresult in the teeth turning to gray color. With time

and age, the teeth accumulate more stains and tartars,

causing it to look dull and discolored. In addition, as

people grow older, the enamel that protects the teeth gets

eroded, revealing the underlying deeper yellow color of

dentin.4-7 In individuals above 35 years, teeth become

darker and redder except in the cervical region, where

they become more yellow.5 Studies have shown that

women have lighter and lesser yellow teeth than men.7-9

*Principal, Ramaiah Dental College, Bangalore**Head, Medical Services and Clinical rialsR&D Center, Te Himalaya Drug Company, Makali, BangaloreAddress for correspondenceDr Pralhad S PatkiHead, Medical Services and Clinical rialsR&D Center, Te Himalaya Drug CompanyMakali, Bangalore - 562 123E-mail: [email protected]

ABSTRACT

Te present study was conducted to evaluate the efficacy and safety of HiOra-Shine toothpaste in individuals with yellow

discolored teeth. Fifty individuals of either sex, aged above 18 years, with yellow discolored teeth and who were willing to give

the informed consent were included in the study. Included subjects were given HiOra-Shine toothpaste and advised to brush

twice-daily for six weeks. Follow-up was done at intervals of two weeks for a period of six weeks. Subjects were evaluated for

response to the treatment such as reduction in discoloration of the teeth, cleansing effect and overall impression. Statistical

analysis was done by repeated measures of ANOVA using Friedmans test followed by Dunnetts multiple comparison test.

Minimum level of significance was fixed at p< 0.05. Results of the study showed a significant reduction in yellow discoloration

of the teeth in individuals treated with HiOra-Shine toothpaste. Te overall response to the treatment was good in almost

all the individuals. No adverse reactions were either reported or observed during the entire study period and the overall

compliance to the treatment was good. Terefore, it can be concluded that HiOra-Shine toothpaste is effective and safe inindividuals with yellow discolored teeth.

Key words: HiOra-Shine, teeth discoloration, herbal whitening toothpaste

Efficacy and Safety of HiOra-Shine Toothpaste inYellow Discolored Teeth

HN Shama Rao*, Pralhad S Patki**


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ORIGINAL STUDY

190 Indian Journal of Clinical Practice, Vol. 21, No. 4 , September 2010

Tere has been a major increase in the demand

for dental esthetic treatments, including teeth

whitening. raditionally, dentists determine the color

of the human teeth by a visual comparison with

a reference standard set called a shade guide. It is asubjective process whereby the tooth and the shade

guide are observed simultaneously under the same

lighting conditions.10,11

A recent trend observed in tooth bleaching has been

the development of at-home treatments.12A growing

number of products have entered the market, including

low-cost over-the-counter bleaching systems of different

concentrations that are easy to apply. Tey do not

require a customized tray and therefore the patients

no longer feel the need to be treated by a professional

dentist.13

raditionally, at-home whitening is done with

bleaching gel, which is applied to the teeth using

thin guard trays. At-home whitening can also be

done by applying small strips that go over the front

teeth. Oxidizing agents such as hydrogen peroxide or

carbamide peroxide are used to lighten the shade of

the teeth.

HiOra-Shine is a herbal whitening toothpaste

containing potent herbs, such as Symplocos racemosa,

Vitis vinifera, Cinnamomum zeylanicum, Syzygium

aromaticum, Ananas comosus andCarica papaya,which

are known to reduce yellow teeth discoloration.

Aim of the Study

Te aim of the present study was to evaluate the

efficacy and safety of HiOra-Shine toothpaste in

the management of yellow teeth discoloration.

Material and Methods

An open clinical study was conducted on patients

with yellow discoloration of teeth at Ramaiah Dental

College, Bangalore between May 2009 and June 2010

after getting approval from the Institutional Ethics

Committee. A written informed consent was obtained

from the patients and they were informed of the

voluntary nature of the trial.

Inclusion Criteria

Individuals of either sex aged above 18 years presentingwith visible stains on half of their teeth, at least on

eight anterior teeth, without restorations were included

in the study provided they were not wearing any oralprostheses, not having any inadequate restorations oruntreated caries, able to attend the clinic on all the

assessment visits, willing to give the informed consent,and willing to comply with the study procedures.

Exclusion Criteria

Individuals with serious systemic or oral diseases,oral ulceration and known sensitivity/allergy to oral

hygiene products were excluded from the study. Also,pregnant or lactating women, individuals who had

participated in a similar trial during the previous threemonths, and those who were not ready to provide

informed consent or comply with the study procedureswere excluded from the study.

Study Procedure

Fifty individuals, aged between 22 and 50 years, with

teeth discoloration were included in the study. Te

demographic details of these individuals are listed in

able 1. All the patients were advised to brush their

teeth with HiOra-Shine toothpaste twice-daily for

a period of six weeks. Details of the frequency ofbrushing are given in able 2. Patients were told to

restrict themselves to the given treatment for their

Table 1. Demographic Details

Parameters Details

No. of cases studied 50

Age (y) 35.90 10.60

Male:Female 34:26

Duration of discoloration (mo) 12.30 6.80

Vegetarian: Mixed 12:38Chewing tobacco (no. of cases) 20

Chewing betel nut (no. of cases) 32

Table 2. Frequency of Brushing

Parameter Specifcations Number of

subjects

Frequency of

brushing

Once-daily 24

Twice-daily 26


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ORIGINAL STUDY


teeth discoloration complaint and resort to no other

active treatment during the study period.

All adverse events, either reported or observed bypatients, were recorded with information about

severity, duration and action taken regarding the studydrug. Relation of adverse events to study medicationwas predefined as Unrelated (a reaction that doesnot follow a reasonable temporal sequence from theadministration of the drug),Possible (follows a knownresponse pattern to the suspected drug, but could havebeen produced by the patients clinical state or othermodes of therapy administered to the patient), andProbable (follows a known response pattern to thesuspected drug that could not be reasonably explainedby the known characteristics of the patients clinical

state). Subjects were allowed to voluntarily withdrawfrom the study, if they experienced any seriousdiscomfort during the study or sustained seriousclinical events requiring specific treatment. All the 50enrolled individuals completed the study.

Follow-up and Assessment

Response to therapy was evaluated, on a visual analog

scale of 0-10 from no yellow discoloration to yellow

discoloration in an increasing pattern, at intervals of

two weeks for a period of six weeks. Te criteria

for evaluation included signs and symptoms such as

reduction in discoloration of teeth, cleansing effect,

and the overall impression. Te scoring was in turn

correlated with the overall response to the treatment

using a 5-point scale as follows:

Grade Response

0 No improvement

1 Poor: 75% reduction

Primary and Secondary End Points

Te predefined primary end point was improvement

in the whiteness of the teeth and predefined secondary

end points were occurrence of any adverse events and

compliance to the therapy.

Statistical Analysis

Statistical analysis was done by repeated measures of

ANOVA using Friedmans test followed by Dunnetts

multiple comparison test or Fishers exact test. Values are

expressed as mean SD. Minimum level of significance

was fixed at p < 0.05. Analysis was done using GraphPad

Prism Software, Version 4.03 for Windows (GraphPad

Software, San Diego, California, United States).

Results

Results of the study indicated that individuals treated

with HiOra-Shine toothpaste showed significant

whitening of the teeth. Forty-one individuals repor-

ted the color of the sample to be pleasant, 40 reported

the taste to be satisfactory, 28 reported the foaming

effect to be excellent and 45 reported the freshness to

be refreshing even hours after brushing.

Results of the study also indicated that there was a

significant reduction in the discoloration of the teethfrom the second week of treatment with a score of

3.96 1.65 (p < 0.001). With further treatment, the

score improved to 2.10 1.43 (at fourth week) and

0.76 0.95 (at sixth week) (p < 0.0001) with 86.27%

protection. Discoloration of the teeth was not reduced

in six individuals in whom a history of tobacco and

betel nut chewing was observed. Te cleansing effect

was found to be significant in 47 cases with 94%

effect at the end of six weeks (able 3).

Te overall response to the treatment was expressed asexcellent by 20 cases, good by 15 cases and satisfactory

Table 3. Overall Response at the End of Treatment

Parameters At entry 2 weeks 4 weeks 6 weeks Protection at

sixth week (%)

Visual analog score (0-10) Yellow discolored teeth 6.48 1.50 3.96 1.65* 2.10 1.43** 0.76 0.95** 86.27

No. of cases Cleansing effect 0 36** 44** 47** 94

*p < 0.001 as compared to the at entry values.

**p < 0.0001 as compared to the at entry values.


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ORIGINAL STUDY

192 Indian Journal of Clinical Practice, Vol. 21, No. 4 , September 2010

by 11 cases (able 4). None of the individuals

complained of irritation, erythema or peeling of the oral

mucosa membrane. Tere were no clinically significant

adverse reactions, either reported or observed, during

the entire study period and the overall compliance to

the treatment was excellent.

Discussion

Te effectiveness of toothpastes in reducing or remov-

ing extrinsic dental stain has improved with time. A

key feature of whitening toothpastes is the presence

of proteolytic enzymes, which remove extrinsic stains

from the teeth. In the present study, a significant

whitening effect was observed in individuals treated

with HiOra-Shine toothpaste. Tis effect can be

attributed to the potent herbs such as S. racemosa,V. vinifera, C. zeylanicum, S. aromaticum, A. comosus

andC. papayapresent in the formulation.

S. racemosais known to exhibit antimicrobial activity as

shown by the zone of inhibition of Propionibacterium

acnes and Staphylococcus epidermidis.14 It is also found

to possess antioxidant and antitumor activities.15

Seeds of V. vinifera, which are rich sources of

polyphenolic compounds, are known to possess

antioxidant and antimicrobial activities. Several studies

have shown that V. vinifera seed extract possessessignificant antimicrobial activity against two oral

anaerobes closely associated with periodontal diseases.

Te extract exhibited high EAC (rolox-equivalent

antioxidant capacity assay) values and greater anti-

oxidant capacity than vitamins C and E.16

S. aromaticum has antifungal, antiviral, analgesic/

anesthetic, antiseptic, anticoagulant, antimicrobial,17

and antioxidant properties. Te oil of the herb is

generally used by dentists as an oral anesthetic for

toothaches.

C. zeylanicumhas antibacterial, antioxidant, antiseptic,

and anti-inflammatory properties.18,19

Te enzyme complex of A. comosus called bromelainis known for its antibiotic and anti-inflammatory

properties. Te mechanism of action of bromelain

relates in part to its modulation of the arachidonate

cascade.20

Papain (also known as papaya proteinase I), a cysteine

protease enzyme present in C. papaya, is used as aningredient in some toothpastes and mints as teeth

whitener. Te use of a papain-based gel to remove

dental caries did not interfere in the bond strength of

restorative materials to dentin.21

Conclusion

From the above findings, it can be concluded thatHiOra-Shine toothpaste significantly improved yellow

discoloration of teeth. No adverse reactions were

either reported or observed during the entire study

period and the overall compliance to the treatmentwas excellent. Terefore, it can be concluded that

HiOra-Shine toothpaste is effective and safe in

individuals with discolored teeth.

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Table 4. Overall Effect of the Treatment

Parameters Number of

subjects

Percentage

of cases

Excellent 20 39.21

Good 15 29.41

Satisfactory 11 21.57

Poor/not happy 02 3.92

No improvement 03 5.88


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ORIGINAL STUDY


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Esan A, Olusile AO, Akeredolu PA. Factors influencingtooth shade selection for completely edentulous patients.J Contemp Dent Pract 2006;7(5):80-7.

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Lee R, Balick MJ. Sweet wood - cinnamon and itsimportance as a spice and medicine. Explore (NY)2005;1(1):61-4.

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