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1 Efficacy and Safety of HiOra-Shine Toothpaste in Yellow Discolored Teeth HN Shama Rao*, Pralhad S Patki** Abstract The 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 Friedman s test followed by Dunnett s multiple comparison test. Minimum level of significance was fixed at p < Results of the study showed a significant reduction in yellow discoloration of the teeth in individuals treated with HiOra-Shine toothpaste. The 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. Therefore, it can be concluded that HiOra-Shine toothpaste is effective and safe in individuals with yellow discolored teeth. Key words: HiOra-Shine, teeth discoloration, herbal whitening toothpaste The 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 the color of the teeth; these include whitening toothpaste, professional cleaning to remove stain, bleaching agents, bleaching strips, bleaching pen, bleaching gel and laser bleaching. 2,3 As teeth whitening has become a routine dental procedure, its quantification and efficacy have been recognized and are of great concern in esthetic dentistry. The 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 discoloration vary; consumption of certain types of food and drink such as coffee, tea and red wine can stain teeth. Foods *Principal, Ramaiah Dental College, Bangalore **Head, Medical Services and Clinical Trials R&D Center, The Himalaya Drug Company, Makali, Bangalore Address for correspondence Dr Pralhad S Patki Head, Medical Services and Clinical Trials R&D Center, The Himalaya Drug Company Makali, Bangalore dr.patki@himalayahealthcare.com 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 for teeth 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 may result 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

2 There has been a major increase in the demand for dental esthetic treatments, including teeth whitening. Traditionally, dentists determine the color of the human teeth by a visual comparison with a reference standard set called a shade guide. It is a subjective 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. 12 A growing number of products have entered the market, including low-cost over-the-counter bleaching systems of different concentrations that are easy to apply. They do not require a customized tray and therefore the patients no longer feel the need to be treated by a professional dentist. 13 Traditionally, 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 and Carica papaya, which are known to reduce yellow teeth discoloration. Aim of the Study The 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 presenting with 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 oral prostheses, not having any inadequate restorations or untreated 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 three months, and those who were not ready to provide informed consent or comply with the study procedures were excluded from the study. Study Procedure Fifty individuals, aged between 22 and 50 years, with teeth discoloration were included in the study. The demographic details of these individuals are listed in Table 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 of brushing are given in Table 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) ± Male:Female 34:26 Duration of discoloration (mo) ± 6.80 Vegetarian: Mixed 12:38 Chewing tobacco (no. of cases) 20 Chewing betel nut (no. of cases) 32 Table 2. Frequency of Brushing Parameter Specifications Number of subjects Frequency of brushing Once-daily 24 Twice-daily

3 teeth discoloration complaint and resort to no other active treatment during the study period. All adverse events, either reported or observed by patients, were recorded with information about severity, duration and action taken regarding the study drug. Relation of adverse events to study medication was predefined as Unrelated (a reaction that does not follow a reasonable temporal sequence from the administration of the drug), Possible (follows a known response pattern to the suspected drug, but could have been produced by the patient s clinical state or other modes of therapy administered to the patient), and Probable (follows a known response pattern to the suspected drug that could not be reasonably explained by the known characteristics of the patient s clinical state). Subjects were allowed to voluntarily withdraw from the study, if they experienced any serious discomfort during the study or sustained serious clinical events requiring specific treatment. All the 50 enrolled 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. The criteria for evaluation included signs and symptoms such as reduction in discoloration of teeth, cleansing effect, and the overall impression. The 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: <25% reduction 2 Moderate: 25-49% reduction 3 Good: 50-74% reduction 4 Excellent: >75% reduction Primary and Secondary End Points The 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 Friedman s test followed by Dunnett s multiple comparison test or Fisher s exact test. Values are expressed as mean ± SD. Minimum level of significance was fixed at p < 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 reported 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 teeth from 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 < ) 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. The cleansing effect was found to be significant in 47 cases with 94% effect at the end of six weeks (Table 3). The overall response to the treatment was expressed as excellent 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 ± ± 1.65* 2.10 ± 1.43** 0.76 ± 0.95** No. of cases Cleansing effect 0 36** 44** 47** 94 *p < as compared to the at entry values. **p < as compared to the at entry values. 191

4 Table 4. Overall Effect of the Treatment Parameters by 11 cases (Table 4). None of the individuals complained of irritation, erythema or peeling of the oral mucosa membrane. There 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 Number of subjects Percentage of cases Excellent Good Satisfactory Poor/not happy No improvement The effectiveness of toothpastes in reducing or removing 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. This effect can be attributed to the potent herbs such as S. racemosa, V. vinifera, C. zeylanicum, S. aromaticum, A. comosus and C. papaya present in the formulation. S. racemosa is 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 possesses significant antimicrobial activity against two oral anaerobes closely associated with periodontal diseases. The extract exhibited high TEAC (Trolox-equivalent antioxidant capacity assay) values and greater antioxidant capacity than vitamins C and E. 16 S. aromaticum has antifungal, antiviral, analgesic/ anesthetic, antiseptic, anticoagulant, antimicrobial, 17 and antioxidant properties. The oil of the herb is generally used by dentists as an oral anesthetic for toothaches. C. zeylanicum has antibacterial, antioxidant, antiseptic, and anti-inflammatory properties. 18,19 The enzyme complex of A. comosus called bromelain is known for its antibiotic and anti-inflammatory properties. The 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 an ingredient in some toothpastes and mints as teeth whitener. The 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 that HiOra-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 treatment was excellent. Therefore, it can be concluded that HiOra-Shine toothpaste is effective and safe in individuals with discolored teeth. References Watts A, Addy M. Tooth discoloration and staining: a review of the literature. Br Dent J 2001;190(6): Joiner A. Tooth color: a review of the literature. J Dent 2004;32(Suppl 1):3-12. Joiner A, Hopkinson I, Deng Y, Westland S. A review of tooth color and whiteness. J Dent 2008;36(Suppl 1): S2-7. Jahangiri L, Reinhardt SB, Mehra RV, Matheson PB. Relationship between tooth shade value and skin color: an observational study. J Prosthet Dent 2002;87(2): Goodkind RJ, Schwabacher WB. Use of a fiber-optic colorimeter for in vivo color measurements of 2830 anterior teeth. J Prosthet Dent 1987;58(5): Hasegawa A, Ikeda I, Kawaguchi S. Color and translucency of in vivo natural central incisors. J Prosthet Dent 2000;83(4): Gozalo-Diaz D, Johnston WM, Wee AG. Estimating the color of maxillary central incisors based on age and gender. J Prosthet Dent 2008;100(2):

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