Clinical evaluation of two novel self-directed bleaching agents for the treatment of teeth affected by fluorosis: In-vivo study

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1 Original article: Clinical evaluation of two novel self-directed bleaching agents for the treatment of teeth affected by fluorosis: In-vivo study 1Dr. Mansi Dhanak*, 2 Dr. Girish Parmar 1Assistant Professor, Dept. of Conservative Dentistry and Endodontia, Govt. Dental College and Hospital, Ahmedabad, India 2Dean; Prof. and HOD, Dept. of Conservative Dentistry and Endodontia, Govt. Dental College and Hospital, Ahmedabad, India Name of the Institute/college: Govt. Dental College and Hospital, Civil Hospital campus, Ahmedabad, Gujarat, India *Corresponding author: mansisdave@gmail.com Abstract: Introduction: The purpose of the present study was to compare the efficiency and efficacy of two dentist prescribed, patient administered at-home bleaching gels including Vivastyle Paint on from IvoclarVivadent containing 6% carbamide peroxide and Enamel White from Perfect Smile containing 6% hydrogen peroxide. Methodology: The methodologies used to evaluate efficiency and efficacy of these products included use of Vitapan Shade Guide to determine the shade change, measuring teeth sensitivity by tactile and thermal methods, evaluating gingival conditions using Silness and Loe Gingival Index and comparing preoperative and post operative photographs. Results and Conclusion: Considering the results both products are found to be effective with Enamel White Click and brush on pen containing 6% hydrogen peroxide more effective in bleaching as it contains higher concentration of hydrogen peroxide. However, the patient groups are too small to lead to a conclusive result. Keywords: Bleaching, Fluorosis, Carbamide peroxide INTRODUCTION The present work was planned compare the efficiency and efficacy of two dentist prescribed, patient administered at-home bleaching gels 1,2,3,4 including Vivastyle Paint On from IvoclarVivadent containing 6% carbamide peroxide 7 and Enamel White from Perfect Smile containing 6% hydrogen peroxide 5,6,7. The methodologies used to evaluate 8 efficiency and efficacy of these products included use of Vitapan Shade Guide to determine the shade change, measuring teeth sensitivity by tactile and thermal methods, evaluating gingival conditions using Silness and Loe Gingival Index and comparing preoperative and post operative photogr-aphs 9,10,11. Smile is a gateway to a good personality. Good smile with healthy, white teeth makes a person look more young, attractive and confident. Dental fluorosis is a form of enamel hypoplasia 12 characterized by moderate to severe staining of the tooth surface. Several treatment methods 13 are available to improve the esthetic appearance of the dentition affected with fluorosis, which includes laminates or porcelain veneers, full coverage crowns, bonding, mechanical abrasion and chemical stain removal ( bleaching ) 14. The determination of which clinical procedure is best used to optimize tooth color depends on variables such as the nature and intensity of stain 15. Vital tooth bleaching 16 refers to the clinical application of a chemical solution on the tooth surface in order to 70

2 achieve a lightening effect. Vital tooth bleaching is considered to be the treatment of choice if the patient has realistic expectations and the teeth are acceptably shaped, intact and moderately stained. One novel tooth bleaching approach 17 includes a direct-to-consumer bleaching gel/varnish using a paint-on delivery. The paint-on polish application is reported to offer some specific advantages over other delivery systems, particularly in the area of convenience. After application, this gel is reported to dissolve over time in saliva without any tray or other external barrier. The advantages of paint on delivery systems are more convenience, more predictable results, lesser gingival irritation, no tray fabrication, less time consuming and less interfering with the daily routine schedule of the patient 18. MATERIALS AND METHODS The pursuit for better esthetics has led to introduction of many new bleaching systems with different peroxide concentrations, different consistencies and different formulations. This study was carried out to see the effect of two newly introduced self directed bleaching systems 19,20 for removal of fluorosis stains which includes: VivaStyle Paint On from IvoclarVivadent and Enamel White a click and brush on bleaching penperfect Smile Corporation. METHODOLOGY: Twenty subjects were selected to take part in this clinical study. They were divided into two groups each with ten subjects. Group I patients received treatment using VivaStyle Paint On from IvoclarVivadent, while group II patients received treatment using Enamel White from Perfect Smile Corporation. Six maxillary anterior teeth with minor fluorosis stains were selected per patient. The six mandibular anterior teeth in each patient were used as a control group. The subjects selected had tooth shade darker or same as A3. Step by step application method for VivaStyle Paint On 21 : 1. Clean the teeth thoroughly using prophylaxis paste. Use dental floss to clean between the teeth. Rinse well. 2. Fill the dispensing cup up to the brim with VivaStyle Paint On. The dispensed amount is usually enough for treating maxillary anterior teeth. 3. Pull the lips up and to the side so that the teeth are clearly visible. Place a cheek retractor if deemed necessary for better retraction and convenience. 4. Use a soft absorbent paper towel to blot dry the maxillary anterior teeth. 5. Apply a thin even layer of VivaStyle Paint On to the front teeth with the brush. Paint along the sides of the teeth as well as along the gumline. Make sure that the varnish does not get on the gums. 6. Allow the varnish to dry for about 30 seconds. The varnish will exhibit matt white appearance. Once this is achieved, cheek retractor can be removed. 7. Subject is allowed to close the mouth. The varnish is left on the teeth for 20 minutes. 8. After 20 minutes, remove varnish by brushing teeth with a tooth brush without use of a toothpaste. Rinse thoroughly. Spit everything out do not swallow. 9. Use VivaStyle Paint On daily without skipping a day until the treatment is finished. The varnish 71

3 may be applied once or twice a day, depending on how the treatment fits into the daily schedule and how fast the results are to be achieved. A new dispensing cup and brush should be used for every application. Step by step application method for ENAMEL WHITE bleaching pen 21 : 1. Clean the teeth thoroughly using prophylaxis paste. Use dental floss to clean proximally. Rinse well. 2. Pull the lips up and to the side so that the teeth are clearly visible. Place a cheek retractor if deemed necessary for better retraction and convenience. 3. Unlike VivaStyle Paint On, there is no need to dry the teeth because Enamel White is a water-based formula. 4. Click the Enamel White click and brush on bleaching pen several times before the first use. Apply a thin layer of Enamel White on one tooth at a time using an up and down motion. Periodically, click the pen to extrude more gel. 5. The gel dries in seconds and forms an invisible shield on the surface of the teeth. Tiny bubbles will begin to appear in the film applied on the teeth. That means that the gel is working do not wipe off. 6. Lips or tongue should not touch the teeth for about 15 seconds. Instruct patient to refrain from eating or drinking for about 30 minutes to allow Enamel White to work. 7. There is no need to brush Enamel White off, it slowly dissolves as it bleaches. 8. Use Enamel White bleaching pen daily without skipping during the treatment. The gel may be applied once or twice a day, depending on how the treatment fits into the daily schedule and how fast the results are to be achieved. OBSERVATIONS AND RESULTS: Among all the 20 subjects, not a single patient had dropped out from the study and all of them had followed the treatment regime strictly as per the instructions. RESULTS OF TOOTH SHADE CHANGE :For shade assessment with the Vita Shade Guide, the shade guide was arranged in the value from lightest to darkest according to the following order : B1, A1, B2, D2, A2, C1, C2, D4, A3, D3, B3, A3.5, B4, C3, A4, C4 as recommended by the manufacturer. Table 1: Vita Shade Value order B1 A1 B2 D2 A2 C1 C2 D4 A3 D3 B3 A3.5 B4 C3 A4 C

4 Table 2: Vita shade change using VivaStyle Paint On bleaching varnish. The following table shows the data of the subjects in respect to their initial tooth shade, final tooth shade, unit change ( calculated by subtracting the value order of initial tooth shade score from final tooth shade score) and the number of applications needed to achieve effective bleaching. Subject Initial Final Unit Number of Serial No shade Shade Change applications needed 1. A3 B B3 C A3.5 C D3 D3 0* A3 A B4 C D3 C A3 B B3 C C3 D In this case negative change was also evident. This may be the result of subjective assessment of tooth colour. Mean Shade Change = 4.4 Vita tabs.tooth shade comparisons were made at the initiation and the termination of the study. An average shade change of 4.4Vita tabs was observed. Table 3 : Vita shade change using Enamel White click and brush on bleaching pen. Subject Serial No Initial shade Final Shade Unit Changes Number of applications needed 1. B3 C A3 A D3 C B4 D A3.5 C B4 C B4 D A3 D A3 A3 0* B3 A

5 With this product also negative changes were evident, as with VivaStyle Paint On. This may be the result of subjective assessment of tooth colour. In group II, two subjects reported of gingival irritation with Gingival Index score of 1, while the rest of the subjects did not complain of any gingival irritation and the Gingival Index scores remained the same as like the preoperative score.the severity of sensitivity decreased with time. The within-treatment analysis indicated a significant increase in sensitivity after 4 and 7 days of treatment; however, these results appear to be typical for peroxide bleaching systems. All the sensitivity was transient and resolved within a few days after completion of the bleaching application.the results showed no clinical evidence of significant adverse effects from using VivaStyle Paint On or Enamel White on oral tissues. Evidence of mild gingival inflammation was found in one subject in group I and two subjects in group II. Angular cheilitis and an ulcer at the tip of the tongue was observed in one subject in group II. Both the lesions resolved during the course of the study. No changes in hard tissues were observed 2 CASE I PREOPERATIVE PHOTOGRAPH POSTOPERATIVE PHOTOGRAPH CASE II International Journal of Healthcare and Biomedical Research PREOPERATIVE PHOTOGRAPH Is now listed in MedHunt 70 74

6 DISCUSSION Significant effort has been directed towards understanding the nature of tooth discolouration and devising methods to improve dental esthetics. 25 Currently, several methods are available to restore discoloured dentitions. 25,26 The paint-on polish application is reported to offer some specific advantages over other delivery systems, particularly in the area of convenience 25,26,27. Comparing the paint on gel bleaching agents with other modes of treating discoloured dentition provides inset view of the advantages of this method over other popular treatment options. Use of abrasives, such as prophy pastes, is a common and accepted procedure to remove superficial stains by an abrading action. Abrasion of tooth surfaces removes extrinsic stains, but does not satisfactorily remove gross discolourations. Another accepted method to whiten the teeth is by the use of chemical agents, such as peroxides. This method is considered to be the safest means to restore discoloured dentition because it does not entail removal of sound tooth structure, it is the least invasive and the agents used in this procedure have a safety record. However, they do cause gingival irritation 23 and tooth sensitivity 22 following the treatment, which is much reduced using the paint on delivery system. Use of laminates and porcelain veneers as a treatment option to cover the stains is most invasive because sound tooth structure is removed to achieve an acceptable level of esthetics. Thus, considering the above facts, the direct-toconsumer paint on bleaching gels are considered to be the safest with least gingival irritation and teeth sensitivity, least invasive, least time consuming, patient friendly, convenient and effective 28. The two novel paint on bleaching gels used in this study includes VivaStyle Paint On from IvoclarVivadent and Enamel White a click and brush on bleaching pen fromperfect Smile Corporation. Carbamide peroxide is the active ingredient used in bleaching procedures. Chemically, carbamide peroxide contains approximately 35% by volume hydrogen peroxide and it decomposes to form hydrogen peroxide and urea in aqueous solution 27. Thus, the pigments in enamel and dentin are altered and a lightening effect is achieved 27,28.At the end of the study, ( i.e. after 7 days if treatment was carried out twice a day and after 14 days if treatment was carried out once a day) the subjects were evaluated for baseline examinations. Thus, considering the results both products are found to be effective with Enamel White Click and brush on pen more effective in bleaching as it contains higher concentration of hydrogen peroxide. However, the patient groups are too small to lead to a conclusive result. One important outcome of this trial is the evidence that concentration and duration alone may not sufficiently predict clinical response to peroxide use. While both of the peroxide containing products in this trial used a similar regimen, these two products differed with respect to starting peroxideconcentration 31,33. The Enamel white click and brush on pen containing 6% hydrogen peroxide started at a measurably higher concentration that VivaStyle Paint On with 6% carbamide peroxide. But with patient sample size these small, results can be considered inconclusive. CONCLUSION Considering the results both products are found to be effective with Enamel White Click and brush on pen containing 6% hydrogen peroxide more effective in bleaching as it contains higher concentration of hydrogen peroxide. However, the patient groups are 75 71

7 too small to lead to a conclusive result. The direct-toconsumer paint on bleaching gels are considered to be the safest with least gingival irritation and teeth sensitivity, least invasive, least time consuming, patient friendly, convenient and effective in comparison with other methods of treating discoloured dentition,33,34,35. ACKNOWLEDGEMENT The main credit for such support should undoubtedly go to Dr. GirishParmar, Dean, Prof. & Head of Dept., Dept. of Conservative Dentistry and Endodontia, whose inspiring interest and ceaseless enthusiasm for the topic explored here has meant a great deal to me. I feel inadequate in trying to convey my sense of appreciation to Dr. SunitaGarg, Dr. GeetaAsthana, Dr.ShikhaKanodia from Dept. of Conservative Dentistry and Endodontia, whose vast knowledge, great experience, clear judgement and generous cooperation helped me in accomplishing my task. REFERENCES 1.GerlachRW : Shifting paradigms in whitening : introduction of a novel system for vital tooth bleaching. The Compendium of Continuing Education in Dentistry. 2000; 21 ( supplement 29), Page No Gerlach RW, Zhou X : Vital bleaching with whitening strips : Summary of clinical research on effectiveness and tolerability. Journal of Contemporary Dental Practise. 2001;2: GerlachRW : Whitening paradigms 1 year later : introduction of a novel professional tooth bleaching system. The Compendium of Continuing Education in Dentistry. 2002;23: Gerlach RW, Barker ML, SagelPA : Comparative efficacy and tolerability of two direct-to-consumer tooth whitening systems. Journal of American Dental Association. 2001;14: Gerlach RW, Gibb RD, SagelPA : A randomized clinical trial comparing a novel 5.3% hydrogen peroxide whitening strip to 10%, 15% and 20% carbamide peroxide tray based bleaching systems. The Compendium of Continuing Education in Dentistry. 2000;21(supplement 29):S22-S28. 6.Gerlach RW, Zhou X : Comparative clinical efficacy of two professional bleaching systems. The Compendium of Continuing Education in Dentistry.2002;23: Matiz BA, Cochran MA, Eckert G, et al: The efficacy and safety of 6% carbamide peroxide and 6% hydrogen peroxide bleaching gel. Quintessence International, 1998;29: Gegauff AG, Rosensteil SF, Langhout KJ, et al, : Evaluating tooth color change from carbamide peroxide gel. Journal of American Dental Association. 123:65-72, Li Y: Peroxide containing tooth whiteners: An update on safety. The Compendium of Continuing Education in Dentistry.2000;21(supplement 28):S4-S9. 10.Li Y: Toxicological considerations of tooth bleaching using peroxide containing agents. Journal of American Dental Association, 1997; 128(supplement 29): 31S-36S. 11.Li Y: Tooth bleaching using peroxide containing agents: current status of safety issues. 19(8): , NathooS : The chemistry and mechanism of extrinsic and intrinsic discolourations. Journal of American Dental Association. 1997;12(supplement): 6S-10S. 7672

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9 31.Christensen GJ : To bleach or not to bleach. Journal of American Dental Association. 122:64-65, Howard WR : Patient applied tooth whiteners : Are they safe, effective with supervision? Journal of American Dental Association, 1992; 123: Nathoo S, Giniger M, Proskin H, et al : Comparative 3 week clinical tooth shade evaluation of a novel liquid whitening gel containing 18% carbamide peroxide and a commercially available whitening dentrifice. The Compendium of Continuing Education in Dentistry. 2002;23(supplement1): Nathoo S, Santana E 3rd, Zhang VP, et al : Comparative seven day evaluation of two tooth whitening products. The Compendium of Continuing Education in Dentistry. 2001:22; FeinmanRA : Reviewing vital bleaching and clinical alterations. Journal of American Dental Association. 122:55-56, Date of submission: 12 Aug 2013 Date of provisional acceptance: 25 Aug 2013 Date of Final acceptance: 18 September 2013 Date of Publication: 03 October 2013 Source of support: Nil; Conflict of Interest: Nil 78 72