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Rajiv Gandhi University of Health Sciences, Bangalore, Karnataka. ANNEXURE II Proforma For Registration Of Subjects For Dissertation 1. Name of the candidate DR. AMIT GOYAL Address PG in Dept. of Orthodontics, J.S.S. Dental College & Hospital, S.S. Nagar, Mysore-570015 2. Name of the institution J.S.S. Dental College & Hospital, S.S. Nagar, Mysore – 570015. 3. Course of the study and Master of Dental Surgery subject Orthodontics & Dentofacial Orthopedics. 4. Date of admission to course 5. Title of the topic: 11-06-2008 Effect of self-etchant pH on the shear bond strength of orthodontic brackets—an in vitro study. 6. Brief resume of the intended work: 6.1 Need for the study: Over the last 50 years, the bonding of various adhesives to enamel and dentin has developed a niche in orthodontics. The bonding of orthodontic brackets onto tooth surfaces has greatly improved with the advent of new products with excellent adhesive properties.1 Traditional orthodontic bracket bonding systems required the use of a 3-step procedure involving 3 separate agents- an enamel conditioner, a priming agent, and an adhesive resin.2 Self-etching primers were introduced in an effort to reduce the 3-step procedure to 2 steps, effectively reducing chair time and increasing cost effectiveness, which resulted in increased convenience and potentially reducing costs to the patient. Self-etching primers have been used to successfully bond orthodontic brackets with shear bond strength values similar to those for conventional acid etch technique.3 Self-etching primers have different pH’s, penetration abilities, and shear bond strength values. Historically, it was assumed that a deeper etching pattern would provide a greater surface area for bonding and, thus greater bonding strengths. However, in a test of 3 SEP’s on unground enamel, no correlation was seen between etching aggressiveness and tensile strength.4 It was demonstrated that the most acidic of 5 self-etchants produced the deepest hybrid layer but had the weakest bond strengths to both enamel and dentin.5 It was suggested that the bond strength of less aggressive SEP’s might produce lower bond strength when used on intact enamel.6 However, there seems to be little information in the literature on how the pH and aggressiveness of SEP’s affect the enamel surface and bracket bonding. Therefore, the purpose of this study was to determine how the pH differences of 3 SEP’s affect the SBS of orthodontic brackets. 6.2 Review of Literature: A study7 was done to see the effects of self-etchant primer/adhesive on shear bond strength of orthodontic brackets. The in-vitro findings indicated that the use of a self-etch primer to bond orthodontic brackets to the enamel surface resulted in a significantly lower, but clinically acceptable shear bond force as compared with the conventional adhesive systems. The effect of saliva contamination on shear bond strength of orthodontic brackets was also studied8 when using a self-etching primer. The results indicated that the newly introduced self-etch primers have the potential to be successfully used in bonding orthodontic brackets even after light salivary contamination. A microscopic evaluation of dentin interface obtained with 10 contemporary selfetching systems in correlation with their pH has also been done.9 The study concluded that the morphology of the hybrid layer depends on the composition of the primer and that the pH is not the determining factor conditioning the action of self-etching adhesives. A study10 was done to see the effect of self-etchant pH on the shear bond strength of orthodontic brackets bonded to molars. The study clearly showed that the selfetching primer with the highest pH (least acidic) bonded brackets successfully and with the strongest shear bond strength. 6.3 Objectives of the Study: To study the effect of self-etchant pH on shear bond strength of orthodontic brackets. 7. Materials and methods: The study will be conducted at the Department of Orthodontics, JSS Dental College & Hospital, Mysore. 7.1 Source of data (Materials) : 1. 90 freshly extracted premolars will be collected and stored in 0.2% (weight/volume) thymol. 2. MBT stainless steel premolar brackets (slot size 0.022”X 0.028”) will be used. 3. 3 self-etchant primers with 3 different pH will be used— A. pH 1.0 (Transbond Plus) B. pH 2.7 (Adper Prompt L-Pop) C. pH 0.9 (Clearfil S3 Bond) 4. Visible light curing unit (Dentsply) will be used. 5. A light-cured composite adhesive resin (Transbond XT) will be used to bond all groups. 6. A universal testing machine (Instron) will be used to determine the shear bond strength of the brackets. Inclusion criteria Freshly extracted premolar teeth will be selected only if they— 1. have an intact buccal enamel. Exclusion criteria: 1. Teeth having surface cracks from extraction forceps, 2. Teeth treated with chemical agents, and 3. Teeth having caries. 7.2 Method of collection of data: Teeth randomly divided into 3 groups (30 each) with regard to the self-etchant primer used— 1. Group I, SEP Transbond Plus, pH 1.0 will be used 2. Group II, SEP Adper Prompt L-Pop, pH 2.7 will be used 3. Group III, SEP Clearfil S3 Bond, pH 0.9 will be used The self-etching primer will be applied to the tooth surface according to manufacturer’s guidelines. The metallic premolar brackets will be bonded with light cure composite adhesive resin Transbond XT and cured with Dentsply visible light curing unit. The shear bond strength of each group will be determined within half an hour after bonding to simulate the clinical conditions when archwires are first tied to newly bonded teeth and a universal testing machine will be used to determine the same. A steel rod with a flattened end will be attached to the crosshead of the universal testing machine to apply an occlusogingival load to the bracket-tooth interface. The results of each test will be recorded by a computer electronically connected to the testing machine. Following statistical methods will be applied: 1. ANOVA 2. Duncan multiple range test 3. Chi-square test. 7.3 Does the study require any investigation or intervention on patients or other humans or animals? If so, please describe briefly. Yes, extracted human premolar teeth. 7.4 Has ethical clearance been obtained from your institution in case 7.3? Yes 8. List of references: 1. Amra I, Samsodien G, Shaikh A, Lalloo R. Xeno III self-etching adhesive in orthodontic bonding: the next generation. Am J Orthod Dentofacial Orthop 2007;131:160-65. 2. Bishara SE, Gordan VV, Von Wald L, Olson ME. Effect of an acidic primer on shear bond strength of orthodontic brackets. Am J Orthod Dentofacial Orthop 1998;114:243-7. 3. Bishara SE, Oonsombat C, Ajlouni R, Laffoon JF. Comparison of the shear bond strength of 2 self-etch primer/adhesive systems. Am J Orthod Dentofacial Orthop 2004;125:348-50. 4. Pashley DH, Tay FR. Aggressiveness of contemporary self-etching adhesives. Part II: etching effects on unground enamel. Dent Mater 2001;17:430-44. 5. De Munck J, Vargas M, Iracki J, Van Landuyt K, Poiterin A, Lambrechts P, et al. One day bonding effectiveness of new self-etch adhesives to bur-cut enamel and dentin. Oper Dent 2005;30:39-49. 6. Kanemura N, Sano H, Tagami J. Tensile bond strength to and SEM evaluation of ground and intact enamel surfaces. J Dent 1999;27:523-30. 7. Bishara SE, Von Wald L, Laffoon JF, Warren JJ. Effect of a self-etch primer/adhesive on the shear bond strength of orthodontic brackets. Am J Orthod Dentofacial Orthop 2001;119:621-4. 8. Samir E Bishara, Charuphan Oonsombat, Raed Ajlouni, Gerald Denehy. The effect of saliva contamination on shear bond strength of orthodontic brackets when using a self-etching primer. Angle Orthod 2002;72:554-7. 9. Gregoire G, Millas A. Microscopic evaluation of dentin interface obtained with 10 contemporary self-etching systems:correlation with their pH. Oper Dent 2005;30:481-91. 10. Adam W Ostby, Samir E Bishara. Geralh E Denehy, John F Laffoon, John J Warren. Effect of self-etchant pH on the shear bond strength of orthodontic brackets. Am J Orthod Dentofacial Orthop 2008;134:203-8. 9. Signature of the Candidate 10. Remarks of the Guide 11. 11.1 Name and Designation of Guide: DR. JYOTHIKIRAN H. DEPT. OF ORTHODONTICS JSS DENTAL COLLEGE & HOSPITAL MYSORE. 11.2 Signature 11.3 Co-guide 11.4 Signature 11.5 Head of Department DR. SHIVALINGA. B.M. , MDS PROFESSOR & INCHARGE OF PG STUDIES. DEPT. OF ORTHODONTICS JSS DENTAL COLLEGE & HOSPITAL MYSORE. 11.6 Signature 12 12.1 Remarks of the Chairman and Principal 12.2 Signature