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RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGALORE, KARNATAKA. ANNEXURE – II SYNOPSIS FOR REGISTRATION OF SUBJECTS FOR DISSERTATION 1. NAME OF THE CANDIDATE Dr. AMRUTHA UJJAMMA.B POST GRADUATE STUDENT, AND ADDRESS DEPARTMENT OF PEDODONTICS AND PREVENTIVE DENTISTRY, (IN BLOCK LETTERS) BAPUJI DENTAL COLLEGE AND HOSPITAL, DAVANGERE-577004, KARNATAKA. 2. NAME OF THE INSTITUTION BAPUJI DENTAL COLLEGE AND HOSPITAL, DAVANGERE– 577 004, KARNATAKA. 3. COURSE OF STUDY AND MASTER OF DENTAL SURGERY (M.D.S) IN SUBJECT PEDODONTICS & PREVENTIVE DENTISTRY. 4. DATE OF ADMISSION TO 15-04-2011 COURSE 5. TITLE OF THE TOPIC “COMPARATIVE EVALUATION OF CALCIUM AND PHOSPHATE ION UPTAKE FROM THREE COMMERCIALLY AVAILABLE DENTIFRICES: AN IN VITRO STUDY” 6. BRIEF RESUME OF THE INTENDED WORK: 6.1 6.1 Need for the study: Dental caries is an infectious, microbiological disease that results in localized dissolution and destruction of calcified tissues of teeth. It is still one of the most prevalent diseases affecting mankind. Prevention of caries occurs through the regulation of remineralization and demineralization. The battle to keep teeth strong and healthy is dependent upon the ratio between demineralization and remineralization. Remineralization is a natural repair process for non cavitated lesions and it relies on calcium and phosphate ions assisted by fluoride to rebuild a new surface on existing crystal remnants in subsurface lesions that remains after demineralization. Non invasive treatment of early lesions by remineralisation has the potential to be a major advance in clinical management of caries. Many dental products have been introduced in to the market which aids in the prevention of dental caries. Among them, the one with fluoride releasing ability provide an added advantage. Though fluoride is one of the most important component in preventing caries, its effect is limited in the presence of calcium and phosphate ions. Dental products containing calcium, phosphate and fluoride are claimed to enhance remineralization over products containing only fluoride.1 Hence, products containing calcium, phosphate and fluoride in their bioavailable form have been introduced in to the market. Based on these observations and facts this study is intended to evaluate and compare calcium and phosphate ion uptake from three commercially available dentifrices. 6.2 Review of Literature : Dental caries is an infectious disease resulting in tooth decay and eventual tooth loss. It is highly prevalent, affecting most of world’s population at least once in their life time.2 The demineralization and remineralization are dynamic processes in caries initiation, progression and reversal. Therefore, regulation of demineralizationremineralization balance is the key to caries prevention.3 Fluoride containing dental products has demonstrated a decrease in caries experience. Fluoride promotes formation of fluorapatite in the presence of calcium and phosphate ions which is believed to be the major mechanism of fluoride action. Ability of fluoride ion to promote net remineralization is limited by availability of calcium and phosphate ions.1 To overcome this incompatibility of calcium, phosphate and fluoride ions, calcium phosphate technologies were developed, which were stable in presence of fluoride ions. Reynolds in 1980, in his study on anti caries activity of dental products found that casein phosphopeptide (CPP) can rebuild subsurface enamel defects including white spot lesions because of its remineralizing properties. The CPP-ACP (casein phosphopeptide amorphous calcium phosphate) molecule acts in dual manner by providing source of calcium and phosphate while also supplying a soluble format for delivery of these essential minerals to tooth surface.2 Casein phosphopeptide stabilized amorphous calcium phosphate (CPPACP), is incorporated in a product called Tooth Mousse Plus containing CPP-ACP and 900 ppm F. It is proposed that presence of CPP stabilizes the amorphous calcium phosphate phase to deliver bio-available calcium, phosphate and fluoride ions to tooth surface to promote remineralization of enamel subsurface lesions.1 Studies have shown that calcium phosphate in form of CPP-ACP added to fluoride containing tooth crème can enhance level of remineralization.1CPP-ACP has shown to reduce demineralization and promote remineralization of carious lesions both in vitro and in vivo.4 The second technology is functionalized tricalcium phosphate (fTCP) where tricalcium particles have been ball milled with sodium lauryl sulphate. This has been included in a tooth crème with sodium fluoride marketed as Clinpro Tooth Crème. This product is superior in its ability to remineralize enamel subsurface lesions.1 Novamin is a bioactive glass. Its active ingredient is calcium sodium phosphosilicate which on exposure to aqueous media, provides calcium and phosphate ions forming a hydroxy carbonate apatite with time.5 In vitro studies have shown that Novamin alone and in combination with fluoride, can enhance remineralization of enamel and dentin lesions as well as prevent demineralization from acid challenges6. RESEARCH HYPOTHESIS There is influence on the Calcium and Phosphate ion uptake from three commercially available dentifrices which are:1. Tooth mousse plus 2. Clinpro tooth crème 3. Novamin containing dentifrice NULL HYPOTHESIS There is no influence on the Calcium and Phosphate ion uptake from three commercially available dentifrices which are:1. Tooth mousse plus 2. Clinpro tooth crème 3. Novamin containing dentifrice 6.3 Objectives of the study: To evaluate and compare the amount of Calcium ion uptake between Tooth Mousse Plus, Clinpro Tooth Crème and Novamin containing dentifrices. To evaluate and compare the amount of Phosphate ion uptake between Tooth Mousse Plus, Clinpro Tooth Crème and Novamin containing dentifrices 7. MATERIALS AND METHODS : Sample size is determined by: n = 2 t2α s2 / d2 = 2 (2.13)2 (25.3)2 / (20)2 = 14.5 which is approximated to 15 Where, n = required sample size for each group s = pooled standard deviation observed in multiple group is 25.3 d = anticipated small difference in calcium estimation in each group is 20µg/mm2 tα = is usually taken as “t” at 5% level is 2.13 From above observation minimum sample size for each group will be taken as 15. 7.1 Source of data: 30 caries free sound permanent molars extracted for therapeutic reasons are taken and washed thoroughly to remove blood, saliva and tissue debris and stored in physiologic saline solution containing 0.1% thymol. Materials required: 30 caries free sound permanent molars Tooth Mousse Plus Clinpro Tooth Crème Novamin containing dentifrice Double deionized water 7.2 Methodology: Study design: An experimental, in vitro, between group study. 30 caries free sound permanent molars extracted for therapeutic reasons are taken. Enamel specimens of standard dimensions are prepared from molars by sectioning from buccal and lingual surfaces using diamond discs.7 The 60 specimens obtained will be evaluated for mineral content. All the above 60 specimens will then be placed in demineralizing solution for 48hrs to produce artificial carious lesion. The mineral content will be evaluated again. The above specimens are randomly divided in to 3 experimental groups and 1 control group of 15 specimens each. Each experimental group will be treated with dentifrice slurries and control group will be treated with double deionized water. GROUP 1 Treated with dentifrice slurry containing Tooth mousse plus. GROUP 2 Treated with dentifrice slurry containing Clinpro tooth crème GROUP 3 Treated with dentifrice slurry containing Novamin dentifrice GROUP 4 (CONTROL) Treated with double deionized water. Brushing for all groups is carried out twice daily for 10 days. After each brushing session, specimens are washed under running tap water and kept in artificial saliva filled container. To evaluate Calcium and Phosphate ion uptake:All the samples are then subjected to X-ray microanalysis for the evaluation of Calcium and Phosphate ion uptake. STATISTICAL ANALYSIS All the results will be tabulated and statistically analyzed by: 1. One way ANOVA for multiple group comparison. 2. POST-HOC TUKEY’S test for group wise comparison. 7.3 Does the study require any investigation or interventions to be conducted on patients or other humans or animals? If so, please describe briefly: Yes, this study requires the collection of human molar teeth extracted for therapeutic purposes. 7.4 Has ethical clearance been obtained from your institution in case of 7.3? Yes, recommendations of ethical committee are enclosed. 8. LIST OF REFERENCES: 1) Shen P, Manton DJ, Cochrane NJ, Walker GD, Yuan Y, Reynolds C et al Effect of added calcium phosphate on enamel remineralization by fluoride in a randomized controlled in situ trial. J Dent 2011;39(7):518-25. 2) Marchisio O, Esposito MR, Genovesi A. Salivary pH level and bacterial plaque evaluation in orthodontic patients treated with recaldent products. Int J Dent Hyg 2010;8(3):232-6. 3) Zhang Q, Zou Z, Yang R, Zhou X. Remineralization effects of casein phospopeptide amorphous calcium phosphate crème on artificial early enamel lesions of primary teeth. Int J Paediatr Dent 2011;21(5):374-81. 4) Srinivasan N, Kavitha M, Loganathan SC. Comparison of the remineralization potential of CPP-ACP and CPP-ACP with 900ppm fluoride on eroded human enamel. An situ study. Arch Oral Biol 2010;55:541-4. 5) Wefel JS. Novamin – likely clinical success. Adv dent res 2009;21(1):40-3. 6) Burwell AK, Litowski LJ, Greenspan DC. Calcium Sodium Phosphosilicate (Novamin) : Remineralisation potential. Adv dent res 2009;21(1):35-9. 7) Hegde MN, Shetty S ,Pardal D. Remineralisation of enamel sub-surface lesion using casein phosphopeptide amorphous calcium phosphate (CPP-ACP) – a quantitative energy dispersive x-ray analysis. J conserv dent 2007;10(1):19-25.