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RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, KARNATAKA, BANGALORE. . ANNEXURE II PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION 1. NAME OF THE CANDIDATE Dr. GOPALAKRISHNAN. S AND ADDRESS POSTGRADUATE STUDENT, (IN BLOCK LETTERS) DEPARTMENT OF PERIODONTICS, COLLEGE OF DENTAL SCIENCES, DAVANGERE - 577 004. 2. NAME OF THE INSTITUTION COLLEGE OF DENTAL SCIENCES, DAVANGERE – 577 004, KARNATAKA. 3. 4. COURSE OF STUDY MASTER OF DENTAL SURGERY AND SUBJECT PERIODONTICS DATE OF ADMISSION TO THE 24-04-2009 COURSE 5. TITLE OF THE DISSERTATION “EVALUATION OF GC TOOTH MOUSSETM (THE PRODUCT BASED ON RECALDENT TECHNOLOGY) ON PATENT DENTINAL TUBULES IN THE TREATMENT OF DENTINAL HYPERSENSITIVITY - A SCANNING ELECTRON MICROSCOPIC STUDY” 6. BRIEF RESUME OF THE INTENDED WORK : 6.1 Need for the study : Dentine hypersensitivity is a painful condition which may affect 8-57% of the adult population and is associated with exposure of dentine to oral environment.1 Dentin hypersensitivity is stated in patients with gingival recession as well as cervical root exposure due to, most frequently periodontal diseases, after periodontal and surgical treatment, and in teeth with non-carious lesions.2 Hydrodynamic theory is assumed to be the most probable theory concerning dentin hypersensitivity occurrence.3 According to this theory, painful stimuli coming from the oral environment act on the surface of the exposed dentin and cause a rapid fluid movement inside the dentinal tubules. Therefore, the most appropriate treatment for dentin hypersensitivity seems to be the obliteration of the dentinal tubule orifices.4 The fact that many of the agent clinically used to desensitize dentin are effective in reducing dentine permeability tends to support the hydrodynamic theory. Recently the product GC tooth mousse based on RecaldentTM technology has been introduced to the market. RecaldentTM is a unique complex containing amorphous calcium phosphate (ACP) and casein phosphopeptide (CPP) obtained from milk casein. The manufacturer compares the material to “liquid enamel”. CPP-ACP complex make a strong binding with the biofilm on teeth and form calcium and phosphate reservoir, which is incorporated into the surface of enamel and dentin. It is recommended after tooth whitening, professional tooth cleaning, root planning, and curettage. It is also recommended in dentin hypersensitivity reduction due to its ability to block opened tubules.2 Therefore, aim of the study is the assessment of GC tooth mousseTM effectiveness in the treatment of dentin hypersensitivity. 6.2Review of literature : A in vitro study was done to evaluate the ability of agents that have been used previously for clinical dentin desensitization to reduce the rate of fluid flow through dentin and the results suggested that those agents that desensitize dentin reduces fluid flow and also particularly occluded tubular orifices.5 A SEM in vitro study was conducted to evaluate the patency of dentinal tubules in sensitive and non sensitive cervical dentine and results stated that hypersensitive teeth showed highly significantly increased numbers of tubules per unit area and tubule diameters were significantly wider compared to non sensitive teeth. The results further provide evidence that stimulus transmission across dentine in hypersensitive teeth is mediated by hydrodynamic mechanisim.6 A clinical and morphological study of cervical hypersensitivity was conducted and result suggest a significantly high correlation between the dentinal tubule morphology and dentin hypersensitivity. SEM of the models of hypersensitivity spots showed enlarged dentinal tubules, agglutinated dentinal tubules, belt like groups of agglutinated dentinal tubules and tubule morphology not clear.7 A clinical study was done for evaluation of product based on RecaldentTM technology in treatment of hypersensitivity and results suggest it regarded as soothing effect rather as remineralizing effect of medicine.2 6.3 Aims and Objectives of the study : This study will be carried out with the following aims and objectives: Evaluate the dentinal tubule occluding ability of GC Tooth mousseTM for dentin hypersensitivity. Identify the active component using X-ray microanalysis. MATERIALS AND METHODS : 7.1 Source of data : The tooth extracted for surgical or orthodontic purpose would be collected from the department of Oral and maxillofacial surgery, College of dental sciences, Davangere. 7.2 Method of Collection of Data (including sampling procedure, if any) : Sample size : A total of 30 freshly extracted impacted third molars teeth would be used in the study Study period : The duration of this cross sectional study would be for 3 months. Study design: 30 impacted third molar teeth or teeth extracted for orthodontic reasons from young patients aged between 20-25 years would be selected for the study. These teeth will be stored in formalin until required. 2mm thickness coronal dentin discs would be prepared from the teeth. Each disc would be conditioned with 6% citric acid for 2 minutes and rinsed with distilled water in order to expose the dentinal tubules and simulate hypersensitive dentin, according to the experimental approach proposed by Pashley et al.8 Then, the teeth professionally cleaned using zinc oxide and water according to manufacturer indications2 and agent application would be done for 2 minutes for 7 days. The specimens would be stored in artificial saliva9 during the experimental period. The treated specimens will be coated with gold sputter and will be subjected for Scanning electron microscopic study to evaluate surface characteristics of dentinal surface of the cut section. Specimens would be divided into 3 groups of 10 specimens each. Experimental group I : Specimens brushed for 2 minutes twice daily for 7 days with distilled water. Experimental group II : Specimens brushed for 2 minutes twice daily for 7 days with non fluoridated toothpaste. Experimental group III : Specimens brushed for 2 minutes twice daily for 7 days with GC Tooth mousseTM Study parameters: I. Number of tubules occluded per unit area. II. Number of tubules patent per unit area Patency of tubules is graded as follows (West et al, 1998)10. Grade A: Smear layer with some tubules just apparent. Grade B: Less than or equal to 10 tubules visible with majority occluded. Grade C: Greater than 10 tubules visible with majority occluded. Grade D: Less than or equal to 10 tubules visible with majority patent. Grade E: Greater than 10 tubules visible with the majority patent. Selection criteria: Inclusion criteria: 1. 3rd molar tooth indicated for extraction due to impaction. 2. Teeth with intact root surfaces. 3. Tooth surface unaltered by extraction procedure. 4. No previous history of professional periodontal treatment. Exclusion criteria : 1. Previous history of periodontal treatment. 2. Teeth which had undergone root canal therapy or had any apical lesion or caries or roughness of root surfaces. 3. Teeth with developmental anomalies such as concrescence, fusion etc. Statistical analysis : Number of tubules occluded per unit area will be expressed in percentage. Multiple group comparison will be done using ANOVA followed by POST-HOC test for inter group comparison. 7.3 Does the study require any investigations or interventions to be conducted on patients or other humans or animals? If so, please describe briefly. No (in vitro) 7.4. Has ethical clearance been obtained from your institution in case of 7.3? Not applicable 8. REFERENCES: 1. Markowitz K, Pashley DH. Personal reflections on a sensitive subject. J Dent Res, 2007; 86: 292-5. 2. Kowalczyk A, Botulinski B, Jaworska M, Kierklo A, Pawinska M, Dabrowska E. Evaluation of the product based on RecaldentTM technology in the treatment of dentin hypersensitivity. Advances in medical sciences, 2006; 51 suppl 1: 40-2. 3. Zero DT. Etiology of dental erosion-extrinsic factors. Eur J Oral Sci, 1996; 104: 162-77. 4. Pereira J C, Martineli, Tung M S. Replica of human dentin treated with different desensitizing agents. A methodological SEM study in vitro. Braz Dent J, 2002; 13(2): 75-85. 5. Greenhill JD and Pashley DH. The effects of desensitizing agents on the hydraulic conductance of human dentin in vitro. J Dent Res,1981; 60(3): 686-98. 6. Absi EG, Addy M and Adams D. Dentin hypersensitivity-A study of the patency of dentinal tubules in sensitive and non-sensitive cervical dentine. J Clin Periodontol 1987; 14: 280-4. 7. Takao O, Matsumoto K. A clinical and morphological study of cervical hypersensitivity. Journal of Endodontics, 1991; 17:500-02. 8. Pashley DH, Kalathoor S, Burnham D. The effects of calcium hydroxide on dentin permeability. J Dent Res 1986; 65: 417-420. 9. Suge T, Ishikawa K, Kawasaki A, Yoshiyama M, Asaoaka K, Ebisu S. Duration of dentinal tubule occlusion formed by calcium phosphate precipitation method: In vitro evaluation using synthetic saliva. J Dent Res 1995; 74(10): 17091714. 10. West N, Addy M, Hughes J. Dentin hypersensitivity: the effects of brushing desensitizing toothpastes, their solid and liquid phases and detergent on dentine and acrylic: studies in vitro. Journal of oral rehabilitation 1998; 25: 885-895. 9. SIGNATURE OF THE CANDIDATE 10. REMARKS OF THE GUIDE 11. 11.1 NAME AND DESIGNATION OF GUIDE ( IN BLOCK LETTERS ) Dr. NARAYAN. N. VALAVALKAR M.D.S. PROFESSOR DEPARTMENT OF PERIODONTICS COLLEGE OF DENTAL SCIENCES, DAVANGERE -577004S 11.2 SIGNATURE 11.3 CO-GUIDE (IF ANY) 11.4 SIGNATURE 11.5 HEAD OF THE DEPARTMENT Dr. SHOBHA PRAKASH M.D.S. PROFESSOR AND HEAD DEPARTMENT OF PERIODONTICS COLLEGE OF DENTAL SCIENCES, DAVANGERE -577004 11.6 SIGNATURE 12 12.1 REMARKS OF THE CHAIRMAN AND THE PRINCIPAL 12. 2 SIGNATURE