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5. TITLE OF THE TOPIC “EFFECTS OF MOUTHWASHES WITH AND WITHOUT BLEACHING AGENTS AND DIFFERENT CONCENTRATIONS OF CHLORHEXIDINE ON FORCE DECAY OF ELASTOMERIC CHAIN – AN IN-VITRO STUDY” 6. BRIEF RESUME OF THE INTENDED STUDY: 6.1 NEED FOR THE STUDY: Elastomeric chains are widely used in orthodontics to facilitate tooth movement and to consolidate space. However, force decay of these materials has been a clinical problem. A rapid loss of force causes inefficient tooth movement. The use of mouthwashes during orthodontic treatment is recommended by orthodontist for the maintenance of oral hygiene because presence of orthodontic appliance in the oral cavity leads to accumulation of bacterial plaque. The patients who are unable to maintain good oral hygiene should implement chemical plaque control. Among the antiseptics for oral use, chlorhexidine is one of the most powerful antimicrobial agents. Also, the presence of orthodontic appliance in the oral cavity leads to formation of stains on the teeth. In order to remove these stains, orthodontists use various dental bleaching techniques. Therefore, the aim of this study is to evaluate the effect of mouthwashes with and without bleaching agents and different concentrations of chlorhexidine on force degradation of elastomeric chains. 6.2 REVIEW OF THE LITERATURE 1. A study conducted by Pakhan Kanchana and Keith Godfrey (2000)1 determined the force-extension and force degradation characteristics of orthodontic latex elastics. Orthodontic latex elastics by 4 manufacturers were subjected to static testing for evaluation of force extension characteristic under dry condition and force degradation under wet condition to simulate the oral environment. An Instron testing machine (Model 4301) with load cell capacity of 100 newtons was used. For the dry test, each elastic was stretched by continuous extension from slack condition to 60 mm. Resultant force versus length changes was recorded. For the wet test, each elastic was stretched to 20, 26, 32, 40mm. There were significant differences in force extension and force degradation characteristics between different extensions and force magnitudes for the elastics of the different manufactures. 2. A study conducted by Kyung-Ho Kim, Chun-His Chung, Kwnagchul Choy, JeongSub Lee and Robert L.Vanarsdall (2005)2, investigated effects of prestreching on force decay of elastomeric chain. Two different modules, 5-unit (12.5mm) and 6-unit (15.5mm) modules were prestreched 100% for 1 hour, 24 hours, 2 weeks and 4 weeks in distilled water. The prestreched and unprestreched (control) modules were then stretched to 30mm in 370C water and their forces were measured at zero hour, 1 hour, 24 hours and weekly for 4 weeks with a digital force gauge. The prestreched 5 and 6unit modules yielded significantly lower initial force than the controls. The effects of prestreching on force decay of elastomeric chains were noted mainly in the 1st hour. Thus, the clinical value of prestreching a synthetic elastomeric chain is questionable. 3. Another study done by Nora Buchmann, Christiane senn, Judith Ball, Lorenz Brauchli (2012)3 investigated the dependence of force decay on the initial strain applied to currently available elastic chains. Eight different elastic chains from eight major companies were tested for force decay by using Instron 3344 over a period of three weeks at 50% and 100% strain. At 50% strain, the % of force decay varied from 28% to 70% with in the first 24hours, and from 37% to 75% after 21days. For all chains combined, force decay between the different time intervals was significant for all measurements on the first day, but was not significant for measurements between 24 hours and 21days. 4. Another study by Terrah M. Larrabee, Sean Shih-Yao Liu et al (2012; 82)4 tested the effect of alcohol exposure on force decay of orthodontic elastomeric chain. A total of 450 specimens were divided into five test groups. Two test groups were exposed to different alcohol concentrations (14% and 26.9%) and the other two test groups were exposed to different commercially available mouth rinses (Cephacol-14% alcohol and Listerine-26.9% alcohol) for 60 seconds twice a day. Control group was exposed only to deionized water. Force measurements were taken at six time intervals (initial, 1 day, 1 7 days, 14 days, 21 days and 28 days). Statistically significant effects of time on force decay were seen in all groups. All test groups showed significantly more force decay than the control group. They concluded that alcohol causes an increase in force decay of elastomeric chain over time. 5. Another study conducted by Matheus Melo Pithon, Dandara Andrade Santana, Kassio Henrique Sousa, Isa Mara Andrade Oliveria Farias et al (2013)5 evaluated the effects of different concentrations of chlorhexidine on the decline in force of orthodontic elastics. Five groups of samples were tested, with one control group represented by distilled group (group 1) and four experiments groups: 0.12% manipulated chlorhexidine (group 2), 0.2% manipulated chlorhexidine (group 3), 0.12% chlorhexidine gluconate based oral solution (0.12% perioguard; group 4) and 0.2% cleanform (group 5). Force was measured with a digital dynamometer at six different time intervals 0,1,7,14,21 and 28 days. In this study, chlorhexidine showed no significant influence on the force degradation of the elastics chain tested. 6. Another study by Matheus Melo Pithon, Ailana Cardoso Rodrigues, Erica Luiza Santana Moreira Sousa, Lilia Paula de Souza Santos, Natalia dos Santos Soares et al (2013)6 evaluated the effects of mouthwashes with and without bleaching on the force of elastomeric chains. A total of 108 elastomeric chain specimens was divided into six groups (n=18 in each group). Two test groups were exposed to two types of commonly used mouthwashes (Plax and Listerine whitening). Immersions in the solutions was performed twice a day for 60 seconds. One control group immersed in artificial saliva and other control group were exposed to distilled water throughout the entire experimental period. Force measurements were performed at six time intervals (initial, 1 day, 7 days, 14 days, 21 days, and 28 days). The presence of bleaching agent has no influence on the force degradation of elastomeric chain. 6.3 OBJECTIVES OF THE STUDY 1. To test the effects of mouthwashes with and without bleaching agents on force degradation of elastomeric chain. 2. To compare the effects of different concentrations of chlorhexidine mouth wash on the force degradation of elastomeric chain. 3. To determine the force degradation of elastomeric chain by using different mouthwashes. 2 MATERIALS AND METHODS 7.1 SOURCE OF THE DATA This in-vitro study will be done in Department of Orthodontics and Dentofacial Orthopedics, Sri Rajiv Gandhi College Of Dental Sciences and Hospital, Bangalore. Materials: 1. Elastomeric chain- Short spacing type. 2. Artificial saliva. 3. Mouthwashes : a. “Listerine Whitening freshening whitening rinse” manufactured by Johnson & Johnson Healthcare products, USA. b. “Colgate Optic White” manufactured by Colgate-Palmolive Company, USA. c. “Listerine mouthwash” manufactured by Johnson & Johnson limited, India. d. “Colgate Plax” manufactured by Colgate-Palmolive Company, India. e. “Clohex Plus” manufactured by Dr.Reddy’s Laboratories limited, India. f. “Octowash” manufactured by Octane Biotech Private limited, India. Equipment’s: Dontrix force gauge. Stabilizing zig 7.2 METHOD OF COLLECTION OF DATA Seven groups of samples will be tested. Each group included 12 elastomeric chain (total n=84). The elastomeric chains to be used will be of short spacing type. For each elastomeric chain, five links will be left free and two links will be used for fixation on to the jigs. The specimens will be mounted on personalized test jigs. To fabricate the personalized jigs, PVC tubes will be used, in which small holes will be made to insert the supporting rods for elastomeric chains. To fix the rods self-polymerizing acrylic resin will 3 be injected. The holes will be separated by a mean horizontal distance of 0.5cm. On the test set up, the elastomeric chain will be stretched along a vertical distance of 23.5mm. This measure will be constant during the measurement. These jigs will allow the elastomeric chain to be submerged in an artificial saliva solution throughout the experimental period and allow immersion in the test solution as well. Control group: Group 1 - Elastomeric chains exposed only to artificial saliva for 28 days. Experimental groups: Group 2 – Elastomeric chains exposed to Listerine Whitening freshening whitening rinse. Group 3 – Elastomeric chains exposed to Colgate Optic White rinse. Group 4 – Elastomeric chains exposed to Listerine mouthwash. Group 5 – Elastomeric chains exposed to Colgate Plax rinse. Group 6 – Elastomeric chains exposed to Clohex Plus rinse. Group 7 – Elastomeric chains exposed to Octowash rinse. The test groups will be exposed to mouthwashes twice a day for 60 seconds each with an interval of 12 hours between one daily exposure. The test period will be for 28 days. Force measurements will be performed at six different intervals (initial, 1, 7, 14, 21 and 28 days). PLAN FOR DATA ANALYSIS The statistical tests which will be used in this study are : 1. Descriptive statistical analyses, including means and standard deviations, will be performed for the groups. 2. Analysis of variance to determine whether there will be statistical differences among the groups and the Tukey test will be performed subsequently. INCLUSION CRITERIA 1. Elastomeric chain – Short spacing type. 2. Chlorhexidine mouthwash -0.2% and 2%. EXCLUSION CRITERIA 1. Elastomeric chain – long spacing and continuous type. 2. Chlorhexidine mouthwash – not more than 2%. 4 7.3 DOES THE STUDY REQUIRE ANY INVESTIGATIONS OR INTERVENTIONS TO BE CONDUCTED IN PATIENTS OR OTHER HUMANS OR ANIMALS No 7.4 HAS ETHICAL CLEARANCE BEEN OBTAINED FROM YOUR INSTITUTION Not applicable LIST OF REFERENCES 1. Kanchana P, Godfrey k. Calibration of force extension and force degradation characteristics of orthodontic latex elastics. Am J Orthod Dentofacial Orthop 2000;118:280-287 2. Ho Kim K, His Chung C, Choy K, Sub Lee J, Vanarsdall R L. Effects of prestreching on force degradation of synthetic elastomeric chains. Am J Orthod Dentofacial Orthop 2005; 128: 477- 482. 3. Buchmann N, Senn C, Ball J, Brauchli L. Influence of initial strain on the force decay of currently available elastic chains over time. Angle Orthod.2012; 82:529535. 4. Larrabee T M, Yao Liu S S, Gorena A T, Rojas A S, Eckert G J, Stewart K T. The effects of varying alcohol concentrations commonly found in mouth rinses on the force decay of elastomeric chain. Angle Orthod. 2012; 82:849-899. 5. Pithon M M, Santana D A, Sousa K H, Farias I M A O. Does chlorhexidine in different formulations interfere with the force of orthodontic elastics? Angle Orthod. 2013; 83:313-318. 6. Pithon M M, Rodrigues A C, Sousa E L S M, Santos L P S, Soares N S. Do mouthwashes with and without bleaching agents degrade the force of elastomeric chains? Angle Orthod. 2013; 83:712-717. 5