1 Presented by, Dr Lakshmi J First Year Post Graduate Student Department of Public Health Dentistry ANTIPLAQUE AND ANTIGINGIVAL EFFECTIVENESS OF NOVEL MOUTH RINSE CONTAINING ASHWAGANDHA AND SOLUBLE CURCUMINE –RANDOMIZED CLINICAL TRIAL Guided by, Dr B.K Srivastava HOD& Professor Department of Public Health Dentistry
2 CONTENT NEED FOR THE STUDY AIM OF THE STUDY OBJECTIVES MATERIALS AND METHODS INCLUSION & EXCLUSION CRITERIA STUDY PROCEDURE STATISTICAL ANALYSIS BUDGET
Oral flora is quite diverse and complex; Streptococcus Mutans and Streptococcus Sobrinus in the dental biofilm play a major role in the pathogenesis of the oral disease Reduction or elimination of growth and virulence properties of Streptococcus Mutans and Streptococcus Sobrinus in Decrease dental biofilm formation Decrease gingivitis and subsequently dental caries initiation But Preventable Dental diseases are chronic and irreversible If appropriate model is adopted at an earlier stage NEED FOR THE STUDY
To address the same Preventive dentistry Health Promotion Specific Protection NOVEL MOUTH RINSE CONTAINING ASHWAGANDHA AND SOLUBLE CURCUMIN Anti biofilm effect Anti bacterial Anti inflammatory Anti stress immunomodulatory ASHWAGANDHA SOLUBLE CURCUMIN Antimicrobial Anti inflammatory Antioxidant Anti diabetic Anti hypertensive
AIM OF THE STUDY To evaluate the effectiveness of ashwagandha and soluble curcumine in plaque and gingivitis control among children aged 12-15 years attending schools of Bangalore city 5
OBJECTIVES 6 To evaluate the effectiveness of ashwagandha mouth rinse in control of plaque and gingivitis To evaluate the effectiveness of soluble curcumine mouth rinse in control of plaque and gingivitis To evaluate the effectiveness of soluble curcumine and ashwagandha mouth rinse in control of plaque and gingivitis To compare the effectiveness of novel mouth rinse containing ashwagandha and soluble curcumine against chlorhexidine in control of plaque and gingivitis Cost effectiveness analysis of the novel mouth rinse containing ashwagandha and soluble curcumine in the control of plaque and gingivitis.
MATERIALS AND METHODS
SELECTION CRITERIA INCLUSION CRITERIA: Children of 12-15 years of age group, attending schools in Bengaluru city Children who gives consent EXCLUSION CRITERIA: Children who cannot cooperate for the study. Children who doesn’t give consent Children suffering from compromised health conditions and/or on medications for systemic conditions
STUDY PROCEDURE 9 BASELINE RANDOMIZATION BLINDING ORAL EXAMINATION INDICES GROUP A (Ashwagandha) N=13 GROUP B (Soluble curcumin) N=13 GROUP C (Ashwagandha and soluble curcumin) N=13 GROUP D (CHX) N=13 POST INTERVENTION ORAL EXAMINATION with PI & GI COST EFFECTIVENESS ANALYSIS PHASE 1 PHASE 2 PHASE 3 15 DAYS FOLLOW UP 45 DAYS & 90 DAYS
ASSESSED FOR ELIGIBILITY FINAL SAMPLE SIZE (n=52) RANDOMIZATION INTERVENTION( n=52) CONTROL (n=18) GROUP A Ashwagandha mouth rinse n=13 GROUP B Soluble Curcumin mouth rinse n=13 GROUP C Ashwagandha + Soluble curcumin mouth rinse n=13 GROUP D CHX mouth rinse n=13 BASELINE CHECKUP Follow up with PI and GI(45 &90 days) ANALYSIS
STATISTICAL ANALYSIS Data will be processed and analysed using Statistical Package for Social Sciences [SPSS] for Windows Version 22.0 Released 2013. Armonk, NY: IBM Corp The following statistical tests will be used: ANOVA test/ Kruskal Wallis test Repeated measure ANOVA/Friedman test
ETHICAL CONCERNS OF THE STUDY • INTERVENTIONS – Development of novel mouth rinse containing ashwagandha and soluble curcumin with antiplaque and anti-gingival properties • BENEFIT vs RISK – Nil • DEVIATIONS FROM STANDARD OPERATING PROCEDURES – Nil • VULNERABLE GROUP – None 12
BUDGET To prepare group A containing ashwagandha mouth rinse- Rs 3000 To prepare group B containing soluble curcumin mouth rinse –Rs4000 To buy chlorhexidine mouth rinse – 26 bottles -Rs6500 TOTAL- Rs 13500 All costs of the project will be borne by the principal investigator; none of the participants will be charged during the course of the study 13