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CTRI Trial Data PDF of Trial CTRI Website URL - http://ctri.nic.in Clinical Trial Details (PDF Generation Date :- Thu, 23 Sep 2021 10:33:37 GMT) CTRI Number CTRI/2020/03/024093 [Registered on: 20/03/2020] - Trial Registered Prospectively Last Modified On 13/04/2021 Post Graduate Thesis Yes Type of Trial Interventional Type of Study Dentistry Study Design Randomized, Parallel Group, Active Controlled Trial Public Title of Study To compare and evaluate two mouthwashes that is Droova(Cynodon dactylon) and 0.2% Chlorhexidine Gluconate(standard) in people suffering from gum problem Scientific Title of Comparative evaluation of Cynodon dactylon mouthwash with 0.2% Chlorhexidine Gluconate Study mouthwash in treatment of c Chronic Gingivitis: A prospective randomized controlled double blinded clinical trail Secondary IDs if Any Secondary ID Identifier NIL NIL Details of Principal Details of Principal Investigator Investigator or overall Name SRILAXMI BN Trial Coordinator (multi-center study) Designation Postgraduate student Affiliation Manipal College of Dental Sciences, Manipal Address Department of Periodontology Manipal College of Dental Sciences Manipal Madhav Nagar Eshwar Nagar Manipal karnataka Udupi KARNATAKA 576104 India Phone 9902545202 Fax Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Dr Santhosh Kumar Query) Designation Associate Professor Affiliation Manipal College of Dental Sciences, Manipal Address Department of Periodontology Manipal College of Dental Sciences Manipal Madhav Nagar Eshwar Nagar Manipal karnataka Udupi KARNATAKA 576104 India Phone 9741968550 Fax Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Dr Lakshmi P Designation Assistant Professor Affiliation Manipal College of Dental Sciences, Manipal Address Department of Periodontology Manipal College of Dental Sciences Manipal Madhav Nagar Eshwar Nagar Manipal karnataka Udupi KARNATAKA 576104 India page 1 / 4 PDF of Trial CTRI Website URL - http://ctri.nic.in Phone 9895318015 Fax Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > self funded Dr. SRILAXMI BN Department of Periodontolgy Manipal College of Dental Sciences Manipal Madhav Nagar Eshwar Nagar Manipal Primary Sponsor Primary Sponsor Details Name Dr SRILAXMI B N Address Department of Periodontology Manipal College of Dental Sciences Manipal Madhav Nagar Eshwar Nagar Manipal karnataka Type of Sponsor Other [self Funded] Details of Secondary Name Address Sponsor NIL NIL Countries of List of Countries Recruitment India Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator Dr SriLaxmi BN Manipal college of Department of 9902545202 Dental Sciences, periodontology room Manipal no. 3 Manipal college of [email protected] dental sciences Manipal om madhav nagar Eshwar nagar Manipal karnataka Udupi KARNATAKA Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? Institutional Ethical Approved 13/01/2020 No committe Regulatory Clearance Status Date Status from DCGI Not Applicable No Date Specified Health Condition / Health Type Condition Problems Studied Patients Chronic gingivitis Intervention / Type Name Details Comparator Agent Intervention Cynodon dactylon mouthwash Cynodon dactylon mouthwash study prepared. Patient is advised to mix 1Oml of mouthwash with equal quantity of water, and rinse twice daily for 30-60 seconds for a period of 15 days Comparator Agent 0.2% Chlorhexidine Gluconate Comparing Cynodon dactylon mouthwash mouthwash with 0.2% Chlorhexidine Gluconate. Patient advised to mix 10ml of mouthwash with equal amount of water,and rinse twice daily for 30-60 seconds for a period of 15 days in treatment of chronic gingivitis Inclusion Criteria Inclusion Criteria page 2 / 4 PDF of Trial CTRI Website URL - http://ctri.nic.in Age From 18.00 Year(s) Age To 45.00 Year(s) Gender Both Details with minimum of 20 teeth present<br/> systemically healthy patients<br/> patients with moderate to severe gingivitis<br/> bleeding on probing present<br/> probing depth not more than 3-4mm Exclusion Criteria Exclusion Criteria Details patients who have recieved any periodontal therapy or antibiotics prior to 6 months patients with known hypersensitivity to Cynodon dactylon medically compromised patients pregnant women and lactating mothers smokers Method of Generating Stratified block randomization Random Sequence Method of On-site computer system Concealment Blinding/Masking Participant and Investigator Blinded Primary Outcome Outcome Timepoints Increase or Decrease in Gingival Index Scores, 15th day, 1 month and 3 months Plaque Index Scores, Thiol level and Nitric oxide level Secondary Outcome Outcome Timepoints By participating in this study you may help other 15th day, 1 month and 3 months patients with Chronic Gingivitis to get benefits from the Herbal mouthwash (Cynodon dactylon), by contributing knowledge on this investigational herb Target Sample Size Total Sample Size=66 Sample Size from India=66 Final Enrollment numbers achieved (Total)=Applicable only for Completed/Terminated trials Final Enrollment numbers achieved (India)=Applicable only for Completed/Terminated trials Phase of Trial Phase 4 Date of First 28/03/2020 Enrollment (India) Date of First No Date Specified Enrollment (Global) Estimated Duration of Years=2 Trial Months=0 Days=0 Recruitment Status of Other (Terminated) Trial (Global) Recruitment Status of Other (Terminated) Trial (India) Publication Details NIL Brief Summary In-vitro study design: Preparation of Cynodon dactylon extract will be carried out in SDM Ayurveda college kuthpady, Udupi. After which in-vitro evaluation of Minimum Inhibitory Concentration and Minimum Bactericidal page 3 / 4 PDF of Trial CTRI Website URL - http://ctri.nic.in Concentration against gingivitis (species of streptococcus , fusobacterium, actinomyces) will be performed. Mouthwash will be prepared based on MIC and MBC results. In-vivo study design: The clinical trial will follow a randomized controlled double blinded study design which will be conducted on patients diagnosed with chronic gingivitis during routine visit to department of periodontology, Manipal college of dental sciences, Manipal. Patients will be screened and will be recruited in the study if they fulfil the inclusion criteria after obtaining their informed consent. Gingival index (Loe H And Silness In 1963), plaque index (Silness P and loe H in 1964) will be recorded. Saliva will be collected after recording the indices for biochemical evaluation of Nitric oxide level and Thiol level. Supragingival scaling and oral hygiene instructions will be given, soft bristle toothbrush will be provided at the initial visit, the patients will be randomly allocated using block randomization method into 2 groups (Group A and Group B). Each group containing of 33 number of patients. Both principal investigator and patient will be blinded in this study. The mouthwash will be dispensed by guide/ person who is not aware of group allocation and treatment received. Patient will be recalled after 15 days and 1month and 3 months respectively. All clinical parameters will be recorded and saliva will be collected for biochemical evaluation of nitric oxide level and thiol level. Group A (Test group) : Will receive Cynodon dactylon based mouthwash after Supragingival scaling Group B (Control group) : will receive 0.2% chlorhexidinie gluconate mouthwash after Supragingival scaling page 4 / 4 Powered by TCPDF (www.tcpdf.org).
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