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CTRI Number  CTRI/2020/08/027128 [Registered on: 13/08/2020] Trial Registered Prospectively
Last Modified On: 05/08/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparative evalution of Triphala Green tea and Chlorhexidine Mouthwashes on Gingivitis 
Scientific Title of Study   Comparative evaluation of Triphala,Camellia (Green tea) and Chlorhexidine mouthwashes on gingivitis - A Randomized controled clinical trail 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  M Rajya Lakshmi 
Designation  Post Graduate 
Affiliation  Vishnu dental college 
Address  Block No 2 Room no 7 Department of Periodontics Vishnu Dental College Vishnupur Bhimavaram
Block No 2 Room no 7 Department of Periodontics Vishnu Dental College Vishnupur Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India 
Phone  9441952538  
Fax    
Email  rajimikkili123@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Gautami s penmetsa 
Designation  Head Of the Department 
Affiliation  Vishnu dental college 
Address  Block No 2 Room no 7 Department of Periodontics Vishnu Dental College Vishnupur Bhimavaram
Block No 2 Room no 7 Department of Periodontics Vishnu Dental College Vishnupur Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India 
Phone  9951011618  
Fax    
Email  gautamipenmetsa@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Gautami S Penmetsa 
Designation  Head Of the Department 
Affiliation  Vishnu Dental College 
Address  Block No 2 Room no 7 Department of Periodontics Vishnu Dental College Vishnupur Bhimavaram
Block No 2 Room no 7 Department of Periodontics Vishnu Dental College Vishnupur Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India 
Phone  9951011618  
Fax    
Email  gautamipenmetsa@gmail.com  
 
Source of Monetary or Material Support  
Vishnu dental college Vishnupur Bhimavaram West godavari district 534202  
 
Primary Sponsor  
Name  M Rajya lakshmi 
Address  Block No 2 Room no 7 Department of Periodontics Vishnu Dental college Vishnupur Bhimavaram 534202 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
M Rajya Lakshmi   Vishnu Dental College  VISHNU DENTAL COLLEGE VISHNUPUR
West Godavari
ANDHRA PRADESH 
09441952538

rajimikkili123@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Vishnu Dental College Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  healthy humans suffering with gingivitis  
Patients  (1) ICD-10 Condition: K050||Acute gingivitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Camelia mouth wash  Frequency is twice daily (after braekfast and at bed time Measure 1/2 ounce (15 milliliters) of the solution using the supplied measuring cup. Swish the solution in your mouth for 30 seconds, and then spit it out. 
Comparator Agent  Chlorhexidine Mouth wash  Frequency is twice daily (after braekfast and at bed time Measure 1/2 ounce (15 milliliters) of the solution using the supplied measuring cup. Swish the solution in your mouth for 30 seconds, and then spit it out. 
Comparator Agent  Triphala Mouthwash  Frequency is twice daily (after braekfast and at bed time Measure 1/2 ounce (15 milliliters) of the solution using the supplied measuring cup. Swish the solution in your mouth for 30 seconds, and then spit it out. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details 
Patients with minimum of 20 teeth.
Patients who have not taken periodontal treatment in past 6months
 
 
ExclusionCriteria 
Details  Pregnancy and lactating women
Patients on antibiotic therapy from past 1 month
Smokers
Patients allergic to chlorhexidine, aloevera, triphala.

 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment    
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Plaque Index
Gingival Index
Bleeding Index
 
baseline
15th day
30th day 
 
Secondary Outcome  
Outcome  TimePoints 
.. 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 1 
Date of First Enrollment (India)   17/08/2020 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="0"
Days="30" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Dental plaque is associated with the most prevalent oral diseases like dental caries and periodontal diseases. The removal of plaque is a determining component in the prevention of these diseases. The use of mechanical agents is a simple and cost effective method that has been demonstrated to be effective in control of gingivitis. Most of the individuals do not practice an acceptable standard of mechanical plaque removal due lack of dexterity in performing oral hygiene methods.Green tea, Camellia Sinensis from the family of Thea Cease is mostly cultivated in coasts of Caspian sea in North of Iran. Its remedial effects are associated with the polyphenol contents comprising catechin, epicatechin, gallocatechin, epigallocatechin, epicatechin gallate, and epigallocatechin gallate. Green tea consumption was found to lower the incidence of cardiovascular disease, diabetes, and obesity. Green tea is made solely with the leaves of C. sinensis that have undergone minimal oxidation during processing and hence it has more antioxidant and antibacterial properties. Studies have shown that green tea polyphenols inhibit the growth of oral and periodontopathic bacteria thereby preventing dental caries, halitosis, gingivitis, and periodontitis.

The beneficial effects of the natural products along with the lower prevalence of side effects could enhance patient compliance and long-term usage. The purpose of the study is to evaluate the efficacy of the green tea in treatment of gingivitis 
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