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CTRI Number  CTRI/2025/07/090322 [Registered on: 07/07/2025] Trial Registered Prospectively
Last Modified On: 07/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Can a Natural Plant Compound (Quercetin) is helpful in Fighting with Gum related problems in Adult. 
Scientific Title of Study   Quercetin as a Natural Adjunct in managing Plaque and Gingivitis in Adolescents : A Randomized control trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
U1111-1323-4212  UTN 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ankita Rawal 
Designation  Postgraduate 
Affiliation  Pacific Dental College and Hospital 
Address  Room no. 7, Department of Public Health Dentistry, Pacific Dental College and Hospital, Airport Road, Debari, Udaipur

Udaipur
RAJASTHAN
313024
India 
Phone  8769891166  
Fax    
Email  ankitarawal14@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Mridula Tak 
Designation  Professor 
Affiliation  Pacific Dental College and Hospital 
Address  Room no. 7, Department of Public Health Dentistry, Pacific Dental College and Hospital, Airport Road, Debari, Udaipur

Udaipur
RAJASTHAN
313024
India 
Phone  9928840140  
Fax    
Email  mtak1084@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Ankita Rawal 
Designation  Postgraduate 
Affiliation  Pacific Dental College and Hospital 
Address  Room no. 7, Department of Public Health Dentistry, Pacific Dental College and Hospital, Airport Road, Debari, Udaipur

Udaipur
RAJASTHAN
313024
India 
Phone  8769891166  
Fax    
Email  ankitarawal14@gmail.com  
 
Source of Monetary or Material Support  
Room no. 7, Department of Public Health Dentistry, Pacific Dental College and Hospital, Airport Road, Debari, Udaipur, 313024, Rajasthan, India 
 
Primary Sponsor  
Name  Ankita Rawal 
Address  Room No 7, Department of Public Health Dentistry, Pacific Dental and Hospital, Airport Road, Debari, Udaipur, Rajasthan  
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 
Ankita Rawal  Pacific Dental College and Hospital  Room no. 7, Department of Public Health Dentistry, Pacific Dental College and Hospital, Airport Road, Debari, Udaipur
Udaipur
RAJASTHAN 
08769891166

ankitarawal14@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Pacific Dental College and Hospital Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Gingivitis 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  chlorhexidine mouthwash  Duration: till 1 month Total amount daily: 20 ml, 10 in morning before breakfast and another 10 ml in night after dinner Content in mouthwash:0.2% chlorhexidine  
Comparator Agent  Placebo  Duration: till 1 month Total amount daily: 20 ml, 10 in morning before breakfast and another 10 ml in night after dinner Formula: 0.3% Sucrose 0.01% Sodium Lauryl sulphate 0.001% Preservative 
Intervention  Quercetin Mouthwash  Duration: till 1 month Total amount daily: 20 ml, 10 in morning before breakfast and another 10 ml in night after dinner Formula: 2% Quercetin 0.3% Sucrose 0.01% Sodium lauryl sulphate 0.001 Preservative 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  27.00 Year(s)
Gender  Both 
Details  Subjects who agreed to cooperate and willing to participate in the study.
Subjects with good systemic health.
Subjects with Gingival Index more than 1 and Periodontal Pocket Depth less or equal to 3 mm
Subjects with Clinical Attachment loss to be 0
 
 
ExclusionCriteria 
Details  Subjects who were on antibiotic therapy within the last 2 weeks and who have a history of hypersensitivity to any tested product used.
Subject who self-reported pregnancy, intent to become pregnant during the study, or brestfeeding.
Subject with severe crowding, malocclusion, and wearing orthodontic appliances or prosthesis,
Subject who were aware of their immunocompromised states.
Subjects under influence of oral tissue abusive habits like alcohol, smoking, tobacco chewing etc.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Effectiveness of Quercetin on gingiva and plaque  3 months 
 
Secondary Outcome  
Outcome  TimePoints 
Side effects of quercetin   3 months 
 
Target Sample Size   Total Sample Size="45"
Sample Size from India="45" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="45" 
Phase of Trial   Phase 1 
Date of First Enrollment (India)   10/08/2025 
Date of Study Completion (India) 31/10/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Double blind, parallel group Randomized control trial for 3 months on 45 subjects, 15 subjects of three group one is of placebo, one is of quercetin and one is of chlorhexidine to know the effectiveness of quercetin mouthwash and secondary outcome will be side effect of quercetin. Gingival and plaque index will be take on baseline, on 15 days and after 1 month to know the effectiveness of quercetin. 
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