| 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
|
|
|
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
|
|
|
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. |