| CTRI Number |
CTRI/2025/10/096294 [Registered on: 22/10/2025] Trial Registered Prospectively |
| Last Modified On: |
21/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Role of mouthwash in reducing bleeding and plaque |
|
Scientific Title of Study
|
Antiplaque efficacy of herbal based mouthwash with a novel resveratrol-based mouthwash. A Randomized clinical trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sudhir Rama Varma |
| Designation |
Clinical Assistant Professor |
| Affiliation |
Ajman University |
| Address |
Deaprtment of clinical dentistry
Dental clinics
Ground floor J1 Block Clinics A B C D E
Ajman University
20381
Other |
| Phone |
0506595075 |
| Fax |
|
| Email |
s.varma@ajman.ac.ae |
|
Details of Contact Person
Scientific Query
|
| Name |
Biju Thomas |
| Designation |
Professor |
| Affiliation |
AB Shetty memorial institute of dental sciences |
| Address |
College of dentistry
Dental Clinics Ground floor
AB Shetty memorial institute of dental sciences
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
919448953418 |
| Fax |
|
| Email |
drbiju@nitte.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Sudhir Rama Varma |
| Designation |
Clinical Assistant Professor |
| Affiliation |
Ajman University |
| Address |
Center for medical and bioallied health sciences research
Dental clinics
Ajman University
20381
Other |
| Phone |
0506595075 |
| Fax |
|
| Email |
s.varma@ajman.ac.ae |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sudhir Rama Varma |
| Address |
College of dentistry
Ajman University
POBOX 346
Ajman
Ph: 97167482222 |
| Type of Sponsor |
Other [Self funded] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India
United Arab Emirates |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR Sudhir Rama Varma |
Ajman University |
Department of clinical sciences
Dental Clinics-Ground floor-J1 block
Ajman University
|
0506595075
s.varma@ajman.ac.ae |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Deanship of Graduate Studies and Research Research Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K051||Chronic gingivitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Eucalyptus |
In the Initial Visit-Baseline, and subsequent visits,
participants will be called in the morning. Morning
hours will be chosen for examination, as it will reduce
the risk of bias and also help in quantifying results.
plaque and gingival scores will be recorded and the
First herbal mouthwashes will be given, participants
will also be provided new tooth-brushes (Oral B-soft).
• They will be asked to follow their routine oral hygiene
habits. They will be asked to come back after 2 weeks
for plaque and gingival bleeding scores recording
for the second visit and again after 2weeks post the
second visit for the third and final visit to record their
plaque and gingival bleeding scores. |
| Intervention |
Resveratrol |
In the Initial Visit-Baseline, and subsequent visits, participants will be called in the morning. Morning hours will be chosen for examination, as it will reduce the risk of bias and also help in quantifying results. plaque and gingival scores will be recorded and the First herbal mouthwashes will be given, participants will also be provided new tooth-brushes (Oral B-soft). • They will be asked to follow their routine oral hygiene habits. They will be asked to come back after 2 weeks for plaque and gingival bleeding scores recording for the second visit and again after 2weeks post the second visit for the third and final visit to record their plaque and gingival bleeding scores |
| Comparator Agent |
Tea Tree Oil |
In the Initial Visit-Baseline, and subsequent visits, participants will be called in the morning. Morning hours will be chosen for examination, as it will reduce the risk of bias and also help in quantifying results. plaque and gingival scores will be recorded and the First herbal mouthwashes will be given, participants will also be provided new tooth-brushes (Oral B-soft). • They will be asked to follow their routine oral hygiene habits. They will be asked to come back after 2 weeks for plaque and gingival bleeding scores recording for the second visit and again after 2weeks post the second visit for the third and final visit to record their plaque and gingival bleeding scores |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients who are medically fit
2. Patients with gingival inflammation not progressed into periodontitis
3. Patients between the age of 18-60 years |
|
| ExclusionCriteria |
| Details |
1. Patients who are medically compromised
2. Patient who have undergone a periodontal therapy for the past 3 months
3. Patients who are healthy but have been using herbal mouthwashes |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Dental Plaque |
From Baseline to preintervention to the end of treatment at 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Gingival Bleeding score |
From Baseline to preintervention to the end of treatment at 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="10"
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
|
N/A |
|
Date of First Enrollment (India)
|
03/11/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
03/11/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Mouthwashes are used by an estimated 80% of the world’s population for primary health care. They have gained popularity as a dietary supplement for illness prevention and as an alternative/complementary therapy in recent years. Mouthwashes come in a wide variety of forms and can be found on the market all over the world.
Detailed Description: Mouthwashes have been increasingly popular over time. Ethnomedicines are the term used to describe them. Various substances have been tested, with phytopharmacological analyses yielding contradictory results. Many previous studies had tested the antiplaque efficiency of one herbal mouthwash with contradicting results, other studies have tested the Antiplaque efficiency of chlorhexidine, tea tree oil and Miswak, some studies had given positive outcomes and benefits of Miswak on the gingiva and others when comparing between the efficacy of Miswak over chlorhexidine mouth wash in dental practice provided results favouring both these mouthwashes. In our proposed study we will compare the antiplaque efficiency of three mouthwashes, Eucalyptus, tea tree oil and Resveratrol mouthwash. Plaque and gingival bleeding scores will be taken before the study from 6 different teeth and retaken after 2 weeks and four weeks respectively the use of the mouthwash. This study is single-blinded. Antiplaque and gingival bleeding scores from the three mouthwashes will be recorded over a period of a month and statistical analysis will be performed |