| CTRI Number |
CTRI/2025/01/079024 [Registered on: 20/01/2025] Trial Registered Prospectively |
| Last Modified On: |
18/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Evaluation of efficacy of Herbal, Chlorine dioxide and Probiotic based mouthwashes on reduction of biofilm in children of 6-12 years |
|
Scientific Title of Study
|
Comparative evaluation of Herbal, Chlorine dioxide and Probiotic based mouthwashes on reduction of biofilm in 6-12 years old children: An Invivo study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shaik Salma |
| Designation |
PG Student |
| Affiliation |
GITAM Dental College and Hospital |
| Address |
Department Of Pedodontics ,GITAM Dental College, Gandhi nagar Campus,Rushikonda,Visakhapatnam,Andhra Pradesh ,530045
India
India
Visakhapatnam
ANDHRA PRADESH
530045
India |
| Phone |
9502454348 |
| Fax |
|
| Email |
shaik.salma535@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jayalakshmi Pandranki |
| Designation |
Professor |
| Affiliation |
Dr.NTR University of Health Sciences |
| Address |
Department Of Pedodontics ,GITAM Dental College, Gandhi nagar Campus,Rushikonda, Visakhapatnam ,Andhra Pradesh ,530045
India
Visakhapatnam
ANDHRA PRADESH
530045
India |
| Phone |
9912860194 |
| Fax |
|
| Email |
mds.deepthi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jayalakshmi Pandranki |
| Designation |
Professor |
| Affiliation |
Dr.NTR University of Health Sciences |
| Address |
Department Of Pedodontics ,GITAM Dental College, Gandhi nagar Campus,Rushikonda, Visakhapatnam ,Andhra Pradesh ,530045
India
Visakhapatnam
ANDHRA PRADESH
530045
India |
| Phone |
9912860194 |
| Fax |
|
| Email |
mds.deepthi@gmail.com |
|
|
Source of Monetary or Material Support
|
| GITAM Dental College and Hospital, Visakhapatnam, Andhra Pradesh 530045, India. |
|
|
Primary Sponsor
|
| Name |
Dr. Shaik Salma |
| Address |
Department Of Pedodontics, GITAM Dental College and Hospital,Gandhi nagar Campus,Rushikonda, Visakhapatnam,Andhra Pradesh, 530045
|
| Type of Sponsor |
Other [Self supported study] |
|
|
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 |
| Dr Shaik Salma |
GITAM Dental College and Hospital |
Department Of Pedodontics GITAM Dental College and Hospital, Gandhi nagar Campus,Rushikonda, Visakhapatnam,Andhra Pradesh,530045
India
Visakhapatnam
ANDHRA PRADESH |
9502454348
shaik.salma535@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Research Review Board (IRRB) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K051||Chronic gingivitis, (2) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Chlorine dioxide mouthwash |
Oral rinse with 10ml of mouthwash for 60 sec once daily for 14 days |
| Intervention |
Herbal mouthwash |
Oral rinse with 10ml of mouthwash for 60 sec once daily for 14 days |
| Comparator Agent |
Placebo (Distilled water) |
Oral rinse with water for 60 sec once daily for 14 days |
| Intervention |
Probiotic mouthwash |
Oral rinse with 10ml of mouthwash for 60 sec once daily for 14 days |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1)Children within the age range of 6-12 years.
2)Children with DMFT score ≤ 2
3)Children with no history of antibiotic or probiotics in any form in the past three months. |
|
| ExclusionCriteria |
| Details |
1)Medically compromised children
2)Children with history of systemic allergies and diseases.
3)Children using any prosthodontic/orthodontic appliance. |
|
|
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 and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Sillness and Loe Plaque Index |
Pre evaluation(baseline plaque scores will be assessed) After 14 days of intervention, post evaluation of plaque scores will be assessed. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| s.mutans bacterial load |
pre evaluation(baseline s.mutans count on Day 0) & After 14 days of intervention, post evaluation of s.mutans count (Day 15) |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
03/02/2025 |
| Date of Study Completion (India) |
21/02/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="15" |
|
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
|
Oral hygiene practices that intervene with plaque formation play a crucial role in preventing dental caries. Raising concerns of toxicity with conventional mouthwash usage led to the search for biologically safe mouth rinsing agents in children. The present study aims to evaluate the efficacy of Herbal (Botanical Oral rinse) and Stabilized Chlorine Dioxide (ClO2) mouth wash in beneficially altering the oral ecological niche in children aged 6-12 years. Prior to intervention, the plaque accumulation will be assessed using Sillness and Loe Plaque index and unstimulated saliva samples will be collected to quantify S. mutans as a baseline data. The children will then be instructed to rinse the allocated mouthwash once daily for 60 sec for 14 days and fill the supplied checklist . The assessment of all the parameters will be repeated after 14 days of intervention and the values will be subjected to statistical analysis. |