| CTRI Number |
CTRI/2025/11/097051 [Registered on: 07/11/2025] Trial Registered Prospectively |
| Last Modified On: |
28/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Chorhexidine Gluconate, Sodium Fluoride and Xylitol based mouthwashes are going to be prescribed to patients with dental caries to evaluate the caries causing Streptococcus Mutans count before and after using mouthwashes for 10 days. |
|
Scientific Title of Study
|
Comparative evaluation of effectiveness of three different mouthwashes on Streptococcus Mutans count in children having dental caries. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ashish Narayan Vhatkar |
| Designation |
PG Student |
| Affiliation |
Saraswati Dhanwantari Dental College and Hospital |
| Address |
111/2 Swapna Nivas, Dhanlaxmi Nagar, Near B Raghunath College, Jintur Road, Parbhani
Ground Floor, 6, Department of Pediatric and Preventive Dentistry, Saraswati Dhanwantari Dental College and Hospital, Pathri Road, Parbhani 431401
Parbhani
MAHARASHTRA
431401
India |
| Phone |
8308409777 |
| Fax |
|
| Email |
ashishvhatkar4916@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrRehan Khan |
| Designation |
Professor and Head of Department of Pediatric and Preventive dentistry |
| Affiliation |
Saraswati Dhanwantari Dental College and Hospital |
| Address |
Ground Floor, 6, Department of Pediatric and Preventive Dentistry, Saraswati Dhanwantari Dental College and Hospital, Pathri Road, Parbhani 431401
Parbhani
MAHARASHTRA
431401
India |
| Phone |
8237425282 |
| Fax |
|
| Email |
dent_dr1@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrRehan Khan |
| Designation |
Professor and Head of Department of Pediatric and Preventive dentistry |
| Affiliation |
Saraswati Dhanwantari Dental College and Hospital |
| Address |
Ground Floor, 6, Department of Pediatric and Preventive Dentistry, Saraswati Dhanwantari Dental College and Hospital, Pathri Road, Parbhani 431401
MAHARASHTRA
431401
India |
| Phone |
8237425282 |
| Fax |
|
| Email |
dent_dr1@rediffmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DrAshish Vhatkar |
| Address |
111/2 Swapna Nivas, Dhanlaxmi Nagar, Near B Raghunath college, Jintur Road, Parbhani, India 431401. |
| 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 |
| Dr Ashish Vhatkar |
Saraswathi Dhanwantari Dental College |
Department no.6, Ground floor, Department of Pediatric and Preventive dentistry, Saraswathi Dhanwantari Dental College and hospital, Parbhani,India 431401.
Parbhani
MAHARASHTRA |
8308409777
ashishvhatkar4916@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SDDC PBN IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Chlorhexidine Gluconate |
Mouthwash to be given to 8 out of 32 children. |
| Intervention |
Fluoritop Mouthwash |
10 days |
| Intervention |
Hexidine Mouthwash |
10 days |
| Intervention |
Sensodent-K |
10 days |
| Comparator Agent |
Sodium fluoride |
Mouthwash to be given to 8 out of 32 children. |
| Comparator Agent |
Water |
Plain Water is to be given in 8 out of 32 patients. |
| Comparator Agent |
Xylitol with sodium fluoride and potassium Nitrate |
Mouthwash to be given to 8 out of 32 children. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Children with caries.
Non mobile tooth.
Healthy patient |
|
| ExclusionCriteria |
| Details |
Immunocompromised patient,Uncooperative patient
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Chorhexidine gluconate mouthwash is effective in reducing Streptococcus mutans count as compared to Sodium fluoride and Xylitol mouthwash |
After 10 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| All the mouthwash are equally effective in their action |
10 days |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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)
|
20/11/2025 |
| 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="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Three different mouthwahes are going to be compared against Streptococcus Mutans bacteria. A sample of saliva will be taken prior to mouthwash prescription and patient will be told to use mouthwash two times a day for 10 days. Then the post sample is going to be taken and sent for microbial evaluation in the laboratory. The data will be measured and compared and finally the result will be determined. |