| CTRI Number |
CTRI/2024/09/074330 [Registered on: 25/09/2024] Trial Registered Prospectively |
| Last Modified On: |
29/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Which works better to prevent cavities in kids aged 3-6: Probiotic tablets or yogurt |
|
Scientific Title of Study
|
Comparative evaluation of effectiveness of Probiotic chewing tablets and Probiotic curd in prevention of dental caries in 3-6 years old children: A Randomised controlled 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 |
Dr Rehan Khan |
| Designation |
Professor and Head of the department |
| Affiliation |
Maharashtra University of Health Sciences, Nashik |
| Address |
Ground floor, Department of Pediatric and Preventive Dentistry, Saraswati Dhanwantari Dental college and hospital Parbhani 431401, Maharashtra
Parbhani
MAHARASHTRA
431401
India |
| Phone |
8237425282 |
| Fax |
|
| Email |
dent_dr1@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Laxmi Narayan Darmode |
| Designation |
PG student |
| Affiliation |
Maharashtra University of Health Sciences, Nashik |
| Address |
Ground floor 6, Department of Pediatric and Preventive Dentistry, Saraswati Dhanwantari Dental college and hospital Parbhani 431401, Maharashtra
Parbhani
MAHARASHTRA
431401
India |
| Phone |
8459654447 |
| Fax |
|
| Email |
lndarmode@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rehan Khan |
| Designation |
Professor and Head of the department |
| Affiliation |
Maharashtra University of Health Sciences, Nashik |
| Address |
Ground floor, Department of Pediatric and Preventive Dentistry, Saraswati Dhanwantari Dental college and hospital Parbhani 431401, Maharashtra
Parbhani
MAHARASHTRA
431401
India |
| Phone |
8237425282 |
| Fax |
|
| Email |
dent_dr1@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Saraswati Dhanwantari Dental college and hospital Parbhani 431401, Maharashtra |
|
|
Primary Sponsor
|
| Name |
Laxmi Narayan Darmode |
| Address |
Ground floor 6, Department of Pediatric and Preventive Dentistry, Saraswati Dhanwantari Dental college and hospital, Pathri road,Parbhani 431401, Maharashtra, India |
| Type of Sponsor |
Other [Self ( Laxmi Narayan Darmode)] |
|
|
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 Rehan Khan |
Saraswati Dhanwantari Dental college and hospital Parbhani 431401, Maharashtra |
Ground floor 6, Department of Pediatrics and Preventive Dentistry
Parbhani
MAHARASHTRA |
8237425282
dent_dr1@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maharashtra University of Health Sciences, Nashik |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
NIL |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
HealthyHey Junior Probiotic Gummies and Amul curd |
Comparative agent:
- group 1- Probiotic chewing tablets OD for 21 days
- Group 2- probiotic curd 100gm BD for 21 days |
| Comparator Agent |
Probiotic tablets and Probiotic curd |
Comparative agent:
-Group 1: Probiotic chewing tablets OD for 21 days
-Group 2: Probiotic curd 100gm BD for 21 days |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
1.Children with the age group of 3-6 years.
2.Children irrespective of gender will be selected.
3.Absence of severe systemic disease or allergy
4.Co-operative children |
|
| ExclusionCriteria |
| Details |
1.Ongoing medication with antibiotics
2.Regular use of other probiotic products (dairy products or other supplements)
3.Caries lesions with a need for extractions
4.Mentally or physically disabled children
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Probiotic curd was more effective in reducing Streptococcus mutans (a bacteria associated with tooth decay) counts in saliva and plaque.
2.Both groups showed significant reduction in dental caries incidence and plaque accumulation. |
At baseline, 1 month, 3 month and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Both probiotic chewable tablets and probiotic curd were effective in preventing dental caries. |
At baseline, 1 month, 3 month and 6 months |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
30/09/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
30/09/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="4"
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
|
The preventive role of probiotics using chewing tablets and curd is well
describe in the literature. Curd contains probiotic bacterial strains L.
acidophilus (La5) and B. lactis (Bb12). It is preferred because fresh
curd contains starter cultures (Lactobacillus delbrueckii subspecies
bulgaricus and streptococcus thermophilus). Curd is widely accepted
and eaten regularly. Curd is a semisolid food with a continuous gellike consistency that gradually disappears from the mouth. A dairybased carrier was chosen to hold the probiotic bacteria in order to
avoid bacterial acidogenicity. |