| CTRI Number |
CTRI/2025/06/089735 [Registered on: 27/06/2025] Trial Registered Prospectively |
| Last Modified On: |
24/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Probiotic
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Do Probiotic Lozenges and Toothpaste Lower Cavity-Causing Bacteria in Braces Users? A Clinical Trial |
|
Scientific Title of Study
|
Comparative Efficacy of Probiotic Lozenges and Probiotic Toothpaste on the Reduction of Salivary Streptococcus mutans in Orthodontic Patients: A Randomized Clinical Trial |
| Trial Acronym |
PROSMORT Trial
Probiotic intervention on Salivary Mutans in Orthodontic patients |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Suresh Kangane |
| Designation |
Principal, HOD and Professor |
| Affiliation |
maharashtra institute of dental sciences and research , latur |
| Address |
maharashtra institute of dental sciences and research, latur, maharashtra -413512, india
Latur
MAHARASHTRA
413512
India |
| Phone |
9823267063 |
| Fax |
|
| Email |
drsureshkangane@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Riya Gala |
| Designation |
post graduate student |
| Affiliation |
maharashtra institute of dental sciences and research, latur maharashtra -413512, india |
| Address |
maharashtra institute of dental sciences and research, latur, maharashtra -413512, india
Latur
MAHARASHTRA
413512
India |
| Phone |
9004894036 |
| Fax |
|
| Email |
galariya25@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Riya Gala |
| Designation |
post graduate student |
| Affiliation |
Maharashtra Institute of Dental Sciences and Research (Dental College), Maharashtra |
| Address |
maharashtra institute of dental sciences and research, latur,maharahstra. Department of orthodontics and dentofacial orthopedics
Latur
MAHARASHTRA
413512
India |
| Phone |
9004894036 |
| Fax |
|
| Email |
galariya25@gmail.com |
|
|
Source of Monetary or Material Support
|
| Self-supported by ( Dr. Riya Shailesh Gala and Dr. Suresh Kangane). Monetary support
from Maharashtra Institute of Dental Sciences and Research Dental College Latur |
|
|
Primary Sponsor
|
| Name |
MIDSR dental college |
| Address |
Maharashtra institute of dental sciences and research, latur, maharashtra 413512 India |
| Type of Sponsor |
Other [Private dental college ] |
|
|
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 |
| riya gala |
MIDSR Dental College Latur |
Department of
Orthodontics and
Dentofacial Orthopedics
MIDSR DENTAL
COLLEGE AND
RESEARCH DENTRE
AMBEJOGAI ROAD
LATUR
Latur
MAHARASHTRA
Latur
MAHARASHTRA |
9004894036
galariya25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee MIDSR Latur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
no probiotic products |
samples will be instructed not to consume any probiotic products during trial |
| Intervention |
probiotic lozenges |
samples will be given probiotic lozenge and saliva sample will be collected to check salivary streptococcus mutans count |
| Intervention |
probiotic toothpaste |
samples will be using probiotic toothpaste then saliva sample will be collected to check salivary streptococcus mutans count |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Orthodontic treatment with MBT.
Permanent dentition. |
|
| ExclusionCriteria |
| Details |
1.Patients consuming tobacco in any form (smoking or chewing).
2. Systemic antibiotic consumption within 4 weeks.
3. Topical fluoride treatment within 4 weeks.
4. Active carious lesion
5. Periodontal problem
6. Individuals with habitual use of probiotics products not related to the study. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the efficacy of probiotic lozenges and probiotic toothpaste in reducing level of
salivary Streptococcus mutans in patient undergoing orthodontic treatment.
|
8 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate level of Streptococcus mutans in saliva without consuming probiotic
products in patients undergoing orthodontic treatment. |
8 months |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
Final Enrollment numbers achieved (Total)= "45"
Final Enrollment numbers achieved (India)="45" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
15/07/2025 |
| Date of Study Completion (India) |
20/01/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
20/01/2026 |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| 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
|
To investigate the effect of probiotic lozenges and probiotic toothpaste on reduction of salivary Streptococcus mutans levels in patients undergoing orthodontic treatment. 45 subjects are included in study. saliva is collected before using probiotic products and 4 weeks after use of probiotic products. |