| CTRI Number |
CTRI/2017/07/009072 [Registered on: 18/07/2017] Trial Registered Retrospectively |
| Last Modified On: |
18/07/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic
Preventive
Dentistry |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
A study to check the effect of Useful Bacteria on Caries causing Microorganisms in Saliva and Plaque of Children |
|
Scientific Title of Study
|
Evaluation of the effect of Bacillus coagulans on pH and levels of Mutans streptococci, Lactobacilli in saliva and plaque |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Surendra Reddy Munnangi |
| Designation |
Reader |
| Affiliation |
SVS Institute of dental sciences |
| Address |
Department of Pedodontics and Preventive Dentistry, SVS Institute of dental sciences, Appannapally
Mahbubnagar
ANDHRA PRADESH
509002
India |
| Phone |
08542-2311212 |
| Fax |
|
| Email |
surendra.mds@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Surendra Reddy Munnangi |
| Designation |
Reader |
| Affiliation |
SVS Institute of dental sciences |
| Address |
Department of Pedodontics and Preventive Dentistry, SVS Institute of dental sciences, Appannapally
Mahbubnagar
ANDHRA PRADESH
509002
India |
| Phone |
08542-2311212 |
| Fax |
|
| Email |
surendra.mds@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Surendra Reddy Munnangi |
| Designation |
Reader |
| Affiliation |
SVS Institute of dental sciences |
| Address |
Department of Pedodontics and Preventive Dentistry, SVS Institute of dental sciences, Appannapally
Mahbubnagar
ANDHRA PRADESH
509002
India |
| Phone |
08542-2311212 |
| Fax |
|
| Email |
surendra.mds@gmail.com |
|
|
Source of Monetary or Material Support
|
| Unique Biotech Ltd, G - 43, Madhura Nagar, Yousufguda,
Hyderabad - 500 038, India |
|
|
Primary Sponsor
|
| Name |
Unique Biotech Ltd |
| Address |
Plot No - 2, Phase - 2, Kolthur. |
| Type of Sponsor |
Other [Company] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| SVS Institute of Dental Sciences |
Appannapally, Mahabubnagar. |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Surendra Reddy Munnangi |
SVS Institute of Dental Sciences |
Department of Pedodontics & Preventive Dentistry, Room No 8
Mahbubnagar
ANDHRA PRADESH |
9885148981
surendra.mds@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SVS Institute of Dental Sciences Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
2 billion counts of Bacillus coagulans OD for 14 days |
Chewable tablet form |
| Comparator Agent |
Placebo OD for 14 days |
Chewable tablet form |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
Had not taken antibiotic or probiotic in any form within 2 weeks
prior to the study.
Who are willing to chew the tablet and participate in the study
|
|
| ExclusionCriteria |
| Details |
- Children with acute infections, systemic diseases, immune-compromising conditions and special children.
- Those who are not willing to participate in the study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in levels of Mutans Streptococci, Lactobacilli and change in pH of saliva and plaque |
6 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| No change in levels of Mutans Streptococci, Lactobacilli and change in pH of saliva and plaque |
6 Months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "96"
Final Enrollment numbers achieved (India)="96" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
16/11/2016 |
| Date of Study Completion (India) |
08/02/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not Published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a randomized, double blind, parallel group, uni-centre placebo controlled trail to evaluate the effect of 1 billion and 2 billion counts of Bacillus Coagulans daily for 14 days on pH, levels of Mutans Streptococci and Lactobacilli in saliva and plaque that will be conducted in India. The primary outcome will be the reduction of the levels of Mutans Streptococci and Lactobacilli and neutralisation of pH in saliva and plaque. |