A study to check the effect of Useful Bacteria on Caries causing Microorganisms in Saliva and Plaque of Children

Phase 2

Completed

• Conditions: Healthy

• Registration Number: CTRI/2017/07/009072
• Lead Sponsor: Unique Biotech Ltd

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11-16
• Last Update Posted: 2017-07-18
• Study Completion: 2017-08-02

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• 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.

Exclusion Criteria

• Children with acute infections, systemic diseases, immune-compromising conditions and special children.
• Those who are not willing to participate in the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction in levels of Mutans Streptococci, Lactobacilli and change in pH of saliva and plaque	6 Months

Secondary Outcome Measures

Name	Time	Method
No change in levels of Mutans Streptococci, Lactobacilli and change in pH of saliva and plaque	6 Months

Trial Locations

Locations (1)

SVS Institute of Dental Sciences; 🇮🇳 Mahbubnagar, ANDHRA PRADESH, India

SVS Institute of Dental Sciences

🇮🇳Mahbubnagar, ANDHRA PRADESH, India

Dr Surendra Reddy Munnangi

Principal investigator

9885148981

surendra.mds@gmail.com