Consumption of Probiotics on Salivary Bacteria Causing Dental Caries

April 26, 2016 updated by: G.RATNA VELUGU, Sharda University

Evaluation of the Consumption of Probiotics on the Bacteria Causing Dental Caries: A Randomised Clinical Trial

Dental caries is a multifactorial disease effecting majority of the human population.One of the etiological factor causing dental caries is salivary mutans streptococci. Reducing the levels of this bacteria in the saliva can significantly reduce the incidence of dental caries. A non-invasive intervention, such as the administration of probiotics reduced the salivary mutans streptococci levels.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

40 candidates were selected from a pre-determined group and were randomly assigned to two groups. Group A (n=20) was administered probiotic drink and Group B (n=20) was administered placebo for 14 consecutive days. Saliva was collected on day 1 and day 15 to compare the salivary mutans streptococci levels.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 25 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Decayed Missing Filled Surfaces less than or equal to 6
  • Brushes twice daily

Exclusion Criteria:

  • undergoing orthodontic treatment
  • topical fluoride therapy in the past 2 yrs
  • using sugar free gums

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: probiotic
2 mg of probiotic powder mixed in 10 ml of distilled water
Biological: probiotic
Probiotic was administered for a period of 14 consecutive days. Saliva was collected on Day 1, before intervention and on Day 15, after intervention
Other Names:
  • bacillus coagulans
Other: placebo
placebo was administered for a period of 14 consecutive days. Saliva was collected on Day 1, before intervention and on Day 15, after intervention
Placebo Comparator: placebo
10 ml of distilled water
Biological: probiotic
Probiotic was administered for a period of 14 consecutive days. Saliva was collected on Day 1, before intervention and on Day 15, after intervention
Other Names:
  • bacillus coagulans
Other: placebo
placebo was administered for a period of 14 consecutive days. Saliva was collected on Day 1, before intervention and on Day 15, after intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
counts of streptococcus mutans after the consumption of probiotic
Time Frame: 15 days
Human saliva was assessed for the counts of streptococcus mutans, one of the major etiological factor for dental caries
15 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sharda University

Investigators

  • Principal Investigator: G. RATNA VELUGU, MDS, Sharda University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

April 18, 2016

First Submitted That Met QC Criteria

April 26, 2016

First Posted (Estimate)

April 27, 2016

Study Record Updates

Last Update Posted (Estimate)

April 27, 2016

Last Update Submitted That Met QC Criteria

April 26, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D22052015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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