Back to resultsConsumption of Probiotics on Salivary Bacteria Causing Dental Caries
Primary Purpose
Dental Caries
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
probiotic
placebo
Sponsored by
About this trial
This is an interventional prevention trial for Dental Caries focused on measuring probiotic, mutans streptococci, bacillus coagulans, caries
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
probiotic
placebo
Arm Description
2 mg of probiotic powder mixed in 10 ml of distilled water
10 ml of distilled water
Outcomes
Primary Outcome Measures
counts of streptococcus mutans after the consumption of probiotic
Human saliva was assessed for the counts of streptococcus mutans, one of the major etiological factor for dental caries
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02752594
Brief Title
Consumption of Probiotics on Salivary Bacteria Causing Dental Caries
Official Title
Evaluation of the Consumption of Probiotics on the Bacteria Causing Dental Caries: A Randomised Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sharda University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries
Keywords
probiotic, mutans streptococci, bacillus coagulans, caries
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
probiotic
Arm Type
Experimental
Arm Description
2 mg of probiotic powder mixed in 10 ml of distilled water
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
10 ml of distilled water
Intervention Type
Biological
Intervention Name(s)
probiotic
Other Intervention Name(s)
bacillus coagulans
Intervention Description
Probiotic was administered for a period of 14 consecutive days. Saliva was collected on Day 1, before intervention and on Day 15, after intervention
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
placebo was administered for a period of 14 consecutive days. Saliva was collected on Day 1, before intervention and on Day 15, after intervention
Primary Outcome Measure Information:
Title
counts of streptococcus mutans after the consumption of probiotic
Description
Human saliva was assessed for the counts of streptococcus mutans, one of the major etiological factor for dental caries
Time Frame
15 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
G. RATNA VELUGU, MDS
Organizational Affiliation
Sharda University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Consumption of Probiotics on Salivary Bacteria Causing Dental Caries
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