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NCT02752594 Clinical Trial

Consumption of Probiotics on Salivary Bacteria Causing Dental Caries

Dental Caries Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02752594
Other study ID # D22052015
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received April 18, 2016
Last updated April 26, 2016
Start date April 2015
Est. completion date April 2015

Study information
Verified date April 2016
Source Sharda University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date April 2015
Est. primary completion date April 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 25 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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:
• 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

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Sharda University

Outcome
Type Measure Description Time frame Safety issue
Primary 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 15 days
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