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Consumption of Probiotics on Salivary Bacteria Causing Dental Caries

NCT ID: NCT02752594

Last Updated: 2016-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2015-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Dental Caries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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probiotic

2 mg of probiotic powder mixed in 10 ml of distilled water

Group Type EXPERIMENTAL

probiotic

Intervention Type BIOLOGICAL

Probiotic was administered for a period of 14 consecutive days. Saliva was collected on Day 1, before intervention and on Day 15, after intervention

placebo

Intervention Type OTHER

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

10 ml of distilled water

Group Type PLACEBO_COMPARATOR

probiotic

Intervention Type BIOLOGICAL

Probiotic was administered for a period of 14 consecutive days. Saliva was collected on Day 1, before intervention and on Day 15, after intervention

placebo

Intervention Type OTHER

placebo was administered for a period of 14 consecutive days. Saliva was collected on Day 1, before intervention and on Day 15, after intervention

Interventions

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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

Intervention Type BIOLOGICAL

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

Intervention Type OTHER

Other Intervention Names

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bacillus coagulans

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sharda University

OTHER

Sponsor Role lead

Responsible Party

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G.RATNA VELUGU

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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G. RATNA VELUGU, MDS

Role: PRINCIPAL_INVESTIGATOR

Sharda University

Other Identifiers

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D22052015

Identifier Type: -

Identifier Source: org_study_id

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