NCT02752594

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Apr 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

April 18, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 27, 2016

Completed
Last Updated

April 27, 2016

Status Verified

April 1, 2016

Enrollment Period

Same day

First QC Date

April 18, 2016

Last Update Submit

April 26, 2016

Conditions

Dental Caries

Keywords

probioticmutans streptococcibacillus coagulanscaries

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

probiotic

EXPERIMENTAL

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

Biological: probioticOther: placebo

placebo

PLACEBO COMPARATOR

10 ml of distilled water

Biological: probioticOther: placebo

Interventions

probioticBIOLOGICAL

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

Also known as: bacillus coagulans
placeboprobiotic
placeboOTHER

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

placeboprobiotic

Eligibility Criteria

Age20 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dental Caries

Interventions

Probioticsexopolysaccharide biopolymer, Bacillus coagulans

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • G. RATNA VELUGU, MDS

    Sharda University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 18, 2016

First Posted

April 27, 2016

Study Start

April 1, 2015

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

April 27, 2016

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will not share