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Trial record 25 of 1236 for:    tooth decay

Consumption of Probiotics on Salivary Bacteria Causing Dental Caries

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ClinicalTrials.gov Identifier: NCT02752594
Recruitment Status : Completed
First Posted : April 27, 2016
Last Update Posted : April 27, 2016
Sponsor:
Information provided by (Responsible Party):
G.RATNA VELUGU, Sharda University

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.

Condition or disease Intervention/treatment Phase
Dental Caries Biological: probiotic Other: placebo Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Evaluation of the Consumption of Probiotics on the Bacteria Causing Dental Caries: A Randomised Clinical Trial
Study Start Date : April 2015
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tooth Decay

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 Name: 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 Name: 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




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   20 Years to 25 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02752594


Sponsors and Collaborators
Sharda University
Investigators
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Principal Investigator: G. RATNA VELUGU, MDS Sharda University

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Responsible Party: G.RATNA VELUGU, Assistant Professor, Sharda University
ClinicalTrials.gov Identifier: NCT02752594     History of Changes
Other Study ID Numbers: D22052015
First Posted: April 27, 2016    Key Record Dates
Last Update Posted: April 27, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by G.RATNA VELUGU, Sharda University:
probiotic
mutans streptococci
bacillus coagulans
caries
Additional relevant MeSH terms:
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Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases