Effect of Probiotic Drink on Number of Salivary Mutans Streptococci in School Going Children

NCT01943123 | Completed DMC

• 1 other identifier: vani-1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study was conducted to assess the effects of commercially available probiotic drink on the number of salivary mutans streptococci in school going children, aged 12-14 years in Bangalore city in India

Conditions

Dental Caries

Keywords

probiotics,; streptococcus mutans,; lactobacilli,; plaque index,; gingival index

Outcome Measures

Primary Outcomes (1)

• saliva samples were tested for CFU for streptococci mutans and lactobacilli

  Saliva samples were tested and the results reveled that number of CFU for both streptococci mutans and lactobacilli varied significantly at the baseline and post intervention in study group (subjects who received probiotic drink). There was reduction in number of CFU of streptococci mutans and lactobacilli in study group.

  feburary 2011 and july 2011 (6 months)

Other Outcomes (1)

• plaque and gingival indices were used

  feburary 2011- july 2011 (6 months)

Study Arms (2)

probiotic drink

EXPERIMENTAL

experimental group (30 subjects) were given 50 ml of probiotic drink for 6 months on daily basis

Dietary Supplement: probiotic drink

plain, unsweetend, unflavored pasturised milk

PLACEBO COMPARATOR

control group/ placebo group (30 subjects) were given pasteurized milk (50 ml) for 6 months on regular basis

Dietary Supplement: Placebo Comparator: plain, unsweetend, unflavored pasturised milk

Interventions

probiotic drink DIETARY_SUPPLEMENT

comparison of study group (probiotic group) with the control group regarding the number of CFU of microbes in oral cavity and the overall oral health status measured using indices

Also known as: yakult probiotic drink

probiotic drink

Placebo Comparator: plain, unsweetend, unflavored pasturised milk DIETARY_SUPPLEMENT

comparison of control group with the study group (probiotic group) regarding the number of CFU of microbes in oral cavity and the overall oral health status measured using indices

plain, unsweetend, unflavored pasturised milk

Eligibility Criteria

• Age: 12 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• no active carious lesion
• restored dental cavities
• on no systemic antibiotic medication 6 weeks before commencing the study

You may not qualify if:

• habitual consumers of probiotics or xylitol chewing gums
• recent exposure to topical/ systemic fluoride treatment
• undergoing any orthodontic treatment during the entire study tenure

Sponsors & Collaborators

• The Oxford Dental College, Hospital and Research Center, Bangalore, India: lead

Study Sites (1)

The Oxford Dental College

Bangalore, Karnataka, 560068, India

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• vani shree nanjundaiah, MDS

  The Oxford Dental College, Bangalore, India

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: September 5, 2013
• First Posted: September 16, 2013
• Study Start: February 1, 2011
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: September 16, 2013

Record last verified: 2013-09

Locations

IN (1)