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

Not Applicable

Completed

• Conditions: Dental Caries
• Interventions: Dietary Supplement: probiotic drink

• Registration Number: NCT01943123
• Lead Sponsor: The Oxford Dental College, Hospital and Research Center, Bangalore, India

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

Detailed Description

Probiotic bacteria are thought to reduce the risk of diseases in oral cavity, namely dental caries. Studies have suggested that oral cavity can benefit immensely from these friendly bacteria, although more clinical trials are needed to establish concrete results. Hence, this study was undertaken as a 6 month clinical trial to assess the effects of probiotic on the most frequent resident of oral micro flora- the mutans streptococci.

Method- Design: parallel arm design Sample size: 60 subjects (30 subjects in each group) Duration: 6 months

Material used- Intervention/manipulation: 50ml commercially available probiotic drink for one group (30 subjects in study group) and 50 ml of plain, unsweetened and unflavored milk to control group (30 subjects in control group)for a period of 6 months.

Indices used: plaque index- Turskey Gilmore-Glikman modification of Quigley-Hein, Plaque Index (1970)

Gingival Index-Loe.H and Silness P. gingival index (1963)

Both the indices were used twice, at the start of the study, that is, to collect base line data and at the end of the intervention period (6 months)as final data collected.

Sample collection: stimulated saliva was collected (5ml) and analyzed for CFU of streptococcus mutans and lactobacilli at the start of the study and after 6 months, at the end of the intervention.

Statistical analysis: students t test, fisher exact test and chi-square test were used to compare the baseline data with the final data collected at the end of the intervention.

Study Timeline

• Study Start: 2011-02
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Status Verified: 2013-09
• Study First Submitted: 2013-09-05
• Study First Submitted QC: 2013-09-11
• Last Update Submitted: 2013-09-11
• Study First Posted: 2013-09-16
• Last Update Posted: 2013-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
saliva samples were tested for CFU for streptococci mutans and lactobacilli	feburary 2011 and july 2011 (6 months)	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.

Trial Locations

Locations (1)

The Oxford Dental College; 🇮🇳 Bangalore, Karnataka, India