NCT01943123

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

Effect of Commercially Available Probiotic Drink on Number of Salivary Mutans Streptococci in School Going Children Aged 12-14 Years in Bangalore City (India): Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: The Oxford Dental College, Hospital and Research Center, Bangalore, India · Academic / Other
• Sex: All
• Age: 12 Years – 14 Years
• Healthy volunteers: Accepted

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.

Conditions

• Dental Caries

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	probiotic drink	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
DIETARY_SUPPLEMENT	Placebo Comparator: plain, unsweetend, unflavored pasturised milk	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

Timeline

• Start date: 2011-02-01
• Primary completion: 2011-07-01
• Completion: 2011-07-01
• First posted: 2013-09-16
• Last updated: 2013-09-16

Locations

1 site across 1 country: India