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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Dental Caries

Intervention / Treatment
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* Dietary Supplement: probiotic drink
* Dietary Supplement: Placebo Comparator: plain, unsweetend, unflavored pasturised milk


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: probiotic drink<br>experimental group (30 subjects) were given 50 ml of probiotic drink for 6 months on daily basis | Dietary Supplement: probiotic drink<br>* 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<br>* Other names: yakult probiotic drink;|
| Placebo Comparator: plain, unsweetend, unflavored pasturised milk<br>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<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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probiotics,, streptococcus mutans,, lactobacilli,, plaque index,, gingival index