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

The Oxford Dental College, Hospital and Research Center, Bangalore, India

Status: Completed

Conditions: Dental Caries

Treatments: Dietary Supplement: probiotic drink; Dietary Supplement: Placebo Comparator: plain, unsweetend, unflavored pasturised milk

Study type: Interventional

Funder types: Other

Identifiers

NCT01943123

vani-1

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 12 to 14 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

probiotic drink

Experimental group

Description:

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

Treatment:

Dietary Supplement: probiotic drink

plain, unsweetend, unflavored pasturised milk

Placebo Comparator group

Description:

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

Treatment:

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