Trial | NCT01943123  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    autologous microbiome ...

  • Study Participants

    60
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
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 Started
Feb 28
2011
Primary Completion
Jul 31
2011
Study Completion
Jul 31
2011
Last Update
Sep 16
2013
Estimate

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

  • Other names: yakult probiotic drink

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

probiotic drink Experimental

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

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

Criteria 

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
No Results Posted