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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01943123
Enrollment
60
Registered
2013-09-16
Start date
2011-02-28
Completion date
2011-07-31
Last updated
2013-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Caries

Keywords

probiotics,, streptococcus mutans,, lactobacilli,, plaque index,, gingival index

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.

Interventions

DIETARY_SUPPLEMENTprobiotic 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_SUPPLEMENTPlacebo 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

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
12 Years to 14 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
saliva samples were tested for CFU for streptococci mutans and lactobacillifeburary 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.

Other

MeasureTime frameDescription
plaque and gingival indices were usedfeburary 2011- july 2011 (6 months)Plaque index- Turskey Gilmore-Glikman modification of Quigley-Hein, Plaque Index (1970)and Gingival Index-Loe.H and Silness P. Gingival index (1963)were used at the beginning of the study and after the intervention was over, the indices were again used to collect the final data. Significant reduction in the mean scores was observed for both the indices in study group (the subjects who were given probiotic drink)whereas the results did not vary markedly in the control group.

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026