Effect of Probiotic Drink on Number of Salivary Mutans Streptococci in School Going Children
NCT ID: NCT01943123
Last Updated: 2013-09-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2011-02-28
2011-07-31
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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probiotic drink
experimental group (30 subjects) were given 50 ml of probiotic drink for 6 months on daily basis
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
plain, unsweetend, unflavored pasturised milk
control group/ placebo group (30 subjects) were given pasteurized milk (50 ml) for 6 months on regular basis
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
Interventions
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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
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* restored dental cavities
* on no systemic antibiotic medication 6 weeks before commencing the study
Exclusion Criteria
* recent exposure to topical/ systemic fluoride treatment
* undergoing any orthodontic treatment during the entire study tenure
12 Years
14 Years
ALL
Yes
Sponsors
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The Oxford Dental College, Hospital and Research Center, Bangalore, India
OTHER
Responsible Party
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Dr. Aman deep Pabbla
assistant professor
Principal Investigators
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vani shree nanjundaiah, MDS
Role: STUDY_DIRECTOR
The Oxford Dental College, Bangalore, India
Locations
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The Oxford Dental College
Bangalore, Karnataka, India
Countries
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Other Identifiers
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vani-1
Identifier Type: -
Identifier Source: org_study_id