Effect of Probiotic Drink on Number of Salivary Mutans Streptococci in School Going Children
Primary Purpose
Dental Caries
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
probiotic drink
Placebo Comparator: plain, unsweetend, unflavored pasturised milk
Sponsored by
About this trial
This is an interventional prevention trial for Dental Caries focused on measuring probiotics,, streptococcus mutans,, lactobacilli,, plaque index,, gingival index
Eligibility 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
Sites / Locations
- The Oxford Dental College
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
probiotic drink
plain, unsweetend, unflavored pasturised milk
Arm Description
experimental group (30 subjects) were given 50 ml of probiotic drink for 6 months on daily basis
control group/ placebo group (30 subjects) were given pasteurized milk (50 ml) for 6 months on regular basis
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01943123
First Posted
September 5, 2013
Last Updated
September 11, 2013
Sponsor
The Oxford Dental College, Hospital and Research Center, Bangalore, India
1. Study Identification
Unique Protocol Identification Number
NCT01943123
Brief Title
Effect of Probiotic Drink on Number of Salivary Mutans Streptococci in School Going Children
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Oxford Dental College, Hospital and Research Center, Bangalore, India
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries
Keywords
probiotics,, streptococcus mutans,, lactobacilli,, plaque index,, gingival index
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
probiotic drink
Arm Type
Experimental
Arm Description
experimental group (30 subjects) were given 50 ml of probiotic drink for 6 months on daily basis
Arm Title
plain, unsweetend, unflavored pasturised milk
Arm Type
Placebo Comparator
Arm Description
control group/ placebo group (30 subjects) were given pasteurized milk (50 ml) for 6 months on regular basis
Intervention Type
Dietary Supplement
Intervention Name(s)
probiotic drink
Other Intervention Name(s)
yakult probiotic drink
Intervention Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo Comparator: plain, unsweetend, unflavored pasturised milk
Intervention Description
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
Primary Outcome Measure Information:
Title
saliva samples were tested for CFU for streptococci mutans and lactobacilli
Description
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.
Time Frame
feburary 2011 and july 2011 (6 months)
Other Pre-specified Outcome Measures:
Title
plaque and gingival indices were used
Description
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.
Time Frame
feburary 2011- july 2011 (6 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
vani shree nanjundaiah, MDS
Organizational Affiliation
The Oxford Dental College, Bangalore, India
Official's Role
Study Director
Facility Information:
Facility Name
The Oxford Dental College
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560068
Country
India
12. IPD Sharing Statement
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Effect of Probiotic Drink on Number of Salivary Mutans Streptococci in School Going Children
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