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

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ClinicalTrials.gov Identifier: NCT01943123
Recruitment Status : Completed
First Posted : September 16, 2013
Last Update Posted : September 16, 2013
Sponsor:
Information provided by (Responsible Party):
Dr. Aman deep Pabbla, The Oxford Dental College, Hospital and Research Center, Bangalore, India

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

Condition or disease Intervention/treatment Phase
Dental Caries Dietary Supplement: probiotic drink Dietary Supplement: Placebo Comparator: plain, unsweetend, unflavored pasturised milk Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
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 Start Date : February 2011
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Arm Intervention/treatment
Experimental: probiotic drink
experimental group (30 subjects) were given 50 ml of probiotic drink for 6 months on daily basis
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 Name: yakult probiotic drink

Placebo Comparator: plain, unsweetend, unflavored pasturised milk
control group/ placebo group (30 subjects) were given pasteurized milk (50 ml) for 6 months on regular basis
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




Primary Outcome Measures :
  1. saliva samples were tested for CFU for streptococci mutans and lactobacilli [ Time Frame: feburary 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 Outcome Measures:
  1. plaque and gingival indices were used [ Time Frame: feburary 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.



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Ages Eligible for Study:   12 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01943123


Locations
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India
The Oxford Dental College
Bangalore, Karnataka, India, 560068
Sponsors and Collaborators
The Oxford Dental College, Hospital and Research Center, Bangalore, India
Investigators
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Study Director: vani shree nanjundaiah, MDS The Oxford Dental College, Bangalore, India

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Responsible Party: Dr. Aman deep Pabbla, assistant professor, The Oxford Dental College, Hospital and Research Center, Bangalore, India
ClinicalTrials.gov Identifier: NCT01943123     History of Changes
Other Study ID Numbers: vani-1
First Posted: September 16, 2013    Key Record Dates
Last Update Posted: September 16, 2013
Last Verified: September 2013

Keywords provided by Dr. Aman deep Pabbla, The Oxford Dental College, Hospital and Research Center, Bangalore, India:
probiotics,
streptococcus mutans,
lactobacilli,
plaque index,
gingival index

Additional relevant MeSH terms:
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Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases