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

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

Study Overview

• Status: Completed
• Conditions: Dental Caries
• Intervention / Treatment: Dietary supplement: probiotic drink; Dietary supplement: Placebo Comparator: plain, unsweetend, unflavored pasturised milk

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Karnataka
    • Bangalore, Karnataka, India, 560068
      • The Oxford Dental College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 14 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	feburary 2011 and july 2011 (6 months)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
plaque and gingival indices were used	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.	feburary 2011- july 2011 (6 months)

Collaborators and Investigators

• Sponsor: The Oxford Dental College, Hospital and Research Center, Bangalore, India
• Investigators: Study Director: vani shree nanjundaiah, MDS, The Oxford Dental College, Bangalore, India

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): July 1, 2011
• Study Completion (Actual): July 1, 2011

Study Registration Dates

• First Submitted: September 5, 2013
• First Submitted That Met QC Criteria: September 11, 2013
• First Posted (Estimate): September 16, 2013

Study Record Updates

• Last Update Posted (Estimate): September 16, 2013
• Last Update Submitted That Met QC Criteria: September 11, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: gingival index; probiotics,; streptococcus mutans,; lactobacilli,; plaque index,
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: vani-1