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

Dental Caries Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01943123
• Other study ID #: vani-1
• Status: Completed
• Phase: N/A
• First received: September 5, 2013
• Last updated: September 11, 2013
• Start date: February 2011
• Est. completion date: July 2011

Study information

• Verified date: September 2013
• Source: The Oxford Dental College, Hospital and Research Center, Bangalore, India
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Years to 14 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Dental Caries

Intervention

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
• 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

Locations

Country	Name	City	State
India	The Oxford Dental College	Bangalore	Karnataka

Sponsors (1)

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

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)	No
Primary	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)	No