Clinical trial NCT01943123: 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
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries
Keywords: probiotics,
streptococcus mutans,
lactobacilli,
plaque index,
gingival index
Lead sponsor: The Oxford Dental College, Hospital and Research Center, Bangalore, India
Sponsor class: OTHER
First posted: 2013-09-16
Enrollment: 60
Sex: ALL
Minimum age (years): 12
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: saliva samples were tested for CFU for streptococci mutans and lactobacilli
timeFrame: feburary 2011 and july 2011 (6 months)
Secondary outcomes:
Other outcomes:
measure: plaque and gingival indices were used
timeFrame: feburary 2011- july 2011 (6 months)
Locations:
city: Bangalore
country: India
facility: The Oxford Dental College
state: Karnataka
Study officials:
affiliation: The Oxford Dental College, Bangalore, India
name: vani shree nanjundaiah, MDS
role: STUDY_DIRECTOR
References: