Effect of the Consumption of Probiotics in the Reduction of Incidence of Carious Lesions in Preschool Children

Caries Prevention Clinical Trial

— Probiotics  

Official title:

Effect of the Consumption of Probiotics Lactobacilli Enriched Milk in the Reduction of Incidence of Carious Lesions in Preschool Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01648075
• Other study ID #: Universidad de Chile
• Status: Completed
• Phase: N/A
• First received: July 9, 2012
• Last updated: January 20, 2014
• Start date: July 2012
• Est. completion date: January 2014

Study information

• Verified date: January 2014
• Source: University of Chile
• Contact: n/a
• Is FDA regulated: No
• Health authority: Chile: University of ChileChile: Fundación Integra
• Study type: Interventional

Clinical Trial Summary

Probiotics are microorganisms that when administered in adequate amounts can confer health benefits. In vitro and clinical studies support the idea that lactobacilli have protective effects on oral health. A recent study in which preschoolers consumed milk drinks enriched with Lactobacillus rhamnosus, reported a reduction in caries, as well as additional benefits to children.

The aim of this study is to evaluate the effect of daily consumption of milk beverages enriched with Lactobacillus rhamnosus on the incidence of caries in preschool Chilean children.

Description:

In this randomized controlled trial, preschool children belonging to Integra Foundation will be invited to participate. After obtaining parent´s informed consent, clinical and microbiological testing of saliva at baseline, 6 m, 12m and 18m will be performed. Differences in prevalence and incidence of caries, dmft and microbial diversity between groups will be assessed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 261
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 3 Years

Eligibility

Inclusion Criteria:

• Healthy children from a general health perspective, with or without cavitated carious lesions at baseline.

Exclusion Criteria:

• Children with systemic disorders who need special care and / or who have intolerance to milk drinks or allergy to any of the components of the experimental and / or placebo beverage.

Study Design

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

Related Conditions & MeSH terms

• Caries Prevention
• Caries Reduction
• Dental Caries

Intervention

Dietary Supplement:
• Experimental: Probiotic enriched milk
Milk will be enriched with lactobacillus rhamnosus for the experimental group.

Locations

Country	Name	City	State
Chile	Integra Preschools	Santiago	Metropolitan Region

Sponsors (1)

Lead Sponsor	Collaborator
University of Chile

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of caries incidence in 1 unit of DMF-T (decayed, missing and filled teeth) from baseline up to the 18th month	Preschool children that in regular basis consume enriched milk with probiotics will present less caries incidence than those that consume milk without probiotics, measured by differences in dmft index between baseline, 6 months, 12 months and 18 months dental exams.	18 months	Yes