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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gonzalo Rodriguez, DDS, University of Chile
ClinicalTrials.gov Identifier:
NCT01648075
First received: July 9, 2012
Last updated: January 20, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Caries Reduction
Caries Prevention
Dietary Supplement: Experimental: Probiotic enriched milk

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of the Consumption of Probiotics Lactobacilli Enriched Milk in the Reduction of Incidence of Carious Lesions in Preschool Children

Resource links provided by NLM:


Further study details as provided by University of Chile:

Primary Outcome Measures:
  • Reduction of caries incidence in 1 unit of DMF-T (decayed, missing and filled teeth) from baseline up to the 18th month [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 261
Study Start Date: July 2012
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental: Probiotic enriched milk
150 ml of skimmed milk enriched with probiotic (Lactobacillus rhamnosus LRH08) once a day
Dietary Supplement: Experimental: Probiotic enriched milk
Milk will be enriched with lactobacillus rhamnosus for the experimental group.
Other Name: probiotic: Lactobacillus rhamnosus
Placebo Comparator: Skimmed Milk
150 ml of skimmed milk once a day
Dietary Supplement: Experimental: Probiotic enriched milk
Milk will be enriched with lactobacillus rhamnosus for the experimental group.
Other Name: probiotic: Lactobacillus rhamnosus

Detailed 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.

  Eligibility

Ages Eligible for Study:   2 Years to 3 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01648075

Locations
Chile
Integra Preschools
Santiago, Metropolitan Region, Chile
Sponsors and Collaborators
University of Chile
  More Information

No publications provided

Responsible Party: Gonzalo Rodriguez, DDS, Effect of the consumption of probiotics lactobacilli enriched milk in the reduction of incidence of carious lesions in preschool children, University of Chile
ClinicalTrials.gov Identifier: NCT01648075     History of Changes
Other Study ID Numbers: Universidad de Chile
Study First Received: July 9, 2012
Last Updated: January 20, 2014
Health Authority: Chile: University of Chile
Chile: Fundación Integra

Keywords provided by University of Chile:
caries
probiotics
lactobacilli

ClinicalTrials.gov processed this record on April 14, 2014