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

Sponsor
University of Chile (Other)
Overall Status
Completed
CT.gov ID
NCT01648075
Collaborator
(none)
261
Enrollment
1
Location
2
Arms
18
Duration (Months)
14.5
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Experimental: Probiotic enriched milk
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
261 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, 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
Study Start Date :
Jul 1, 2012
Actual Primary Completion Date :
Jan 1, 2014
Actual Study Completion Date :
Jan 1, 2014

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • 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 Names:
  • probiotic: Lactobacillus rhamnosus

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Reduction of caries incidence in 1 unit of DMF-T (decayed, missing and filled teeth) from baseline up to the 18th month [18 months]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    2 Years to 3 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Integra Preschools Santiago Metropolitan Region Chile

    Sponsors and Collaborators

    • University of Chile

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None 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
    Other Study ID Numbers:
    • Universidad de Chile
    First Posted:
    Jul 24, 2012
    Last Update Posted:
    Jan 22, 2014
    Last Verified:
    Jan 1, 2014
    Keywords provided by 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
    caries
    probiotics
    lactobacilli
    Additional relevant MeSH terms:
    Dental Caries

    Study Results

    No Results Posted as of Jan 22, 2014