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

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ClinicalTrials.gov Identifier: NCT01648075
Recruitment Status : Completed
First Posted : July 24, 2012
Last Update Posted : January 22, 2014
Sponsor:
Information provided by (Responsible Party):
Gonzalo Rodriguez, DDS, University of Chile

Study Description
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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
Caries Reduction Caries Prevention Dietary Supplement: Experimental: Probiotic enriched milk Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
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 : July 2012
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

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Arms and Interventions
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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 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


Outcome Measures
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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 [ Time Frame: 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
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Ages Eligible for Study:   2 Years to 3 Years   (Child)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01648075


Locations
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Chile
Integra Preschools
Santiago, Metropolitan Region, Chile
Sponsors and Collaborators
University of Chile
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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
First Posted: July 24, 2012    Key Record Dates
Last Update Posted: January 22, 2014
Last Verified: January 2014
Keywords provided by Gonzalo Rodriguez, DDS, University of Chile:
caries
probiotics
lactobacilli
Additional relevant MeSH terms:
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Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases