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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Caries Reduction, Caries Prevention

Intervention / Treatment
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* Dietary Supplement: Experimental: Probiotic enriched milk


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 3 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: Probiotic enriched milk<br>150 ml of skimmed milk enriched with probiotic (Lactobacillus rhamnosus LRH08) once a day | Dietary Supplement: Experimental: Probiotic enriched milk<br>* Milk will be enriched with lactobacillus rhamnosus for the experimental group.<br>* Other names: probiotic: Lactobacillus rhamnosus;|
| Placebo Comparator: Skimmed Milk<br>150 ml of skimmed milk once a day | Dietary Supplement: Experimental: Probiotic enriched milk<br>* Milk will be enriched with lactobacillus rhamnosus for the experimental group.<br>* Other names: probiotic: Lactobacillus rhamnosus;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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caries, probiotics, lactobacilli