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
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Caries Reduction Caries Prevention | Dietary Supplement: Experimental: Probiotic enriched milk | Not Applicable |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: Experimental: Probiotic enriched milk
150 ml of skimmed milk enriched with probiotic (Lactobacillus rhamnosus LRH08) once a day
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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 |
- 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.

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Ages Eligible for Study: | 2 Years to 3 Years (Child) |
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.

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
Chile | |
Integra Preschools | |
Santiago, Metropolitan Region, Chile |
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: | July 24, 2012 Key Record Dates |
Last Update Posted: | January 22, 2014 |
Last Verified: | January 2014 |
caries probiotics lactobacilli |
Dental Caries Tooth Demineralization Tooth Diseases Stomatognathic Diseases |