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

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

History of Changes

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:

MedlinePlus related topics: Toddler Health Tooth Decay

Drug Information available for: Lactobacillus

U.S. FDA Resources

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 (Child)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Rodríguez G, Ruiz B, Faleiros S, Vistoso A, Marró ML, Sánchez J, Urzúa I, Cabello R. Probiotic Compared with Standard Milk for High-caries Children: A Cluster Randomized Trial. J Dent Res. 2016 Apr;95(4):402-7. doi: 10.1177/0022034515623935. Epub 2016 Jan 8.


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

Additional relevant MeSH terms:


Dental Caries Tooth Demineralization Tooth Diseases Stomatognathic Diseases

ClinicalTrials.gov processed this record on September 27, 2016

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