Back to resultsEffect of the Consumption of Probiotics in the Reduction of Incidence of Carious Lesions in Preschool Children (Probiotics)
Primary Purpose
Caries Reduction, Caries Prevention
Status
Completed
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
Experimental: Probiotic enriched milk
Sponsored by
About this trial
This is an interventional prevention trial for Caries Reduction focused on measuring caries, probiotics, lactobacilli
Eligibility 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.
Sites / Locations
- Integra Preschools
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Experimental: Probiotic enriched milk
Skimmed Milk
Arm Description
150 ml of skimmed milk enriched with probiotic (Lactobacillus rhamnosus LRH08) once a day
150 ml of skimmed milk once a day
Outcomes
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
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01648075
Brief Title
Effect of the Consumption of Probiotics in the Reduction of Incidence of Carious Lesions in Preschool Children
Acronym
Probiotics
Official Title
Effect of the Consumption of Probiotics Lactobacilli Enriched Milk in the Reduction of Incidence of Carious Lesions in Preschool Children
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Chile
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Caries Reduction, Caries Prevention
Keywords
caries, probiotics, lactobacilli
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
261 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental: Probiotic enriched milk
Arm Type
Experimental
Arm Description
150 ml of skimmed milk enriched with probiotic (Lactobacillus rhamnosus LRH08) once a day
Arm Title
Skimmed Milk
Arm Type
Placebo Comparator
Arm Description
150 ml of skimmed milk once a day
Intervention Type
Dietary Supplement
Intervention Name(s)
Experimental: Probiotic enriched milk
Other Intervention Name(s)
probiotic: Lactobacillus rhamnosus
Intervention Description
Milk will be enriched with lactobacillus rhamnosus for the experimental group.
Primary Outcome Measure Information:
Title
Reduction of caries incidence in 1 unit of DMF-T (decayed, missing and filled teeth) from baseline up to the 18th month
Description
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.
Time Frame
18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Integra Preschools
City
Santiago
State/Province
Metropolitan Region
Country
Chile
12. IPD Sharing Statement
Citations:
PubMed Identifier
26747421
Citation
Rodriguez G, Ruiz B, Faleiros S, Vistoso A, Marro ML, Sanchez J, Urzua 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.
Results Reference
derived
Learn more about this trial
Effect of the Consumption of Probiotics in the Reduction of Incidence of Carious Lesions in Preschool Children
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