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Effect of the Consumption of Probiotics in the Reduction of Incidence of Carious Lesions in Preschool Children (Probiotics)
This study has been completed.
Sponsor:
University of Chile
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
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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 Intervention Model: Parallel Assignment Masking: Double Blind (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 |
Resource links provided by NLM:
Further study details as provided by Gonzalo Rodriguez, DDS, 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 ]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) |
| 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01648075
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):
| 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 |
Keywords provided by Gonzalo Rodriguez, DDS, University of Chile:
|
caries probiotics lactobacilli |
Additional relevant MeSH terms:
|
Dental Caries Tooth Demineralization Tooth Diseases Stomatognathic Diseases |
ClinicalTrials.gov processed this record on June 22, 2017