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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:
ClinicalTrials.gov Identifier:
NCT01648075
First Posted: July 24, 2012
Last Update Posted: January 22, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Gonzalo Rodriguez, DDS, University of Chile
July 9, 2012
July 24, 2012
January 22, 2014
July 2012
January 2014   (Final data collection date for primary outcome measure)
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.
Change in caries incidence. [ Time Frame: 18 months ]
Preschool children that in regular basis consume enriched milk beverages with probiotics will present less caries incidence than those that consume milk beverages without probiotics, measured by diferences in dmft index between baseline, 6 months, 12 months and 18 months dental exams.
Complete list of historical versions of study NCT01648075 on ClinicalTrials.gov Archive Site
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Effect of the Consumption of Probiotics in the Reduction of Incidence of Carious Lesions in Preschool Children
Effect of the Consumption of Probiotics Lactobacilli Enriched Milk in the Reduction of Incidence of Carious Lesions in Preschool Children

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.

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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
  • Caries Reduction
  • Caries Prevention
Dietary Supplement: Experimental: Probiotic enriched milk
Milk will be enriched with lactobacillus rhamnosus for the experimental group.
Other Name: probiotic: Lactobacillus rhamnosus
  • Experimental: Experimental: Probiotic enriched milk
    150 ml of skimmed milk enriched with probiotic (Lactobacillus rhamnosus LRH08) once a day
    Intervention: Dietary Supplement: Experimental: Probiotic enriched milk
  • Placebo Comparator: Skimmed Milk
    150 ml of skimmed milk once a day
    Intervention: Dietary Supplement: Experimental: Probiotic enriched milk
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
261
January 2014
January 2014   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
2 Years to 3 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Chile
 
 
NCT01648075
Universidad de Chile
No
Not Provided
Not Provided
Gonzalo Rodriguez, DDS, University of Chile
University of Chile
Not Provided
Not Provided
University of Chile
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP