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

This study is currently recruiting participants.
Verified July 2012 by University of Chile
Sponsor:
Collaborator:
Fundación Integra
Information provided by (Responsible Party):
Gonzalo Rodriguez, DDS, University of Chile
ClinicalTrials.gov Identifier:
NCT01648075
First received: July 9, 2012
Last updated: July 19, 2012
Last verified: July 2012

July 9, 2012
July 19, 2012
July 2012
January 2014   (final data collection date for primary outcome measure)
Change in caries incidence. [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
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.
Same as current
Complete list of historical versions of study NCT01648075 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Prevention
  • Caries Reduction
  • Caries Prevention
Dietary Supplement: Probiotics enriched milk beverages
Milk beverages will be enriched with lactobacillus rhamnosus for the experimental group.
Other Name: probiotic: Lactobacillus rhamnosus
  • Experimental: Probiotic enriched milk beverage
    Intervention: Dietary Supplement: Probiotics enriched milk beverages
  • Placebo Comparator: Milk beverage
    Intervention: Dietary Supplement: Probiotics enriched milk beverages
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
340
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.
Both
2 Years to 3 Years
No
Contact: Gonzalo Rodriguez, DDS, MDS grodrigu@odontologia.uchile.cl
Chile
 
NCT01648075
Universidad de Chile
No
Gonzalo Rodriguez, DDS, University of Chile
University of Chile
Fundación Integra
Not Provided
University of Chile
July 2012

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