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

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ClinicalTrials.gov Identifier: NCT01648075
Recruitment Status : Completed
First Posted : July 24, 2012
Last Update Posted : January 22, 2014
Sponsor:
Information provided by (Responsible Party):
Gonzalo Rodriguez, DDS, University of Chile

Tracking Information
First Submitted Date  ICMJE July 9, 2012
First Posted Date  ICMJE July 24, 2012
Last Update Posted Date January 22, 2014
Study Start Date  ICMJE July 2012
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 20, 2014)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 19, 2012)
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.
Change History Complete list of historical versions of study NCT01648075 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of the Consumption of Probiotics in the Reduction of Incidence of Carious Lesions in Preschool Children
Official Title  ICMJE Effect of the Consumption of Probiotics Lactobacilli Enriched Milk in the Reduction of Incidence of Carious Lesions in Preschool Children
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Caries Reduction
  • Caries Prevention
Intervention  ICMJE Dietary Supplement: Experimental: Probiotic enriched milk
Milk will be enriched with lactobacillus rhamnosus for the experimental group.
Other Name: probiotic: Lactobacillus rhamnosus
Study Arms  ICMJE
  • 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
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 20, 2014)
261
Original Estimated Enrollment  ICMJE
 (submitted: July 19, 2012)
340
Actual Study Completion Date  ICMJE January 2014
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 3 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Chile
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01648075
Other Study ID Numbers  ICMJE Universidad de Chile
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gonzalo Rodriguez, DDS, University of Chile
Study Sponsor  ICMJE University of Chile
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Chile
Verification Date January 2014

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