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

NCT01648075 | Completed

• 1 other identifier: Universidad de Chile
• Study Type: interventional
• Target: 261
• Locations: 1 country
• Sites: 1

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.

Conditions

Caries Reduction; Caries Prevention

Keywords

caries; probiotics; lactobacilli

Outcome Measures

Primary Outcomes (1)

• 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.

  18 months

Study Arms (2)

Experimental: Probiotic enriched milk

EXPERIMENTAL

150 ml of skimmed milk enriched with probiotic (Lactobacillus rhamnosus LRH08) once a day

Dietary Supplement: Experimental: Probiotic enriched milk

Skimmed Milk

PLACEBO COMPARATOR

150 ml of skimmed milk once a day

Dietary Supplement: Experimental: Probiotic enriched milk

Interventions

Experimental: Probiotic enriched milk DIETARY_SUPPLEMENT

Milk will be enriched with lactobacillus rhamnosus for the experimental group.

Also known as: probiotic: Lactobacillus rhamnosus

Experimental: Probiotic enriched milk; Skimmed Milk

Eligibility Criteria

• Age: 2 Years - 3 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Healthy children from a general health perspective, with or without cavitated carious lesions at baseline.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Chile: lead

Study Sites (1)

Integra Preschools

Santiago, Metropolitan Region, Chile

Location

Related Publications (2)

• Ibacache RC, Faleiros S, Diaz-Dosque M, Ruiz B, Contador R, Moreno B, Godoy EF, Martinez GR. Effect of probiotic supplementation on the progression of non-cavitated carious lesions in children: A 12-month randomized controlled trial. Eur J Oral Sci. 2025 Dec 15:e70061. doi: 10.1111/eos.70061. Online ahead of print.

  PMID: 41398922 DERIVED

• 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.

  PMID: 26747421 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Effect of the consumption of probiotics lactobacilli enriched milk in the reduction of incidence of carious lesions in preschool children

Study Record Dates

• First Submitted: July 9, 2012
• First Posted: July 24, 2012
• Study Start: July 1, 2012
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: January 22, 2014

Record last verified: 2014-01

Locations

CL (1)