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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01648075

Acronym

Probiotics

Enrollment

261

Registered

2012-07-24

Start date

2012-07-31

Completion date

2014-01-31

Last updated

2014-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Caries Prevention, Caries Reduction

Keywords

caries, probiotics, lactobacilli

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.

Interventions

DIETARY_SUPPLEMENTExperimental: Probiotic enriched milk

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

2 Years to 3 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Reduction of caries incidence in 1 unit of DMF-T (decayed, missing and filled teeth) from baseline up to the 18th month	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.

Countries

Chile

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026