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Effectiveness of Fluoride Varnish in the Prevention of Early Childhood Caries: A Randomized Controlled Trial

NCT02742038 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 275

Last updated 2017-10-30

No results posted yet for this study

Summary

Triple-blind randomized controlled trial with two parallel arms conducted between 2012 and 2014. Children 2-3 years old, from 28 rural public preschools, located in low socioeconomic areas of Chile were invited to participate. Oral health education component was given to children, parents and educators, twice yearly. A new toothbrush and toothpaste for each child was delivered to the parents at baseline and in each of the follow-up visits. The experimental group was treated with fluoride varnish every six months while the control group received placebo applications. 277 preschoolers (2 to 3 years) Main outcome: Number of Caries Incident Cases, increment dmft index

Conditions

  • Dental Caries

Interventions

OTHER

Fluoride varnish plus education

Biannual varnish every 6 month/ 24 months plus educational component

Sponsors & Collaborators

  • Universidad de La Frontera

    lead OTHER

Principal Investigators

  • Carlos Zaror, Master · Universidad de La Frontera

  • María José Martínez, Doctor · Cochrane

  • Patricia Muñoz, Master · U. Frontera

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
24 Months
Max Age
47 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2014-08-31
Completion
2014-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02742038 on ClinicalTrials.gov