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

October 26, 2017 updated by: Patricia Muñoz Millán, Universidad de La Frontera

Effectiveness of Fluoride Varnish in the Prevention of Early Childhood Caries in Non-fluoridated Areas: A 24-month Randomized Controlled Trial

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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. A trained, calibrated dentists blinded to treatment arm performed a visual-tactile dental assessment at 6, 12, 18 and 24 months. The number of incidents children with caries were recollected as the number of caries during the follow-up visits.

Nº of participant/ centres: 277 preschoolers (2 to 3 years) of 28 public preschools in non-fluoridated areas.

Main outcome: Number of Caries Incident Cases, increment dmft index

Study Type

Interventional

Enrollment (Actual)

275

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 3 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children between 24 an 47 months, free of caries, preschooler of a public centre and living in a non-fluoridated community.

Exclusion Criteria:

  • Children compromised medically, or with developmental or learning disabilities, or with a temporary residence or with dental developmental anomalies.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fluoride varnish plus education
Biannual fluoride varnish every 6 month/ 24 months plus educational component
Other: Fluoride varnish plus education
Biannual varnish every 6 month/ 24 months plus educational component
Placebo Comparator: Placebo varnish plus education
Biannual placebo varnish every 6 month/ 24 months plus educational component
Other: Fluoride varnish plus education
Biannual varnish every 6 month/ 24 months plus educational component

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dental Caries
Time Frame: 24 months
Number of caries and incident cases
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Caries increment
Time Frame: 24 months
caries increment measured by the amount of change in dmfs index from baseline
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de La Frontera

Investigators

  • Study Director: Carlos Zaror, Master, Universidad de La Frontera
  • Study Chair: María José Martínez, Doctor, Cochrane
  • Study Chair: Patricia Muñoz, Master, U. Frontera

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

April 13, 2016

First Submitted That Met QC Criteria

April 13, 2016

First Posted (Estimate)

April 18, 2016

Study Record Updates

Last Update Posted (Actual)

October 30, 2017

Last Update Submitted That Met QC Criteria

October 26, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FON11-0002
  • SA1154 (Other Identifier: CONICYT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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