Effectiveness of Fluoride Varnish in the Prevention of Early Childhood Caries: A Randomized Controlled Trial
2 other identifiers
interventional
275
0 countries
N/A
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2012
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 13, 2016
CompletedFirst Posted
Study publicly available on registry
April 18, 2016
CompletedOctober 30, 2017
October 1, 2017
2.4 years
April 13, 2016
October 26, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Dental Caries
Number of caries and incident cases
24 months
Secondary Outcomes (1)
Caries increment
24 months
Study Arms (2)
Fluoride varnish plus education
EXPERIMENTALBiannual fluoride varnish every 6 month/ 24 months plus educational component
Placebo varnish plus education
PLACEBO COMPARATORBiannual placebo varnish every 6 month/ 24 months plus educational component
Interventions
Biannual varnish every 6 month/ 24 months plus educational component
Eligibility Criteria
You may qualify if:
- Children between 24 an 47 months, free of caries, preschooler of a public centre and living in a non-fluoridated community.
You may not qualify if:
- Children compromised medically, or with developmental or learning disabilities, or with a temporary residence or with dental developmental anomalies.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Munoz-Millan P, Zaror C, Espinoza-Espinoza G, Vergara-Gonzalez C, Munoz S, Atala-Acevedo C, Martinez-Zapata MJ. Effectiveness of fluoride varnish in preventing early childhood caries in rural areas without access to fluoridated drinking water: A randomized control trial. Community Dent Oral Epidemiol. 2018 Feb;46(1):63-69. doi: 10.1111/cdoe.12330. Epub 2017 Aug 29.
PMID: 28850712RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Carlos Zaror, Master
Universidad de La Frontera
- STUDY CHAIR
María José Martínez, Doctor
Cochrane
- STUDY CHAIR
Patricia Muñoz, Master
U. Frontera
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Staff
Study Record Dates
First Submitted
April 13, 2016
First Posted
April 18, 2016
Study Start
March 1, 2012
Primary Completion
August 1, 2014
Study Completion
December 1, 2014
Last Updated
October 30, 2017
Record last verified: 2017-10
Data Sharing
- IPD Sharing
- Will share