Effectiveness of Fluoride Varnish in the Prevention of Early Childhood Caries: A Randomized Controlled Trial
Primary Purpose
Dental Caries
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Fluoride varnish plus education
Sponsored by
About this trial
This is an interventional prevention trial for Dental Caries
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Fluoride varnish plus education
Placebo varnish plus education
Arm Description
Biannual fluoride varnish every 6 month/ 24 months plus educational component
Biannual placebo varnish every 6 month/ 24 months plus educational component
Outcomes
Primary Outcome Measures
Dental Caries
Number of caries and incident cases
Secondary Outcome Measures
Caries increment
caries increment measured by the amount of change in dmfs index from baseline
Full Information
NCT ID
NCT02742038
First Posted
April 13, 2016
Last Updated
October 26, 2017
Sponsor
Universidad de La Frontera
1. Study Identification
Unique Protocol Identification Number
NCT02742038
Brief Title
Effectiveness of Fluoride Varnish in the Prevention of Early Childhood Caries: A Randomized Controlled Trial
Official Title
Effectiveness of Fluoride Varnish in the Prevention of Early Childhood Caries in Non-fluoridated Areas: A 24-month Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de La Frontera
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
275 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fluoride varnish plus education
Arm Type
Experimental
Arm Description
Biannual fluoride varnish every 6 month/ 24 months plus educational component
Arm Title
Placebo varnish plus education
Arm Type
Placebo Comparator
Arm Description
Biannual placebo varnish every 6 month/ 24 months plus educational component
Intervention Type
Other
Intervention Name(s)
Fluoride varnish plus education
Intervention Description
Biannual varnish every 6 month/ 24 months plus educational component
Primary Outcome Measure Information:
Title
Dental Caries
Description
Number of caries and incident cases
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Caries increment
Description
caries increment measured by the amount of change in dmfs index from baseline
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
24 Months
Maximum Age & Unit of Time
47 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlos Zaror, Master
Organizational Affiliation
Universidad de La Frontera
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
María José Martínez, Doctor
Organizational Affiliation
Cochrane
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Patricia Muñoz, Master
Organizational Affiliation
U. Frontera
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
Yes
Citations:
PubMed Identifier
28850712
Citation
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.
Results Reference
result
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Effectiveness of Fluoride Varnish in the Prevention of Early Childhood Caries: A Randomized Controlled Trial
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