Effectiveness of Fluoride Varnish in the Prevention of Early Childhood Caries: A Randomized Controlled Trial
- Conditions
- Dental Caries
- Interventions
- Other: Fluoride varnish plus education
- Registration Number
- NCT02742038
- Lead Sponsor
- Universidad de La Frontera
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 275
- Children between 24 an 47 months, free of caries, preschooler of a public centre and living in a non-fluoridated community.
- Children compromised medically, or with developmental or learning disabilities, or with a temporary residence or with dental developmental anomalies.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Fluoride varnish plus education Fluoride varnish plus education Biannual fluoride varnish every 6 month/ 24 months plus educational component Placebo varnish plus education Fluoride varnish plus education Biannual placebo varnish every 6 month/ 24 months plus educational component
- Primary Outcome Measures
Name Time Method Dental Caries 24 months Number of caries and incident cases
- Secondary Outcome Measures
Name Time Method Caries increment 24 months caries increment measured by the amount of change in dmfs index from baseline