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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Dental Caries

Intervention / Treatment
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* Other: Fluoride varnish plus education


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 24 Months
Maximum Age: 47 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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