Clinical trial NCT02742038: 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
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries
Lead sponsor: Universidad de La Frontera
Sponsor class: OTHER
First posted: 2016-04-18
Enrollment: 275
Sex: ALL
Minimum age (years): 24
Maximum age (years): 47
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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.

Primary outcomes:
measure: Dental Caries
timeFrame: 24 months
Secondary outcomes:
measure: Caries increment
timeFrame: 24 months
Other outcomes:
Locations:
Study officials:
affiliation: Universidad de La Frontera
name: Carlos Zaror, Master
role: STUDY_DIRECTOR
affiliation: Cochrane
name: María José Martínez, Doctor
role: STUDY_CHAIR
affiliation: U. Frontera
name: Patricia Muñoz, Master
role: STUDY_CHAIR
References:
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.