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

NCT ID: NCT02742038

Last Updated: 2017-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

275 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2014-12-31

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

Conditions

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Dental Caries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Fluoride varnish plus education

Biannual fluoride varnish every 6 month/ 24 months plus educational component

Group Type EXPERIMENTAL

Fluoride varnish plus education

Intervention Type OTHER

Biannual varnish every 6 month/ 24 months plus educational component

Placebo varnish plus education

Biannual placebo varnish every 6 month/ 24 months plus educational component

Group Type PLACEBO_COMPARATOR

Fluoride varnish plus education

Intervention Type OTHER

Biannual varnish every 6 month/ 24 months plus educational component

Interventions

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Fluoride varnish plus education

Biannual varnish every 6 month/ 24 months plus educational component

Intervention Type OTHER

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.
Minimum Eligible Age

24 Months

Maximum Eligible Age

47 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universidad de La Frontera

OTHER

Sponsor Role lead

Responsible Party

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Patricia Muñoz Millán

Staff

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Carlos Zaror, Master

Role: STUDY_DIRECTOR

Universidad de La Frontera

María José Martínez, Doctor

Role: STUDY_CHAIR

Cochrane

Patricia Muñoz, Master

Role: STUDY_CHAIR

U. Frontera

References

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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.

Reference Type RESULT
PMID: 28850712 (View on PubMed)

Other Identifiers

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SA1154

Identifier Type: OTHER

Identifier Source: secondary_id

FON11-0002

Identifier Type: -

Identifier Source: org_study_id