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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
Universidad de La Frontera
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dental Caries

Eligibility Criteria

24 Months - 47 Months (Child)All SexesAccepts Healthy Volunteers

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

    First Posted
    April 13, 2016
    Last Updated
    October 26, 2017
    Sponsor
    Universidad de La Frontera
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    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

    Learn more about this trial

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

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