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Prevention of Dental Caries Lesions With Fluoride Varnish in Erupting First Permanent Molars

Primary Purpose

Dental Caries

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Fluoride Varnish
Control Group
Sponsored by
Universidad Iberoamericana
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dental Caries focused on measuring Dental Caries, Fluoride Varnish, Preschool child, Prevention

Eligibility Criteria

6 Years - 7 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Informed Consent from parents.
  • Child assent
  • High risk of dental caries
  • At least one sound first permanent molar (ICDAS=0)

Exclusion Criteria:

  • Bad behaviour
  • Any systemic condition, disability

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Active Comparator

    Arm Label

    Fluoride Varnish each 6 months

    Fluoride Varnish each 3 months

    Fluoride tooth paste

    Arm Description

    Fluoride Varnish application every 6 months.

    Fluoride Varnish application every 3 months.

    Control group. Twice a day brush with fluoride toothpaste.

    Outcomes

    Primary Outcome Measures

    Number of first permanent molars with caries Lesion (taking into account ICDAS criteria)
    We are going to measure changed to decay surfaces in first permanent molars = ICDAS > 0 in a year.

    Secondary Outcome Measures

    Full Information

    First Posted
    October 28, 2015
    Last Updated
    November 2, 2016
    Sponsor
    Universidad Iberoamericana
    Collaborators
    Colgate Palmolive
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02592278
    Brief Title
    Prevention of Dental Caries Lesions With Fluoride Varnish in Erupting First Permanent Molars
    Official Title
    Prevention of Dental Caries Lesions With Fluoride Varnish in Erupting First Permanent Molars
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2015 (undefined)
    Primary Completion Date
    March 2016 (Actual)
    Study Completion Date
    March 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Universidad Iberoamericana
    Collaborators
    Colgate Palmolive

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The aim of this study is to determine the effectiveness of fluoride varnishes in the prevention of dental caries lesions in erupting permanent first molars, in high-risk patients. Using as reference ICDAS criteria, when the success means that the surface maintain an ICDAS value 0 and failure that has change in ICDAS value 0 to 1. Sample: The sample comprise 180 patients between 6-7 years old with high-risk of dental caries. Study design: It proposed an experimental design randomized into 3 groups according to the frequency of topical fluoride application.(Group A: every 6 month; Group B: every 3 month; Group C: positive control).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dental Caries
    Keywords
    Dental Caries, Fluoride Varnish, Preschool child, Prevention

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    180 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Fluoride Varnish each 6 months
    Arm Type
    Experimental
    Arm Description
    Fluoride Varnish application every 6 months.
    Arm Title
    Fluoride Varnish each 3 months
    Arm Type
    Experimental
    Arm Description
    Fluoride Varnish application every 3 months.
    Arm Title
    Fluoride tooth paste
    Arm Type
    Active Comparator
    Arm Description
    Control group. Twice a day brush with fluoride toothpaste.
    Intervention Type
    Drug
    Intervention Name(s)
    Fluoride Varnish
    Other Intervention Name(s)
    Duraphat (Colgate)
    Intervention Description
    Application of fluoride varnish every 3 and 6 months.
    Intervention Type
    Drug
    Intervention Name(s)
    Control Group
    Other Intervention Name(s)
    Colgate Total Toothpaste
    Intervention Description
    Twice a day brush with fluoride toothpaste.
    Primary Outcome Measure Information:
    Title
    Number of first permanent molars with caries Lesion (taking into account ICDAS criteria)
    Description
    We are going to measure changed to decay surfaces in first permanent molars = ICDAS > 0 in a year.
    Time Frame
    One year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    7 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Informed Consent from parents. Child assent High risk of dental caries At least one sound first permanent molar (ICDAS=0) Exclusion Criteria: Bad behaviour Any systemic condition, disability
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ninoska Abreu
    Organizational Affiliation
    Universidad Iberoamericana
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Prevention of Dental Caries Lesions With Fluoride Varnish in Erupting First Permanent Molars

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