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Comparison of the Effect of Fluoride Remineralizer Gel and Foam

Primary Purpose

Dental Caries

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Fluoride Foam
Fluoride gel
Sponsored by
University Center of João Pessoa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dental Caries

Eligibility Criteria

7 Years - 10 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Child with active incipient caries lesions (white spots) on upper anterior permanent teeth; permission from parents / guardians through the consent form, authorization of the minor through the term of assent, children at high risk for dental caries.

Exclusion Criteria:

  • Children who used braces, medications that alter the flow / salivary composition or antibiotics in the month before the exam. Not patients with syndromes or changes in tooth development, patients with cognitive and motor disorders were included.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    G1

    G2

    Arm Description

    Thirty children aged seven to twelve years who had seventy one active white spots lesions in permanent anterior teeth randomly assigned to four or eight weekly intervals applications of fluoride foam, Flúor Care (NaF 1.23%), to verified the activity (visual scores) and the dimensional changes of whit spot lesions (with WHO probe and millimeter ruler), caries Management by Risk Assessment (CAMBRA) and OHI-S (Simplified Oral Hygiene Index) of children.

    Twenty-eight children aged seven to twelve years who had seventy five active white spots lesions in permanent anterior teeth randomly assigned to four or eight weekly intervals applications of fluoride gel, Flugel FFA (NaF 1.23%), to verified the activity (visual scores) and the dimensional changes of whit spot lesions (with WHO probe and millimeter ruler), caries Management by Risk Assessment (CAMBRA) and OHI-S (Simplified Oral Hygiene Index) of children.

    Outcomes

    Primary Outcome Measures

    visual scores
    activity changes of whit spot lesions
    millimeters (with WHO probe and millimeter ruler)
    dimensional changes of whit spot lesions

    Secondary Outcome Measures

    Full Information

    First Posted
    October 28, 2014
    Last Updated
    July 6, 2015
    Sponsor
    University Center of João Pessoa
    Collaborators
    Universidade Cruzeiro do Sul
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02490592
    Brief Title
    Comparison of the Effect of Fluoride Remineralizer Gel and Foam
    Official Title
    Comparison of the Effect of Fluoride Remineralizer Gel and Foam: a Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2014 (undefined)
    Primary Completion Date
    April 2014 (Actual)
    Study Completion Date
    August 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University Center of João Pessoa
    Collaborators
    Universidade Cruzeiro do Sul

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Compare the remineralizing effect of acidulated fluoride gel Flugel (1.23% FFA, DFL) and acidulated Fluoride Foam Flúor Care (1.23% FFA, FGM) in maxillary anterior permanent teeth of 58 children aged 7 to 12 years of age. to verified the activity (visual scores) and the dimensional changes of whit spot lesions (with WHO probe and millimeter ruler), risk for caries (CAMBRA) and OHI-S (Simplified Oral Hygiene Index) of children.
    Detailed Description
    This randomized clinical trial was composed permantentes previous teeth with white spot esolares belonging to the age group 7-12 years of the interior of Paraíba (Brazil). To calculate the sample considered the study of Soares and Valencia (2003) who obtained success rate of inactivity for white patches of fluoride gel (41%) compared with fluoride varnish (33%). By means of the Epi Info program™ 6 was used maximum acceptable error α and β of 5% to 20% ratio equal to 1.0 between the two products, resulting in a representative sample of 47 cases for each group for a total 94 white spots. To account for any loss sample, the sample was extended to 146 white spots being the case 71 formed by G1 and G2 for 75 cases. Prior to implementation of the proposed study called a calibration INLUX through 46 images of white spots followed by the investigation of the reproducibility of tests using Kappa coefficient intra and inter examiner with 10% of the sample (n = 14) was performed. The interpretation of these statistical testing was performed according to scale Bulman and Osborn (1989). There was a correlation of intra k = 1.00 (good) activity for k = 1.00 (good) scale for all considered good. Already on inter-examiner agreement, the investigators observed values of k = 1.00 (good) for activity k = 0.65 (substantial) for dimension being considered, good and substantial, respectively. For this study the investigators followed the following protocol: the IHO S-Record (Simplified Oral Hygiene Index); Supervised brushing; Professional prophylaxis; drying; Evaluation of white spot (the enamel was visually assessed at the initial examination (S1), after the 4th (S5) and 8th (S9) weeks of fluoride products only stains that were not remineralized to S5, the activity (visual scores by Nyvad et al (1999)) and the dimensional changes (with WHO probe and millimeter ruler); Caries Management by Risk Assessment (CAMBRA); Application of fluoride products: group 1 (G1) where children received weekly therapeutic applications of fluoridated foam FFA, Flúor Care (NaF 1.23%) or group 2 (G2) where children received applications weekly therapeutic fluoride gel Flugel FFA (1.23% NaF) the management of this study was performed according to the CONSORT (Consolidated Standards of ReportingTrials) your flowchart comprises four stages of a controlled clinical trial:. recruitment, allocation, follow-up . analysis and the project was approved by the ethics committee in Brazil on February 27, 2014 (CAAE: 25687413.8.000.5176).

    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
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    58 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    G1
    Arm Type
    Experimental
    Arm Description
    Thirty children aged seven to twelve years who had seventy one active white spots lesions in permanent anterior teeth randomly assigned to four or eight weekly intervals applications of fluoride foam, Flúor Care (NaF 1.23%), to verified the activity (visual scores) and the dimensional changes of whit spot lesions (with WHO probe and millimeter ruler), caries Management by Risk Assessment (CAMBRA) and OHI-S (Simplified Oral Hygiene Index) of children.
    Arm Title
    G2
    Arm Type
    Experimental
    Arm Description
    Twenty-eight children aged seven to twelve years who had seventy five active white spots lesions in permanent anterior teeth randomly assigned to four or eight weekly intervals applications of fluoride gel, Flugel FFA (NaF 1.23%), to verified the activity (visual scores) and the dimensional changes of whit spot lesions (with WHO probe and millimeter ruler), caries Management by Risk Assessment (CAMBRA) and OHI-S (Simplified Oral Hygiene Index) of children.
    Intervention Type
    Other
    Intervention Name(s)
    Fluoride Foam
    Intervention Description
    Fluoride foam - Flúor Care (NaF 1.23%) (G1)
    Intervention Type
    Other
    Intervention Name(s)
    Fluoride gel
    Intervention Description
    Fluoride gel - Flugel FFA (NaF 1.23%) (G2)
    Primary Outcome Measure Information:
    Title
    visual scores
    Description
    activity changes of whit spot lesions
    Time Frame
    within the first 60 days
    Title
    millimeters (with WHO probe and millimeter ruler)
    Description
    dimensional changes of whit spot lesions
    Time Frame
    within the first 60 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    7 Years
    Maximum Age & Unit of Time
    10 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Child with active incipient caries lesions (white spots) on upper anterior permanent teeth; permission from parents / guardians through the consent form, authorization of the minor through the term of assent, children at high risk for dental caries. Exclusion Criteria: Children who used braces, medications that alter the flow / salivary composition or antibiotics in the month before the exam. Not patients with syndromes or changes in tooth development, patients with cognitive and motor disorders were included.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jainara Ferreira, Phd
    Organizational Affiliation
    UNIPÊ
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Comparison of the Effect of Fluoride Remineralizer Gel and Foam

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