- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02490592
Comparison of the Effect of Fluoride Remineralizer Gel and Foam
Comparison of the Effect of Fluoride Remineralizer Gel and Foam: a Randomized Clinical Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 4
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: G1
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.
|
Fluoride foam - Flúor Care (NaF 1.23%) (G1)
|
Experimental: G2
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.
|
Fluoride gel - Flugel FFA (NaF 1.23%) (G2)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
visual scores
Time Frame: within the first 60 days
|
activity changes of whit spot lesions
|
within the first 60 days
|
millimeters (with WHO probe and millimeter ruler)
Time Frame: within the first 60 days
|
dimensional changes of whit spot lesions
|
within the first 60 days
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jainara Ferreira, Phd, UNIPÊ
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CAAE: 25687413.8.000.5176
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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