A Phase 4 interventional study of Fluoride Foam and Fluoride gel in Dental Caries, sponsored by University Center of João Pessoa. Completed. Open to participants aged 7 Years to 10 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-07-07.
Sponsored by University Center of João Pessoa · Phase 4, Interventional, and Prevention
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.
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).
1,109 studies on the registry are indexed under Dental Caries; 197 are open to participants now.
This study's enrollment of 58 is close to the median of 60 across 916 interventional studies indexed under Dental Caries.
Browse Dental Caries studies →This is the only study on the registry with University Center of João Pessoa as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Other: Fluoride Foam
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.
Other: Fluoride gel
Fluoride foam - Flúor Care (NaF 1.23%) (G1)
Fluoride gel - Flugel FFA (NaF 1.23%) (G2)
visual scores
activity changes of whit spot lesions
Time frame: within the first 60 days
millimeters (with WHO probe and millimeter ruler)
dimensional changes of whit spot lesions
Time frame: within the first 60 days
No study locations are listed for this record.
This study is completed, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.