Comparison of the Effect of Fluoride Remineralizer Gel and Foam
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional
Phase: Phase 4

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).
    

Intervention name(s): Fluoride Foam; Fluoride gel
Intervention type(s): Other; Other
Intervention description(s): Fluoride foam - Flúor Care (NaF 1.23%) (G1); Fluoride gel - Flugel FFA (NaF 1.23%) (G2)
Intervention MeSH terms: Fluorides
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention