Comparison of the Effect of Fluoride Remineralizer Gel and Foam

NCT ID: NCT02490592

Last Updated: 2015-07-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2014-08-31

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).

Conditions

Dental Caries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Fluoride Foam

Intervention Type: OTHER

Fluoride foam - Flúor Care (NaF 1.23%) (G1)

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.

Group Type: EXPERIMENTAL

Fluoride gel

Intervention Type: OTHER

Fluoride gel - Flugel FFA (NaF 1.23%) (G2)

Interventions

Fluoride Foam

Fluoride foam - Flúor Care (NaF 1.23%) (G1)

Intervention Type: OTHER

Fluoride gel

Fluoride gel - Flugel FFA (NaF 1.23%) (G2)

Intervention Type: OTHER

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.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universidade Cruzeiro do Sul

OTHER

Sponsor Role: collaborator

University Center of João Pessoa

OTHER

Sponsor Role: lead

Responsible Party

JAINARA MARIA SOARES FERREIRA

JAINARA MARIA SOARES FERREIRA

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jainara Ferreira, Phd

Role: PRINCIPAL_INVESTIGATOR

UNIPÊ

Other Identifiers

CAAE: 25687413.8.000.5176

Identifier Type: -

Identifier Source: org_study_id