Fluoride Controlled-release System for Initial Lesions of Caries

• Status: Completed
• Trial end date: 2018-12-12
• Target enrollment: 0
• Participant gender: All

Summary

OBJECTIVE: To evaluate in vivo the efficacy of fluoride-containing dentifrice incorporated in a controlled-release system (F-CSL, patent pending) in the remineralization of white spot lesions of caries in caries-active individuals. METHODS: A double-blind randomized clinical trial to evaluate the bioavailability of intraoral fluoride in biomarkers of exposure (biofilm and saliva) after the use of experimental toothpaste in the control of dental caries. The study will last three months. The participants of the study will be divided into three groups according to the dentifrice used. The sample will be selected randomly and composed of children and adolescents who seek the service of cariology of the UFPB. There will be participants of both sexes, preferably of the metropolitan region of João Pessoa in order to guarantee the low fluorine exposure by the water of supply. Intrabucal photographs will be obtained. Samples of saliva will be collected after 3 hours of the last meal. The benefits will be achieved by obtaining the reduction of the white spot area (mm2) plus the fact that all the children will be examined and will receive information on the treatment needs and forwading for the same.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Federal University of Paraíba
• Treatments: Fluorides

Criteria

Inclusion Criteria:

• residents of a city without water fluoridation program

Exclusion Criteria:

• The use of orthodontic appliances, smokers, treatment with fluoride products and / or the use of antimicrobial in the last 4 weeks, carious lesions, periodontal disease and dental sensitivity