drugset / Trial / NCT05139966

Fluoride Controlled-release System for Initial Lesions of Caries

NCT05139966 ↗

Phase 2/3 Completed 21 enrolled Federal University of Paraíba
RandomizedCrossoverSingle-blindTreatment

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.

Timeline

Start
2017-08-03
Primary completion
2018-09-12
Completion
2018-12-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Mouthwash Product Unknown 225 ppm Other
Subject nanoF Unknown 225 ppm Other

Indications

No indication recorded.