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Fluoride Controlled-release System for Initial Lesions of Caries

NCT05139966 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2021-12-01

No results posted yet for this study

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.

Conditions

  • White Spot Lesion

Interventions

DRUG

Mouthwash Product

The participants were requested to rinse 10 ml of the mouthwash 2 times / day (morning and evening) for 1 min after toothbrushing (a non-F dentifrice was used throughout the study).

Sponsors & Collaborators

  • Federal University of Paraíba

    lead OTHER

Principal Investigators

  • FABIO C SAMPAIO, PhD · Hospital Universitário Lauro Wanderley

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05139966 on ClinicalTrials.gov