Fluoride Controlled-release System for Initial Lesions of Caries

NCT05139966 | Completed Phase 2 DMC

• 1 other identifier: NaFnano brushing
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

fluorine; dental plaque; Toothbrushing

Outcome Measures

Primary Outcomes (1)

• levels of fluoride concentration in saliva and biofilm

  It is expected that a concentration of fluoride would differ according to the type of formulation providing beneficial support in remineralization of the tooth enamel and preventing carious lesions.

  12 hours

Study Arms (4)

G0 - placebo

PLACEBO COMPARATOR

All placebo mouthwashes were formulated with the following common ingredients: WATER (AQUA), POLYSORBATE 80, HYDROXYPROPYL GUAR,,SODIUM BENZOATE, POTASSIUM SORBATE. Finally, NO FLUORIDE WAS INCORPORATED.

Drug: Mouthwash Product

G1: 100% - sodium fluoride (100% free NaF)

EXPERIMENTAL

These mouthwashes were formulated with the following common ingredients: WATER (AQUA), POLYSORBATE 80, HYDROXYPROPYL GUAR,,SODIUM BENZOATE, POTASSIUM SORBATE. Finally, 225 ppm NaF (SODIUM FLUORIDE) WAS INCORPORATED.

Drug: Mouthwash Product

G2: 50% nano fluoride (225 ppm, 50% free NaF + 50% nanoF)

EXPERIMENTAL

These mouthwashes were formulated with the following common ingredients: WATER (AQUA), POLYSORBATE 80, HYDROXYPROPYL GUAR,,SODIUM BENZOATE, POTASSIUM SORBATE. Finally, 225 ppm (50% free NaF + 50% nanoF) WAS INCORPORATED.

Drug: Mouthwash Product

G3: 100% nano fluoride (225 ppm)

EXPERIMENTAL

These mouthwashes were formulated with the following common ingredients: WATER (AQUA), POLYSORBATE 80, HYDROXYPROPYL GUAR,,SODIUM BENZOATE, POTASSIUM SORBATE. Finally, 225 ppm (100% nanoF) WAS INCORPORATED.

Drug: Mouthwash Product

Interventions

Mouthwash Product DRUG

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).

Also known as: nano fluoride

G0 - placebo; G1: 100% - sodium fluoride (100% free NaF); G2: 50% nano fluoride (225 ppm, 50% free NaF + 50% nanoF); G3: 100% nano fluoride (225 ppm)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• residents of a city without water fluoridation program

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal University of Paraíba: lead

Study Sites (1)

Federal University of Paraíba

João Pessoa, Paraíba, 58051900, Brazil

Location

MeSH Terms

Conditions

Dental Plaque

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases

Study Officials

• FABIO C SAMPAIO, PhD

  Hospital Universitário Lauro Wanderley

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: The products have a serial number and different colors
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Titular Professor of Cariology Clinic

Model Details: A randomized, triple-blind crossover clinical trial study was performed to evaluate the bioavailability of intraoral fluoride in biomarkers of exposure (biofilm and saliva) after the use of mouthwash with experimental fluoride for one week, with wash-out periods between them

Study Record Dates

• First Submitted: November 18, 2021
• First Posted: December 1, 2021
• Study Start: August 3, 2017
• Primary Completion: September 12, 2018
• Study Completion: December 12, 2018
• Last Updated: December 1, 2021

Record last verified: 2021-11

Locations

BR (1)