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NOT YET RECRUITING
NCT07625670
PHASE3

Clinical Study to Evaluate Remineralization Using an in Situ Model.

Sponsor: Colgate Palmolive

View on ClinicalTrials.gov

Summary

This is a phase III clinical trial that aims to evaluate the enamel remineralization efficacy of three dentifrices on artificial caries lesions using an in situ model. The study involves 30 healthy volunteers, aged 18 to 70, who will participate in a randomized, triple-blind, three-period crossover design. Researchers will compare a 750 ppm MFP dentifrice against a 1450 ppm MFP positive control and a fluoride-free negative control to measure variations in mineral gain. Participants will wear a removable intraoral appliance containing human enamel blocks for three 14-day experimental phases. A 7-day washout period using will be implemented before and between each treatment phase.

Official title: Clinical Study to Evaluate Enamel Remineralization Using Three Dentifrices in an in Situ Model.

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2026-06

Completion Date

2026-10

Last Updated

2026-06-04

Healthy Volunteers

Yes

Interventions

DRUG

Fluoride toothpaste containing 750 ppm MFP in a Dical base

Subjects will brush using a fluoride toothpaste containing 750 ppm MFP in a Dical base and a soft bristle toothbrush for 14 days

DRUG

Fluoride toothpaste containing 1450 ppm MFP in a Dical base

Subjects will brush using a fluoride toothpaste containing 1450 ppm MFP in a Dical base and a soft bristle toothbrush for 14 days

DRUG

Fluoride-free toothpaste in a Dical base

Subjects will brush using a fluoride-free toothpaste in a Dical base and a soft bristle toothbrush for 14 days

DEVICE

Toothbrush

A commercially available adult soft bristle toothbrush

Locations (1)

Federal University of Paraíba

João Pessoa, Paraíba, Brazil