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Clinical Study to Evaluate Remineralization Using an in Situ Model.
Sponsor: Colgate Palmolive
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
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
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
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
Toothbrush
A commercially available adult soft bristle toothbrush
Locations (1)
Federal University of Paraíba
João Pessoa, Paraíba, Brazil