Clinical Study to Evaluate Remineralization Using an in Situ Model.
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-70
SponsorColgate Palmolive
About this trial
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.
Eligibility criteria
Qualifiers
Males and females, between 18-70 years of age (inclusive);
Informed Consent Form signed and availability for the duration of the study;
Good general health (absence of any condition that, in the opinion of the Principal Investigator, might constitute a risk to the subject while participating in the study. Examples include heart problems, valve/hip replacements, etc);
Willingness to provide information related to their medical history;
Disqualifiers
Oral pathology, chronic disease, or a history of allergy to testing products;
Subject using anticonvulsants, antihistamines, antidepressants, sedatives, tranquilizers, anti-inflammatory medication or daily analgesics within one month prior to the start of the study or scheduled to start such intake during the course of the study;
Subject participating in any other clinical study;
Subject pregnant or breastfeeding;
Trial design
Treatments tested in this trial
- Fluoride toothpaste containing 750 ppm MFP in a Dical base
- Fluoride toothpaste containing 1450 ppm MFP in a Dical base
- Fluoride-free toothpaste in a Dical base
- Toothbrush
Treatment groups
30 Participants
are divided into 3 treatment groupsSponsors and collaborators
Colgate Palmolive
Lead sponsor
Federal University of Paraíba
Collaborator
Source ClinicalTrials.gov