Clinical Study to Evaluate Remineralization Using an in Situ Model.

NCT07625670 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: CRO-2026-02-REMIN-BZ-CB
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Remineralization; Enamel Subsurface Lesion; Enamel Lesions

Keywords

enamel remineralization; transverse micro-radiography

Outcome Measures

Primary Outcomes (1)

• Change in integrated mineral loss (Δz)

  Integrated mineral loss (Δz) will be assessed by transverse microradiography (TMR). This outcome will evaluate the change from the baseline demineralized state (Δz0) to the post-treatment state (Δz1) to quantify the net mineral gain or loss.

  9 weeks

Secondary Outcomes (4)

• Change in lesion depth

  9 weeks

• Change from Baseline in Fluorescence Loss

  9 weeks

• Change from Baseline in Maximum Fluorescence Loss ΔFmax at 9 Weeks

  9 weeks

• Change from Baseline in Fluorescence Loss Volume (ΔQ) at 9 Weeks

  9 weeks

Study Arms (3)

Test Group

EXPERIMENTAL

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

Drug: Fluoride toothpaste containing 750 ppm MFP in a Dical base; Device: Toothbrush

Positive Control Group

ACTIVE COMPARATOR

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

Drug: Fluoride toothpaste containing 1450 ppm MFP in a Dical base; Device: Toothbrush

Negative Control Group

SHAM COMPARATOR

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

Drug: Fluoride-free toothpaste in a Dical base; Device: Toothbrush

Interventions

Fluoride toothpaste containing 750 ppm MFP in a Dical base DRUG

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

Test Group

Fluoride toothpaste containing 1450 ppm MFP in a Dical base DRUG

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

Positive Control Group

Fluoride-free toothpaste in a Dical base DRUG

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

Negative Control Group

Toothbrush DEVICE

A commercially available adult soft bristle toothbrush

Negative Control Group; Positive Control Group; Test Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Minimum of 20 uncrowned permanent natural teeth (excluding third molars);
• Normal salivary flow;
• Willingness to wear an intra-oral appliance all day as instructed except when eating and drinking.

You may not qualify if:

• 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;
• Subject allergic to oral care products, personal care consumer products, or their ingredients;
• Extended use of antibiotics or therapeutic mouthwash any time during the three months prior to entry into the study;
• A medical history reporting that the subject has a current systemic or autoimmune disease, such as diabetes, lupus, etc.;
• Ongoing use of medications known to affect the gingival tissues (i.e. calcium channel blockers, phenytoin, cyclosporine);
• Advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone). Pocket depth equal or greater than 4 mm;
• Five or more decayed, untreated dental sites (cavities);
• Current smokers and subjects with a history of alcohol or drug abuse;
• Dental work prevents wearing of the appliance or a reported need to wear a night guard.

Sponsors & Collaborators

• Colgate Palmolive: lead
• Federal University of Paraíba: collaborator

Study Sites (1)

Federal University of Paraíba

João Pessoa, Paraíba, 58.051-900, Brazil

Location

Study Officials

• Fábio Correia Sampaio, PhD

  Federal University of Paraíba

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fábio Correia Sampaio, PhD

CONTACT

+55 83 999821111; fabio.correia.sampaio@academico.ufpb.br

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a Phase III, randomized, single-center, crossover, triple-blind clinical study utilizing an intra-oral enamel remineralization in situ model. The design is divided into three 14-day experimental phases, each separated by a 7-day washout period. Participants will be randomly assigned to a sequence of three test products (750 ppm MFP, 1450 ppm MFP, or fluoride-free control) across totaling 8 clinical visits.

Study Record Dates

• First Submitted: May 14, 2026
• First Posted: June 4, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: June 4, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)