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Clinical Study to Evaluate Remineralization Using an in Situ Model.

NCT07625670 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-06-04

No results posted yet for this study

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 Lesions
  • Enamel Subsurface Lesion

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

Sponsors & Collaborators

  • Federal University of Paraíba

    collaborator OTHER

  • Colgate Palmolive

    lead INDUSTRY

Principal Investigators

  • Fábio Correia Sampaio, PhD · Federal University of Paraíba

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2026-10-31
Completion
2026-10-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07625670 on ClinicalTrials.gov