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Evaluation of the Anti-cavity Efficacy of Three Dentifrices Using an Intra-oral Enamel Demineralization - Remineralization In-Situ Model

NCT06732518 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2025-08-06

No results posted yet for this study

Summary

Clinical study to evaluate the anti-cavity efficacy of three dentifrices using an intra-oral enamel Demineralization - Remineralization In-Situ Model. This is a Phase III, single-center, triple-blind with a crossover design. It involves 36 participants aged between 18 and 70, randomized into 3 different groups + a washout group, and spans 6 weeks.

Conditions

  • Enamel Lesions
  • Demineralization, Tooth
  • Remineralization
  • Dental Cavity

Interventions

DRUG

Fluoride Toothpaste

Fluoride toothpaste containing 1000 ppm MFP and 1.5% arginine in a PCC/RNCC base

DRUG

Fluoride free toothpaste in a chalk base

Fluoride free toothpaste in a chalk base with herbal ingredients

DRUG

Fluoride free toothpaste in a PCC/RNCC base

Fluoride free toothpaste in a PCC/RNCC base

DEVICE

Toothbrush

A commercially available adult soft bristle toothbrush

Sponsors & Collaborators

  • Federal University of Alagoas

    collaborator OTHER

  • Colgate Palmolive

    lead INDUSTRY

Principal Investigators

  • Natanael Silva, PhD · Federal University of Alagoas

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
2025-03-13
Primary Completion
2025-04-24
Completion
2025-04-24

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 NCT06732518 on ClinicalTrials.gov