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In Situ Comparison of the Remineralization Potential of Optimized Fluoride Dentifrice With Control Fluoride Dentifrice

NCT06010732 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2025-06-15

Study results available
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Summary

The purpose of this study is to compare the remineralization potential of an optimized fluoride dentifrice to a control fluoride dentifrice in an in situ caries model.

Conditions

  • Caries

Interventions

DRUG

0 ppm F (placebo, negative control)

• Each subject will use this product during one of the three treatment periods in the crossover study design.

DRUG

1100 ppm F as sodium fluoride (positive control)

• Each subject will use this product during one of the three treatment periods in the crossover study design.

DRUG

1100 ppm F as sodium fluoride Test Product

• Each subject will use this product during one of the three treatment periods in the crossover study design.

Sponsors & Collaborators

  • HALEON

    collaborator INDUSTRY

  • Indiana University

    lead OTHER

Principal Investigators

  • Domenick Zero, DDS, MS · Indiana University

  • Anderson Hara, DDS, PhD · Indiana University

  • Frank Lippert, PhD · Indiana University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2023-10-02
Primary Completion
2024-02-22
Completion
2024-02-22
FDA Drug
Yes

Countries

  • United States

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 NCT06010732 on ClinicalTrials.gov