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Intraoral Appliance (IOA) Model Evaluating the Efficacy of a Whitening Toothpaste

NCT07419685 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2026-02-19

No results posted yet for this study

Summary

This single-center, randomized, double-blind, three-period crossover in situ study evaluated the enamel remineralization potential and fluoride bioavailability of three dentifrices-one fluoride-free negative control, one positive control with 0.243% sodium fluoride, and one investigational dentifrice containing 0.243% sodium fluoride and 20% sodium bicarbonate. Healthy adult subjects wore a palatal acrylic appliance containing demineralized enamel specimens for three 9-day treatment periods, during which in vivo brushing/slurry exposure and ex vivo sucrose challenges were performed. Outcomes included percent surface microhardness recovery (%SMHR) and post-treatment enamel fluoride concentration.

Conditions

  • Dental Caries

Interventions

DRUG

Negative Control Toothpaste

Fluoride-free toothpaste

DRUG

Active Comparator

Commercially available fluoride toothpaste

DRUG

Test Toothpaste

lnvestigational fluoride toothpaste

Sponsors & Collaborators

  • Church & Dwight Company, Inc.

    lead INDUSTRY

Principal Investigators

  • Annahita Ghassemi, PhD · Church & Dwight, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-10-08
Primary Completion
2025-01-17
Completion
2025-01-17

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 NCT07419685 on ClinicalTrials.gov