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

Completed · Not applicable

Conditions studied: Dental Caries

In brief

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.

Key facts

Study ID

NCT07419685

Run by

Church & Dwight Company, Inc.

People needed

31

Starts

2024-10-08

Expected to finish

2025-01-17

Last updated by the study team

2026-02-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Adults ≥18 years
• Good general and oral health
• Normal unstimulated salivary flow (≥1.5 mL/5 min)
• Functional dentition
• Oral conditions adequate to support the palatal appliance
• Ability to comply with brushing, slurry, appliance wear, and sucrose challenge procedures

You may not qualify if…

• Inability to tolerate appliance
• Oral pathology that interferes with participation
• Antibiotic use that violates withdrawal criteria
• Use of fluoride toothpaste during washout
• Participation in another appliance study in the past 4 weeks

Where it is running

• Therametric Technologies, Inc. — Noblesville, Indiana, United States

Full record on ClinicalTrials.gov

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