NCT07419685

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

Intraoral Appliance (IOA) Model Evaluating the Efficacy of Three Dentifrices on Enamel Lesion Remineralization

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Church & Dwight Company, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

This in situ intraoral appliance (IOA) model evaluates anticaries potential by exposing demineralized enamel specimens to oral conditions while allowing for ex vivo treatment assessments. Subjects wore acrylic palatal appliances containing four enamel specimens covered with steel gauze to promote plaque formation. Each of the three treatment periods lasted nine days and included twice-daily toothbrushing and dentifrice slurry swishing, plus three daily sucrose challenges. A minimum 4-day fluoride-free washout preceded each period. Post-treatment specimens were analyzed for %SMHR and enamel fluoride concentration.

Conditions

• Dental Caries

Interventions

Type	Name	Description
DRUG	Negative Control Toothpaste	Fluoride-free toothpaste
DRUG	Active Comparator	Commercially available fluoride toothpaste
DRUG	Test Toothpaste	lnvestigational fluoride toothpaste

Timeline

• Start date: 2024-10-08
• Primary completion: 2025-01-17
• Completion: 2025-01-17
• First posted: 2026-02-19
• Last updated: 2026-02-19

Locations

1 site across 1 country: United States