NCT07419763

Intra Oral Appliance (IOA) Model Evaluating the Efficacy of Sensitive Toothpaste

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (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: a fluoride-free negative control, a positive control with 0.243% sodium fluoride, and an investigational dentifrice containing 0.243% sodium fluoride, 5.0% potassium nitrate (KNO₃), and 20% sodium bicarbonate. Adult subjects wore acrylic palatal appliances containing demineralized enamel specimens for three 7-day treatment periods, each preceded by a 5-day fluoride-free washout. Primary outcomes were percent surface microhardness recovery (%SMHR) and 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 seven days and included twice-daily toothbrushing and dentifrice slurry swishing, plus three daily sucrose challenges. A minimum 5-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	Investigational fluoride toothpaste

Timeline

• Start date: 2025-04-15
• Primary completion: 2025-06-10
• Completion: 2025-06-10
• First posted: 2026-02-19
• Last updated: 2026-02-19

Locations

1 site across 1 country: United States