Clinical Trial

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

Completed
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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.
Trial Details
NCT Number NCT07419763
Lead Sponsor Church & Dwight Company, Inc.
Conditions Dental Caries
Enrollment 30 participants
Start Date 2025-04-15
Primary Completion 2025-06-10 (estimated)
Study Completion 2025-06-10 (estimated)
Updated on ClinicalTrials.gov 2026-02-19