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

Key facts

Study ID

NCT07419763

Run by

Church & Dwight Company, Inc.

People needed

30

Starts

2025-04-15

Expected to finish

2025-06-10

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 saliva flow (≥1.5 mL unstimulated saliva in 5 minutes)
• ≥16 teeth and functional maxillary dentition to support palatal appliance
• Agree to abstain from other oral care products and preventive dental procedures during study
• No advanced periodontal disease, no visible untreated caries
• If female, not pregnant or breastfeeding (self-reported)
• No significant oral soft tissue pathology; no peri/oral piercings; no removable partial dentures
• No antibiotics or immunosuppressives within 30 days of screening
• No palatal torus; no medical condition that would interfere with safety
• No allergy or significant adverse events to impression materials, acrylics, or common oral product

You may not qualify if…

• Unable to tolerate appliance or comply with procedures
• Oral pathology that interferes with participation
• Use of fluoride toothpaste during washout periods
• Participation in another appliance study within the last 4 week

Where it is running

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

Full record on ClinicalTrials.gov

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