drugset / Trial / NCT07419763
Intra Oral Appliance (IOA) Model Evaluating the Efficacy of Sensitive Toothpaste
RandomizedCrossoverTriple-blindPrevention
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.
Timeline
- Start
- 2025-04-15
- Primary completion
- 2025-06-10
- Completion
- 2025-06-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Potassium Nitrate | Other / unclassified | 5 % | Oral |
| Subject | sodium bicarbonate | Diagnostic / imaging agent | 20 % | Oral |
| Comparator | sodium fluoride | Unknown | 0.243 % | Oral |