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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
30
Fluoride-free toothpaste
Commercially available fluoride toothpaste
Investigational fluoride toothpaste
Therametric Technologies, Inc.
Noblesville, Indiana, United States
Percent Surface Microhardness Recovery (%SMHR)
Time frame: End of each 7-day test period (three periods total)
Enamel Fluoride Concentration (EFU)
Post-treatment enamel fluoride concentration (µg F/cm³)
Time frame: End of each 7-day test period (three periods total)
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