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

Part of paid clinical trials in Noblesville, Indiana.

Sponsor
Church & Dwight Company, Inc.
Study ID
NCT07419763
Status
Completed

Conditions

  • Dental Caries

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Negative Control Toothpaste — DRUG
    Fluoride-free toothpaste
  • Active Comparator — DRUG
    Commercially available fluoride toothpaste
  • Test toothpaste — DRUG
    Investigational fluoride toothpaste

Study Details

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 Dates

Start date
Apr 15, 2025
Status verified
Feb 2026
Primary completion
Jun 10, 2025
Completion
Jun 10, 2025

Study Design

Enrollment
30 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION

Arms

  • Placebo Comparator: Negative Control Toothpaste
    Fluoride-free dentifrice (0 ppm fluoride). Used for twice-daily brushing and slurry swishing per protocol during each 7-day test period.
  • Active Comparator: Comparator
    Sodium fluoride dentifrice (0.243% sodium fluoride). Used for twice-daily brushing and slurry swishing per protocol during each 7-day test period.
  • Experimental: Test Toothpaste
    Test dentifrice containing 0.243% sodium fluoride, 5.0% potassium nitrate, and 20% sodium bicarbonate. Used for twice-daily brushing and slurry swishing per protocol during each 7-day test period.

Primary Outcome Measure

Percent Surface Microhardness Recovery (%SMHR) [ Time Frame: End of each 7-day test period (three periods total) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Therametric Technologies, Inc.NoblesvilleIndiana46060-

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Therametric Technologies, Inc.· Noblesville, IN

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