Intraoral Appliance (IOA) Model Evaluating the Efficacy of a Whitening Toothpaste

Part of paid clinical trials in Noblesville, Indiana.

Sponsor
Church & Dwight Company, Inc.
Study ID
NCT07419685
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
    lnvestigational 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-one fluoride-free negative control, one positive control with 0.243% sodium fluoride, and one investigational dentifrice containing 0.243% sodium fluoride and 20% sodium bicarbonate. Healthy adult subjects wore a palatal acrylic appliance containing demineralized enamel specimens for three 9-day treatment periods, during which in vivo brushing/slurry exposure and ex vivo sucrose challenges were performed. Outcomes included percent surface microhardness recovery (%SMHR) and post-treatment enamel fluoride concentration.

Key Dates

Start date
Oct 8, 2024
Status verified
Feb 2026
Primary completion
Jan 17, 2025
Completion
Jan 17, 2025

Study Design

Enrollment
31 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 during each test day.
  • Active Comparator: Comparator
  • Experimental: Test Toothpaste

Primary Outcome Measure

Percent Surface Microhardness Recovery (%SMHR) [Time Frame: End of each 9-day test period (three test periods in total)] [ Time Frame: End of each 9#day test period (three test periods in total) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Therametric Technologies, Inc.NoblesvilleIndiana46060-

Find similar trials in Noblesville, IN

By research site
Therametric Technologies, Inc.· Noblesville, IN

Related Studies