Intra Oral Application (IOA) Testing Study of a Stannous Toothpaste

Part of paid clinical trials in Noblesville, Indiana.

Sponsor
Church & Dwight Company, Inc.
Study ID
NCT07419672
Status
Completed

Conditions

  • Dental Caries

Eligibility Criteria

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

Interventions

  • Negative Control Treatment Slurry (Fluoride-Free) — DRUG
    Fluoride-free toothpaste used with an intra-oral appliance (IOA) containing enamel specimens. Toothbrushing and rinsing with slurry twice daily for 2 minutes per administration while wearing the IOA, followed by expectoration without rinsing. Used to provide a baseline reference for enamel fluoride uptake and remineralization outcomes in an IOA model.
  • Active Comparator Fluoride Treatment (0.454% SnF) — DRUG
    Commercially available stannous fluoride toothpaste Toothbrushing and rinsing with slurry twice daily for 2 minutes per administration while wearing the IOA containing enamel specimens, followed by expectoration without rinsing. Serves as an established reference for promoting enamel fluoride uptake and surface remineralization in an IOA model.
  • Test Fluoride Treatment (0.454% SnF) (Investigational Toothpaste) — DRUG
    Investigational stannous fluoride toothpaste Toothbrushing and rinsing with slurry twice daily for 2 minutes per administration while wearing the IOA containing enamel specimens, followed by expectoration without rinsing. Intended to evaluate enamel fluoride uptake and remineralization performance versus negative control and active comparator treatments in an IOA model.

Study Details

The primary objective of this crossover in-situ study is to determine the fluoride bioavailability and enamel remineralization potential of an experimental, placebo, and a positive control reference toothpaste.

Key Dates

Start date
Aug 12, 2024
Status verified
Feb 2026
Primary completion
Nov 21, 2024
Completion
Nov 21, 2024

Study Design

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

Arms

  • Placebo Comparator: Negative Control Toothpaste
    Participants will wear an intra-oral appliance (IOA) containing enamel specimens and brush and rinse twice daily with a negative-control toothpaste and slurry that contains no active fluoride. This arm provides a baseline reference for evaluating enamel fluoride uptake and remineralization responses relative to the test and comparator treatments.
  • Active Comparator: Comparator
    Participants will wear an intra-oral appliance (IOA) containing enamel specimens and brush and rinse twice daily with a commercially available fluoride toothpaste and slurry of known efficacy in promoting enamel fluoride uptake and surface remineralization. This arm serves as an established reference standard for evaluating the performance of the test formulation.
  • Experimental: Test Toothpaste
    Participants will wear an intra-oral appliance (IOA) containing enamel specimens and brush and rinse twice daily with the investigational fluoride toothpaste and slurry. This arm evaluates the ability of the test formulation to promote enamel fluoride uptake and remineralization relative to both the negative control and active comparator treatments.

Primary Outcome Measure

Percent Surface Microhardness Recovery (%SMHR) [ 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