NCT07419672

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

Intra Oral Application (IOA) Testing Study of TheraBreath Toothpaste

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Church & Dwight Company, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

Each 9-day test period was preceded by a washout period of at least four days during which subjects used a fluoride-free toothpaste. The washout phase ensured removal of residual fluoride exposure prior to beginning the next assigned dentifrice treatment. Subjects remained in good oral health and compliance was verified at the start of each test period.

Conditions

• Dental Caries

Interventions

Type	Name	Description
DRUG	Negative Control Treatment Slurry (Fluoride-Free)	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.
DRUG	Active Comparator Fluoride Treatment (0.454% SnF)	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.
DRUG	Test Fluoride Treatment (0.454% SnF) (Investigational Toothpaste)	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.

Timeline

• Start date: 2024-08-12
• Primary completion: 2024-11-21
• Completion: 2024-11-21
• First posted: 2026-02-19
• Last updated: 2026-02-19

Locations

1 site across 1 country: United States