MedTrace Logo

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

NCT07419672 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2026-02-19

No results posted yet for this study

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.

Conditions

  • Dental Caries

Interventions

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.

Sponsors & Collaborators

  • Therametrics

    collaborator INDUSTRY

  • Church & Dwight Company, Inc.

    lead INDUSTRY

Principal Investigators

  • Annahita Ghassemi, PhD · Church & Dwight, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-08-12
Primary Completion
2024-11-21
Completion
2024-11-21

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07419672 on ClinicalTrials.gov