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

February 12, 2026 updated by: Church & Dwight Company, Inc.

Intraoral Appliance (IOA) Model Evaluating the Efficacy of Three Dentifrices on Enamel Lesion Remineralization

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This in situ intraoral appliance (IOA) model evaluates anticaries potential by exposing demineralized enamel specimens to oral conditions while allowing for ex vivo treatment assessments. Subjects wore acrylic palatal appliances containing four enamel specimens covered with steel gauze to promote plaque formation. Each of the three treatment periods lasted nine days and included twice-daily toothbrushing and dentifrice slurry swishing, plus three daily sucrose challenges. A minimum 4-day fluoride-free washout preceded each period. Post-treatment specimens were analyzed for %SMHR and enamel fluoride concentration.

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Noblesville, Indiana, United States, 46060
        • Therametric Technologies, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Adults ≥18 years
  • Good general and oral health
  • Normal unstimulated salivary flow (≥1.5 mL/5 min)
  • Functional dentition
  • Oral conditions adequate to support the palatal appliance
  • Ability to comply with brushing, slurry, appliance wear, and sucrose challenge procedures

Exclusion Criteria:

  • Inability to tolerate appliance
  • Oral pathology that interferes with participation
  • Antibiotic use that violates withdrawal criteria
  • Use of fluoride toothpaste during washout
  • Participation in another appliance study in the past 4 weeks

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Comparator
Drug: Active Comparator
Commercially available fluoride toothpaste
Placebo Comparator: Negative Control Toothpaste
Fluoride-free dentifrice (0 ppm fluoride). Used for twice-daily brushing and slurry swishing during each test day.
Drug: Negative Control Toothpaste
Fluoride-free toothpaste
Experimental: Test Toothpaste
Drug: Test Toothpaste
lnvestigational fluoride toothpaste

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
End of each 9#day test period (three test periods in total)
Post-treatment fluoride concentration (µg F/g enamel)
Time Frame: End of each 9-day test period (three test periods in total
End of each 9-day test period (three test periods in total

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Church & Dwight Company, Inc.

Investigators

  • Study Director: Annahita Ghassemi, PhD, Church & Dwight, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 8, 2024

Primary Completion (Actual)

January 17, 2025

Study Completion (Actual)

January 17, 2025

Study Registration Dates

First Submitted

February 12, 2026

First Submitted That Met QC Criteria

February 12, 2026

First Posted (Actual)

February 19, 2026

Study Record Updates

Last Update Posted (Actual)

February 19, 2026

Last Update Submitted That Met QC Criteria

February 12, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ST-24-U44

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The sponsor does not plan to share individual participant data (IPD) from this study. Summary results will be provided as required, but no de-identified datasets or additional supporting documents will be made available.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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