Skip to main content
OpenTrials
Completed

NCT Number: NCT07419685

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Therametric Technologies, Inc.

Noblesville, Indiana, 46060, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Negative Control Toothpaste

Drug

Fluoride-free toothpaste

Active Comparator

Drug

Commercially available fluoride toothpaste

test toothpaste

Drug

lnvestigational fluoride toothpaste

Primary outcomes

  1. 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)

  2. Post-treatment fluoride concentration (µg F/g enamel)

    Time frame: End of each 9-day test period (three test periods in total

Sponsors and collaborators

Lead sponsor

Church & Dwight Company, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 19, 2026
Registry last updated
Feb 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.