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

NCT07419685 | Completed

• 1 other identifier: ST-24-U44
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dental Caries

Outcome Measures

Primary Outcomes (2)

• Percent Surface Microhardness Recovery (%SMHR) [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)

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

Study Arms (3)

Negative Control Toothpaste

PLACEBO COMPARATOR

Fluoride-free dentifrice (0 ppm fluoride). Used for twice-daily brushing and slurry swishing during each test day.

Drug: Negative Control Toothpaste

Comparator

ACTIVE COMPARATOR

Drug: Active Comparator

Test Toothpaste

EXPERIMENTAL

Drug: Test Toothpaste

Interventions

Negative Control Toothpaste DRUG

Fluoride-free toothpaste

Negative Control Toothpaste

Active Comparator DRUG

Commercially available fluoride toothpaste

Comparator

Test Toothpaste DRUG

lnvestigational fluoride toothpaste

Test Toothpaste

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Church & Dwight Company, Inc.: lead

Study Sites (1)

Therametric Technologies, Inc.

Noblesville, Indiana, 46060, United States

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Annahita Ghassemi, PhD

  Church & Dwight, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2026
• First Posted: February 19, 2026
• Study Start: October 8, 2024
• Primary Completion: January 17, 2025
• Study Completion: January 17, 2025
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)