Intra Oral Appliance (IOA) Model Evaluating the Efficacy of Sensitive Toothpaste

NCT07419763 | Completed

• 1 other identifier: ST-25-U04
• Study Type: interventional
• Target: 30
• 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: a fluoride-free negative control, a positive control with 0.243% sodium fluoride, and an investigational dentifrice containing 0.243% sodium fluoride, 5.0% potassium nitrate (KNO₃), and 20% sodium bicarbonate. Adult subjects wore acrylic palatal appliances containing demineralized enamel specimens for three 7-day treatment periods, each preceded by a 5-day fluoride-free washout. Primary outcomes were percent surface microhardness recovery (%SMHR) and enamel fluoride concentration.

Conditions

Dental Caries

Outcome Measures

Primary Outcomes (2)

• Percent Surface Microhardness Recovery (%SMHR)

  End of each 7-day test period (three periods total)

• Enamel Fluoride Concentration (EFU)

  Post-treatment enamel fluoride concentration (µg F/cm³)

  End of each 7-day test period (three periods total)

Study Arms (3)

Negative Control Toothpaste

PLACEBO COMPARATOR

Fluoride-free dentifrice (0 ppm fluoride). Used for twice-daily brushing and slurry swishing per protocol during each 7-day test period.

Drug: Negative Control Toothpaste

Comparator

ACTIVE COMPARATOR

Sodium fluoride dentifrice (0.243% sodium fluoride). Used for twice-daily brushing and slurry swishing per protocol during each 7-day test period.

Drug: Active Comparator

Test Toothpaste

EXPERIMENTAL

Test dentifrice containing 0.243% sodium fluoride, 5.0% potassium nitrate, and 20% sodium bicarbonate. Used for twice-daily brushing and slurry swishing per protocol during each 7-day test period.

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

Investigational 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 saliva flow (≥1.5 mL unstimulated saliva in 5 minutes)
• ≥16 teeth and functional maxillary dentition to support palatal appliance
• Agree to abstain from other oral care products and preventive dental procedures during study
• No advanced periodontal disease, no visible untreated caries
• If female, not pregnant or breastfeeding (self-reported)
• No significant oral soft tissue pathology; no peri/oral piercings; no removable partial dentures
• No antibiotics or immunosuppressives within 30 days of screening
• No palatal torus; no medical condition that would interfere with safety
• No allergy or significant adverse events to impression materials, acrylics, or common oral product

You may not qualify if:

• Unable to tolerate appliance or comply with procedures
• Oral pathology that interferes with participation
• Use of fluoride toothpaste during washout periods
• Participation in another appliance study within the last 4 week

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: April 15, 2025
• Primary Completion: June 10, 2025
• Study Completion: June 10, 2025
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)