NCT06010732

In Situ Comparison of the Remineralization Potential of Optimized Fluoride Dentifrice With Control Fluoride Dentifrice

Comparison of the Remineralization Potential of an Optimized Fluoride Dentifrice With a Control Fluoride Dentifrice Using an in Situ Caries Model

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to compare the remineralization potential of an optimized fluoride dentifrice to a control fluoride dentifrice in an in situ caries model.

Detailed description

This will be a double blind, single center, 3-way crossover design study. Two to three days before the start of each treatment period the subjects will have their teeth cleaned to remove all accessible plaque and calculus and will be provided with a non-fluoride dentifrice to use until their next visit. At the beginning of each testing period, two gauze-covered 4 mm round partially demineralized bovine enamel specimens will be placed in the buccal surface of two posterior denture teeth (the specimen site may extend into the buccal flange area, if needed) of the same side of the partial denture. Once specimens are placed, subjects will wear their partial dentures twenty-four hours a day and use their assigned toothpaste twice daily, as instructed, until their next visit. Specimens will be removed after two weeks, and the subjects will undergo at least a four- to five-day washout period followed by another cleaning and two to three day lead in period. This process will be repeated until all subjects have used all three test products. Changes in the mineral content of the enamel specimens will be assessed using surface microhardness (SMH) and transverse microradiography (TMR). Enamel fluoride uptake (EFU) will be determined using the microdrill enamel biopsy technique. In addition, the net acid resistance (NAR) and the comparative acid resistance (CAR) of the demineralized enamel specimens will be determined.

Conditions

• Caries

Interventions

Type	Name	Description
DRUG	0 ppm F (placebo, negative control)	• Each subject will use this product during one of the three treatment periods in the crossover study design.
DRUG	1100 ppm F as sodium fluoride (positive control)	• Each subject will use this product during one of the three treatment periods in the crossover study design.
DRUG	1100 ppm F as sodium fluoride Test Product	• Each subject will use this product during one of the three treatment periods in the crossover study design.

Timeline

• Start date: 2023-10-02
• Primary completion: 2024-02-22
• Completion: 2024-02-22
• First posted: 2023-08-25
• Last updated: 2025-06-15
• Results posted: 2025-06-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study