NCT03383783

Evaluation of the Fluoride Dose Response of a Modified In Situ Caries Model

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Domenick Zero · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the fluoride dose response of different dentifrice fluoride concentrations - 0, 250, 500 and 1100 ppm fluoride of our existing in situ model involving the use of human enamel specimens placed in the buccal flange area of the subjects partial denture with the modified model involving placement of bovine enamel specimens in a denture tooth location.

Detailed description

This will be a double blind, single center, 4-way crossover design study involving 34 adult subjects, between the ages of 18 and 85 years. 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 × 4 mm partially demineralized human enamel specimens will be placed in the buccal flange area of the subject's mandibular partial denture. In addition, two gauze-covered 4 mm round partially demineralized bovine enamel specimens will be placed in the buccal surface of two posterior denture teeth 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 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 four test products. Changes in the mineral content of the enamel specimens will be assessed using the SMH and 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 remineralized 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 four treatment periods in the crossover study design.
DRUG	250 ppm F as NaF (dose-response control)	Each subject will use this product during one of the four treatment periods in the crossover study design.
DRUG	500 ppm F as NaF (dose-response control)	Each subject will use this product during one of the four treatment periods in the crossover study design.
DRUG	1100 ppm F as NaF (positive control)	Each subject will use this product during one of the four treatment periods in the crossover study design.

Timeline

• Start date: 2017-12-19
• Primary completion: 2018-05-02
• Completion: 2018-05-02
• First posted: 2017-12-26
• Last updated: 2019-05-20
• Results posted: 2019-05-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study