NCT06140745

Evaluation of Dentifrice Formulations to Remineralize Enamel and Dentine Subsurface Lesions in a Double-Blind In-Situ Clinical Trial

Evaluation of Efficacy of Experimental Dentifrice Formulations With Different Forms of Fluoride and/or Other Agents to Remineralize Enamel and Dentine Subsurface Lesions in a Double-Blind Randomized In-Situ Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Procter and Gamble · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

To compare the remineralization and demineralization inhibition potential of early subsurface carious lesions in enamel in situ after rinsing with five different aqueous slurries of toothpaste formulations. Percent remineralization (%R), i.e. the % change in ΔZ values relative to ΔZd, will be the primary outcome measure.

Conditions

• Caries

Interventions

Type	Name	Description
DRUG	0 ppm Fluoride Dentifrice 1	Each subject will use this product during one of the five treatment periods in the crossover study design.
DRUG	1100 ppm NaF Fluoride Dentifrice	Each subject will use this product during one of the five treatment periods in the crossover study design.
DRUG	1500 ppm NaMFP Fluoride Dentifrice	Each subject will use this product during one of the five treatment periods in the crossover study design.
DRUG	0 ppm Fluoride Dentifrice 2	Each subject will use this product during one of the five treatment periods in the crossover study design.
DRUG	0 ppm Fluoride Dentifrice 3	Each subject will use this product during one of the five treatment periods in the crossover study design.

Timeline

• Start date: 2020-10-05
• Primary completion: 2021-02-21
• Completion: 2021-02-21
• First posted: 2023-11-20
• Last updated: 2023-11-20

Locations

1 site across 1 country: Australia