NCT06949072

A Clinical Study to Assess an Experimental Dentifrice in an Experimental Model of Early Stage Caries

A Randomized, Single-Blind, Cross-Over Clinical Study to Assess an Experimental Dentifrice in an in Situ Model of Early Stage Caries

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: HALEON · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

Summary

The aim of this study is to evaluate the relative efficacy of an experimental dentifrice containing 1150 parts per million (ppm) fluoride (as sodium fluoride \[NaF\]) to remineralize early stage caries type lesions in an in situ model compared to a negative control and a reference dentifrice.

Detailed description

This is a randomized, single-blind, single-center, controlled, three period, three treatment, cross-over caries in situ model in healthy participants who wear a suitable removable mandibular partial denture. The denture will be modified to accommodate 2 gauze-covered, 4 millimeter (mm) round specimens of bovine dental enamel that have been previously demineralized in vitro to form artificial caries lesions. After 14 days of twice daily product use off-site, the specimens will be removed at the study site to determine the remineralization ability of the treatments. The same procedure will be followed for period 2 and 3 with a washout period of 2-3 days prior to each treatment period. Sufficient participants will be screened to randomize up to 50 participants to the study.

Conditions

• Dental Caries

Interventions

Type	Name	Description
DRUG	Test Dentifrice	Dentifrice containing 5 percent (%) weight by weight (w/w) Potassium nitrate (KNO3) and 1150ppm fluoride as sodium fluoride.
DRUG	Reference Dentifrice	Dentifrice containing 1100ppm fluoride as stannous fluoride.
DRUG	Negative Control Dentifrice	Dentifrice containing 5% KNO3 with no fluoride.

Timeline

• Start date: 2025-04-28
• Primary completion: 2025-09-11
• Completion: 2025-09-11
• First posted: 2025-04-29
• Last updated: 2025-09-24

Locations

1 site across 1 country: United States