NCT06242444

An Erosion Study to Investigate the Efficacy of an Experimental Dentifrice to Remineralize Enamel

A Randomized, Examiner Blind, Crossover, in Situ Erosion Study To Investigate The Efficacy Of An Experimental Dentifrice In Remineralization Of Softened Enamel Compared To Placebo and Reference Dentifrices

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: HALEON · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to investigate the ability of an experimental dentifrice containing 1150 parts per million (ppm) fluoride to remineralize acid-softened dental enamel and help prevent further demineralization compared to a 0 ppm fluoride placebo dentifrice and a marketed, fluoride-containing dentifrice (Reference Dentifrice).

Detailed description

This will be a randomized, controlled, single center, single-blind, 3 period, 3 treatment, cross-over, in situ design study. Previously demineralized bovine enamel specimens will be placed intra orally using a palatal appliance and the remineralizing performance of the experimental, reference and placebo dentifrices will be evaluated at 4 and 12 hours post toothbrushing, based on surface micro hardness measurements of the bovine enamel specimens. At each treatment visit, once the palatal the appliance is fitted in the mouth, a five minute equilibration period will ensue following which each participant will brush their teeth with their assigned product. Participants will remove the appliance for 30 minutes at 4 and 8.5 hours post brushing and will remove and store the appliance 13 hours post brushing (12 hours intraoral exposure). Sufficient participants will be screened to randomize approximately 33 participants to study treatment to ensure approximately 30 participants complete the study.

Conditions

• Tooth Erosion

Interventions

Type	Name	Description
DRUG	Experimental Dentifrice	Dentifrice containing 1150 ppm fluoride and 5% KNO3.
DRUG	Placebo Control Dentifrice	Dentifrice containing 0 ppm fluoride and 5% KNO3.
DRUG	Reference Dentifrice	Dentifrice containing 1100 ppm fluoride as SnF2.

Timeline

• Start date: 2024-02-26
• Primary completion: 2024-05-07
• Completion: 2024-05-07
• First posted: 2024-02-05
• Last updated: 2025-05-08
• Results posted: 2025-05-08

Locations

1 site across 1 country: United States