NCT00752089

Experimental Dentifrice Remineralization/Fluoride Uptake in an in Situ Model

Exploratory Evaluation of an Experimental Fluoride Dentifrice Formulation Using an in Situ Remineralization/Fluoride Uptake Model

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 78 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine whether an experimental fluoridated dentifrice is effective in the treatment of dental caries

Detailed description

Topical fluorides have been proven to be clinically effective in the prevention of dental caries. It is generally agreed that anti-caries effect of fluoride (F) is mainly by decreasing the rate of enamel demineralization and enhancing the rate of enamel remineralization. An in-situ Surface Micro-hardness (SMH) test is widely used to evaluate enamel demineralization and remineralization during the caries process. Determination of fluoride uptake in-situ also provides better estimation of true fluoride bioavailability of fluoride dentifrice products. In this study, an in-situ remineralization fluoride uptake model will be used to compare the efficacy of experimental dentifrice with a marketed dentifrice and placebo dentifrice. Participants wore partial dentures containing two partially demineralized enamel specimens for two weeks- 24 hours per day, except when brushing (twice daily) with test dentifrice. Following each treatment period, the enamel specimens were analyzed for SMH recovery and fluoride uptake through microdrill enamel biopsy technique.

Conditions

• Dental Erosion

Interventions

Type	Name	Description
DRUG	NaF/ KNO3/isopentane Dentifrice	Experimental toothpaste
DRUG	NaF/KNO3 Dentifrice	Experimental toothpaste
DRUG	NaF Dentifrice	Active comparator
OTHER	Placebo Dentifrice	Placebo comparator

Timeline

• Start date: 2007-09-01
• Primary completion: 2008-01-01
• Completion: 2008-01-01
• First posted: 2008-09-15
• Last updated: 2016-12-08
• Results posted: 2016-12-08