NCT00708123

In Situ Caries of Fluoride Toothpastes

Comparison of the Clinical Efficacy From the Retention Phase of Fluoride Delivery of Fluoride Toothpastes Using an in Situ Caries Model

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 78 Years
• Healthy volunteers: Accepted

Summary

This study is to evaluate the effect of fluoride dentifrices on enamel with artificial caries lesions in an in situ model.

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. The aim of this study was to evaluate the efficacy of toothpaste formulations containing fluoride from different sources \[sodium fluoride (NaF) and sodium monofluorophosphate (NaMFP)\] using an in situ caries model.

Conditions

• Healthy Subjects
• Partial Denture Wearers
• Caries

Interventions

Type	Name	Description
DRUG	Sodium fluoride toothpaste	Various fluoride toothpastes containing 1350 ppm F, 1450 ppm F, 1400 ppm F and 250 ppm F
DRUG	Placebo toothpaste	Fluoride free toothpaste (0 ppm F)

Timeline

• Start date: 2007-11-01
• Primary completion: 2008-04-01
• Completion: 2008-04-01
• First posted: 2008-07-02
• Last updated: 2013-04-22
• Results posted: 2012-11-19