NCT01657903

Evaluation of Efficacy of Experimental Gel to Foam Dentifrices in Dental Erosion

A Placebo Controlled Study to Evaluate the Effectiveness of Experimental Foaming Gel Toothpastes Using an In-situ Erosion Remineralization Model

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to compare and evaluate the ability of two European Union (EU) regulated gel to foam toothpaste formulations versus a non-fluoride toothpaste using a modified in-situ model of dental erosion and remineralization. A positive control i.e fluoride containing toothpaste marketed in EU will also be compared to non-fluoride toothpaste.

Detailed description

The aim of this study is to assess the remineralization effects of two EU gel to foam toothpaste formulations with 1450 parts per million (ppm) of fluoride as sodium fluoride (NaF) and 5% potassium nitrate (KNO3) versus a non-fluoride (0 ppm F)/KNO3 toothpaste as a negative control. The two experimental gel to foam toothpaste formulations differ in their relative dentine abrasivity (RDA) values which is an in-vitro measure of a toothpaste abrasivity to the dentinal tissues. A marketed toothpaste containing NaF and KNO3 will serve as a positive control.

Conditions

• Dental Erosion
• Acid Wear

Interventions

Type	Name	Description
DRUG	Sodium Fluoride	Toothpaste containing 1450 ppm F - EU level as NaF.
DRUG	Potassium nitrate	All study treatments contain 5% w/w KNO3.

Timeline

• Start date: 2011-11-01
• Primary completion: 2012-02-01
• Completion: 2012-02-01
• First posted: 2012-08-06
• Last updated: 2015-01-26
• Results posted: 2015-01-26

Locations

1 site across 1 country: United States