Clinical Trial: Clinical Study to Evaluate the Efficacy of Two Dentifrices for Dentine Hypersensitivity

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Clinical Study to Evaluate the Efficacy of Two Dentifrices for Dentine Hypersensitivity

Brief Summary: An 8 week clinical study to evaluate the ability of an experimental dentifrice containing calcium sodium phosphosilicate and sodium fluoride to provide relief from dentine hypersensitivity compared to a marketed dentifrice containing calcium sodium phosphosilicate and sodium monofluorophosphate.

Detailed Summary: A single centre, multi-site, randomised, examiner blind, two treatment, parallel group, non-inferiority design clinical study conducted in healthy subjects with self-reported and clinically diagnosed dentine hypersensitivity (DH). This study will compare the effectiveness of a test dentifrice containing 5% w/w calcium sodium phosphosilicate and fluoride as sodium fluoride to a commercially available dentifrice containing 5% w/w calcium sodium phosphosilicate and fluoride as sodium monofluorophosphate, in providing relief from DH after 4 and 8 weeks twice daily treatment.
Sponsor: GlaxoSmithKline

Current Primary Outcome: Evaporative Air Sensitivity measured by VAS at Week 8 [ Time Frame: Change from baseline to Week 8 ]

To determine if a dentifrice containing 5% w/w calcium sodium phosphosilicate and 1426 ppm fluoride as sodium fluoride is non-inferior to a dentifrice containing 5% w/w calcium sodium phosphosilicate and 1426 ppm fluoride as sodium monofluorophosphate in reducing dentine hypersensitivity, as measured by evaporative air sensitivity (0-100 mm Visual Analogue Scale-VAS), after 8 weeks twice daily brushing (0 indicates No pain and 100 indicates worst pain imaginable)


Original Primary Outcome: Same as current

Current Secondary Outcome: Evaporative Air Sensitivity measured by VAS at Week 4 [ Time Frame: Change from baseline to Week 4 ]

To determine if a dentifrice containing 5% w/w calcium sodium phosphosilicate and 1426 ppm fluoride as sodium fluoride is non-inferior to a dentifrice containing 5% w/w calcium sodium phosphosilicate and 1426 ppm fluoride as sodium monofluorophosphate in reducing dentine hypersensitivity, as measured by evaporative air sensitivity (0-100 mm Visual Analogue Scale-VAS), after 4 weeks twice daily brushing (0 indicates No pain and 100 indicates worst pain imaginable)


Original Secondary Outcome: Same as current

Information By: GlaxoSmithKline

Dates:
Date Received: February 19, 2015
Date Started: September 2014
Date Completion:
Last Updated: January 16, 2017
Last Verified: January 2017