Clinical Trial: Impact of Long Term Management of Dentine Hypersensitivity (DH) With a Daily Use Anti-sensitivity Toothpaste on the Quality of Life Related to Oral Health

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

Official Title: Study to Investigate the Impact on Oral Health Related Quality of Life of Managing Dentine Hypersensitivity With a Daily Use Anti-Sensitivity Toothpaste

Brief Summary: This multicentre, non-comparative design study will monitor the impact of long term management of DH with daily use of a sensitivity toothpaste on the quality of life of a population of sensitivity sufferers. Changes in oral health related quality of life will be monitored using the Dentine Hypersensitivity Experience Questionnaire (DHEQ). The study will be conducted in participants in good general health, with pre-existing self-reported and clinically diagnosed tooth sensitivity at screening.

Detailed Summary: This will be multicenter, non-comparative design to monitor the impact of long term management of DH with daily use of a sensitivity toothpaste on the quality of life of a population of sensitivity sufferers, using the DHEQ. Changes in DH will be monitored clinically over the 24 week treatment period.
Sponsor: GlaxoSmithKline

Current Primary Outcome: Change from baseline in DHEQ [ Time Frame: Baseline to 24 weeks ]

The Dentine Hyersensitivity Experience Questionnaire will be completed by the participants at Baseline and Week 24, prior to any clinical assessments (including OST assessment). Section 1 of the questionnaire will have questions about participants sensitive teeth and the impact it has on their everyday life. Section 2 will have questions about the ways in which the sensations in the teeth affect participants in daily life. It is grouped into domains as follows: Restrictions (Section 2, Q1-4), Adaptation (Section 2, Q5-16)


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: GlaxoSmithKline

Dates:
Date Received: April 25, 2016
Date Started: May 2016
Date Completion:
Last Updated: March 3, 2017
Last Verified: March 2017