Effect of a new toothpaste on dentine hypersensitivity
Research type
Research Study
Full title
A Clinical Study Investigating the Efficacy of an Occluding Dentifrice in Providing Relief from Dentinal Hypersensitivity. Clinical Protocol 207212
IRAS ID
213959
Contact name
Nicola West
Contact email
Sponsor organisation
GSK Consumer Healthcare
Duration of Study in the UK
0 years, 4 months, 8 days
Research summary
Sensitive teeth (also known as dentine hypersensitivity) can be a painful condition which occurs when dentine, a part of the tooth that is normally protected by the enamel covering of the tooth or the gum, becomes exposed. This normally happens at the gum edge of the tooth. Tooth sensitivity is usually triggered by stimuli such as hot, cold, touch, sweet and/or sour, and the pain is usually sharp, but short in duration. Products used to treat the symptoms of sensitive teeth are varied with toothpastes being routinely used. These toothpastes are thought to work by blocking the tiny open tubes in the exposed dentine thus stopping the painful stimuli from traveling down the tubules and causing pain. Stannous fluoride has been used in oral hygiene products aimed at reducing tooth sensitivity for many years and its long term effect well reported.
The aim of this study is to investigate the ability of an experimental stannous fluoride toothpaste in providing relief from tooth sensitivity following short term use when compared to a standard fluoride toothpaste. This will be a single centre, three day, randomised, examiner blind, two treatment arm, parallel design, stratified (by maximum baseline Schiff sensitivity score of the two selected test teeth), controlled study, in subjects with at least two sensitive teeth that meet all the study criteria at the screening and baseline (pre-treatment) visits. The participants recruited for this study will be adults in good general health, with pre-existing self-reported and clinically diagnosed tooth sensitivity at the screening visit. Assessments of tooth sensitivity on 2 selected sensitive teeth will taken prior to treatment, immediately after treatment and finally following 3 days of twice daily brushing. For treatment, the toothpastes will be applied by the participants, using their finger, directly to the gum line of the selected sensitive teeth.
REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
16/WM/0407
Date of REC Opinion
7 Oct 2016
REC opinion
Further Information Favourable Opinion