205072 Occluding Dentifrice Efficacy for Dentinal Hypersensitivity
Research type
Research Study
Full title
A Clinical Study Investigating the Efficacy of an Occluding Dentifrice in Providing Relief from Dentinal Hypersensitivity
IRAS ID
190494
Contact name
George Hardie
Contact email
Sponsor organisation
GlaxoSmithKline Consumer Healthcare
Duration of Study in the UK
0 years, 3 months, 4 days
Research summary
This study will be conducted by Intertek CRS on behalf of GlaxoSmithKline Consumer Healthcare and is considered to have minimal risk, burden or intrusion for the research participants.
Tooth sensitivity is a common and painful condition. The aim of this study is to compare the effectiveness of an experimental stannous fluoride containing dentifrice in relieving dentinal hypersensitivity after the first use compared with a standard fluoride dentifrice using a direct application approach to the sensitive teeth with dentifrice.
Single centre, multisite trial. Healthy participants aged 18 to 55, with tooth sensitivity will be accepted onto this study.
Participants will be required to attend the following visits:
• Screening: eligibility will be determined and participants will be issued a standard lead-in paste to use for at least 4 weeks in order to provide a standardised oral hygiene regime.
• Visit 2 Pre Treatment: an oral soft tissue exam (OST), followed by response to pressure and air on the teeth, will be performed to determine that the participant has the required level of tooth sensitivity. Those who qualify will undergo supervised direct application using their finger with allocated study treatment.
• Visit 2 Post Treatment: an oral soft examination, followed by response to pressure and air on the teeth will be performed as before.The study will then be complete.
REC name
North West - Preston Research Ethics Committee
REC reference
15/NW/0784
Date of REC Opinion
19 Oct 2015
REC opinion
Favourable Opinion