205212 Occluding Dentifrice Efficacy for Dentinal Hypersensitivity
Research type
Research Study
Full title
Short Term Clinical Study Investigating the Efficacy of an Occluding Dentifrice in Providing Relief from Dentinal Hypersensitivity.
IRAS ID
196696
Contact name
Robert Maclure
Contact email
Sponsor organisation
GlaxoSmithKline Consumer Healthcare
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 2 months, 12 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 twice daily brushing, over a 7 and 14 day period compared with a standard fluoride dentifrice.
Single centre, multisite trial. Healthy participants aged 18 to 65, 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 acclimatisation paste to use for at least 4 weeks (maximum of 8 weeks) in order to provide a standardised oral hygiene regime. First use of this product is supervised on site.
• Visit 2: 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 brushing with either the test or control product toothpaste which is used at home twice daily for 1 week.
• Visit 3: an oral soft examination, followed by response to pressure and air on the teeth will be performed as before. Supervised brushing with their allocated toothpaste which is used at home twice daily for more 1 week.
Visit 4: 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 - Liverpool Central Research Ethics Committee
REC reference
16/NW/0065
Date of REC Opinion
10 Feb 2016
REC opinion
Further Information Favourable Opinion