RH02566 - Efficacy of two Dentifrices for Dentine Hypersensitivity
Research type
Research Study
Full title
A Clinical Study to Evaluate the Efficacy of two Dentifrices for Dentine Hypersensitivity
IRAS ID
163580
Contact name
George Hardie
Contact email
Sponsor organisation
GlaxoSmithKline Consumer Healthcare
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 2 toothpastes in providing relief of tooth sensitivity following 8 weeks of twice daily brushing.
Single centre, multi-site trial in healthy participants aged 18 to 60, 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 1 week in order to provide a standardised oral hygiene regime.
• Visit 2: an oral soft tissue exam (OST), followed by response to pressure and air on the teeth, and questionnaires, will be performed to determine that the participant has the required level of tooth sensitivity. Those who qualify will be given one of two toothpastes to use for the first time at the study centre and then for the subsequent 8 weeks.
• Visit 3 (4 weeks after product use): oral soft tissue exam, followed by response to pressure and air on the teeth, including a questionnaire. Participants will then be requested to brush with the toothpaste at the study centre.
• Visit 4 (8 weeks after product use): oral soft tissue exam, followed by response to pressure and air on the teeth, including a questionnaire. The study will then be complete.REC name
East Midlands - Nottingham 1 Research Ethics Committee
REC reference
14/EM/1149
Date of REC Opinion
22 Sep 2014
REC opinion
Further Information Favourable Opinion