Impact of Dental Sensitivity on Oral Health Related Quality of Life
Research type
Research Study
Full title
Study to Investigate the Impact on Oral Health Related Quality of Life of Managing Dentine Hypersensitivity by a Daily Use Anti-Sensitivity Toothpaste
IRAS ID
189570
Contact name
Yoshita Anandarajah
Contact email
Duration of Study in the UK
0 years, 6 months, 25 days
Research summary
The 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 evaluate changes in dentine hypersensitivity with twice daily use of a sensitivity toothpaste over 24 weeks, (with the total length of study involvement being approximately 30 weeks including screening).
The study is a single centre, single-site trial. Healthy participants aged 18-55 years with tooth sensitivity will be accepted onto this study.
Participants will be required to attend the following visits:
•Visit 1 (Screening): Eligibility to continue on the study will be determined (this will include a blast of air on teeth). Participants will be issued a standard acclimatisation toothpaste and brush to use between the screening and baseline visit to provide a standardised oral hygiene regime. Participants will use this acclimatisation paste and brush on site.
•Visit 2 (Baseline): Oral soft tissue exam & oral hard tissue exam (OST & OHT), followed by a response to evaporative air assessment, and DHEQ & LMS questionnaires will be performed to determine whether the participant has the required level of tooth sensitivity. Those who qualify will be given the study toothpaste to use for the first time at the study centre and then for the subsequent 24 weeks.
•Visit 3, 4 ,5 6 & 7 (4, 8, 12, 16 & 20 weeks after first product use): oral soft & hard tissue exam, followed by an evaporative air assessment and questionnaire. Participants will then be requested to brush with the toothpaste at the study centre.
•Visit 8 (24 weeks after first product use): oral soft & hard tissue exam, followed by an evaporative air assessment and questionnaire. The study will then be complete.REC name
South Central - Hampshire B Research Ethics Committee
REC reference
15/SC/0612
Date of REC Opinion
3 Oct 2015
REC opinion
Favourable Opinion