A modified In-situ model to study dentine tubule occlusion
Research type
Research Study
Full title
Assessment of Dentine Tubule Occlusion in a Modified in situ Model - Protocol 205699
IRAS ID
206101
Contact name
Nicola West
Contact email
Sponsor organisation
GlaxoSmithKline Consumer Healthcare
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 3 months, 25 days
Research summary
Tooth Sensitivity can arise when tiny holes in the dentine of a tooth become exposed. Triggers such as cold air or touch travel down the small holes or tubules in dentine reaching the tooth nerve and cause a short sharp pain.\nThis modified in situ model study will look at the effect of an experimental toothpaste containing stannous fluoride (a toothpaste ingredient proven to be effective against tooth sensitivity) to block dentine tubules compared to a regular fluoride toothpaste and a negative control (mineral water).\nPreviously, this model has been used to evaluate 4 days of treatment, however in this modified study, study treatments will be administered for a total of 10 days, with subjects wearing two lower appliances in their mouth that will hold samples of dentine. The dentine samples will be examined after 1, 4, 8 and 10 days of treatment using scanning electron microscopy (SEM) and the resulting images graded for the amount of dentine tubule blocking (occlusion). In addition, the strength of any dentine tubule occlusion provided by the treatments will be tested by exposing the dentine samples to an acid challenge (orange juice) after 9 and 10 days treatment.\nThis study will be funded by GlaxoSmithKline Consumer Healthcare (GSKCH) and will recruit subjects in the United Kingdom.\n
REC name
South West - Cornwall & Plymouth Research Ethics Committee
REC reference
16/SW/0123
Date of REC Opinion
11 May 2016
REC opinion
Favourable Opinion