Oral and Dental Tolerance and Efficacy on Dental Hypersensitivity
Research type
Research Study
Full title
Oral and Dental Tolerance and Efficacy on Dental Hypersensitivity of a Dental Gel on Adults
IRAS ID
181890
Sponsor organisation
Pierre Fabre Dermo-cosmetique
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
clinicaltrials.gov, NCT02466945; ,
Duration of Study in the UK
0 years, 2 months, 3 days
Research summary
Dentinal hypersensitivity (DH) is defined as short, sharp pain arising from exposed dentine (the layer of the tooth covered by enamel) in response to stimuli such as hot and cold, which cannot be due to any other form of dental defect or pathology.
This study evaluates the safety of a dental gel based on clinical examinations of the oral and dental cavity (teeth, gums, mucous membrane) and functional signs observed by the participants. The efficacy of the dental gel will also be evaluated.
This study will be conducted by Intertek CRS on behalf of Pierre Fabre Dermo-Cosmetique and is considered to have minimal risk, burden or intrusion of the research participants.
Single centre, single site, exploratory, open and single arm study in healthy participants aged 18-70 years with tooth sensitivity will be accepted.
Screening - Participants who meet the inclusion and exclusion criteria will have a blast of cold air directed at their teeth to identify if they are suffering with tooth sensitivity. Those that show a response typical of sensitivity will be asked to attend Visit 2.
Visit 2 (Enrollment) - An oral soft tissue (OST) examination will be performed and participants will have a blast of cold air (Schiff assessment) directed at their teeth, if the participants have the desired amount of sensitivity on two non-adjacent teeth, they will be accepted onto the study. Participants will be given brushing instructions by a dental clinician and will brush their teeth and use the test product, a dental gel. A Schiff assessment will be repeated 5 and 60 minutes after product use. Participants will be required to use the toothpaste and dental gel three times daily at home.
Visits 3, 4 & 5 - OST and Schiff assessment performed, at visit 5 a product acceptability questionnaire will be completed and females of child bearing potential will have a pregnancy test.REC name
North West - Haydock Research Ethics Committee
REC reference
15/NW/0554
Date of REC Opinion
20 Jul 2015
REC opinion
Favourable Opinion