REFRAME RPD
Research type
Research Study
Full title
REFRAME RPD Post-Market Clinical Study
IRAS ID
191041
Contact name
Shawn Shorrock
Contact email
Sponsor organisation
Solvay Dental 360™, A division of Solvay Speciality Polymers
Duration of Study in the UK
0 years, 6 months, 8 days
Research summary
The REFRAME Study is a post market clinical study where a maximum of 3 sites (in the UK and the USA) will enrol 40 patients.
The primary objective of this study is to evaluate the change in patient Oral Health, via a quality of life questionnaire, between their current Removable Partial Denture (RPD) and the new polymer Removable Partial Denture(RPD).
Patients aged 18 years and over, who have been wearing a cobalt chrome (CoCr) removable partial denture for 24 months or less will be invited to participate in the study to try the new polymer denture.
Patients who meet the inclusion/exclusion criteria will be asked to provide voluntary, written informed consent to take part in the study, once given they will be assessed by the dentist/research nurse and followed up for approximately 8 weeks, which includes attendance at 8 study visits.Tooth loss is prevalent in people aged 65 and over, and can affect an individuals overall oral health and quality of life. It is hoped that these new polymer removable partial dentures (RPDs) can offer cost savings and can eliminate risk of metal sensitivity in some patients.
REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
16/WM/0434
Date of REC Opinion
29 Nov 2016
REC opinion
Further Information Favourable Opinion