Autologous Platelet Concentrate (APC) in intrabony defects
Research type
Research Study
Full title
Regenerative treatment of intrabony defects with GTR and PRGF. A randomised, single-blind, parallel-group clinical trial .
IRAS ID
259229
Contact name
Nikos Donos
Contact email
Sponsor organisation
Queen Mary University
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 0 months, 30 days
Research summary
The aim of this 12-month clinical study is to treat patients affected by gum disease (periodontitis) by a minor gum surgery that aims to reduce the depth of the gum pockets. In particular, the study will compare two types of gum surgery, one based on the use of a product derived from the patients' own blood (PRGF, platelet autologous concentrate), and the other based on the use of an animal-derived bone graft and membrane that have been in the market for the past 30 years. Both procedures aim to regenerate bone and gum tissue that is damaged by the disease. 74, ≥ 18-year-old, otherwise healthy, patients affected by gum disease will be recruited at the Barts and The London Dental Hospital. Participants will be randomly (by chance) assigned to receive one of the two treatments. Throughout the study, we will assess gum’s health by taking some measurements around teeth and gums. In addition, we will use non-invasive technologies to assess changes in temperature, blood flow and face’s swelling at different time-points. Patients will be given specific questionnaires to evaluate their preferences and the impact that each surgical treatment had in their everyday life. One intra-oral x-ray will be performed before the surgery and after 12 months to assess if new bone has formed around the teeth involved in the surgery, as per standard procedure.
REC name
London - Bromley Research Ethics Committee
REC reference
20/LO/0836
Date of REC Opinion
30 Jun 2020
REC opinion
Further Information Favourable Opinion