Extract

Background and study aims Periodontitis is a very common chronic gum infection with many causes that damages the soft tissue and destroys the bone supporting the teeth. It can lead to tooth loss, difficulties chewing, poor appearance of teeth and gums and it can even increase the risk of a heart attack or stroke. Treatments can be surgical, where the gum is raised so that the tooth can be cleaned, or non-surgical, where the cleaning is done without the gum being raised. If surgical treatment is required, bone rebuilding procedures can also be performed in cases where some if the bone around the tooth has been destroyed. A new way of aiding the rebuilding and healing of tissue around teeth following surgery is with the use of a product from the patient’s own blood called PRGF (plasma rich in growth factors, marketed as PRGFEndoret). It is known that PRGF helps tissue healing and minimises postoperative complications such as pain and inflammation/swelling. Blood from the patient’s vein is taken before they have their surgery. The blood is treated and heated to form a gel like structure which is then inserted around the diseased tooth at the treatment site. The PRGF then acts on the surrounding tissues to aid healing and regeneration. We want to investigate wound healing and regeneration of bone in patients with periodontal bone defects following surgical use of PRGF compared to surgical treatment without PRGF. Who can participate? Adult dental patients (aged at least 18) who have two bony defects caused by periodontal disease (vertical interproximal bony defects) requiring surgical treatment. What does the study involve? For each participant taking part in the study, one of the bony defects is randomly chosen to be treated with PRGF and the other is treated using standard surgical procedures. All participants receive the same two treatments, one for each defect. What are the possible benefits and risks of participating? While we cannot be sure that the PRGF will improve results, previous studies in which PRGF has been used in other oral surgical procedures have shown it be beneficial in reducing inflammation and healing times. The risks in taking part in the study are no greater than that of standard periodontal surgery, with some pain or discomfort likely, but normal for this type of procedure. Where is the study run from? Bristol Dental Hospital (UK) When is the study starting and how long is it expected to run for? October 2014 to April 2015 Who is funding the study? The University of Bristol (UK) Who is the main contact? Professor Nicola West [email protected]

Inclusion criteria

• Periodontal disease

Links

• isrctn
• ictrp