Role of PRF in ORN prevention in head and neck cancer patients
Research type
Research Study
Full title
Use of Platelet Rich Fibrin in healing of dental extraction sockets and its role in prevention of osteoradionecrosis in head and neck cancer patients-A prospective, Triple blind ,randomised controlled pilot trial
IRAS ID
311616
Contact name
Yashoda Ashok
Contact email
Sponsor organisation
Swansea Bay University Health Board
Duration of Study in the UK
1 years, 6 months, 30 days
Research summary
Osteoradionecrosis (ORN) of the jaw is one of the most severe and well-known complications of radiotherapy(RT) for head and neck cancer(HNC) 1 . ORN occurs most commonly in the mouth during the treatment of head and neck cancer, and can arise over 5 years after radiation.49 Common signs and symptoms include pain, difficulty chewing, trismus, mouth-to-skin fistulas and non-healing ulcers. Clinically established ORN is difficult to treat and recalcitrant to multiple conventional therapeutic modalities.The estimated cost of conservative management (antibiotics, debridement) ranges from $4000–$35 000, although estimates as high as $74 000 have been reported. There are some promising case reports on ORN treatment performed with platelet concentrates 6,7,8,9,10. However, there is insufficient evidence to evaluate whether the use of L-PRF could promote early healing of dental extraction sockets and thereby reduce the risk of ORN following tooth extractions in Head and neck cancer. Our study aims to test this via a prospective ,triple blind ,randomised ,control trial . A pilot study consisting of 20 patients among those reporting to the Morriston Hospital Head and Neck oncology department would be considered. Patients with biopsy proven oral and oropharyngeal squamous cell carcinoma needing dental extractions would be recruited . The patients will be randomised into two groups . The study group receives the platelet concentrate (L-PRF) into the extraction socket whereas the control group receives a conventional hemostatic agent. L-PRF is extracted from the patient by obtaining 20mls of venous blood and subjecting it to a centrifugation process prior to the dental extraction procedure . Socket healing is evaluated in both groups at the end of 10days . These patients are additionally followed up for a year to evaluate the incidence of ORN in both groups
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
22/EE/0110
Date of REC Opinion
6 Jul 2022
REC opinion
Further Information Favourable Opinion