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Shaw RJ, Butterworth CJ, Silcocks P, Tesfaye BT, Bickerstaff M, Jackson R, Kanatas A, Nixon P, McCaul J, Praveen P, Lowe T, Blanco-Guzman M, Forner L, Brennan P, Fardy M, Parkin R, Smerdon G, Stephenson R, Cope T, Glover M, et al.
International journal of radiation oncology, biology, physics. Date of publication 2019 Mar 7;volume ():.
1. Int J Radiat Oncol Biol Phys. 2019 Mar 7. pii: S0360-3016(19)30288-3. doi: 10.1016/j.ijrobp.2019.02.044. [Epub ahead of print] HOPON (Hyperbaric Oxygen for the Prevention of Osteoradionecrosis): A Randomized Controlled Trial of Hyperbaric Oxygen to Prevent Osteoradionecrosis of the Irradiated Mandible After Dentoalveolar Surgery. Shaw RJ(1), Butterworth CJ(2), Silcocks P(3), Tesfaye BT(4), Bickerstaff M(3), Jackson R(3), Kanatas A(5), Nixon P(6), McCaul J(7), Praveen P(8), Lowe T(9), Blanco-Guzman M(10), Forner L(11), Brennan P(12), Fardy M(13), Parkin R(14), Smerdon G(15), Stephenson R(16), Cope T(17), Glover M(18). Author information: (1)University of Liverpool, Liverpool, United Kingdom. Electronic address: rjshaw@liv.ac.uk. (2)Maxillofacial Prosthodontics, Department of Maxillofacial Surgery, University Hospital Aintree, Liverpool, United Kingdom. (3)Cancer Research UK Liverpool Clinical Trials Unit, University of Liverpool, Liverpool, United Kingdom. (4)Cancer Research UK Liverpool Cancer Trials Unit, Department of Molecular and Clinical Cancer Medicine, University of Liverpool, Liverpool, United Kingdom. (5)OMFS Department, Leeds Dental Institute, Leeds, United Kingdom. (6)Restorative Department, Leeds Dental Institute, Leeds, United Kingdom. (7)Regional Maxillofacial Unit, Queen Elizabeth University Hospital, Glasgow, United Kingdom. (8)Maxillofacial Office, Queen Elizabeth Hospital, Birmingham, United Kingdom. (9)Aberdeen Royal Infirmary, Aberdeen, Scotland. (10)Maxillofacial Unit, Musgrove Park Hospital, Taunton and Somerset NHS Foundation Trust, Taunton, United Kingdom. (11)Departments of Anesthesia and Oral and Maxillofacial Surgery, Centre of Head and Orthopedics, Copenhagen University Hospital, Copenhagen, Denmark. (12)Maxillofacial Unit, Queen Alexandra Hospital, Portsmouth, United Kingdom. (13)University Hospital of Wales, Cardiff, Wales, United Kingdom. (14)OMFS Department, ABUHB, Newport, Wales, United Kingdom. (15)DDRC Healthcare, Hyperbaric Medical Centre, Plymouth, United Kingdom. (16)NHS Grampian, Aberdeen Royal Infirmary, Aberdeen, Scotland. (17)North West Recompression Unit, Murrayfield Hospital, Holmwood, United Kingdom. (18)Hyperbaric Medicine Unit, St. Richard's Hospital, Chichester, United Kingdom. PURPOSE: Hyperbaric oxygen (HBO) has been advocated in the prevention and treatment of osteoradionecrosis (ORN) of the jaw after head and neck radiation therapy, but supporting evidence is weak. The aim of this randomized trial was to establish the benefit of HBO in the prevention of ORN after high-risk surgical procedures to the irradiated mandible. METHODS AND MATERIALS: HOPON was a randomized, controlled, phase 3 trial. Participants who required dental extractions or implant placement in the mandible with prior radiation therapy >50 Gy were recruited. Eligible patients were randomly assigned 1:1 to receive or not receive HBO. All patients received chlorhexidine mouthwash and antibiotics. For patients in the HBO arm, oxygen was administered in 30 daily dives at 100% oxygen to a pressure of 2.4 atmospheres absolute for 80 to 90 minutes. The primary outcome measure was the diagnosis of ORN 6 months after surgery, as determined by a blinded central review of clinical photographs and radiographs. The secondary endpoints included grade of ORN, ORN at other time points, acute symptoms, pain, and quality of life. RESULTS: A total of 144 patients were randomized, and data from 100 patients were analyzed for the primary endpoint. The incidence of ORN at 6 months was 6.4% and 5.7% for the HBO and control groups, respectively (odds ratio, 1.13; 95% confidence interval, 0.14-8.92; P = 1). Patients in the hyperbaric arm had fewer acute symptoms but no significant differences in late pain or quality of life. Dropout was higher in the HBO arm, but the baseline characteristics of the groups that completed the trial were comparable between the 2 arms. CONCLUSIONS: The low incidence of ORN makes recommending HBO for dental extractions or implant placement in the irradiated mandible unnecessary. These findings are in contrast with a recently published Cochrane review and previous trials reporting rates of ORN (non-HBO) of 14% to 30% and challenge a long-established standard of care. Copyright © 2019 Elsevier Inc. All rights reserved. DOI: 10.1016/j.ijrobp.2019.02.044 PMID: 30851351
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Osteoradionecrosis - Mandibular