HOPON (Hyperbaric Oxygen for the Prevention of Osteoradionecrosis): a randomised controlled trial of hyperbaric oxygen to prevent osteoradionecrosis of the irradiated mandible after dentoalveolar surgery.



Shaw, Richard J ORCID: 0000-0002-5157-4042, Butterworth, Christopher J ORCID: 0000-0002-5025-7467, Silcocks, Paul, Tesfaye, Binyam T, Bickerstaffe, Matthew, Jackson, Richard, Kanatas, Anastios, Nixon, Peter, McCaul, James, Praveen, Prav
et al (show 10 more authors) (2019) HOPON (Hyperbaric Oxygen for the Prevention of Osteoradionecrosis): a randomised controlled trial of hyperbaric oxygen to prevent osteoradionecrosis of the irradiated mandible after dentoalveolar surgery. International journal of radiation oncology, biology, physics.

[img] Text
1-s2.0-S0360301619302883-main.pdf - Accepted Version
Access to this file is embargoed until 7 March 2020.

Download (1MB)

Abstract

PURPOSE:Hyperbaric oxygen (HBO) has been advocated in the prevention and treatment of osteoradionecrosis of the jaws following head and neck radiotherapy, but supporting evidence is weak. The aim of this randomized trial was to establish the benefit of HBO in prevention of osteoradionecrosis following high risk surgical procedures to the irradiated mandible. METHODS AND MATERIALS:XXXXXX was a randomized controlled phase 3 trial. Participants were recruited who required dental extractions or implant placement in the mandible with prior radiotherapy >50Gy. 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 ATA for 80-90 minutes. The primary outcome measure was the diagnosis of osteoradionecrosis six months following surgery as determined by a blinded central review of clinical photographs and radiographs. Secondary endpoints included grade of osteoradionecrosis, osteoradionecrosis at other time-points, acute symptoms, pain and quality of life. RESULTS:144 patients were randomised, and 100 were analysed for the primary endpoint. The incidence of osteoradionecrosis at 6 months was 6.4% and 5.7% for the HBO and control groups respectively, OR 1.13, P = 1 (95% CI: 0.14 to 8.92). Patients in the hyperbaric arm had fewer acute symptoms but no significant differences in late pain or quality of life. Drop-out was higher in the HBO arm, but baseline characteristics of groups completing the trial were comparable between the two arms. CONCLUSIONS:The low incidence of osteoradionecrosis seen makes it unnecessary to recommend HBO for dental extractions or implant placement in the irradiated mandible. These findings are in contrast to a recently published Cochrane review and previous trials reporting rates of ORN (non-HBO) of 14-30%, and challenge a long-established standard of care.

Item Type: Article
Depositing User: Symplectic Admin
Date Deposited: 15 Mar 2019 13:56
Last Modified: 13 Nov 2019 19:13
DOI: 10.1016/j.ijrobp.2019.02.044
URI: http://livrepository.liverpool.ac.uk/id/eprint/3034287
Repository Staff Access