PENtoxyphylline+TOcopherol+/-CLOdronate (PENTOCLO) vs Hyperbaric oxygen (HBO): a randomised assessor blinded pilot study comparing two therapies for Osteoradionecrosis of the mandible.

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Introduction: Osteoradionecrosis (ORN) of the mandible is a painful and debilitating condition frequently occurring after radiotherapy to the head and neck to treat cancer. For decades Hyperbaric oxygen (HBO) has formed the mainstay of non-surgical management of ORN. Literature about the efficacy of HBO is contentious. Recently a combination of medications known as PENTOCLO has shown promising results in treating ORN. The purpose of this pilot study is to generate a hypothesis that can be tested in larger multi-centre controlled trials. Who is it for? You may be eligible for this study if you are an adult who has been diagnosed with osteoradionecrosis by an Oral and Maxillofacial surgeon. Study details For this pilot study, we will recruit 16 participants. These participants will be randomly allocated to up to 18 months of either Hyperbaric Oxygen or PENTOCLO treatment after completing 4 weeks of ‘pre-treatment’. Pre-treatment involves taking daily medications (Amoxicillin + Clavulanic acid, Fluconazole, and Prednisolone) for 4 weeks, with the overall goal of reducing inflammation, infection and pain. Participants will have an initial appointment to take some measurements and record their medical history as well as having X-rays of their jaw taken. They will then be followed up at two weeks, four weeks, six weeks, eight weeks, twelve weeks, six months, nine months, twelve months and eighteen months and have photographs and a further assessment at each visit. Further X-rays will be taken throughout the follow-up period according to when they are needed such as if a participants condition improves or worsens. No other tests need to be performed during the study. It is hoped that this research will help us to conduct much larger studies in the future about whether each treatment is suitable for use in Australia as well as providing international doctors and patients with meaningful information about which treatment for ORN is better. This will help to improve the lives of patients currently suffering with ORN and those who may develop the condition in the future by limiting their pain and suffering. Ethics and dissemination: This study will be registered with the clinical trials database of the TGA in Australia as well as the Australian New Zealand Clinical Trials Registry of the NHMRC. Data generated by conducting this study will be uploaded to an open access repository in a de-identified form. Results from this study will be disseminated at national and international conferences as well as peer reviewed medical publications.