A randomised controlled trial of hyperbaric oxygen to prevent osteoradionecrosis of the irradiated mandible

niversity of Liverpool (UK)0 个研究点目标入组 200 人开始时间: 2008年6月13日最近更新: 2016年12月19日

试验速览

暂无简介。

•1. Both males and females, age >18 years
•2. Prior history of external beam radiotherapy (dose >50 Gy) to mandible or prior history of brachytherapy with equivalent radiation dose as above
•3. No evidence of cancer recurrence
•4. Condition requiring surgery to mandible (commonest examples but not limited to: dental extraction, implant placement, surgical tooth, cyst or osteosynthesis plate removal)
•5. Patient has read and understood information leaflet and is willing to be randomised
•6. Patient competent to consent and psychologically/ physically fit for HBO

•1. Known contraindications to HBO:
•1.1. Lung disease: Severe chronic obstructive airways disease; bullous lung disease, acute or chronic pulmonary infection; uncontrolled asthma, untreated pneumothorax
•12. Middle ear disease (such as previous middle ear operations, eustachian tube dysfunction or recurrent attacks of vertigo) that proves refractory to simple interventions such as grommet insertion
•2. Prior hyperbaric oxygen therapy
•3. Prior diagnosis of osteoradionecrosis of the mandible
•4. Previous surgery for osteoradionecrosis
•5. Any history of systemic bisphosphonate therapy, pentoxyphylline or tocopherol
•6. Pregnancy

发起方

niversity of Liverpool (UK)