Hyperbaric Oxygen for the Prevention of OsteoradioNecrosis

Phase 3

Completed

• Conditions: Osteoradionecrosis subsequent to a surgical procedure in an irradiated mandible; N/A; Injury, Occupational Diseases, Poisoning

• Registration Number: ISRCTN39634732
• Lead Sponsor: niversity of Liverpool (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06-13
• Last Update Posted: 19 December 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified