Efficacy of hyperbaric oxygen therapy in the treatment of late radiation damage, osteoradionecrosis, of the lower jaw. - Efficacy of hyperbaric oxygen therapy in the treatment of osteoradionecrosis of the jaw
- Conditions
- Osteoradionecrosis of the jaw due to previous radiotherapy treatment in the head and neck region
- Registration Number
- EUCTR2008-001972-55-NL
- Lead Sponsor
- MC St Radboud
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 128
Informed consent
age >18yrs
WHO performance status 0-2
Last radiotherapy treatment 6 months or more ago.
Radiotherapy with curative intent > 55Gy. Osteoradionecrosis in primary radiotherapy field.
No signs of local recurrence or primary tumour
Necrosis of the jaw and / or bone exposition of at least 1 cm, non-healing extraction wound, dehiscence of the alveolar proces or linea mylohyoidea.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Hyperbaric oxygen treatment in medical history
Bisphosphonate treatment in medical history
Re-radiation
Osteosynthesis material in the affected area
Distant metastases
Local recurrence or primary tumour
Synchronous preventive treatment (extraction
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method