Osteoradionecrosis of the jaw due to previous radiotherapy treatment in the head and neck region
Conditions
Interventions
Trade Name: Medical Oxygen
Product Name: medical oxygen
Pharmaceutical Form: Inhalation gas
Sponsors
UMC St Radboud
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Patients with osteoradionecrosis of the jaw;Secondary Objective: ;Primary end point(s): Absence of exposed bone, fistulea and ulceration | — |
Countries
Netherlands
Outcome results
None listed