Hyperbaric oxygen treatment of mandibular osteoradionecrosis. A randomized clinical trial.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-007842-36-SE

Enrollment

150

Registered

2010-11-12

Start date

2011-01-03

Completion date

Unknown

Last updated

2022-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mandibular osteoradionecrosis occuring from radiation treatment of cancer. No healthy volunteers MedDRA version: 9.1 Level: LLT Classification code 10064658 Term: Osteonecrosis of jaw

Interventions

Trade Name: Medicinsk Luft "AGA" Product Name: Medicinsk Luft "AGA" Pharmaceutical Form: Inhalation gas

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Osteoradionecrosis grade 2, 3 or 4 (CTCAE v 3.0.) 2. Localization: Mandibula 3. Age over 18 yrs old 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: 1. Malignant diseases that may affect the course of the treatment or disease 2. Previous HBO treatment for osteoradionecrosis 3. Pregnancy 4. Uncontrolled hypertension 5. Lack of ability to equalize the pressure in the the ears and sinuses, although incision or drain of the tympanic membrane is an accepted adjunctive measure 6. Claustrophobia 7. Pneumothorax

Design outcomes

Primary

Measure	Time frame
Primary end point(s): The primary endpoint recovery from osteoradionecrosis as defined by the NCI Common Toxicity Criteria of Adverse Events (CTCAE) v 3.0. Recovery is defined as no signs of osteoradionecrosis according to these criteria or grade 1 on this scale. Grade 0: No signs of disease Grade 1: Asymptomatic, radiographic findings only. Grade 2: Symptomatic and interfering with function, but not interfering with ADL (Activities of Daily Living). Minimal bone removal indicated i.e. minor sequestrectomy). Grade 3: Symptomatic, interfering with ADL. Operative intervention or hyperbaric oxygen indicated. Grade 4: Disabling Grade 5: Death ;Main Objective: To evaluate the effect of hyperbaric oxygen treatment on mandibular osteoradionecrosis.;Secondary Objective: To evaluate effect of hyperbaric oxygen treatment on life quality in osteoradionecrosis patients.	—

Measure

Time frame

Primary end point(s): The primary endpoint recovery from osteoradionecrosis as defined by the NCI Common Toxicity Criteria of Adverse Events (CTCAE) v 3.0. Recovery is defined as no signs of osteoradionecrosis according to these criteria or grade 1 on this scale. Grade 0: No signs of disease Grade 1: Asymptomatic, radiographic findings only. Grade 2: Symptomatic and interfering with function, but not interfering with ADL (Activities of Daily Living). Minimal bone removal indicated i.e. minor sequestrectomy). Grade 3: Symptomatic, interfering with ADL. Operative intervention or hyperbaric oxygen indicated. Grade 4: Disabling Grade 5: Death ;Main Objective: To evaluate the effect of hyperbaric oxygen treatment on mandibular osteoradionecrosis.;Secondary Objective: To evaluate effect of hyperbaric oxygen treatment on life quality in osteoradionecrosis patients.

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Countries

Denmark, Sweden, United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026