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

Phase 1

• Conditions: Mandibular osteoradionecrosis occuring from radiation treatment of cancer.No healthy volunteers; MedDRA version: 9.1Level: LLTClassification code 10064658Term: Osteonecrosis of jaw

• Registration Number: EUCTR2007-007842-36-SE
• Lead Sponsor: one Elisabeth Forner

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-11-12
• Study Completion: 2018-12-31
• Last Update Posted: 24 January 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 97

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified