UnknownPhase 2

Hyperbaric Oxygen Treatment of Mandibular Osteoradionecrosis. A Randomized Clinical Study

Denmark, Sweden, United Kingdom114 participantsStarted 2008-06

Plain-language summary

There is currently not sufficient evidence that hyperbaric oxygen (HBO) benefits the surgical removal of necrotic bone in osteoradionecrosis patients. This study aims at testing the hypothesis that HBO does improve healing after surgical removal of necrotic bone in irradiated previous head and neck cancer patients compared to not receiving HBO.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Osteoradionecrosis grade 2, 3 or 4 according to the CTCAE v 3.0 criteria * Localized to the mandibula * \> 18 yrs old Exclusion Criteria: * Existing malignant disease * Previous HBO * Pregnancy or lactation * Uncontrollable claustrophobia * Undrained pneumothorax * Blood pressure \> 220/110 * Exposed titanium reconstruction device

What they're measuring

Osteoradionecrosis status according to the National Cancer Institute Common Toxicity Criteria v 3.0

Timeframe: 1 year

Trial details

NCT IDNCT00760682

SponsorLone Forner

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-04

Contact for this trial

Lone Forner, DDS; PhD

+45 35 45 82 11 lone.forner@rh.regionh.dk

View on ClinicalTrials.gov More Osteoradionecrosis trials