Hyperbaric Oxygen Treatment of Mandibular Osteoradionecrosis. A Randomized Clinical Study

1. Study objective

The objective of the study is to evaluate the effect of hyperbaric oxygen (HBO) on mandibular osteoradionecrosis as an adjunctive to surgical treatment in patients previously irradiated for head and neck cancer.

Hypothesis: Osteoradionecrosis lesions heal more frequently when administering HBO as an adjunct to surgery. 2. Introduction and rationale

Each year, 300 danish patients are diagnosed with oral cancer. The majority of these cancers are planocellular carcinomas. The established treatments are surgery and radiation therapy. Depending on multiple factors such as total radiation dose, fractionation, localization and use of brachytherapy, mandibular osteradionecrosis occurs in 5-15% of previously head and neck irradiated patients.

Osteradionecrosis is defined by National Cancer Institute (NCI) as radiation-induced cell death in components of bone (e.g., the marrow fat and mineralized tissue). It represents the final common pathway of several disease entities, which result in impaired blood supply to the bone tissue causing bone necrosis. Often, osteoradionecrosis is clinically expressed in relation to surgery or a similar tissue trauma, but may also arise spontaneously several years after radiation treatment. Oral rehabilitation is difficult in these patients as denture wear is painful. Furthermore, radiation-induced hyposalivation complicates retention of dentures, which are normally retained by a thin saliva film. As denture wear appears difficult, insertion of implants seems obvious in these patients. However, the survival rate of dental implants are reduced when inserted in irradiated bone. Thus, osteoradionecrosis patients has great requirements regarding pain therapy as well as oral functional and social rehabilitation.