Stage 0-I osteoradionecrosis of jaws
Conditions
Interventions
Group 1:Hyperbaric oxygen therapy + PENTOCLO + antibiotics
Group 2:Hyperbaric oxygen therapy + placebo + antibiotics
Group 3:Hyperbaric oxygen therapy + PENTOCLO + placebo
Sponsors
Department of Oral & Maxillofacial – Head & Neck Oncology, Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
30 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged from 30 to 65 years, male or female; 2. Patients with clinical diagnoses of osteoradionecrosis of jaws with typical symptoms (skin change, limitation of mouth opening, mucosal fistula, bone exposure and etc.); 3. Patients with early stage of osteoradionecrosis(Stage 0-I); 4; Patients with no severe systemic commobidities.
Exclusion criteria
Exclusion criteria: 1. Patients with existing recurrent diseases (head and neck cancer); 2. Patients with late stage (Stage II-III) osteoradionecrosis of jaws; 3. Patients with history of mandible or maxilla resection (surgery); 4. Patients with history of biphosphonate drugs, ultrasonic physical therapies, hyperbaric oxygen therapy or antibiotics; 5. Patients with severe systemic commobidities (severe cardiac, brain, pulmonary, kidney problems).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quality of Life;Fistula volume;Bone exposure and CT change;Limitation of mouth opening; | — |
Secondary
| Measure | Time frame |
|---|---|
| Facial electromyography (FEMG);Bite force record;Swallowing function analysis;Neutrophils number;C-reaction protein; | — |
Countries
China
Contacts
Public ContactYue He
Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Key Laboratory of Stomatology
Outcome results
None listed