Medication Related Osteonecrosis of the Jaw
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Preventive treatment protocol Patients, who subscribed medications which affect bone metabolism, for the treatment of malignant tumor (ex. bisphosphonate, anti-RANKL ab) but not having MRONJ and need to have an oral surgery (ex. tooth extraction). Age 20 or older. Patients with good oral hygene. Patients who can obtain written informed consent. 2. Surgical treatment protocol MRONJ patients who require surgical treatment (ex. removal of necrotic bone). Diagnosis of MRONJ should be based on the position paper by AAMOS (2014) as follows: (Definition: Patients may be considered to have MRONJ if all of the following characteristics are present: 1. Current or previous treatment with antiresorptive or antiangiogenic agents; 2. Exposed bone or bone that can be probed through an intraoral or extraoral fistula(e) in the maxillofacial region that has persisted for more than eight weeks; and 3. No history of radiation therapy to the jaws or obvious metastatic disease to the jaws.) Age 20 or older. Patients with good oral hygene. Patients who can obtain written informed consent.
Exclusion criteria
Exclusion criteria: Patients with serious endocrine metabolic diseases and autoimmune diseases. Patients with sepsis or potential sepsis. Patients with hematologic diseases, blood disorders, blood coagulation disorders and liver diseases and having difficulty of transplantation. Positive for any of syphilis, HBV antibody, HCV antibody, HIV antibody and HTLV-1 antibody. Patients with transmissible spongiform encephalopathy, potent transmissible spongiform encephalopathy or dementia. Patients with genetic diseases including sclerosing lesion of bone. Any other conditions that the dentists in charge consider inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Presence of bone exposure. (For preventive and surgical treatment studies, the result will be evaluated at three and twelve months after surgery, respectively). | — |
Secondary
| Measure | Time frame |
|---|---|
| Presence of inflammation Presence and level of pain Presence of pus discharge Presence of external fistula (For preventive and surgical treatment studies, the result will be evaluated at three and twelve months after surgery, respectively). | — |
Countries
Japan
Contacts
Matsumoto Dental University Department of Oral and Maxillofacial Surgery