Bisphosphonate-Associated Osteonecrosis of the Jaw, Medication-related Osteonecrosis of the Jaw
Conditions
Keywords
Bisphosphonate, Jaw, Osteonecrosis, Antiresorptive drugs, Denosumab
Brief summary
Approximately 500 patients will be included in this patient registry. Data collection includes demographics, clinical data of underlying disease and use of bisphosphonates, denosumab and antiangiogenic drugs , degree and extension of osteonecrosis, osteonecrosis-specific treatment, outcomes and complications within 1 year after treatment.
Detailed description
Approximately 500 patients diagnosed with medication-related osteonecrosis of the jaw will be enrolled in the study. Patients will undergo standard (routine) of care treatment, either conservative or surgical or both, and followed up during one year after the initiation of the treatment. Treatment outcome (development of the condition), pain and complications will be collected and documented over the duration of the registry.
Interventions
PROCEDUREConservative treatment
Disinfectant mouth rinses, Antibiotic therapy, Antifungal therapy
PROCEDURESurgical treatment
Superficial debridement, Complete removal of necrotic bone, Complete bone resection, When applicable revision and soft tissue coverage
PROCEDUREAdjuvant non-surgical treatment
Hyperbaric oxygen therapy Pentoxifylline and tocopherol Ozone therapy Low level laser therapy Pain relief Anti-inflammatory treatment Platelet rich plasma Parathyroid hormone and teriparatide Bone morphogenetic protein
Sponsors
AOCMF
AO Clinical Investigation and Publishing Documentation
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \> 18 years * Newly diagnosed patients with osteonecrosis in a facial bone other than the jaw, or * Newly diagnosed patients with non-exposed MRONJ (stage 0), or * Newly diagnosed patients with exposed MRONJ, i.e: * Current or previous treatment with antiresorptive or antiangiogenic agents. * 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 8 weeks * No history of radiation therapy to the jaws or obvious metastatic diseases of the jaw * Ability to understand the content of the patient information/ Informed Consent Form * Willingness and ability to participate in the clinical investigation according to the Registry Plan (RP) * Signed and dated IRB/EC-approved written informed consent * Mental capacity to comply with post-operative regimen, evaluation and data collection
Exclusion criteria
* Recent history of substance abuse (i. e., recreational drugs, alcohol) that would preclude reliable assessment * Pregnancy or women planning to conceive within the registry period * Prisoner * Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present registry
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment outcome | 6 months / 1 year | Compared to the baseline status of the patient's condition, the outcome will be evaluated as: * Worsening of the osteonecrosis (e.g. size of the lesion increased) * No change of the osteonecrosis * Reduction of the osteonecrosis (e.g. size of the lesion decrease) * Complete mucosa healing |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain perception | 6 months / 1 year | Numeric Rating Scale |
| Staging of osteonecrosis | 6 months / 1 year | Staging of osteonecrosis according to the American Association of Oral and Maxillofacial Surgeons |
| Site and size of the lesion | 6 months / 1 year | Site (single vs. multiple) and size of the lesion according to Weitzman et al. |
Countries
Finland, Germany, Netherlands, Qatar, Romania, Slovenia, South Korea, Spain, Switzerland, United States
Outcome results
None listed