PROCEDURE
Conservative treatment
Disinfectant mouth rinses, Antibiotic therapy, Antifungal therapy
Status
Unknown
Phase
Not applicable
Enrollment
518
Locations
14
Results
Not posted
Publications
0
Study 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.
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
PROCEDURE
Disinfectant mouth rinses, Antibiotic therapy, Antifungal therapy
PROCEDURE
Superficial debridement, Complete removal of necrotic bone, Complete bone resection, When applicable revision and soft tissue coverage
PROCEDURE
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
Timeline
First posted
Oct 13, 2016
Study start
Aug 14, 2017
Primary completion
Oct 13, 2023
Study completion
Apr 2024
Results posted
Not reported
Registry updated
Mar 20, 2024
Outcomes
Treatment outcome
Time frame · 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
Pain perception
Time frame · 6 months / 1 year
Numeric Rating Scale
Staging of osteonecrosis
Time frame · 6 months / 1 year
Staging of osteonecrosis according to the American Association of Oral and Maxillofacial Surgeons
Site and size of the lesion
Time frame · 6 months / 1 year
Site (single vs. multiple) and size of the lesion according to Weitzman et al.
Eligibility
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
Study locations
Finland · Germany · Netherlands · Qatar · Romania · Slovenia · South Korea · Spain · Switzerland · United States. Showing up to 24 locations stored in the fast local snapshot.
University of Kentucky Chandler Medical Center
Lexington, Kentucky, United States
Helsinki University Hospital
Helsinki, Finland
Charité - Universitätsmedizin Berlin
Berlin, Germany
Universitätskliniken Eppendorf
Hamburg, Germany
Ludwig-Maximilians University Munich, Klinik und Poliklinik für Mund-, Kiefer und Gesichtschirurgie
München, Germany
Eramus MC
Rotterdam, Netherlands
Hamad Medical Corporation
Doha, Qatar
Emergency Clinical County Hospital of Constanta
Constanța, Romania
University Medical Centre Ljubljana
Ljubljana, Slovenia
Kyungpool National University
Daegu, South Korea
12 de Octubre University Hospital
Madrid, Spain
Universitätsspital Basel
Basel, Switzerland
Luzerner Kantonsspital
Lucerne, Switzerland
Universitätsspital Zürich
Zurich, Switzerland
Publications
No PMID-linked publications were present in this registry snapshot.
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