Best Treatment Choice for Osteonecrosis of the Jaw (BETCON)
Medication Related Osteonecrosis of the Jaw
About this trial
This is an interventional treatment trial for Medication Related Osteonecrosis of the Jaw
Eligibility Criteria
Inclusion criteria:
- >18 years of age
- Provision of signed informed consent
- A history of at least one administration of, or an ongoing treatment with, a bone modifying agent in dose registered for the prevention of skeletal related events in bone metastatic disease or multiple myeloma
- Diagnosis of stage I-II MRONJ according to AAOMS 2014 criteria not more than 8 weeks prior to the date of screening
Exclusion criteria:
- Any prior treatment for MRONJ other than local antiseptic rinses, systemic antibiotics, or analgesics
- Prior radiotherapy to the head and neck region
- Medical contraindication to receive any of the possible study treatments
- Stage III MRONJ characterized by very extensive bone necrosis, pathological fracture, or fistulas to the skin or sinuses
- Multiple MRONJ lesions that cannot be closed in a single surgical procedure
Sites / Locations
- ZNA MiddelheimRecruiting
- Antwerp University HospitalRecruiting
- UZ LeuvenRecruiting
- AZ NikolaasRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Experimental
Experimental
Conservative treatment
Minimally invasive approach + LPRF
Primary surgical management
Amoxicillin-based antibiotics and chlorhexidine oral rinse. Minor debridement. Primary wound closure is not part of this treatment strategy.
Amoxicillin-based antibiotics and chlorhexidine oral rinse. Minimally-invasive surgical treatment, including sequestrectomy, debridement of soft tissue, and application of LPRF membranes before tension-free wound closure is obtained. Marginal resection of all necrotic bone is not part of this treatment strategy.
Amoxicillin-based antibiotics and chlorhexidine oral rinse. Removal of the necrotic bone without excessive resection of healthy bone. Buccal mucoperiosteal flaps will be used to achieve a tension-free mucosal coverage.