Best Treatment Choice for Osteonecrosis of the Jaw

• Status: Not yet recruiting
• Trial end date: 2024-01-01
• Target enrollment: 0
• Participant gender: All

Summary

BETCON is a pragmatic randomized controlled open-label multi-center study in patients with newly diagnosed stage I-II MRONJ designed to answer the question whether minimally invasive management with LPRF membranes or primary surgical treatment is better than the standard of care of conservative therapy alone. The primary end-point is the time to mucosal healing. Secondary end-points consist of supporting measures of efficacy, patient reported symptoms, quality of life, well-being, and functioning.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tim Van den Wyngaert
• Collaborators: Kom Op Tegen Kanker; Kom op tegen Kanker (Stand up to Cancer)
• Treatments: Amoxicillin; Anti-Bacterial Agents; Chlorhexidine; Chlorhexidine gluconate

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