125
Participants
Start Date
January 1, 2021
Primary Completion Date
October 1, 2025
Study Completion Date
January 1, 2026
Antibiotics
"Antibiotic treatment is the same in all groups.~Monotherapy for 4 weeks with:~No penicillin contra-indication~* Amoxicillin-clavulanate 875mg tid PO Penicillin contra-indication or intolerance~* Clindamycin 300mg tid PO~After 4 weeks patients will be switched to consolidation antibiotics:~No penicillin contra-indication~* Amoxicillin 1g bid PO Penicillin contra-indication or intolerance~* Clindamycin 300mg tid PO~Antibiotic treatment can be discontinued after 4 weeks when the MRONJ lesions has healed."
Chlorhexidine mouthwash
Patients in all treatment groups will be prescribed aqueous chlorhexidine 0.12% tid rinse for 2 weeks, with subsequent switch to 0.05% for the duration of the study or until healing of the MRONJ lesion has occurred.
Minimally invasive surgery with LPRF
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.
Surgical resection
Primary surgical management consisting of the removal of the necrotic bone without excessive resection of healthy bone. Buccal mucoperiosteal flaps will be used to achieve a tension-free mucosal coverage.
RECRUITING
ZNA Middelheim, Antwerp
RECRUITING
Antwerp University Hospital, Edegem
RECRUITING
UZ Leuven, Leuven
RECRUITING
AZ Nikolaas, Sint-Niklaas
Kom Op Tegen Kanker
OTHER
Tim Van den Wyngaert
OTHER