Best Treatment Choice for Osteonecrosis of the Jaw

PHASE4RecruitingINTERVENTIONAL
Enrollment

125

Participants

Timeline

Start Date

January 1, 2021

Primary Completion Date

October 1, 2025

Study Completion Date

January 1, 2026

Conditions
Medication Related Osteonecrosis of the Jaw
Interventions
DRUG

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."

DRUG

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.

PROCEDURE

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.

PROCEDURE

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.

Trial Locations (4)

2020

RECRUITING

ZNA Middelheim, Antwerp

2650

RECRUITING

Antwerp University Hospital, Edegem

3000

RECRUITING

UZ Leuven, Leuven

9100

RECRUITING

AZ Nikolaas, Sint-Niklaas

All Listed Sponsors
collaborator

Kom Op Tegen Kanker

OTHER

lead

Tim Van den Wyngaert

OTHER