K10.2
Conditions
Interventions
Group 1: Complete necrosis removal (plastic covering using the M. mylohyoideus / Bichat’s fat body)
Group 2: Same procedure as in arm 1, but with an additional layer of the PRF membrane before the ten
Sponsors
Universitätsklinikum Schleswig-Holstein (UKSH)
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: - Patients undergoing MRONJ in stage 1, 2 or 3 according to the criteria of AAOMS - Previous or current use of bisphosphonates or RANK-L inhibitors subcutaneously or intravenously in malignant disease - Peri- and posttherapeutic intravenous high-dose antibiotics until the 5th day postoperative using Unacid 3g i.v. 1-1-1 - Peri- and post-therapeutic diet by means of nasogastric probe food
Exclusion criteria
Exclusion criteria: - positive history of radiation in the head and neck area - MRONJ Diagnosis without Clinical Exposure of Exposed Jaw Bone (Stage 0) - microvascular reconstruction in the head and neck area - Patients with renovations under local anesthesia - Hemorrhagic diathesis or thrombocytopenia <150,000 / µl
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical success (completed wound healing without bone exposure) at time points t1 (5 days postop), t2 (14 days postop, +/- 1 day) and t3 (6 weeks postop, +/- 3 days) | — |
Secondary
| Measure | Time frame |
|---|---|
| - Clinical downstaging based on the AAOMS (American Association of Oral and Maxillofacial Surgeons) classification - Change of pain sensation - Change in the oral health-related quality of life | — |
Countries
Germany
Contacts
Public ContactS. Dembelé
Klinik für Mund-, Kiefer- und Gesichtschirurgie
Outcome results
None listed