on-interventional observational study on the use of autologous platelet-rich fibrin membranes in the therapy of antiresorbiva-associated necrosis of the jaw

• Conditions: K10.2; Inflammatory conditions of jaws

• Registration Number: DRKS00019938
• Lead Sponsor: niversitätsklinikum Schleswig-Holstein (UKSH)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-14
• Study Completion: 2021-08-18
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 52

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

- 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

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
- Clinical downstaging based on the AAOMS (American Association of Oral and Maxillofacial Surgeons) classification<br>- Change of pain sensation<br>- Change in the oral health-related quality of life