Treatment strategies for Medication-related osteonecrosis of the jaw - a prospective, partially randomized patient preference trial

Not Applicable

Conditions: Medication-related osteonecrosis of the jaw
M87.18

Registration Number: DRKS00012888

Lead Sponsor: Klinik und Poliklinik für Mund-, Kiefer- & Gesichtschirurgie, Universitätsklinikum Heidelberg, Ärztlicher Direktor: Prof. Dr. Dr. Jürgen Hoffmann

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 90

Inclusion Criteria

Patients with not infected medication-related osteonecrosis of the jaw (stadium I corresponding to AAOMS classification) who receiced or are receiving antiresorptive therapy (bisphosphonates or RANKL antibody) and who are planned for treatment at Clinic for craniofacial surgery of University hospital Heidelberg

Exclusion Criteria

1. Previous history of a radiation to the head neck region 2. Known metastasis of the jaw

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mucosal healing twelve weeks after beginning of intervention:<br>Mucosal healing is evaluated clinically (visually and probing with special pariodontal probe).<br>The assessment is based on a dichotomous nominal gradation (yes / no).<br>

Secondary Outcome Measures

Name	Time	Method
(1) the mucosal integrity after treatment with/ without infection signs (reddening, swelling, pus)<br>(2) participant health related qulity of life, measured by EORTC QLQ-C30 and supplemented by disease-specific modules for Bone metastases as well as OHIP-G 14 questionnaire for oral health related quality of life at the time of therapy decision and in the course.<br>(3) pain assessment by visual analogue scale<br>(4) period till the resumption of oncological and/ or osteological antiresorptive therapy<br>(5) period till prosthetic rehabilitation<br>(6) radiologic signs for medication related osteonecrosis of the jaw<br>All secondary endpoints (1-5) are aquired to the following measuring points:<br>10-14 days (T1), 30 days (T2), 8 weeks (T3), 3 months (T4), 6 months (T5), 1 year (T6) after the beginning of the intervention (surgical treatment)/ after therapy decision (non-surgical treatment).