Medication-related osteonecrosis of the jaw M87.18
Conditions
Interventions
Group 1: Surgical treatment of medication-related osteonecrosis of the jaw:
The basic treatment is equivalent to the therapeutic concept of the non-surgical treatement, but with the addition of a surg
(3) secure and sufficiently vascularized plastic coverage (optionally with the mylohyoid muscle or the Bichat’s fat pad)
(4) systemic intravenous antibiotic treatment to minimize the peri- and postoperative infection and the related decrease of the tissue’s pH-value
(5) change of diet type in a level scheme: oral liquid/ strained food or temporary bypassing of the oral passage of food by using gastric feeding tubes.
Group 2: Non-surgical treatment of medication-
(2) regular cleaning of the necrotic area with chlorhexidine-gluconate (0,2 %) containing mouth rinsing solution and topical gel to prevent bacterial colonization on the necrotic area
(3) oral antibiotic treatment (Unacid PD 375 mg 1-0-1 or alternatively Moxifloxacin 400 m
Sponsors
Klinik und Poliklinik für Mund-, Kiefer- & Gesichtschirurgie, Universitätsklinikum Heidelberg, Ärztlicher Direktor: Prof. Dr. Dr. Jürgen Hoffmann
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
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
Exclusion criteria: 1. Previous history of a radiation to the head neck region 2. Known metastasis of the jaw
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mucosal healing twelve weeks after beginning of intervention: Mucosal healing is evaluated clinically (visually and probing with special pariodontal probe). The assessment is based on a dichotomous nominal gradation (yes / no). | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) the mucosal integrity after treatment with/ without infection signs (reddening, swelling, pus) (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. (3) pain assessment by visual analogue scale (4) period till the resumption of oncological and/ or osteological antiresorptive therapy (5) period till prosthetic rehabilitation (6) radiologic signs for medication related osteonecrosis of the jaw All secondary endpoints (1-5) are aquired to the following measuring points: 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). | — |
Countries
Germany
Contacts
Public ContactOliver Ristow
Klinik und Poliklinik für Mund-, Kiefer- und Gesichtschirurgie
Outcome results
None listed