Medication-related osteonecrosis of the jaws (MRONJ) in osteoporosis patients Musculoskeletal Diseases
Conditions
Interventions
All patients are randomly divided into two groups, a test group and a control group, in a double-blind manner. The test group will receive the pharmacological preparation with pentoxifylline (600 mg x
Sponsors
Ospedale Generale Regionale Francesco Miulli
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Patients with osteoporosis and MRONJ stage I
Exclusion criteria
Exclusion criteria: 1. Cancer patients with metastatic bone disease 2. Other stages of MRONJ
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Mucosal healing measured clinically by visual inspection at 1 week, 2 weeks, 1 month, 2, 6, and 12 months after the intervention 2. Bone healing measured clinically and radiographically through cone beam computed tomography (CBCT) 6 and 12 months after the intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| The following secondary outcome measures will be observed yearly from 1 year up to 8 years: 1. Stability of mucosal and bone healing measured using clinical observation of the absence of inflammatory signs and maintenance of closure without bone exposure for mucosal healing, and radiographic assessment of healthy bone with normal structure, using cone beam computed tomography (CBCT) 2. Incidences of complications, such as abscess, mucosal fistula, and phlegmon, measured throughout all the study using clinical inspection and patient's reported complaints 3. Relapses occurring when mucosal healing has occurred, but bone healing does not occur, which can lead to two scenarios: 3.1. The mucosa reopens with exposure to underlying necrotic bone 3.2. The mucosa remains closed, but a small fistula is created where it is possible to probe the underlying unhealed necrotic bone measured using clinical and radiographic evaluation | — |
Countries
Italy
Outcome results
None listed