A pharmacological protocol for the management of medication-related osteonecrosis of the jaws: A randomized study
Not Applicable
Completed
- Conditions
- Medication-related osteonecrosis of the jaws (MRONJ) in osteoporosis patientsMusculoskeletal Diseases
- Registration Number
- ISRCTN18375975
- Lead Sponsor
- Ospedale Generale Regionale Francesco Miulli
- Brief Summary
2023 Results article in https://doi.org/10.3390/jcm12144662 (added 06/08/2024)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 202
Inclusion Criteria
Patients with osteoporosis and MRONJ stage I
Exclusion Criteria
1. Cancer patients with metastatic bone disease
2. Other stages of MRONJ
Study & Design
- Study Type
- Other
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Mucosal healing measured clinically by visual inspection at 1 week, 2 weeks, 1 month, 2, 6, and 12 months after the intervention<br>2. Bone healing measured clinically and radiographically through cone beam computed tomography (CBCT) 6 and 12 months after the intervention
- Secondary Outcome Measures
Name Time Method The following secondary outcome measures will be observed yearly from 1 year up to 8 years:<br>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)<br>2. Incidences of complications, such as abscess, mucosal fistula, and phlegmon, measured throughout all the study using clinical inspection and patient's reported complaints<br>3. Relapses occurring when mucosal healing has occurred, but bone healing does not occur, which can lead to two scenarios:<br>3.1. The mucosa reopens with exposure to underlying necrotic bone<br>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<br>