Comparing treatments for osteonecrosis of the jaw
A Multicenter Randomized Controlled Open-label Trial of Conservative Management Versus Minimally Invasive Treatment With Leukocyte- and Platelet-rich Fibrin Versus Primary Surgery in Patients With Newly Diagnosed Osteonecrosis of the Jaw
This study is testing whether a new, less invasive treatment for jaw problems caused by medication can help patients heal better and feel more comfortable compared to the usual care.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 125 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Antwerp Academic / other |
| Locations | 4 sites (Antwerp and 3 other locations) |
| Trial ID | NCT04512638 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of minimally invasive management with LPRF membranes and primary surgical treatment compared to standard conservative therapy in patients with newly diagnosed stage I-II medication-related osteonecrosis of the jaw (MRONJ). It is a pragmatic randomized controlled open-label multi-center study that aims to determine which approach leads to better mucosal healing and improved patient-reported outcomes. The study will measure the time to mucosal healing as the primary endpoint, along with secondary endpoints focusing on symptoms, quality of life, and overall well-being during treatment.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with a recent diagnosis of stage I-II MRONJ and a history of treatment with bone modifying agents.
Not a fit: Patients with stage III MRONJ or those who have received prior treatment for MRONJ may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved healing rates and better quality of life for patients suffering from MRONJ.
How similar studies have performed: Previous studies have shown promising results with minimally invasive surgical techniques for MRONJ, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: * \>18 years of age * Provision of signed informed consent * A history of at least one administration of, or an ongoing treatment with, a bone modifying agent in dose registered for the prevention of skeletal related events in bone metastatic disease or multiple myeloma * Diagnosis of stage I-II MRONJ according to AAOMS 2014 criteria not more than 8 weeks prior to the date of screening Exclusion criteria: * Any prior treatment for MRONJ other than local antiseptic rinses, systemic antibiotics, or analgesics * Prior radiotherapy to the head and neck region * Medical contraindication to receive any of the possible study treatments * Stage III MRONJ characterized by very extensive bone necrosis, pathological fracture, or fistulas to the skin or sinuses * Multiple MRONJ lesions that cannot be closed in a single surgical procedure
Where this trial is running
Antwerp and 3 other locations
- ZNA Middelheim — Antwerp, Belgium (Recruiting)
- Antwerp University Hospital — Edegem, Belgium (Recruiting)
- UZ Leuven — Leuven, Belgium (Recruiting)
- AZ Nikolaas — Sint Niklaas, Belgium (Recruiting)
Study contacts
- Principal investigator: Tim Van den Wyngaert, MD, PhD — University Hospital, Antwerp
- Study coordinator: Tim Van den Wyngaert, MD, PhD
- Email: tim.van.den.wyngaert@uza.be
- Phone: 003238213568
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.