Bisphosphonate Related Osteonecrosis of the Jaws (BRONJ)OxygenTopical AdministrationWound Healing
Investigational drug(s) / intervention(s)
Topical Blue®m applicationPRF membrane placement
Topical Blue®m application: Intraoperative application of Blue®m oral gel to the debrided surgical site before primary closure
PRF membrane placement: Intraoperative placement of an autologous PRF membrane over the debrided surgical site before flap closure.
Study summary
A randomized clinical trial comparing Blue®m oral gel and autologous PRF membrane as adjuncts to surgical debridement in BRONJ/MRONJ patients.
Eligibility
Sex
ALL
Min age
18 Years
Max age
60 Years
Healthy volunteers
No
Inclusion Criteria:
* Patient Age: ≥18 years.
* Patients diagnosed with BRONJ/MRONJ Stage 1-3 (AAOMS criteria).(25)
* History of antiresorptive or antiangiogenic drug use.
* Patients willing to participate in the study's follow-up intervals and to provide informed consent.
Exclusion Criteria:
* Previous radiotherapy to head and neck
* Uncontrolled systemic disease (e.g., uncontrolled diabetes)
* Pregnancy or lactation
* Known allergy to Blue®m components
* Uncooperative patients.
Primary outcome measure(s)
Complete mucosal healing (bone coverage) — 12 weeks post-intervention Mucosal healing will be evaluated clinically by direct inspection of the surgical site.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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