Bisphosphonate Related Osteonecrosis of the Jaws (BRONJ), Oxygen, Topical Administration, Wound Healing
Conditions
Keywords
BRONJ, MRONJ, blue®m, Oxygen-based therapy, Osteonecrosis of the jaw, Wound healing, Oral mucosal healing, Randomized clinical trial
Brief summary
A randomized clinical trial comparing Blue®m oral gel and autologous PRF membrane as adjuncts to surgical debridement in BRONJ/MRONJ patients.
Detailed description
Thirty-six BRONJ/MRONJ patients will be randomly allocated to receive either Blue®m oral gel or PRF membrane following surgical debridement, and healing outcomes will be evaluated clinically.
Interventions
PROCEDURETopical Blue®m application
Intraoperative application of Blue®m oral gel to the debrided surgical site before primary closure
PROCEDUREPRF membrane placement
Intraoperative placement of an autologous PRF membrane over the debrided surgical site before flap closure.
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete mucosal healing (bone coverage) | 12 weeks post-intervention | Mucosal healing will be evaluated clinically by direct inspection of the surgical site. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Soft-Tissue Healing | - One week after intervention - 2 weeks after intervention - 4 weeks after intervention - 12 weeks after intervention | Soft tissue healing will be assessed using the Landry Healing Index, measured on a 5-point scale. |
| Postoperative pain | - 1 week postoperatively - 4 weeks postoperatively | Pain assessment will be evaluated using the Numeric Rating Scale (NRS), measured on a 0-10 scale. |
| Hard Tissue | - Preoperatively - 12 weeks postoperative | Bone density will be measured using CBCT at buccal, palatal, and apical aspects at coronal, middle, and apical levels, and the average value will be recorded. |
Countries
Egypt
Outcome results
None listed