NCT07725107Active, not recruitingNot Applicable
Efficacy of Topically Applied Oxygen-Based Therapy Versus Platelet-Rich Fibrin for Medication-Related Osteonecrosis of the Jaws: A Randomized Controlled Trial
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Mansoura University
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Complete mucosal healing (bone coverage)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts 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.
Outcomes
Primary Outcomes
Complete mucosal healing (bone coverage)
Time Frame: 12 weeks post-intervention
Mucosal healing will be evaluated clinically by direct inspection of the surgical site.
Secondary Outcomes
- Soft-Tissue Healing(- One week after intervention - 2 weeks after intervention - 4 weeks after intervention - 12 weeks after intervention)
- Postoperative pain(- 1 week postoperatively - 4 weeks postoperatively)
- Hard Tissue(- Preoperatively - 12 weeks postoperative)
Investigators
Study Sites (1)
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