NCT07725107进行中（未招募）不适用
Efficacy of Topically Applied Oxygen-Based Therapy Versus Platelet-Rich Fibrin for Medication-Related Osteonecrosis of the Jaws: A Randomized Controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Complete mucosal healing (bone coverage)
研究概览
简要总结
A randomized clinical trial comparing Blue®m oral gel and autologous PRF membrane as adjuncts to surgical debridement in BRONJ/MRONJ patients.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Previous radiotherapy to head and neck
- •Uncontrolled systemic disease (e.g., uncontrolled diabetes)
- •Pregnancy or lactation
- •Known allergy to Blue®m components
- •Uncooperative patients.
结局指标
主要结局
Complete mucosal healing (bone coverage)
时间窗: 12 weeks post-intervention
Mucosal healing will be evaluated clinically by direct inspection of the surgical site.
次要结局
- 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)
研究者
研究点 (1)
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