Clinical Efficacy of Platelet-Rich Fibrin in Osseous Regeneration After Cystic Enucleation
概览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Radiographic bone regeneration in cystic defects following enucleation
概览
简要总结
This randomized controlled clinical trial aims to evaluate the clinical efficacy of autologous platelet-rich fibrin (PRF) in promoting osseous regeneration following cystic enucleation in the jaws. The study will assess bone healing outcomes and compare PRF application with conventional management methods.
详细描述
This study is designed as a randomized controlled clinical trial to evaluate the effectiveness of autologous platelet-rich fibrin (PRF) in enhancing bone regeneration after cystic enucleation in the jaws.
PRF is an autologous biomaterial rich in growth factors that may enhance bone healing and tissue regeneration. Participants undergoing cystic enucleation will be randomly assigned to either a PRF-treated group or a control group receiving conventional treatment without PRF.
Clinical and radiographic assessments will be performed to evaluate bone regeneration, healing rate, and postoperative outcomes. If PRF demonstrates significant improvement in osseous regeneration, it may represent a minimally invasive and cost-effective alternative to traditional bone grafting procedures.
Ethical approval will be obtained from the Ethical Committee of the Faculty of Medicine and Health Sciences, Sana'a University, Yemen.
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
- None
盲法说明
This is an open-label study. Participants, care providers, and investigators are aware of the assigned intervention (PRF or control). No masking is used.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with odontogenic cysts requiring surgical enucleation.
- •Presence of a postoperative osseous defect in the jaws after cyst enucleation.
- •Age ≥ 18 years.
- •Systemically healthy patients (ASA I or II).
- •Patients willing to participate and sign informed consent.
排除标准
- •Patients with systemic diseases affecting bone healing (e.g., uncontrolled diabetes, osteoporosis).
- •Patients receiving bisphosphonates or long-term corticosteroid therapy.
- •Smokers (\>10 cigarettes/day).
- •Pregnant or lactating women.
- •Patients with acute infection at the surgical site.
- •Patients unwilling to participate or unable to attend follow-up visits.
研究组 & 干预措施
PRF Group
Participants undergoing cystic enucleation in the jaws will receive autologous Platelet-Rich Fibrin (PRF) placed into the osseous defect immediately after surgical enucleation.
干预措施: Autologous Platelet-Rich Fibrin (PRF) (Biological)
Control Group
Participants undergoing cystic enucleation of jaw cysts will receive conventional surgical management without the application of platelet-rich fibrin (PRF). The osseous defect will be left to heal naturally following standard enucleation and wound closure procedures.
干预措施: Conventional Surgical Management (Procedure)
结局指标
主要结局
Radiographic bone regeneration in cystic defects following enucleation
时间窗: 6 months after surgery
The amount of bone regeneration will be evaluated radiographically using CBCT imaging to measure the percentage of defect fill and bone density changes at 6 months postoperatively.
次要结局
未报告次要终点
研究者
Lamees Fozi Alareeki
Master's Degree Candidate, Faculty of Dentistry, Sana'a University
Sana'a University