Effect of Scheduled Autologous Platelet-rich Plasma Guided Injection in the Healing Process of Critical-sized Maxillary Bony Defects After Surgical Excision of Non- Malignant Lesions: A Prospective Randomized Clinical Trial.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Volume of the injected bony defect
研究概览
简要总结
Scheduled autologous platelet-rich plasma guided injection is done in critical-sized maxillary bony defects after surgical excision of non- malignant lesions.
详细描述
The study aims to detect the effect of scheduled autologous platelet-rich plasma- guided injection in the healing process of critical-sized maxillary bony defects after surgical removal of non-malignant lesions by using bone volumetric analysis and density measuring with cone beam computed tomography.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
No masking
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18-65 years (adults within a specific age range).
- •Diagnosis: Non-malignant maxillary bony defects (e.g., benign tumors or cysts).
- •Health: Generally healthy participants who can tolerate surgery.
- •Platelet Function: No platelet disorders or blood-related conditions.
- •Willingness: Informed consent and ability to follow the protocol.
- •No Use of Blood Thinners: No current use of anticoagulants like aspirin.
排除标准
- •Age: Children (under 18) and elderly (over 75).
- •Malignant Lesions: Participants with cancer or pre-cancerous conditions.
- •Systemic Illness: Severe conditions (e.g., uncontrolled diabetes, autoimmune disorders).
- •Platelet Disorders: Low platelet count or bleeding disorders (e.g., hemophilia).
- •Infections: Active infections or inflammatory conditions (e.g., periodontal disease).
- •Pregnancy: Women who are pregnant or breastfeeding.
- •Recent Surgery/Trauma: Recent maxillary surgery or trauma.
- •Uncontrolled Medications: Use of blood thinners, NSAIDs, or immunosuppressive drugs.
- •Non-compliance: Unwillingness or inability to follow-up with the protocol.
- •Substance Abuse: Active drug or alcohol abuse.
研究组 & 干预措施
Injection
Scheduled injection of autologous platelet-rich plasma
干预措施: Autologous platelet-rich plasma (Biological)
结局指标
主要结局
Volume of the injected bony defect
时间窗: after 3 months
the volume of the injected bony defect is measured by Cone beam computed tomography in millimeters cubic.
次要结局
- Bone density at the injected site(after 3 months)
研究者
Eman Abdel Salam Yousef
Associate professor
Horus University