The Impact of Using Extracorporeal Radial Shock Wave Therapy as an Adjuvant Therapy vs Conventional Open Reduction and Internal Fixation With No Adjuvant Therapy on Bone Healing for Patients With Mandibular Parasymphyseal, Body and Angle Fractures
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- bone healing (denisty of bone)
研究概览
简要总结
studying if using extracorporeal radial shockwave therapy as an adjuvant therapy help in accelerating the bone healing and regeneration in mandibular fractures by comparing it with the standard protocol for fractures fixation by plates and screws.
详细描述
Firstly the patient heads to the operating room being placed in a supine position, generally anesthetized by the anesthesiologist.
Sterilization of intraoral and extraoral sites and draping has been installed. Intermaxillary fixation (IMF) screws has been inserted in case of there is no arch bar is used.
If the arch bar has been used it was inserted before the operation and being cut at the fracture line between the two segments.
The transoral or extra-oral approach is utilized to expose the fracture line separating the two segments.
Fixation of the bony segments with two plates one Compression 2.3 plate at the inferior border and Tension 2.0 plate five millimeter superiorly to the compression plate.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1 - Patients with age ranges from 18-75 years old. 2- Patients with fresh mandibular fractures (from zero hour till four or five days).
- •3- Patients free of systemic conditions that might affect or interfere with the healing process of bone segments or rather interfere with carrying out the surgical procedure (thyroid condition, rheumatoid arthritis, uncontrolled diabetes and osteoporosis).
排除标准
- •1 - Patients out of the specified range group 2- Patients who went previous operations with infection or malunion. 3- Patients with thyroid condition which affects the serum calcium level. 4- Patients with systemic conditions that might affect the bone health (osteoarthritis, rheumatoid arthritis, uncontrolled diabetes). 5- Patients with heart peacemakers.
结局指标
主要结局
bone healing (denisty of bone)
时间窗: first and fourth month
radiographically we will analyze the bone denisty at the fracture site
次要结局
- pain sensation(immediately after the intervention and 3 days after)
研究者
Khloud Ahmed Mohamed
Khloud Ahmed Mohamed Hussien
Cairo University