The Use of 3d Titanium Plates With Two Different Profile Thickness for Open Reduction and Rigid Fixation of Mandibular Body Fracture : Randomised Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Treatment of Postoperative pain
研究概览
简要总结
Mandibular body fracture pose significant challenges in maxillofacial surgery due to their frequency, potential for functional impairment, and aesthetic concerns. Open reduction and internal fixation (ORIF) using titanium plates and screws have revolutionized the management of mandibular fractures.
Recent advancements in technology have led to the development of patient-specific 3D titanium implants, offering the potential for improved anatomical fit and stability. Moreover, the concept of low-profile implants has gained traction, aiming to minimize soft tissue irritation and enhance patient comfort postoperatively.
详细描述
Facial trauma is common in road traffic accidents (RTA). Due to modernization, increased number of vehicles and failure to follow traffic rules are among various causes of facial trauma. Mandible is one of the frequently fractured bones in RTA. It has been observed that the most common sites of mandibular fracture are angle, body, and ramus.
The incidence of mandibular fracture ranges between 40% and 65% of all facial fractures and so are twice as common as fractures of the midfacial bones. Fractures of the angle of mandible can present with long term disabling sequelae and make up 23%-42% of all fractures in the mandible.
Other than traumatic injuries of the face, there are several factors leading to mandibular body fracture as direct impact or blunt force trauma, indirect trauma to the chin or side of the face, facial fractures, osteoporosis, tumors or cysts in the jawbone, some dental procedures, elderly population, and occupational hazards.
Long term sequel of untreated or poorly treated fractures includes various impairments such as functional, aesthetic, neurological and psychological. The main goal in the treatment of bone fracture is to predictably restore its preinjury anatomical form, with associated aesthetics and function. Techniques for treatment of mandibular fracture have evolved significantly in past decades. These techniques have ranged from closed reduction with maxillomandibular fixation, open reduction with wire osteosynthesis, to open reduction with either rigid internal fixation or adaptive miniplate fixation.
They are best managed by placing one single plate in neutral zone that is sub-apically along with arch bar as tension band. However, in case of severely displaced fractures, inadequate dentition or presence of associated fractures, there are changes in biomechanical vector of forces, which demands for rigid fixation like two plates or load-bearing fixation.
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
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ranging between 20-60 years.
- •Patients with mandibular body fractures requiring open reduction and fixation.
- •Patients with good health (ASA-I and ASA-II) without any contraindication for surgery or anesthesia.
排除标准
- •Patients with pre-existing neurological or musculoskeletal disease.
- •Patients with infected fractures.
- •Patients with simultaneous condylar fracture.
- •Patients with regional malignancy.
- •Medically compromised patients.
- •Patients with blood diseases or severe renal disorders. Patients refuse to share in the study
研究组 & 干预措施
Group A (3d titanium plates of 2 mm):
About 9 patients suffered from mandibular fracture treated by using 3d titanium plates of 2 mm thickness.
干预措施: 3D Titanium Plates (Device)
Group B (3d titanium plates of 0.7 mm):
About 9 patients suffered from mandibular fracture treated by using 3d titanium plates of 0.7 mm thickness.
干预措施: 3D Titanium Plates (Device)
结局指标
主要结局
Treatment of Postoperative pain
时间窗: 48 Hours from the operation
Treatment of the pain resulted from using 3d titanium plates with two different profile thickness for open reduction and fixation of mandibular body fracture by using a standardized pain scale.
次要结局
- Incidence of postoperative Complications(from1 week to 6 months)
研究者
haitham Aldebass
Resident of Oral and maxillofacial Surgery
Cairo University