Accuracy of Computer Guided Screw Holes Locating Guide and Patient Specific Champy Plate vs Conventional Champy Plate Osteosynthesis in Management of Mandibular Angle Fracture: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Accuracy of computer guided screw holes locating guide and Patient Specific Champy plate in management of mandibular angle fracture
研究概览
简要总结
the aim of our study is to assess computer guided mandibular fracture reduction and to prove its lower rate of complications and higher accuracy of reduction compared to the conventional approach in management of mandibular angle fracture.
详细描述
This study will be conducted on 10 patients For each group selected from the Outpatient Clinic of the Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Cairo University. Patients included in the study will have mandibular angle fracture indicated for open reduction and internal fixation. Patients with any systemic disease that could affect bone healing will be excluded from the study.
After accepting to be enrolled in this study, all patients will be subjected to:
I. Preoperative Assessment:
A thorough preoperative assessment of all patients will be carried out, including:
- Dental and Medical history:
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
- 16 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with isolated mandibular angle fracture needs open reduction and internal fixation.
- •Patients with medical history that did not hinder plate placement and adequate proper oral hygiene.
- •Both genders males and females will be included.
排除标准
- •General contraindications to surgery. .
- •Patients with comminuted fractures.
- •Subjected to irradiation in the head and neck area less than 1 year before fixation.
- •Untreated periodontitis.
- •Poor oral hygiene and motivation.
- •Uncontrolled diabetes.
- •Pregnant or nursing.
- •Substance abuse.
- •Psychiatric problems or unrealistic expectations.
- •Severe bruxism or clenching.
- •Immunosuppressed or immunocompromised.
- •Treated or under treatment with intravenous amino-bisphosphonates.
- •Patients participating in other studies, if the present protocol could not be properly followed.
研究组 & 干预措施
computer guided screw holes locating guide and Patient Specific Champy plate osteosynthesis
the operation will under general anesthesia with nasal intubation and oral pack, Injection of 20 cc saline adrenaline 1:00000 to 0 in the sulcus for hemostasis, Vestibular mucosal incision, Reflect the flap to visualize the broken segments.
Full thickness mucoperiosteal flaps were then carefully raised to expose enough underlying alveolar bone to accommodate the screw holes locating guide and the custom-made Champy plate.
In Group I, Put the specific screw holes locating device in place and drill the screw holes, remove the screw holes locating device and mobilize the segments then apply the custom-made Champy plate and fix it with screw for passive reduction of the segments. Then suture the mucosa.
干预措施: computer guided screw holes locating guide and Patient Specific Champy plate (Device)
conventional Champy plate osteosynthesis in management of mandibular angle fracture
the operation will under general anesthesia with nasal intubation and oral pack, Injection of 20 cc saline adrenaline 1:00000 to 0 in the sulcus for hemostasis, Vestibular mucosal incision, Reflect the flap to visualize the broken segments.
Full thickness mucoperiosteal flaps were then carefully raised to expose enough underlying alveolar bone then mobilize the broken segment, Arch bar was made to achieve proper occlusion put the Champy 2.0 plate on the ventral surface of the external oblique of the mandible and remove it for further bending using plate pliers for further accommodation of the plate then fix it in place using mono cortical screws.
干预措施: standard Champy mini plate (Device)
结局指标
主要结局
Accuracy of computer guided screw holes locating guide and Patient Specific Champy plate in management of mandibular angle fracture
时间窗: 3 months
calculate any amount for segments deviation from the virtual plan in mms.
次要结局
未报告次要终点
研究者
ahmed abd ellati tag eldin ahmed
general practioner dentist
Cairo University