Assessment of Mandibular CAD/CAM Angle Fracture Reduction/Plate Guide and Customized 3D Grid Plate Versus Champy's Technique (A Randomized Controlled Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Guide accuracy in repositioning of the fractured segments and in comparison to the preoperative 3D virtual surgical plan.
研究概览
简要总结
This proposed study aims at creating a computer designed patient specific device and titanium plates, that are 3D manufactured in accordance to a preoperative computer aided virtual surgical procedure, aiming to obtain proper alignment of fractured segments of the lower jaw and restore proper teeth positioning therefore overcoming the possible complications of the conventional methods.
Recruited participants will be randomly allocated to a treatment groupp, whether the novel method group or a standard treatment group.
Preoperative panoramic radiograph and a Computed tomography scan will be obtained for each patient.
Surgical procedure will be conducted unde general anesthetic. Medications will be prescribed after surgery and instructions will be given to each patient.
Follow up will be on a weekly basis for the first 6 weeks followed by a followup visit once a month for 6 months.
Postoperative panoramic radiograph and a Computed tomography scan will be obtained at 1 week after the surgical procrdure and again 6 months later.
Digital data obtained from computed tomography scans along with clinical data will be analysed and studied to determine the accuracy of the computer aided device and for comparison with the standard method of treatment.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with unilateral mandibular angle fracture with or without associated mandibular fractures in need of open reduction and internal fixation.
- •Patients above 18 years old
- •Sufficient dentition to reproduce the occlusal relationships
- •Patient's consent to participate
排除标准
- •Patients with comminuted mandibular angle fracture(s)
- •Patients with any systemic disease that may affect normal healing
- •Patients undergoing chemotherapy or radiotherapy related to the head and neck region
- •Intra-bony lesions in the fracture area that may interfere with proper anatomical reduction.
研究组 & 干预措施
Custom made reduction guides and 3D grid plates
Mandibular angle fracture reduction and fixation using digitally designed and fabricated patient specific fracture reduction/plate positioning guide and customized 3D grid plate
干预措施: CAD/CAM patient specfifc fracture reduction/plate guide and customized 3D grid plate (Procedure)
Stock titanium plates
Mandibular angle fracture reduction and fixation using a single superior border 2.0 miniplate
干预措施: Champy's techqniue (Procedure)
结局指标
主要结局
Guide accuracy in repositioning of the fractured segments and in comparison to the preoperative 3D virtual surgical plan.
时间窗: Outcome will be assessed with preoperative CT (T1-Week 1)immediate postoperative CT at (T3-Week 3)
Accuracy of postoperative reduction by superimposition of 3D CT data on a 3D specialized software
次要结局
- Postoperative occlusion(Outcome will be assessed clinically at T2 (Week 2) and T3 (Week 3))
研究者
Arwa Louay Ali Hosni
Principal investigator
Cairo University