Patient Specific 3d Titanium Plate Versus Standard Two Mini Plates in the Fixation of Mandibular Angle Fractures (a Randomized Controlled Clinical Trial)
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Radiographic evaluation for the assessment of mean bone density at the fracture line
研究概览
简要总结
To compare the effectiveness of custom-made (3D) titanium plates to standard two titanium mini plates in fixation of mandibular angle fracture.
详细描述
Eighteen patients with mandibular angle fractures will be selected. In nine fractures, custom-made three dimensional titanium plates will be used for fracture fixation (study group); while in the other nine, conventional two mini plates will be used (control group),via intra oral approach (combined with transbuccal approach) for both groups. Patients will be evaluated clinically, and radiographically (immediate and four months post operative) to evaluate the bone density at the fracture line.
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 (Participant)
盲法说明
Participants complying with the inclusion criteria will be randomly assigned using a computer-generated list of random numbers to one of the two arms. Allocation will be performed by a trial independent individual and the allocation ratio is intended to be equal. Allocation will be in equal blocks to ensure that the study groups have equal number of participants.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients suffering from mandibular angle fracture indicated for open reduction and fixation.
- •Non infected mandibular angle fractures present less than two weeks.
- •Good oral hygiene.
排除标准
- •Medically compromised patients contradicting operation (ASA III, IV & V).
- •Patients receiving radiotherapy or chemotherapy. 3- Bone diseases (Osteoporosis, Osteopetrosis, Osteomalacia…etc.) 4- Pathological fracture. 5- Old untreated fracture.
研究组 & 干预措施
patients with recent mandibular angle fractures managed with custom-made 3D titanium plates
patients that will undergo internal fixation with custom-made 3D titanium plates through intaoral and transbuccal approach .
干预措施: custom-made 3D titanium plates (Device)
patients with recent mandibular angle fractures managed with standared two mini plates
patient that will undergo internal fixation with standared two mini plates through intaoral and transbuccal approach.
干预措施: standared two mini plates (Device)
结局指标
主要结局
Radiographic evaluation for the assessment of mean bone density at the fracture line
时间窗: 4 months
Mean bone density at the fracture line was assessed using Computed Tomography (CT) scan in Hounsfield Units (HU)
次要结局
- Post operative pain(3 months)