Comparison of 3D Titanium Miniplates Versus 3D Titanium Mesh Tray as a Method of Fixation for Double Barrel Vascularized Fibular Graft for Mandibular Reconstruction: Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- bone height changes for the double barrel vascularized fibular graft
研究概览
简要总结
The double barrel fibula flap presents many advantages such as adequate, constant geometry, proper dimensions for implant placement, double periosteal and medullary blood supply allowing multiple osteotomies, correct contouring, an adequate pedicle length and low donor site morbidity. Bone thickness, height and its bi-cortical structure seem to be ideal for long-term implant prosthetic rehabilitation. Fixation of double barrel fibula could be done using 3D titanium mini-plate which offers a low profile, less hardware and less chance to remove for later implant placement. Aim of the study is to compare the efficiency of fixation double barrel vascularized fibular graft for mandibular reconstruction using 3D miniplate versus 3D titanium mesh tray
详细描述
Aim of the study is to compare the efficiency of fixation double barrel vascularized fibular graft for mandibular reconstruction using 3D miniplate versus 3D titanium mesh tray
Hypothesis:
Null hypothesis: There is no difference in the clinical and radio graphical parameters between 3D miniplate fixation versus a 3D titanium mesh tray fixation of double barrel vascularized fibular graft.
If the results are significant (i.e. results are unlikely to be explained by chance alone), the null hypothesis is rejected.
Primary objective: to evaluate bone height changes for double barrel vascularized fibular graft after mandibular reconstruction.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient who require mandibular resection due to tumor, trauma, osteomyelitis or osteoradionecrosis.
- •Patient with Mandibular defect >6 centimeter (cm).
排除标准
- •• Patients with systemic condition counteracting with the surgical procedure.
- •Patients with conditions contraindicating fibular flap.
研究组 & 干预措施
3D titanium mesh tray
3D titanium mesh tray as a method of fixation for double-barrel vascularized fibula
干预措施: fixation of double barrel vascularised fibula (Other)
3D titanium miniplate
3D titanium miniplate as a method of fixation for double-barrel vascularized fibula
干预措施: fixation of double barrel vascularised fibula (Other)
结局指标
主要结局
bone height changes for the double barrel vascularized fibular graft
时间窗: 6 months
measure bone height changes for the double barrel vascularized fibular graft
次要结局
- volumetric bone changes for the double barrel vascularized fibular graft(6 months)
- monitoring viability of the double barrel free vascularized graft(2 weeks)
研究者
Hussam Ashraf Mahmoud Okba
PhD Candidate
Cairo University