Accuracy Of Mandibular Reconstruction Using Fibula Free Flaps With Patient Specific Plates And Immediate Dental Implants In Fresh Versus Delayed Cases A Non Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Accuracy of the fibular segments and dental implants
研究概览
简要总结
The goal of this clinical trial is to learn if mandibular reconstruction with immediate dental implants is as accurate in fresh cases and delayed cases
The accuracy of the fibular segments and dental implants will be compared in both groups
Participants will:
undergo a preoperative CT scan with VSP for mandibular reconstruction Undergo the surgical procedure Undergo an immediate postoperative CT scan and have it superimposed on the virtual plan to detect inaccuracies
详细描述
The goal of this clinical trial is to learn if mandibular reconstruction with immediate dental implants is as accurate in fresh cases and delayed cases
The accuracy of the fibular segments and dental implants will be compared in both groups
Participants will:
undergo a preoperative CT scan with VSP for mandibular reconstruction Undergo the surgical procedure Undergo an immediate postoperative CT scan and have it superimposed on the virtual plan to detect inaccuracies
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •for participants:
- •Adult patients with conditions requiring mandibular reconstruction using fibula free flaps.
- •Adult patients diagnosed with neoplastic conditions requiring resection and agreed to immediate reconstruction
- •Adult patients with segmental mandibular defects resulting from previous pathology, trauma, infectious conditions
- •Patients willing for the surgical procedure and follow-up, with an informed consent.
排除标准
- •for participants:
- •Patients with significant medical diseases and comorbidities preventing them undergoing lengthy procedures under general anesthesia
- •Patients with Peripheral Vascular Disease
- •Patient with known allergy to contrast media in whom a CTA of the lower limbs will not be possible
- •Patients with Peronea Magna where the peroneal artery is the main blood supply of the lower limbs and its harvesting might result in compromise of the leg vascularity
- •Patients with no desire for surgical correction
- •Patients with any diseases that compromise bone or soft tissue healing. Patients with local pathosis that interfere with the bone healing.
研究组 & 干预措施
Fresh cases
Cases needing mandibular resection and reconstruction with no prior intervention history
干预措施: fibula free flap (Procedure)
Delayed cases
Cases needing mandibular reconstruction with history of prior intervention in the form of resection and/or hardware placement
干预措施: fibula free flap (Procedure)
结局指标
主要结局
Accuracy of the fibular segments and dental implants
时间窗: From enrollment "VSP" till the immediate postoperative CT, Throughout the completion of the study, for an average of 1 year
Accuracy of the fibular segments and dental implants in patients compared to the Virtual Surgical plan, Measured in degrees and millimeters
次要结局
未报告次要终点
研究者
Shady Medhat Sabet Shaker
Doctor
Cairo University