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临床试验/NCT07551154
NCT07551154已完成不适用

Effectiveness Of Virtual Surgical Planning of Mandibular Reconstruction Using Custom Made Plate and Split Rib Bundle Bone Graft

Alexandria University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年1月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Wound healing

研究概览

简要总结

In mandibular reconstruction, computer-assisted procedures, including virtual surgical planning (VSP) and Custom-made implants, have become an integral part of routine clinical practice. Especially complex cases with extensive defects after ablative tumor surgery benefit from a computer-assisted approach. Various CAD/ CAM-manufactured tools such as surgical guides (guides for osteotomy, resection and predrilling) support the transition from virtual planning to surgery. Custom made implants are of particular value as they facilitate both osteosynthesis and the positioning of bone elements. Computer-based approaches may be associated with higher accuracy, efficiency, and superior patient outcomes. However, certain limitations should be considered, such as additional costs or restricted availability. In the future, automation of the planning process and augmented reality techniques, as well as MRI as a nonionizing imaging modality, have the potential to further improve the digital workflow.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Benign mandibular tumors planned to be managed by segmental mandibulectomy.
  • Adequate soft tissue coverage after mandibular resection.

排除标准

  • Patients not suitable for general anesthesia because of severe systemic medical problems,
  • Soft Tissue deficiency after resection, which are better treated by free osseo-cutaneous flaps.
  • Planning to have postoperative radiotherapy or with history of head and neck radiotherapy.
  • Obvious preoperative infections at the site of surgical resection.
  • Recurrent lesions where wider resection will necessitate free composite flap reconstruction

研究组 & 干预措施

benign mandibular tumors planned to be managed by segmental mandibulectomy

Experimental

干预措施: ustom made plate and split rib bundle bone graft using virtual surgical planning (Procedure)

结局指标

主要结局

Wound healing

时间窗: 2 weeks

patients will be scored yes if healed and no for not healed wounds

次要结局

  • Aesthetic deformity(4 weeks)
  • Patient satisfaction(3 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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