跳至主要内容
临床试验/NCT07306962
NCT07306962招募中不适用

Does Computer-assist Virtual Lesion Segmentation Ushers to a Change in the Literature Consensus Regarding Mandibular Ameloblastoma Radiographic Safety Margin?. A Clinical Case Series

Alexandria University2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2025年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
10
试验地点
2
主要终点
Histological analysis and degree of lesion invasion determination

研究概览

简要总结

Reconstruction of segmental mandibular defects is in a continuous state of evolution utilizing the recent advances in Computer-Aided Designing (CAD) and preoperative Virtual Surgical Planning (VSP). The anterior iliac crest is one of the ideal reservoirs for autogenous harvesting of a bi-cortical bone block with 1:1 cortical to cancellous bone ratio which is optimal for rapid and predictable consolidation. The aim of this study is the utility of VSP guided by CT and confirmation by histopathological analysis in achieving negative margins and preventing recurrence of mandibular ameloblastoma.

详细描述

A total of 10 patients having segmental mandibular defects will be selected. All defects will be reconstructed using anterior iliac crest in utilizing preoperative virtual surgical planning and intraoperative resection and reconstruction guides. The resected mandible will be evaluated by radiographic three-dimensional that will be performed to determine the accuracy of the VSP guided by CT, along with histopathological analysis.

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

性别
All
接受健康志愿者

入选标准

  • Patients with histologically confirmed ameloblastoma using a preoperative biopsy.
  • Patients with ameloblastoma that require segmental mandibular continuity defect, not involving the condyle.

排除标准

  • Patients with lateral segmental mandibular defect involving the condyle.
  • Patients with an active infection at the site of resection.
  • Patients with recurrent lesion after resection.

结局指标

主要结局

Histological analysis and degree of lesion invasion determination

时间窗: 1 month

The specimen with the the mounted Safety Margin Calibration Guide will be sent for histological evaluation. For light microscopic examination, the specimens will be embedded in paraffin wax blocks after being fixed in 10% formalin, neutrally buffered, cleaned, and dehydrated using increasing ethanol concentrations. Tissue sections will be cut to a thickness of 4 μm, and stained with hematoxylin and eosin to be examined under a light microscope. The specimen will be cut, using the S35 (0.254-mm thickness) microtome blade, at the preoperatively determined margins according to the virtual lesion segmentation from the proximal and distal sides of the lesion. Since the study is limited to segmental mandibular resection, the full lower border of the mandible was resected and their will be no need for assessment of either coronal or apical margins

次要结局

  • Postoperative resection margin accuracy analysis(1 week)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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