跳至主要内容
临床试验/NCT07365657
NCT07365657尚未招募不适用

Subject-specific Finite Element Modelling of Le Fort I Osteotomy Fixation : Patient-specific Implants vs Miniplates

Centre Hospitalier Universitaire de Nice1 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2026年1月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
2
试验地点
1
主要终点
Plate stress levels

研究概览

简要总结

This study aimed to evaluate the biomechanical performance of patient-specific versus conventional fixation for Le Fort I osteotomy using subject-specific finite element models derived from real surgical plans. Two distinct clinical scenarios-a minor advancement without impaction and a moderate advancement with posterior impaction-were analyzed to determine how surgical movements influence implant stress, bone stress, and maxillary micromotion. By combining surgical planning with validated computational modeling, this work provides clinically relevant insight to optimize PSI design and guide fixation strategy selection in orthognathic surgery.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Retrospective

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

  • Patient operated on By Pr SAVOLDELLI.
  • Patient undergoing patient-specific orthognathic surgery.
  • Access to numerical (digital) planning.

排除标准

  • Previous maxillo-facial trauma.
  • Facial cleft.

研究组 & 干预措施

Type II maloclusion

2 patients : one with type II maloclusion, one with type III maloclusion who previously undergone orthognathic surgery

干预措施: In silico orthognathic surgery with customized implants digital only on 3D scanners (Other)

Type III maloclusion

2 patients : one with type II maloclusion, one with type III maloclusion who previously undergone orthognathic surgery

干预措施: In silico orthognathic surgery with customized implants digital only on 3D scanners (Other)

结局指标

主要结局

Plate stress levels

时间窗: At the inclusion

assessed by FORGE software

次要结局

  • Stress on bone(At the inclusion)
  • Maxillary displacement(At the inclusion)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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