跳至主要内容
临床试验/NCT07511296
NCT07511296已完成不适用

Perioperative Outcomes in Orthognathic Surgery With Clear Aligners Versus Conventional Brackets: A Retrospective Comparative Study

Centre Hospitalier Universitaire de Nice1 个研究点 分布在 1 个国家目标入组 420 人开始时间: 2020年1月1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
420
试验地点
1
主要终点
Composite perioperative occlusal management event

研究概览

简要总结

This retrospective single-center observational study compared perioperative and early postoperative outcomes in patients undergoing orthognathic surgery after orthodontic preparation with either conventional fixed brackets or clear aligners. The objective was to assess whether aligner-based preparation was associated with differences in intraoperative occlusal management, including fixation stability, technical difficulties, need for additional intraoperative adaptations, and early occlusal outcomes.

研究设计

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

入排标准

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

入选标准

  • Patients undergoing orthognathic surgery at the study center during the study period.
  • Orthodontic preparation with either conventional fixed brackets or clear aligners.
  • Age 16 years or older.
  • Available perioperative clinical records and required imaging data.

排除标准

  • Missing perioperative data required for the analysis.
  • Missing preoperative or postoperative imaging required for assessment.
  • Explicit opposition to the reuse of data, if applicable.
  • Syndromic conditions.
  • Cleft-related deformities.
  • Distraction osteogenesis.
  • Secondary surgery.
  • Follow-up < 6 months.

研究组 & 干预措施

Conventional brackets group

干预措施: Conventional fixed orthodontic appliances (Device)

Clear aligners group

干预措施: Clear aligner therapy (Device)

结局指标

主要结局

Composite perioperative occlusal management event

时间窗: From surgery to the immediate postoperative assessment

Number of composite perioperative occlusal management event for each patient

次要结局

  • Stable intermaxillary fixation(From begining to the end of the surgery)
  • Surgical revision after surgery(After surgery and the next 6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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