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临床试验/NCT06629935
NCT06629935已完成不适用

Assessment of How Different Instrument Modifications in Le Fort I Surgery Influence the Osteotomy of the Lateral Nasal Wall, With a Focus on the Level of Fractures and the Separation Pattern of the Pterygomaxillary Junction

Bezmialem Vakif University2 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2024年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
46
试验地点
2
主要终点
lateral nasal wall fracture type

研究概览

简要总结

The aim of this study is to investigate the effect of different instrument modifications on the customized osteotomy of the lateral nasal wall in Le Fort I surgery, focusing on the level of lateral nasal wall fractures and the separation pattern of the pterygomaxillary junction.

The primary hypothesis is blade osteotome is useful and facilitate the fracture line in ideal level both for lateral nasal wall and the pterygomaxillary junction.

详细描述

While there are numerous studies in the literature evaluating various parameters related to maxillary down-fracture in Le Fort I osteotomy, studies specifically focused on lateral nasal osteotomy are very rare. There is no study in the literature has addressed customized lateral nasal osteotomy using different instruments. In our study, the lateral nasal wall osteotomy will be performed 2 mm shorter than the measured descending palatine ater distance in the axial computer tomography plane. One group (n=23) will use the routinely employed Nievert osteotome (single guided osteotome), while the other group (n=23) will use a blade osteotome (no guided tip). This study aims to evaluate parameters such as the fracture pattern of the lateral nasal walls and the separation pattern of the pterygomaxillary junction by using different instrument modifications for lateral nasal wall osteotomy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients requiring Le Fort I or bimaxillary surgery
  • Patients who have not previously undergone Le Fort I or bimaxillary surgery (revision)
  • Patients without cleft lip or palate
  • Patients with no history of midface fractures or craniofacial trauma

排除标准

  • Patients with cleft lip and/or palate requiring orthognathic surgery
  • Patients with a history of trauma needing orthognathic surgery for malocclusion correction
  • Patients who have previously undergone orthognathic surgery and require revision surgery

结局指标

主要结局

lateral nasal wall fracture type

时间窗: 6 months

Class 1: Fracture at the osteotomy line Class 2: Fracture 2-4 mm above the osteotomy line Class 3: Fracture more than 4 mm above the osteotomy line

次要结局

  • pterygomaxillary junction fracture type(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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