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临床试验/NCT06233188
NCT06233188已完成不适用

Does the Patient-specific Depth of the Lateral Nasal Wall Osteotomy Affect the Pterygomaxillary Separation During le Fort I Down-fracture?

Bezmialem Vakif University2 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2023年5月3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
43
试验地点
2
主要终点
lateral nasal wall separation

研究概览

简要总结

The goal of this clinical trial is to show the effect of patient specific lateral nasal wall osteotomy to the pterygomaxillary separation during Le Fort I down-fracture.

Participants will be divided into two treatment groups. In study group, surgery planned according to the patients' indivudial anatomy and in the conventional group, surgery planned according to mean anatomical datas.

Researchers will compare patient specific lateral nasal wall osteotomy to see if it affects the pterygomaxillary junction seperation during le fort I downfracture.

详细描述

The same surgical team performed the osteotomies under general anesthesia with nasotracheal intubation. Hypotensive anesthesia was applied as a standard protocol in all patients. Orthognathic surgery, including Le Fort I and sagittal split ramus osteotomy, was used to correct skeletal deformities.

Bone osteotomy was initiated on the bilateral wall of the maxilla with piezosurgery after a mucosal incision and flap elevation.Lateral nasal osteotomy (LNO) with Nievert Anderson single guarded osteotome, median septum separation with double guarded U-shaped osteotome, and pterygomaxillary junction separation with curved osteotome were performed before the down-fracture. The only difference between the conventional and study groups was the depth of the LNO. In the study group, LNO was performed at a depth of 2 mm less than the measured distance in the axial section. In the conventional osteotomy group, LNO was performed at 30 mm for females and 35 mm for males, as suggested in the literature. A curved osteotome and a mallet were used in each case to separate the pterygomaxillary junction. The down-fracture of the maxilla was performed using a hook and a bone spreader in all patients. When the maxilla was down-fractured, LNW and the pterygomaxillary separation types were assessed intraoperatively. The maxilla was stabilized in its new position by four L-shaped osteosynthesis mini-plates at the zygomaticomaxillary buttress and the aperture piriformis regions.

研究设计

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

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

  • The inclusion criteria
  • orthognathic surgery to treat malocclusion
  • sleep apnea
  • jaw asymmetry

排除标准

  • cleft lip and palate
  • previous orthognathic surgery
  • rhinoplasty

结局指标

主要结局

lateral nasal wall separation

时间窗: 1 year

The primary outcome variable is lateral nasal wall separation: Type 1 Separation from the osteotomy line Type 2 Separation 2-4 mm above the osteotomy line Type 3 Separation 4 mm or more above the osteotomy line

次要结局

  • pterygomaxillary junction separation(1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Taha Pergel

Assistant Profesor

Bezmialem Vakif University

研究点 (2)

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