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临床试验/NCT06235138
NCT06235138已完成不适用

Jawline Improvement Using Patient-specific Angle Implants With Virtual Planning in Orthognathic Surgery

Centre Hospitalier Universitaire de Nice2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2017年5月15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
20
试验地点
2
主要终点
Secondary outcome of interest is patients satisfaction

研究概览

简要总结

Background: Jawline improvement is nowadays a strong patients' demand. Among patients undergoing orthognathic surgery, it remains sometimes a challenge to manage angle definition due to the classic mandibular osteotomy trait which mostly allows sagittal mandibular movements but can't modify the ramus height. A few types of osteotomies can be used to improve jawline's shape while correcting malocclusion, but they remain technically difficult and often imply the necessity for bone grafting and/or the use of a specific saw and screwdriver. The advent of computer-assisted surgical planning and computer-aided design/ computer-aided manufacturing (CAD-CAM) techniques for patient-specific implant (PSI) fabrication has enabled new methods for managing the jawline in orthognathic surgery. The aim of this study was to assess jawline improvement with patient-specific angle implants in patients undergoing orthognathic surgery with standard osteotomies.Methods: A virtual simulation of a Le Fort I osteotomy (if needed), a sagittal split ramus osteotomy with patient-specific titanium angle implants, and a genioplasty (if needed) was conducted on a preoperative three-dimensional (3D) model of each patient's skull using ProPlan CMF software (Materialise, Leuven, Belgium). Computer-assisted osteotomy saw-and-drill guides and patient-specific implants (PSIs, titanium plates and angle implants) were produced and used during the surgery. The investigators chose to focus on jawline improvement by comparing the preoperative and the post-operative 3D-photographs using the VECTRA H2 3D imagine system (Canfield Scientific, **).

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 43 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • patients undergoing orthognathic surgery and jawline correction with patient-specific angle implants at Head and Neck Institute, Nice, France

排除标准

  • 未提供

结局指标

主要结局

Secondary outcome of interest is patients satisfaction

时间窗: From post operative week 1 to one year follow-up

Scale title = échelle de Likert. Maximum score 5 (= not satisfied) / minimum score 1 (= total satisfaction)

The primary outcome of interest was the postoperative aspect and position of the gonial angle

时间窗: postoperative week 4

The primary outcome of interest was the postoperative aspect and position of the gonial angle, assessed by 3D-stereophotogrametry

Secondary outcome of interest is number and type of complications

时间窗: From post operative week 1 to one year follow-up

Secondary outcome of interest is number and type of complications

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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