NCT05073757已完成不适用
Prospective Study to Evaluate the Performance and Safety of Personalized Implants in Cranio-Maxillofacial (CMF) Surgery Indicated for Orthognathic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Global D
- 入组人数
- 56
- 试验地点
- 4
- 主要终点
- Orthognatic quality of life questionnaire
研究概览
简要总结
With the digital age, guided surgery and cases of fully computer-assisted surgeries via 3D printing guides and preformed plates are booming.
Our project aims to study the performance and safety of custom-made implants (custom-made guides and plates) in orthognathic surgery in order to obtain specific clinical data on SLS France devices.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patient, adult or minor having reached bone maturity according to the judgment of the investigator,
- •Patient having first orthognathic surgery with SLS France custom-made guides and plates,
- •Patient who received orthodontic treatment prior to orthognathic surgery,
- •Patient able to read, understand and answer the study quality of life questionnaire,
- •Patient (and legal representative if a minor) who is not opposed to his participation in the study or to the processing of his data.
- •Patient affiliated to a social insurance
排除标准
- •Patient allergic to one of the compounds of the plates and / or guides,
- •Patient with physical or mental disability making it impossible to follow up in the study,
- •Patient with significant expansion
- •Patient with a congenital craniofacial malformation
- •Patient with acute or chronic local or systemic infection,
- •Person placed under legal protection,
- •Pregnant or breastfeeding women.
结局指标
主要结局
Orthognatic quality of life questionnaire
时间窗: 12 months post-operatively
To evaluate the performance of custom-made implants indicated for orthognathic surgery by measuring the quality of life of patients
次要结局
- Surgeon satisfaction on the implant's utilisation(Immediately following surgery)
- Security of the implants used for orthognathic surgery(12 months)
研究者
研究点 (4)
Loading locations...
相似试验
已完成
不适用
3D Printed Models in 3D Virtual Treatment Planning of Orthognathic SurgeryOrthognathic SurgeryNCT03986723AZ Sint-Jan AV20
Unknown
不适用
Evaluation of Performance Characteristics and Applicability in Oncology of Devices Customized Medical Devices Made by 3D PrintingIntracranial NeoplasmPelvic Bone NeoplasmSarcomaNCT06291662Kathleen McGreevy12
已完成
不适用
3D Visualization System for Vitreoretinal Diseases in Highly Myopic EyesPatients With Highly Myopic EyesNCT05367193National Taiwan University Hospital40
尚未招募
不适用
Clinical Evaluation of 3D Printed Versus CAD/CAM Milled OnlaysBadly Decayed MolarsNCT06774560Cairo University50
Unknown
不适用
Intelligent Operating RoomSurgeryNCT03955614Imperial College London150