Prospective Study to Evaluate the Performance and Safety of Personalized Implants in Cranio-Maxillofacial (CMF) Surgery Indicated for Orthognathic Surgery

Global D4 个研究点分布在 2 个国家目标入组 56 人2021年9月17日

概览

阶段: 不适用
干预措施: 未指定
疾病 / 适应症: 未指定
发起方: Global D
入组人数: 56
试验地点: 4
主要终点: Orthognatic quality of life questionnaire
状态: 已完成
最后更新: 3个月前

概览研究者入排标准结局指标研究点相似试验

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.

注册库

clinicaltrials.gov

开始日期

2021年9月17日

结束日期

2025年2月25日

最后更新

3个月前

研究类型

Observational

性别

All

研究者

发起方

Global D

责任方

Sponsor

入排标准

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.