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临床试验/NCT06022679
NCT06022679已完成不适用

CBCT Analysis of the Craniofacial Architecture in Young, Non-overweight Apneic Adult Phenotype

Centre Hospitalier Universitaire de Liege1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2022年4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
1
主要终点
maxillary volume

研究概览

简要总结

This prospective, controlled study will compare the 3D cephalometric analysis of bone and craniofacial soft tissues in young (18-35 years) non-overweight apneic adults phenotype between a test group (with AHI 15) and a control group (healthy subjects with AHI < 15).

详细描述

Objectives The goal of this study is to determine an accurate bone and soft tissue phenotype for the non-overweight apneic young adult.

Materials and Methods This study was approved by the ethics medical committee of the University hospital of Liege.

This prospective, controlled study will compare cephalometric 3D analysis of bone and craniofacial soft tissue phenotype of young, non-overweight apneic adults using cephalometric 3D analysis between a test group (with AHI 15) and a control group (healthy subjects with AHI < 15).

The inclusion criteria were : (1) patients aged between 18 and 35 years ; (2) Body Mass Index (BMI) lower than 30kg/m² ; (3) alcohol consumption less than 4 unit per day ; (4) tabacco use less than 6 cigarettes per day ; (5) no illicit drug use ; and (6) absence of chronic pathology or medication.

The exclusion criteria were : (1) presence of an acute illness on the day of admission ; (2) patients treated with orthognathic surgery after apnea screening ; (3) patients with polysomnography with a sleep treatment device (PPCN or Mandibular advancement device).

研究设计

研究类型
Observational
观察模型
Other
时间视角
Other

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • (1) patients aged between 18 and 35 years ;
  • (2) Body Mass Index (BMI) lower than 30kg/m² ;
  • (3) alcohol consumption less than 4 unit per day ;
  • (4) tabacco use less than 6 cigarettes per day ;
  • (5) no illicit drug use ; and
  • (6) absence of chronic pathology or medication.

排除标准

  • (1) presence of an acute illness on the day of admission ;
  • (2) patients treated with orthognathic surgery after apnea screening ;
  • (3) patients with polysomnography with a sleep treatment device (PPCN or Mandibular advancement device).

结局指标

主要结局

maxillary volume

时间窗: 2month

maxillary volume with 3D cephalométric analysis

次要结局

未报告次要终点

研究者

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

Jadoul Mathilde

post graduated dento facial orthopedic department

Centre Hospitalier Universitaire de Liege

研究点 (1)

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