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临床试验/NCT05060133
NCT05060133已完成不适用

Changes of the Upper Airway Volume After Orthognathic Surgery - is This a Treatment Option of Severe Obstructive Sleep Apnea?

Lund University Hospital1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2021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
62
试验地点
1
主要终点
Changes in upper airway volume

研究概览

简要总结

The aim of the present project is to analyze the impact from orthognathic surgery on the upper airway respiratory volume.

The primary objective is comparison of differences in the in the airway changes due to maxillary movements and mandibular movements.

Secondary objectives are the analysis of any correlation between the magnitude of the movement and the airway volume, correlation between the direction of the movements and the changes in airway volume and correlation with Health-Related Quality of Life (HRQoL). Expected confounding factors like smoking habits and Body Mass Index (BMI) will be analyzed.

详细描述

Background Orthognathic surgery affects the position of the teeth and jaws. The upper airway compartment is in close approximation to these tissues. Consequently, changes of the respiratory volume after surgical treatment in this region is expected.

Orthognathic surgery The correction of severe malocclusions and dentofacial deformities has since the beginning of 20th century been treated with orthodontic and surgical methods. Epidemiologic surveys reveal that about 5 % of the western population has dentofacial disproportions of a magnitude that affect both function and facial aesthetics.

Respiratory disability Obstructive sleep apnea, estimated to occur in between 5% and 10% of the western countries' population. Disabilities in the upper airway may affect the patient's general health and quality of life. Breathing incapability often lead to impaired sleep and consequently decrease the individual's overall capacity and performance. Known predisposing factors are obesity, smoking and age.

Treatment of respiratory disabilities Medical, behavioral and surgical treatment options are prospected methods and the treatment is individually planned in detail. The complex nature of obstructive sleep apnea may require multidisciplinary assessment.

Orthognathic surgery as treatment for obstructive sleep apnea syndrome (OSAS) Correction of anatomical abnormalities may cure obstructive sleep apnea or improve compliance with positive airway pressure treatment. Orthognathic surgery with an anterior movement of the jaws can increase the airway volume and facilitate breathing.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Maxillary retrognatism and Angle class III occlusion deviating at least 5 mm in sagittal and/or vertical aspect from normal occlusion measured as interincisal distance
  • Age between 18 to 30 years

排除标准

  • Systemic diseases in the musculoskeletal apparatus
  • Drug abuse
  • Poor psychic status
  • Disease in the temporomandibular joint

结局指标

主要结局

Changes in upper airway volume

时间窗: Preoperative and 12 months postoperative follow up.

Measurements in three dimensional radiographs from pre- and postoperative recordings.

次要结局

  • Correlation BMI and upper airway volume.(Preoperative and 12 months postoperative follow up.)
  • Direction of surgical movements(Preoperative and 12 months postoperative follow up.)

研究者

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

Martin Bengtsson

Consultant Oral and Maxillofacial Surgeon

Lund University Hospital

研究点 (1)

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