此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

Splintless Versus Conventional Maxillomandibular Advancement Surgery for Obstructive Sleep Apnea (SvCMAS)

2026年5月13日 更新者：Prof. dr. J. de Lange, MD DMD、Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Splintless Versus Conventional Maxillomandibular Advancement Surgery for Obstructive Sleep Apnea: a Randomized Controlled Trial

The goal of this clinical trial is to find out whether using a splintless surgical approach improves the accuracy of maxillomandibular advancement (MMA) surgery for treating obstructive sleep apnea (OSA) in adults. The study will also look at the safety, functional outcomes, and cost-effectiveness of the splintless approach. The main questions it aims to answer are:

Does the splintless approach lead to more accurate surgical movements of the jaws compared to the conventional splint-based method? What are the safety profile, functional outcomes, and cost-effectiveness of the splintless approach?

Researchers will compare splintless MMA to conventional MMA.

Patients will:

Undergo MMA surgery using either the splintless or splint-based method; Attend regular follow-up visits as part of routine care; Complete questionnaires and undergo assessments at various time points; Receive one additional CT scan (24 months after surgery) and one overnight sleep study (60 months after surgery).

Bedpartners of patients will:

Complete questionnaires at various time points.

This trial will help determine whether the splintless approach is a better, safer, and more effective alternative for treating OSA with MMA surgery.

研究概览

地位

尚未招聘

条件

干预/治疗

研究类型

介入性

注册 (估计的)

66

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 荷兰
    • North Holland
      • Amsterdam、North Holland、荷兰、1105 AZ
        • Department of Oral and Maxillofacial Surgery, Amsterdam UMC
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

For OSA patients:

  • Adults aged 18 years or older;
  • Moderate to severe OSA (apnea hypopnea index (AHI) ≥ 15 events/hour) as determined by an overnight polysomnography (PSG) preoperatively;
  • Continunous positive airway pressure failure or intolerance;
  • General good health for surgery;
  • MMA surgery indicated for OSA treatment.

For bedpartners of patients:

• Sharing a bed ⩾2 nights/week with patient.

Exclusion Criteria:

For OSA patients:

  • Other adjunctive procedures indicated at the time of MMA (e.g., multi-piece Le Fort I osteotomy, temporomandibular joint reconstruction);
  • Previous history of orthognathic surgery;
  • Cleft palate and syndromic patients;
  • Refusal to participate.

For bedpartners of patients:

• Refusal to participate.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
实验性的：Splintless group
In the splintless group, MMA using patient-specific osteotomy guides and fixation implants (i.e., splintless MMA) will be executed.
程序：Splintless MMA surgery
Splintless orthognathic surgery is a more recent technical innovation in Oral and Maxillofacial surgery, in which patient-specific computer-aided design and manufacturing (CAD/CAM) surgical cutting guides and fixation implants are used to improve surgical precision. Splintless MMA sugery involves virtual surgical planning, surgical procedures, and postoperative monitoring.
有源比较器：Splint group
In the splint group, conventioanl MMA using surgical splints (i.e., splint MMA) will be executed.
程序：Splint MMA surgery
In splint MMA surgery, surgical procedure is virtually planned in three dimensions (3D) and the surgical planning is transfered to the operating room with 3D-printed intermediate and final splints. These splints are used during surgery to place and fixate the maxilla and mandible in the planned position.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Surgical accuracy
大体时间：1 week after MMA

Because the main objective of MMA for OSA is achieving the planned advancement and counter-clockwise rotation to relieve the upper airway collapse, anteroposterior translation of the maxilla and mandible, and pitch of the maxilla and mandible are the main study parameters.

The postoperative CT scan is superimposed on the preoperative virtual planning. The absolute difference between the planned value for a parameter and the postoperative acquired value will be calculated, which provides an intuitive accuracy measurement of MMA surgery.
1 week after MMA

次要结果测量

结果测量
措施说明
大体时间
Other translational surgical movement parameters
大体时间：1 week after MMA
Mediolateral and superoinferior movement of the maxilla and mandible in millimeters measured by CT scan
1 week after MMA
Other rotational surgical movement parameters
大体时间：1 week after MMA
Roll and yaw of the maxilla and mandible in degrees measured by CT scan
1 week after MMA
Duration of surgery
大体时间：During MMA surgery
The time between the start of incision and the suture of the incisions.
During MMA surgery
Blood loss
大体时间：During MMA surgery
Blood loss during surgery
During MMA surgery
Adverse events/complications
大体时间：During MMA surgery and follow-Ups (up to 60 months postoperatively)
Intra- and post-operative adverse events/complications
During MMA surgery and follow-Ups (up to 60 months postoperatively)
Apnea hypopnea index
大体时间：Preoperatively, six months postoperatively, and 60 months postoperatively
The average number of apnea and hypopnea events per hour of sleep during a sleep study (polysomnography)
Preoperatively, six months postoperatively, and 60 months postoperatively
3% oxygen desaturation index
大体时间：Preoperatively, six months postoperatively, and 60 months postoperatively
Number of times per hour of sleep that blood oxygen saturation drops by ≥3% from baseline during a sleep study
Preoperatively, six months postoperatively, and 60 months postoperatively
Lowest oxygen saturation
大体时间：Preoperatively, six months postoperatively, and 60 months postoperatively
The minimum blood oxygen level (%) reached during a sleep study
Preoperatively, six months postoperatively, and 60 months postoperatively
Percentage of sleep time spent with oxygen saturation < 90%
大体时间：Preoperatively, six months postoperatively, and 60 months postoperatively
Percentage of sleep time spent with blood oxygen saturation < 90% during a sleep study
Preoperatively, six months postoperatively, and 60 months postoperatively
Epworth sleep scale (ESS) total score
大体时间：Preoperatively, and 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months after MMA
Daytime sleepiness as assessed with Epworth sleep scale total score (range 0-24; higher scores indicate greater daytime sleepiness / worse outcome)
Preoperatively, and 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months after MMA
Functional Outcomes of Sleep Questionnaire (FOSQ) total score
大体时间：Preoperatively, and 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months after MMA
Functional status as assessed with Functional Outcomes of Sleep Questionnaire total score (range 5-20; higher scores indicate better functional status / less impairment due to sleepiness)
Preoperatively, and 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months after MMA
Pittsburgh Sleep Quality Index (PSQI) global score
大体时间：Preoperatively, and 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months after MMA
Sleep quality as assessed with Pittsburgh Sleep Quality Index global score (range 0-21; higher scores indicate worse sleep quality)
Preoperatively, and 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months after MMA
EuroQol 5-Dimension 5-Level (EQ-5D-5L) utility index
大体时间：Preoperatively, and 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months after MMA
Patient's health status as assessed with EuroQol 5-Dimension 5-Level utility index (utility index ranges from <0 to 1; higher scores indicate better health-related quality of life)
Preoperatively, and 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months after MMA
EuroQol 5-Dimension 5-Level (EQ-5D-5L) visual analogue scale (VAS) score
大体时间：Preoperatively, and 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months after MMA
Patient's health status as assessed with EuroQol 5-Dimension 5-Level visual analogue scale (VAS) score (VAS ranges 0-100, higher scores indicate better health status)
Preoperatively, and 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months after MMA
36-Item Short Form Health Survey (SF-36) domain and summary scores
大体时间：Preoperatively, and 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months after MMA
Quality of life as assessed with 36-Item Short Form Health Survey domain and summary scores (range 0-100; higher scores indicate better health-related quality of life)
Preoperatively, and 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months after MMA
FACE-Q satisfaction with facial appearance score
大体时间：Preoperatively, and 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months after MMA
Patient satisfaction with facial appearance as assessed using the FACE-Q questionnaire (range 0-100; higher scores indicate greater satisfaction with facial appearance / better outcome)
Preoperatively, and 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months after MMA
Patient satisfaction with facial appearance and surgical outcome
大体时间：Preoperatively, and 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months after MMA
Patient's satisfaction with surgery outcomes as assessed with customized patient satisfaction questionnaire (5-point Likert scales; higher ratings indicate greater satisfaction)
Preoperatively, and 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months after MMA
Partner-reported snoring severity, snoring disturbance, and satisfaction with postoperative facial appearance (5- to 6-point Likert scales）
大体时间：Preoperatively and 6 months after MMA
Partner-reported assessment of snoring severity, snoring-related disturbance, and perceived postoperative facial appearance changes using a study-specific questionnaire completed by the participant's partner (higher ratings indicate greater snoring severity/disturbance or more positive perceived facial change, depending on the item).
Preoperatively and 6 months after MMA
Postsurgical relapse measures
大体时间：2 years after MMA
Postsurgical relapse measures in translation parameters (anteroposterior, mediolateral, superoinferior) and rotation parameters (roll, pitch, yaw) of the maxilla and mandible. The discrepancy between immediately post-operation (1 week after MMA) and 2 years after surgery will be used to define the amount of relapse.
2 years after MMA
Facial soft tissue changes
大体时间：6 months after MMA
Facial soft tissue changes following MMA at various soft-tissue points. These are determined by the difference in 3D coordinates of soft tissue landmarks between baseline and 6 months after MMA;
6 months after MMA
Upper airway volume
大体时间：Preoperatively and 6 months after MMA
Upper airway volume (mm³) measured using three-dimensional imaging analysis
Preoperatively and 6 months after MMA
Upper airway length
大体时间：Preoperatively and 6 months after MMA
Upper airway length measured using three-dimensional imaging analysis (mm)
Preoperatively and 6 months after MMA
Upper airway surface area
大体时间：Preoperatively and 6 months after MMA
Upper airway surface area (mm²) measured using three-dimensional imaging analysis
Preoperatively and 6 months after MMA
Upper airway minimum cross-sectional area (minCSA)
大体时间：Preoperatively and 6 months after MMA
Minimum cross-sectional area (mm²) of the upper airway measured using three-dimensional imaging analysis
Preoperatively and 6 months after MMA
Lateral dimension of the minimum cross-sectional area of the upper airway
大体时间：Preoperatively and 6 months after MMA
Lateral dimension of the upper airway minimum cross-sectional area (mm) measured using three-dimensional imaging analysis.
Preoperatively and 6 months after MMA
Anteroposterior dimension of the minimum cross-sectional area of the upper airway
大体时间：Preoperatively and 6 months after MMA
Anteroposterior dimension of the upper airway minimum cross-sectional area (mm) measured using three-dimensional imaging analysis.
Preoperatively and 6 months after MMA
Blood pressure
大体时间：Preoperatively, and 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months after MMA
Systolic and diastolic blood pressure
Preoperatively, and 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months after MMA
Cost-effectiveness
大体时间：6, 12, 24, 36, 48, and 60 months after MMA
Incremental cost-effectiveness ratio (ICER) and incremental cost-utility ratio (ICUR).
6, 12, 24, 36, 48, and 60 months after MMA

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

合作者

Materialise

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年12月1日

初级完成 (估计的)

2028年6月30日

研究完成 (估计的)

2033年2月28日

研究注册日期

首次提交

2026年5月6日

首先提交符合 QC 标准的

2026年5月13日

首次发布 (实际的)

2026年5月20日

研究记录更新

最后更新发布 (实际的)

2026年5月20日

上次提交的符合 QC 标准的更新

2026年5月13日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 2024.0736

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

订阅