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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.

調査の概要

状態

まだ募集していません

条件

介入・治療

研究の種類

介入

入学 (推定)

66

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

  • オランダ
    • North Holland
      • Amsterdam、North Holland、オランダ、1105 AZ
        • Department of Oral and Maxillofacial Surgery, Amsterdam UMC
        • コンタクト：

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：独身

武器と介入

参加者グループ / アーム
介入・治療
実験的：Splintless group
In the splintless group, MMA using patient-specific osteotomy guides and fixation implants (i.e., splintless MMA) will be executed.
手順：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.
アクティブコンパレータ：Splint group
In the splint group, conventioanl MMA using surgical splints (i.e., splint MMA) will be executed.
手順：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.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Surgical accuracy
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Other translational surgical movement parameters
時間枠：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
時間枠：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
時間枠：During MMA surgery
The time between the start of incision and the suture of the incisions.
During MMA surgery
Blood loss
時間枠：During MMA surgery
Blood loss during surgery
During MMA surgery
Adverse events/complications
時間枠：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
時間枠：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
時間枠：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
時間枠：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%
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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）
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

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

協力者

Materialise

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年12月1日

一次修了 (推定)

2028年6月30日

研究の完了 (推定)

2033年2月28日

試験登録日

最初に提出

2026年5月6日

QC基準を満たした最初の提出物

2026年5月13日

最初の投稿 (実際)

2026年5月20日

学習記録の更新

投稿された最後の更新 (実際)

2026年5月20日

QC基準を満たした最後の更新が送信されました

2026年5月13日

最終確認日

2026年5月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • 2024.0736

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いいえ

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睡眠時無呼吸症候群 (OSAS)の臨床試験

Splintless MMA surgeryの臨床試験

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