Splintless Versus Conventional Maxillomandibular Advancement Surgery for Obstructive Sleep Apnea (SvCMAS)
13 mai 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
66
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Ho
- Numéro de téléphone: 020-5663898
- E-mail: j.p.ho@amsterdamumc.nl
Lieux d'étude
-
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North Holland
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Amsterdam, North Holland, Pays-Bas, 1105 AZ
- Department of Oral and Maxillofacial Surgery, Amsterdam UMC
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Contact:
- Ho
- Numéro de téléphone: 020-5663898
- E-mail: j.p.ho@amsterdamumc.nl
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Splintless group
In the splintless group, MMA using patient-specific osteotomy guides and fixation implants (i.e., splintless MMA) will be executed.
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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.
|
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Comparateur actif: Splint group
In the splint group, conventioanl MMA using surgical splints (i.e., splint MMA) will be executed.
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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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Surgical accuracy
Délai: 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
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Other translational surgical movement parameters
Délai: 1 week after MMA
|
Mediolateral and superoinferior movement of the maxilla and mandible in millimeters measured by CT scan
|
1 week after MMA
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Other rotational surgical movement parameters
Délai: 1 week after MMA
|
Roll and yaw of the maxilla and mandible in degrees measured by CT scan
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1 week after MMA
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Duration of surgery
Délai: During MMA surgery
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The time between the start of incision and the suture of the incisions.
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During MMA surgery
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Blood loss
Délai: During MMA surgery
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Blood loss during surgery
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During MMA surgery
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Adverse events/complications
Délai: During MMA surgery and follow-Ups (up to 60 months postoperatively)
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Intra- and post-operative adverse events/complications
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During MMA surgery and follow-Ups (up to 60 months postoperatively)
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Apnea hypopnea index
Délai: Preoperatively, six months postoperatively, and 60 months postoperatively
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The average number of apnea and hypopnea events per hour of sleep during a sleep study (polysomnography)
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Preoperatively, six months postoperatively, and 60 months postoperatively
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3% oxygen desaturation index
Délai: Preoperatively, six months postoperatively, and 60 months postoperatively
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Number of times per hour of sleep that blood oxygen saturation drops by ≥3% from baseline during a sleep study
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Preoperatively, six months postoperatively, and 60 months postoperatively
|
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Lowest oxygen saturation
Délai: Preoperatively, six months postoperatively, and 60 months postoperatively
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The minimum blood oxygen level (%) reached during a sleep study
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Preoperatively, six months postoperatively, and 60 months postoperatively
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Percentage of sleep time spent with oxygen saturation < 90%
Délai: Preoperatively, six months postoperatively, and 60 months postoperatively
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Percentage of sleep time spent with blood oxygen saturation < 90% during a sleep study
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Preoperatively, six months postoperatively, and 60 months postoperatively
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Epworth sleep scale (ESS) total score
Délai: Preoperatively, and 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months after MMA
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Daytime sleepiness as assessed with Epworth sleep scale total score (range 0-24; higher scores indicate greater daytime sleepiness / worse outcome)
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Preoperatively, and 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months after MMA
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Functional Outcomes of Sleep Questionnaire (FOSQ) total score
Délai: Preoperatively, and 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months after MMA
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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)
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Preoperatively, and 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months after MMA
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Pittsburgh Sleep Quality Index (PSQI) global score
Délai: Preoperatively, and 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months after MMA
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Sleep quality as assessed with Pittsburgh Sleep Quality Index global score (range 0-21; higher scores indicate worse sleep quality)
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Preoperatively, and 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months after MMA
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EuroQol 5-Dimension 5-Level (EQ-5D-5L) utility index
Délai: Preoperatively, and 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months after MMA
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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)
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Preoperatively, and 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months after MMA
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EuroQol 5-Dimension 5-Level (EQ-5D-5L) visual analogue scale (VAS) score
Délai: Preoperatively, and 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months after MMA
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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)
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Preoperatively, and 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months after MMA
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36-Item Short Form Health Survey (SF-36) domain and summary scores
Délai: Preoperatively, and 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months after MMA
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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)
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Preoperatively, and 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months after MMA
|
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FACE-Q satisfaction with facial appearance score
Délai: Preoperatively, and 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months after MMA
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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)
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Preoperatively, and 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months after MMA
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Patient satisfaction with facial appearance and surgical outcome
Délai: Preoperatively, and 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months after MMA
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Patient's satisfaction with surgery outcomes as assessed with customized patient satisfaction questionnaire (5-point Likert scales; higher ratings indicate greater satisfaction)
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Preoperatively, and 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months after MMA
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Partner-reported snoring severity, snoring disturbance, and satisfaction with postoperative facial appearance (5- to 6-point Likert scales）
Délai: Preoperatively and 6 months after MMA
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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).
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Preoperatively and 6 months after MMA
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Postsurgical relapse measures
Délai: 2 years after MMA
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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.
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2 years after MMA
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Facial soft tissue changes
Délai: 6 months after MMA
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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;
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6 months after MMA
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Upper airway volume
Délai: Preoperatively and 6 months after MMA
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Upper airway volume (mm³) measured using three-dimensional imaging analysis
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Preoperatively and 6 months after MMA
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Upper airway length
Délai: Preoperatively and 6 months after MMA
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Upper airway length measured using three-dimensional imaging analysis (mm)
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Preoperatively and 6 months after MMA
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Upper airway surface area
Délai: Preoperatively and 6 months after MMA
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Upper airway surface area (mm²) measured using three-dimensional imaging analysis
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Preoperatively and 6 months after MMA
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Upper airway minimum cross-sectional area (minCSA)
Délai: Preoperatively and 6 months after MMA
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Minimum cross-sectional area (mm²) of the upper airway measured using three-dimensional imaging analysis
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Preoperatively and 6 months after MMA
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Lateral dimension of the minimum cross-sectional area of the upper airway
Délai: Preoperatively and 6 months after MMA
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Lateral dimension of the upper airway minimum cross-sectional area (mm) measured using three-dimensional imaging analysis.
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Preoperatively and 6 months after MMA
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Anteroposterior dimension of the minimum cross-sectional area of the upper airway
Délai: Preoperatively and 6 months after MMA
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Anteroposterior dimension of the upper airway minimum cross-sectional area (mm) measured using three-dimensional imaging analysis.
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Preoperatively and 6 months after MMA
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Blood pressure
Délai: Preoperatively, and 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months after MMA
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Systolic and diastolic blood pressure
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Preoperatively, and 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months after MMA
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Cost-effectiveness
Délai: 6, 12, 24, 36, 48, and 60 months after MMA
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Incremental cost-effectiveness ratio (ICER) and incremental cost-utility ratio (ICUR).
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6, 12, 24, 36, 48, and 60 months after MMA
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Collaborateurs et enquêteurs
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Collaborateurs
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 décembre 2026
Achèvement primaire (Estimé)
30 juin 2028
Achèvement de l'étude (Estimé)
28 février 2033
Dates d'inscription aux études
Première soumission
6 mai 2026
Première soumission répondant aux critères de contrôle qualité
13 mai 2026
Première publication (Réel)
20 mai 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
20 mai 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
13 mai 2026
Dernière vérification
1 mai 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2024.0736
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