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

13 de mayo de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

66

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

  • Países Bajos
    • North Holland
      • Amsterdam, North Holland, Países Bajos, 1105 AZ
        • Department of Oral and Maxillofacial Surgery, Amsterdam UMC
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Splintless group
In the splintless group, MMA using patient-specific osteotomy guides and fixation implants (i.e., splintless MMA) will be executed.
Procedimiento: 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.
Comparador activo: Splint group
In the splint group, conventioanl MMA using surgical splints (i.e., splint MMA) will be executed.
Procedimiento: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Surgical accuracy
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Other translational surgical movement parameters
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: During MMA surgery
The time between the start of incision and the suture of the incisions.
During MMA surgery
Blood loss
Periodo de tiempo: During MMA surgery
Blood loss during surgery
During MMA surgery
Adverse events/complications
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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%
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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）
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

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

Colaboradores

Materialise

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de diciembre de 2026

Finalización primaria (Estimado)

30 de junio de 2028

Finalización del estudio (Estimado)

28 de febrero de 2033

Fechas de registro del estudio

Enviado por primera vez

6 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

13 de mayo de 2026

Publicado por primera vez (Actual)

20 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

20 de mayo de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

13 de mayo de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 2024.0736

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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