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

13 maja 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Szacowany)

66

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

  • Holandia
    • North Holland
      • Amsterdam, North Holland, Holandia, 1105 AZ
        • Department of Oral and Maxillofacial Surgery, Amsterdam UMC
        • Kontakt:

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Splintless group
In the splintless group, MMA using patient-specific osteotomy guides and fixation implants (i.e., splintless MMA) will be executed.
Procedura: 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.
Aktywny komparator: Splint group
In the splint group, conventioanl MMA using surgical splints (i.e., splint MMA) will be executed.
Procedura: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Surgical accuracy
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Other translational surgical movement parameters
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: During MMA surgery
The time between the start of incision and the suture of the incisions.
During MMA surgery
Blood loss
Ramy czasowe: During MMA surgery
Blood loss during surgery
During MMA surgery
Adverse events/complications
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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%
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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）
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

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

Współpracownicy

Materialise

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 grudnia 2026

Zakończenie podstawowe (Szacowany)

30 czerwca 2028

Ukończenie studiów (Szacowany)

28 lutego 2033

Daty rejestracji na studia

Pierwszy przesłany

6 maja 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

13 maja 2026

Pierwszy wysłany (Rzeczywisty)

20 maja 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

20 maja 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

13 maja 2026

Ostatnia weryfikacja

1 maja 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 2024.0736

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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