Splintless Versus Conventional Maxillomandibular Advancement Surgery for Obstructive Sleep Apnea

Официальное название

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

Обзор

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.

Вмешательства

• Процедура 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.
• Процедура 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.

Первичные конечные точки

• Surgical accuracy [Срок оценки: 1 week after MMA]

Вторичные конечные точки (12)

• Other translational surgical movement parameters [Срок оценки: 1 week after MMA]
• Other rotational surgical movement parameters [Срок оценки: 1 week after MMA]
• Duration of surgery [Срок оценки: During MMA surgery]
• Blood loss [Срок оценки: During MMA surgery]
• Adverse events/complications [Срок оценки: During MMA surgery and follow-Ups (up to 60 months postoperatively)]
• Apnea hypopnea index [Срок оценки: Preoperatively, six months postoperatively, and 60 months postoperatively]
• 3% oxygen desaturation index [Срок оценки: Preoperatively, six months postoperatively, and 60 months postoperatively]
• Lowest oxygen saturation [Срок оценки: Preoperatively, six months postoperatively, and 60 months postoperatively]
• Percentage of sleep time spent with oxygen saturation < 90% [Срок оценки: Preoperatively, six months postoperatively, and 60 months postoperatively]
• Epworth sleep scale (ESS) total score [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Preoperatively, and 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months after MMA]

Критерии участия

Критерии включения

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.

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Нидерланды · 1 центр

• Department of Oral and Maxillofacial Surgery, Amsterdam UMC — Amsterdam

Идентификаторы

NCT: NCT07598461 · 2024.0736

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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