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Splintless Versus Conventional Maxillomandibular Advancement Surgery for Obstructive Sleep Apnea
Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Summary
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.
Official title: Splintless Versus Conventional Maxillomandibular Advancement Surgery for Obstructive Sleep Apnea: a Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
66
Start Date
2026-12-01
Completion Date
2033-02-28
Last Updated
2026-05-20
Healthy Volunteers
No
Interventions
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.
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.
Locations (1)
Department of Oral and Maxillofacial Surgery, Amsterdam UMC
Amsterdam, North Holland, Netherlands