Clinical Trial

Splintless Versus Conventional Maxillomandibular Advancement Surgery for Obstructive Sleep Apnea

Study acronym: SvCMAS
Not Yet Recruiting
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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.
Trial Details
NCT Number NCT07598461
Lead Sponsor Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborators: Materialise
Conditions Sleep Apnea Syndrome (OSAS), Orthognathic Surgical Procedures, Sleep Apnea - Obstructive
Enrollment 66 participants
Start Date 2026-12-01
Primary Completion 2028-06-30 (estimated)
Study Completion 2033-02-28 (estimated)
Updated on ClinicalTrials.gov 2026-05-20