Splintless Versus Conventional Maxillomandibular Advancement Surgery for Obstructive Sleep Apnea (NCT07598461) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Splintless Versus Conventional Maxillomandibular Advancement Surgery for Obstructive Sleep Apnea
Netherlands66 participantsStarted 2026-12-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Surgical accuracy
Timeframe: 1 week after MMA
Trial details
NCT IDNCT07598461
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)