Splintless Versus Conventional Maxillomandibular Advancement Surgery for Obstructive Sleep Apnea
Key facts
- Who runs it
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Where
- Amsterdam, NetherlandsSee the site
- Trial code
- Status
- Not yet recruiting
- People taking part
- 66 people, planned
- Starts
- 1 Dec 2026
- Expected to end
- 28 Feb 2033
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Splintless MMA surgery
- Splint MMA surgery
- Record updated
- 20 May 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 13 criteriaShow less
Who can take part
- 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
Who cannot take part
- Previous history of orthognathic surgery
- For OSA patients:
- Other adjunctive procedures indicated at the time of MMA (e.g., multi-piece Le Fort I osteotomy, temporomandibular joint reconstruction)
- Cleft palate and syndromic patients
- Refusal to participate; For bedpartners of patients:
- Refusal to participate
Where in Netherlands
- Department of Oral and Maxillofacial Surgery, Amsterdam UMCAmsterdam, NetherlandsContact: HoNo longer taking part
About the trial
What the trial wants to find out
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:
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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.
The 2 groups in the trial
- Splintless groupTreatment being tested
In the splintless group, MMA using patient-specific osteotomy guides and fixation implants (i.e., splintless MMA) will be executed.
Treatment: Splintless MMA surgery
- Splint groupExisting treatment, for comparison
In the splint group, conventioanl MMA using surgical splints (i.e., splint MMA) will be executed.
Treatment: Splint MMA surgery
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Splintless Versus Conventional Maxillomandibular Advancement Surgery for Obstructive Sleep Apnea: a Randomized Controlled Trial
- Record updated
- 20 May 2026