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Splintless Versus Conventional Maxillomandibular Advancement Surgery for Obstructive Sleep Apnea

Key facts

Who runs it
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Where
Netherlands1 site in 1 countryChoose a country to see its sites
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

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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

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

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

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data 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