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Not yet recruiting NCT07598461

Splintless Versus Conventional Maxillomandibular Advancement Surgery for Obstructive Sleep Apnea

No phase Interventional Sleep Apnea Syndrome (OSAS) Orthognathic Surgical Procedures Sleep Apnea - Obstructive

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Splintless MMA surgery, Splint MMA surgery.
Who it may be relevant to
Registry conditions: Sleep Apnea Syndrome (OSAS), Orthognathic Surgical Procedures, Sleep Apnea - Obstructive. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Splintless Versus Conventional Maxillomandibular Advancement Surgery for Obstructive Sleep Apnea: a Randomized Controlled Trial

Overview

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.

Interventions

  • Procedure 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.
  • Procedure 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.

Primary outcome measures

  • Surgical accuracy [Time frame: 1 week after MMA]
Secondary outcome measures (12)
  • Other translational surgical movement parameters [Time frame: 1 week after MMA]
  • Other rotational surgical movement parameters [Time frame: 1 week after MMA]
  • Duration of surgery [Time frame: During MMA surgery]
  • Blood loss [Time frame: During MMA surgery]
  • Adverse events/complications [Time frame: During MMA surgery and follow-Ups (up to 60 months postoperatively)]
  • Apnea hypopnea index [Time frame: Preoperatively, six months postoperatively, and 60 months postoperatively]
  • 3% oxygen desaturation index [Time frame: Preoperatively, six months postoperatively, and 60 months postoperatively]
  • Lowest oxygen saturation [Time frame: Preoperatively, six months postoperatively, and 60 months postoperatively]
  • Percentage of sleep time spent with oxygen saturation < 90% [Time frame: Preoperatively, six months postoperatively, and 60 months postoperatively]
  • Epworth sleep scale (ESS) total score [Time frame: Preoperatively, and 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months after MMA]
  • Functional Outcomes of Sleep Questionnaire (FOSQ) total score [Time frame: Preoperatively, and 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months after MMA]
  • Pittsburgh Sleep Quality Index (PSQI) global score [Time frame: Preoperatively, and 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months after MMA]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Netherlands · 1 center
  • Department of Oral and Maxillofacial Surgery, Amsterdam UMC — Amsterdam

Identifiers

NCT: NCT07598461 · 2024.0736

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗