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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
66
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.
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.
Department of Oral and Maxillofacial Surgery, Amsterdam UMC
Amsterdam, North Holland, Netherlands
Surgical accuracy
Because the main objective of MMA for OSA is achieving the planned advancement and counter-clockwise rotation to relieve the upper airway collapse, anteroposterior translation of the maxilla and mandible, and pitch of the maxilla and mandible are the main study parameters. The postoperative CT scan is superimposed on the preoperative virtual planning. The absolute difference between the planned value for a parameter and the postoperative acquired value will be calculated, which provides an intuitive accuracy measurement of MMA surgery.
Time frame: 1 week after MMA
Other translational surgical movement parameters
Mediolateral and superoinferior movement of the maxilla and mandible in millimeters measured by CT scan
Time frame: 1 week after MMA
Other rotational surgical movement parameters
Roll and yaw of the maxilla and mandible in degrees measured by CT scan
Time frame: 1 week after MMA
Duration of surgery
The time between the start of incision and the suture of the incisions.
Time frame: During MMA surgery
Blood loss
Blood loss during surgery
Time frame: During MMA surgery
Adverse events/complications
Intra- and post-operative adverse events/complications
Time frame: During MMA surgery and follow-Ups (up to 60 months postoperatively)
Apnea hypopnea index
The average number of apnea and hypopnea events per hour of sleep during a sleep study (polysomnography)
Time frame: Preoperatively, six months postoperatively, and 60 months postoperatively
3% oxygen desaturation index
Number of times per hour of sleep that blood oxygen saturation drops by ≥3% from baseline during a sleep study
Time frame: Preoperatively, six months postoperatively, and 60 months postoperatively
Lowest oxygen saturation
The minimum blood oxygen level (%) reached during a sleep study
Time frame: Preoperatively, six months postoperatively, and 60 months postoperatively
Percentage of sleep time spent with oxygen saturation < 90%
Percentage of sleep time spent with blood oxygen saturation \< 90% during a sleep study
Time frame: Preoperatively, six months postoperatively, and 60 months postoperatively
Epworth sleep scale (ESS) total score
Daytime sleepiness as assessed with Epworth sleep scale total score (range 0-24; higher scores indicate greater daytime sleepiness / worse outcome)
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
Functional status as assessed with Functional Outcomes of Sleep Questionnaire total score (range 5-20; higher scores indicate better functional status / less impairment due to sleepiness)
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
Sleep quality as assessed with Pittsburgh Sleep Quality Index global score (range 0-21; higher scores indicate worse sleep quality)
Time frame: Preoperatively, and 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months after MMA
EuroQol 5-Dimension 5-Level (EQ-5D-5L) utility index
Patient's health status as assessed with EuroQol 5-Dimension 5-Level utility index (utility index ranges from \<0 to 1; higher scores indicate better health-related quality of life)
Time frame: Preoperatively, and 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months after MMA
EuroQol 5-Dimension 5-Level (EQ-5D-5L) visual analogue scale (VAS) score
Patient's health status as assessed with EuroQol 5-Dimension 5-Level visual analogue scale (VAS) score (VAS ranges 0-100, higher scores indicate better health status)
Time frame: Preoperatively, and 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months after MMA
36-Item Short Form Health Survey (SF-36) domain and summary scores
Quality of life as assessed with 36-Item Short Form Health Survey domain and summary scores (range 0-100; higher scores indicate better health-related quality of life)
Time frame: Preoperatively, and 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months after MMA
FACE-Q satisfaction with facial appearance score
Patient satisfaction with facial appearance as assessed using the FACE-Q questionnaire (range 0-100; higher scores indicate greater satisfaction with facial appearance / better outcome)
Time frame: Preoperatively, and 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months after MMA
Patient satisfaction with facial appearance and surgical outcome
Patient's satisfaction with surgery outcomes as assessed with customized patient satisfaction questionnaire (5-point Likert scales; higher ratings indicate greater satisfaction)
Time frame: Preoperatively, and 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months after MMA
Partner-reported snoring severity, snoring disturbance, and satisfaction with postoperative facial appearance (5- to 6-point Likert scales）
Partner-reported assessment of snoring severity, snoring-related disturbance, and perceived postoperative facial appearance changes using a study-specific questionnaire completed by the participant's partner (higher ratings indicate greater snoring severity/disturbance or more positive perceived facial change, depending on the item).
Time frame: Preoperatively and 6 months after MMA
Postsurgical relapse measures
Postsurgical relapse measures in translation parameters (anteroposterior, mediolateral, superoinferior) and rotation parameters (roll, pitch, yaw) of the maxilla and mandible. The discrepancy between immediately post-operation (1 week after MMA) and 2 years after surgery will be used to define the amount of relapse.
Time frame: 2 years after MMA
Facial soft tissue changes
Facial soft tissue changes following MMA at various soft-tissue points. These are determined by the difference in 3D coordinates of soft tissue landmarks between baseline and 6 months after MMA;
Time frame: 6 months after MMA
Upper airway volume
Upper airway volume (mm³) measured using three-dimensional imaging analysis
Time frame: Preoperatively and 6 months after MMA
Upper airway length
Upper airway length measured using three-dimensional imaging analysis (mm)
Time frame: Preoperatively and 6 months after MMA
Upper airway surface area
Upper airway surface area (mm²) measured using three-dimensional imaging analysis
Time frame: Preoperatively and 6 months after MMA
Upper airway minimum cross-sectional area (minCSA)
Minimum cross-sectional area (mm²) of the upper airway measured using three-dimensional imaging analysis
Time frame: Preoperatively and 6 months after MMA
Lateral dimension of the minimum cross-sectional area of the upper airway
Lateral dimension of the upper airway minimum cross-sectional area (mm) measured using three-dimensional imaging analysis.
Time frame: Preoperatively and 6 months after MMA
Anteroposterior dimension of the minimum cross-sectional area of the upper airway
Anteroposterior dimension of the upper airway minimum cross-sectional area (mm) measured using three-dimensional imaging analysis.
Time frame: Preoperatively and 6 months after MMA
Blood pressure
Systolic and diastolic blood pressure
Time frame: Preoperatively, and 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months after MMA
Cost-effectiveness
Incremental cost-effectiveness ratio (ICER) and incremental cost-utility ratio (ICUR).
Time frame: 6, 12, 24, 36, 48, and 60 months after MMA
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