Orthognathic Surgical Procedures, Sleep Apnea - Obstructive, Sleep Apnea Syndrome (OSAS)
Conditions
Keywords
OSA, Maxilomandibular advancement surgery, MMA, Patient-specific implants, Splintless orthognathic
Brief 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.
Interventions
PROCEDURESplintless 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.
PROCEDURESplint 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.
Sponsors
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Materialise
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surgical accuracy | 1 week after MMA | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Other translational surgical movement parameters | 1 week after MMA | Mediolateral and superoinferior movement of the maxilla and mandible in millimeters measured by CT scan |
| Other rotational surgical movement parameters | 1 week after MMA | Roll and yaw of the maxilla and mandible in degrees measured by CT scan |
| Duration of surgery | During MMA surgery | The time between the start of incision and the suture of the incisions. |
| Blood loss | During MMA surgery | Blood loss during surgery |
| Adverse events/complications | During MMA surgery and follow-Ups (up to 60 months postoperatively) | Intra- and post-operative adverse events/complications |
| Apnea hypopnea index | Preoperatively, six months postoperatively, and 60 months postoperatively | The average number of apnea and hypopnea events per hour of sleep during a sleep study (polysomnography) |
| 3% oxygen desaturation index | Preoperatively, six months postoperatively, and 60 months postoperatively | Number of times per hour of sleep that blood oxygen saturation drops by ≥3% from baseline during a sleep study |
| Lowest oxygen saturation | Preoperatively, six months postoperatively, and 60 months postoperatively | The minimum blood oxygen level (%) reached during a sleep study |
| Percentage of sleep time spent with oxygen saturation < 90% | Preoperatively, six months postoperatively, and 60 months postoperatively | Percentage of sleep time spent with blood oxygen saturation \< 90% during a sleep study |
| Epworth sleep scale (ESS) total score | Preoperatively, and 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months after MMA | Daytime sleepiness as assessed with Epworth sleep scale total score (range 0-24; higher scores indicate greater daytime sleepiness / worse outcome) |
| Functional Outcomes of Sleep Questionnaire (FOSQ) total score | Preoperatively, and 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months after MMA | 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) |
| Pittsburgh Sleep Quality Index (PSQI) global score | Preoperatively, and 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months after MMA | Sleep quality as assessed with Pittsburgh Sleep Quality Index global score (range 0-21; higher scores indicate worse sleep quality) |
| EuroQol 5-Dimension 5-Level (EQ-5D-5L) utility index | Preoperatively, and 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months after MMA | 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) |
| EuroQol 5-Dimension 5-Level (EQ-5D-5L) visual analogue scale (VAS) score | Preoperatively, and 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months after MMA | 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) |
| 36-Item Short Form Health Survey (SF-36) domain and summary scores | Preoperatively, and 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months after MMA | 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) |
| FACE-Q satisfaction with facial appearance score | Preoperatively, and 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months after MMA | 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) |
| Patient satisfaction with facial appearance and surgical outcome | Preoperatively, and 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months after MMA | Patient's satisfaction with surgery outcomes as assessed with customized patient satisfaction questionnaire (5-point Likert scales; higher ratings indicate greater satisfaction) |
| Partner-reported snoring severity, snoring disturbance, and satisfaction with postoperative facial appearance (5- to 6-point Likert scales） | Preoperatively and 6 months after MMA | 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). |
| Postsurgical relapse measures | 2 years after MMA | 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. |
| Facial soft tissue changes | 6 months after MMA | 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; |
| Upper airway volume | Preoperatively and 6 months after MMA | Upper airway volume (mm³) measured using three-dimensional imaging analysis |
| Upper airway length | Preoperatively and 6 months after MMA | Upper airway length measured using three-dimensional imaging analysis (mm) |
| Upper airway surface area | Preoperatively and 6 months after MMA | Upper airway surface area (mm²) measured using three-dimensional imaging analysis |
| Upper airway minimum cross-sectional area (minCSA) | Preoperatively and 6 months after MMA | Minimum cross-sectional area (mm²) of the upper airway measured using three-dimensional imaging analysis |
| Lateral dimension of the minimum cross-sectional area of the upper airway | Preoperatively and 6 months after MMA | Lateral dimension of the upper airway minimum cross-sectional area (mm) measured using three-dimensional imaging analysis. |
| Anteroposterior dimension of the minimum cross-sectional area of the upper airway | Preoperatively and 6 months after MMA | Anteroposterior dimension of the upper airway minimum cross-sectional area (mm) measured using three-dimensional imaging analysis. |
| Blood pressure | Preoperatively, and 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months after MMA | Systolic and diastolic blood pressure |
| Cost-effectiveness | 6, 12, 24, 36, 48, and 60 months after MMA | Incremental cost-effectiveness ratio (ICER) and incremental cost-utility ratio (ICUR). |
Countries
Netherlands
Contacts
CONTACTHo
Outcome results
None listed