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| Name | Class |
|---|---|
| Materialise | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Splintless group | Experimental | In the splintless group, MMA using patient-specific osteotomy guides and fixation implants (i.e., splintless MMA) will be executed. |
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| Splint group | Active Comparator | In the splint group, conventioanl MMA using surgical splints (i.e., splint MMA) will be executed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Splintless MMA surgery | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 week after MMA |
| Measure | Description | Time Frame |
|---|---|---|
| Other translational surgical movement parameters | Mediolateral and superoinferior movement of the maxilla and mandible in millimeters measured by CT scan | 1 week after MMA |
| Other rotational surgical movement parameters |
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Inclusion Criteria:
For OSA patients:
For bedpartners of patients:
• Sharing a bed ⩾2 nights/week with patient.
Exclusion Criteria:
For OSA patients:
For bedpartners of patients:
• Refusal to participate.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ho | Contact | 020-5663898 | j.p.ho@amsterdamumc.nl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Oral and Maxillofacial Surgery, Amsterdam UMC | Amsterdam | North Holland | 1105 AZ | Netherlands |
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| Splint MMA surgery | Procedure | 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. |
|
Roll and yaw of the maxilla and mandible in degrees measured by CT scan
| 1 week after MMA |
| Duration of surgery | The time between the start of incision and the suture of the incisions. | During MMA surgery |
| Blood loss | Blood loss during surgery | During MMA surgery |
| Adverse events/complications | Intra- and post-operative adverse events/complications | 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) | 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 | Preoperatively, six months postoperatively, and 60 months postoperatively |
| Lowest oxygen saturation | The minimum blood oxygen level (%) reached during a sleep study | 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 | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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). | 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. | 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; | 6 months after MMA |
| Upper airway volume | Upper airway volume (mm³) measured using three-dimensional imaging analysis | Preoperatively and 6 months after MMA |
| Upper airway length | Upper airway length measured using three-dimensional imaging analysis (mm) | Preoperatively and 6 months after MMA |
| Upper airway surface area | Upper airway surface area (mm²) measured using three-dimensional imaging analysis | 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 | 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. | 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. | Preoperatively and 6 months after MMA |
| Blood pressure | Systolic and diastolic blood pressure | 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). | 6, 12, 24, 36, 48, and 60 months after MMA |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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