Sleep Apnea Syndrome (OSAS)SvCMASNCT07598461
Splintless Versus Conventional Maxillomandibular Advancement Surgery for Obstructive Sleep Apnea
A study testing Splintless MMA surgery and Splint MMA surgery in people with Sleep Apnea Syndrome (OSAS) and Orthognathic Surgical Procedures, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea Syndrome (OSAS), Orthognathic Surgical Procedures, Sleep Apnea - Obstructive
- What is being tested?
- Splintless MMA surgery and Splint MMA surgery
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Dec 2026to 28 Feb 2033
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site
Department of Oral and Maxillofacial Surgery, Amsterdam UMC
Amsterdam, North Holland, 1105 AZ
Ho, 020-5663898, j.p.ho@amsterdamumc.nl
About this study
Official title: Splintless Versus Conventional Maxillomandibular Advancement Surgery for Obstructive Sleep Apnea: a Randomized Controlled Trial
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?
Read more
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.
- Being tested
- Splintless MMA surgery, Splint MMA surgery
- Keywords
- OSA, Maxilomandibular advancement surgery, MMA, Patient-specific implants, Splintless orthognathic
- Medical subject headings
- Sleep Apnea Syndromes, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Splintless MMA surgeryProcedure or 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.
Splint MMA surgeryProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| Splintless group | Experimental | In the splintless group, MMA using patient-specific osteotomy guides and fixation implants (i.e., splintless MMA) will be executed. Receives: Procedure: Splintless MMA surgery |
| Splint group | Active comparator | In the splint group, conventioanl MMA using surgical splints (i.e., splint MMA) will be executed. Receives: Procedure: Splint MMA surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 week after MMA
Secondary outcomes (28)
Other translational surgical movement parameters
Mediolateral and superoinferior movement of the maxilla and mandible in millimeters measured by CT scan
Measured: 1 week after MMA
Other rotational surgical movement parameters
Roll and yaw of the maxilla and mandible in degrees measured by CT scan
Measured: 1 week after MMA
Duration of surgery
The time between the start of incision and the suture of the incisions.
Measured: During MMA surgery
Blood loss
Blood loss during surgery
Measured: During MMA surgery
Adverse events/complications
Intra- and post-operative adverse events/complications
Measured: 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)
Measured: 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
Measured: Preoperatively, six months postoperatively, and 60 months postoperatively
Lowest oxygen saturation
The minimum blood oxygen level (%) reached during a sleep study
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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).
Measured: 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.
Measured: 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;
Measured: 6 months after MMA
Upper airway volume
Upper airway volume (mm³) measured using three-dimensional imaging analysis
Measured: Preoperatively and 6 months after MMA
Upper airway length
Upper airway length measured using three-dimensional imaging analysis (mm)
Measured: Preoperatively and 6 months after MMA
Upper airway surface area
Upper airway surface area (mm²) measured using three-dimensional imaging analysis
Measured: 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
Measured: 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.
Measured: 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.
Measured: Preoperatively and 6 months after MMA
Blood pressure
Systolic and diastolic blood pressure
Measured: 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).
Measured: 6, 12, 24, 36, 48, and 60 months after MMA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2026
- Study start1 Dec 2026 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion28 Feb 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea Syndrome (OSAS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Sponsor type
- University, hospital or other
- Collaborators
- Materialise
- Responsible party
- Principal investigator, Prof. dr. J. de Lange, MD DMD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07598461
- Sponsor's protocol ID
- 2024.0736
- Acronym
- SvCMAS
- Status last verified
- May 2026
- First submitted
- 6 May 2026
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Splintless Versus Conventional Maxillomandibular Advancement Surgery for Obstructive Sleep Apnea: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07598461
- Acronym / sponsor ID
- SvCMAS / 2024.0736
- Keywords
- OSA, Maxilomandibular advancement surgery, MMA, Patient-specific implants, Splintless orthognathic
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- Materialise
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 28 Feb 2033 (estimated)
- First posted
- 20 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Splintless group | Experimental | Procedure: Splintless MMA surgeryIn the splintless group, MMA using patient-specific osteotomy guides and fixation implants (i.e., splintless MMA) will be executed. |
| Splint group | Active comparator | Procedure: Splint MMA surgeryIn the splint group, conventioanl MMA using surgical splints (i.e., splint MMA) will be executed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
- Refusal to participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Splintless MMA surgerySplintless 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 or surgery | Splintless group |
| Splint MMA surgeryIn 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. | Procedure or surgery | Splint group |
Primary outcome
Surgical accuracy
Time frame: 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.
28 secondary outcomes
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
EuroQol 5-Dimension 5-Level (EQ-5D-5L) utility index
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
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
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
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
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）
Time frame: Preoperatively and 6 months after MMA
Postsurgical relapse measures
Time frame: 2 years after MMA
Facial soft tissue changes
Time frame: 6 months after MMA
Upper airway volume
Time frame: Preoperatively and 6 months after MMA
Upper airway length
Time frame: Preoperatively and 6 months after MMA
Upper airway surface area
Time frame: Preoperatively and 6 months after MMA
Upper airway minimum cross-sectional area (minCSA)
Time frame: Preoperatively and 6 months after MMA
Lateral dimension of the minimum cross-sectional area of the upper airway
Time frame: Preoperatively and 6 months after MMA
Anteroposterior dimension of the minimum cross-sectional area of the upper airway
Time frame: Preoperatively and 6 months after MMA
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
Time frame: 6, 12, 24, 36, 48, and 60 months after MMA
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Splintless MMA surgery and Splint MMA surgery in people with Sleep Apnea Syndrome (OSAS) and Orthognathic Surgical Procedures, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ho (020-5663898, j.p.ho@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical accuracy (time frame: 1 week after MMA). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.