Splintless Versus Conventional Maxillomandibular Advancement Surgery for Obstructive Sleep Apnea

NCT07598461 | Not Yet Recruiting DMC

• 1 other identifier: 2024.0736
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Apnea Syndrome (OSAS); Orthognathic Surgical Procedures; Sleep Apnea - Obstructive

Keywords

OSA; Maxilomandibular advancement surgery; MMA; Patient-specific implants; Splintless orthognathic

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (28)

• Other translational surgical movement parameters

  1 week after MMA

• Other rotational surgical movement parameters

  1 week after MMA

• Duration of surgery

  During MMA surgery

• Blood loss

  During MMA surgery

• Adverse events/complications

  During MMA surgery and follow-Ups (up to 60 months postoperatively)

Study Arms (2)

Splintless group

EXPERIMENTAL

In the splintless group, MMA using patient-specific osteotomy guides and fixation implants (i.e., splintless MMA) will be executed.

Procedure: Splintless MMA surgery

Splint group

ACTIVE COMPARATOR

In the splint group, conventioanl MMA using surgical splints (i.e., splint MMA) will be executed.

Procedure: Splint MMA surgery

Interventions

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.

Splintless group

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.

Splint group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead
• Materialise: collaborator

Study Sites (1)

Department of Oral and Maxillofacial Surgery, Amsterdam UMC

Amsterdam, North Holland, 1105 AZ, Netherlands

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes; Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Central Study Contacts

Ho

CONTACT

020-5663898; j.p.ho@amsterdamumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, doctor

Study Record Dates

• First Submitted: May 6, 2026
• First Posted: May 20, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): February 28, 2033
• Last Updated: May 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)