[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100639491":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":53,"collaborators":57,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":63,"sex":69,"minAge":70,"maxAge":26,"enrollmentInfo":71,"targetDuration":26,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":82,"overallStatus":88,"whyStopped":26,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Splintless group","EXPERIMENTAL","In the splintless group, MMA using patient-specific osteotomy guides and fixation implants (i.e., splintless MMA) will be executed.",[13],"Procedure: Splintless MMA surgery",{"label":15,"type":16,"description":17,"interventionNames":18},"Splint group","ACTIVE_COMPARATOR","In the splint group, conventioanl MMA using surgical splints (i.e., splint MMA) will be executed.",[19],"Procedure: Splint MMA surgery",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Splintless 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\u002FCAM) surgical cutting guides and fixation implants are used to improve surgical precision. Splintless MMA sugery involves virtual surgical planning, surgical procedures, and postoperative monitoring.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Splint 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.",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Ho","CONTACT","020-5663898","j.p.ho@amsterdamumc.nl",[38],{"facility":39,"status":26,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Department of Oral and Maxillofacial Surgery, Amsterdam UMC","Amsterdam","North Holland","1105 AZ","Netherlands","NL",{"type":46,"coordinates":47},"Point",[48,49],4.88969,52.37403,{"lat":49,"lon":48},[52],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},{"type":54,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Prof. dr. J. de Lange, MD DMD","Professor, doctor",[58],{"name":59,"class":60},"Materialise","INDUSTRY","100639491","splintless-versus-conventional-maxillomandibular-advancement-surgery-for-obstructive-sleep-apnea-100639491",false,"NCT07598461","Splintless Versus Conventional Maxillomandibular Advancement Surgery for Obstructive Sleep Apnea","Splintless Versus Conventional Maxillomandibular Advancement Surgery for Obstructive Sleep Apnea: a Randomized Controlled Trial","SvCMAS","Inclusion Criteria:\n\nFor OSA patients:\n\n* Adults aged 18 years or older;\n* Moderate to severe OSA (apnea hypopnea index (AHI) ≥ 15 events\u002Fhour) as determined by an overnight polysomnography (PSG) preoperatively;\n* Continunous positive airway pressure failure or intolerance;\n* General good health for surgery;\n* MMA surgery indicated for OSA treatment.\n\nFor bedpartners of patients:\n\n• Sharing a bed ⩾2 nights\u002Fweek with patient.\n\nExclusion Criteria:\n\nFor OSA patients:\n\n* Other adjunctive procedures indicated at the time of MMA (e.g., multi-piece Le Fort I osteotomy, temporomandibular joint reconstruction);\n* Previous history of orthognathic surgery;\n* Cleft palate and syndromic patients;\n* Refusal to participate.\n\nFor bedpartners of patients:\n\n• Refusal to participate.","ALL","18 Years",{"count":72,"type":73},66,"ESTIMATED","INTERVENTIONAL",[76],"NA","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:\n\nDoes 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?\n\nResearchers will compare splintless MMA to conventional MMA.\n\nPatients will:\n\nUndergo 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).\n\nBedpartners of patients will:\n\nComplete questionnaires at various time points.\n\nThis trial will help determine whether the splintless approach is a better, safer, and more effective alternative for treating OSA with MMA surgery.",[79,80,81],"Sleep Apnea Syndrome (OSAS)","Orthognathic Surgical Procedures","Sleep Apnea - Obstructive",[83,84,85,86,87],"OSA","Maxilomandibular advancement surgery","MMA","Patient-specific implants","Splintless orthognathic","NOT_YET_RECRUITING","2026-05-13",{"date":91,"type":92},"2026-05-20","ACTUAL",{"date":94,"type":73},"2026-12-01",{"date":96,"type":73},"2033-02-28",{"name":5,"class":6},1]