[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"orthognathic-surgical-procedures\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:orthognathic-surgical-procedures":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,49,70,97,133,163,189],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"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":20,"type":21},66,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28,29],"Sleep Apnea Syndrome (OSAS)","Orthognathic Surgical Procedures","Sleep Apnea - Obstructive",[31,32,33,34,35],"OSA","Maxilomandibular advancement surgery","MMA","Patient-specific implants","Splintless orthognathic","NOT_YET_RECRUITING","2026-05-13",{"date":39,"type":40},"2026-05-20","ACTUAL",{"date":42,"type":21},"2026-12-01",{"date":44,"type":21},"2033-02-28",{"name":46,"class":47},"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":59,"conditions":60,"keywords":63,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":67,"leadSponsor":69,"locationsCount":48},"100637904","natural-history-of-central-and-mixed-sleep-apneas-followed-by-maxillomandibular-advancement-for-obstructive-sleep-apnea-100637904","NCT07596719","Natural History of Central and Mixed Sleep Apneas Followed by Maxillomandibular Advancement for Obstructive Sleep Apnea","CMAI","Inclusion Criteria:\n\n* Adults aged 18 years or older;\n* Mild to severe OSA as determined by a polysomnography (PSG) preoperatively;\n* Completion of MMA for OSA treatment;\n* Subjects with preoperative and postoperative PSG;\n* Patients who are present with MMA treatment-related central apneas postoperatively\n\nExclusion Criteria:\n\n* Patients who underwent other adjunctive procedures at the time of MMA (e.g., multi-piece Le Fort osteotomy, TMJ reconstruction);\n* Previous history of orthognathic surgery;\n* Cleft palate and syndromic patients.",{"count":57,"type":21},60,"OBSERVATIONAL","The goal of this observational prospective cohort study is to learn about the natural course of central and mixed sleep apneas that develop after maxillomandibular advancement (MMA) surgery for obstructive sleep apnea (OSA) in adult patients.\n\nThe main question it aims to answer is:\n\nDo central and mixed apneas resolve, partially resolve, or persist in the long term after MMA?\n\nParticipants will:\n\nUndergo a first postoperative polysomnography (PSG) at 3-6 months after MMA (part of standard care).\n\nBe invited into the study if central\u002Fmixed apneas are detected (CMAI% \\>25%). Undergo a second PSG at least 12 months after MMA (extra study procedure)",[27,61,62,28],"Central Sleep Apnea","Maxillomandibular Advancement Surgery",[31,33,61],{"date":65,"type":40},"2026-05-19",{"date":42,"type":21},{"date":68,"type":21},"2027-12-31",{"name":46,"class":47},{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":76,"sex":17,"minAge":18,"maxAge":77,"enrollmentInfo":78,"targetDuration":4,"studyType":22,"phases":80,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":96},"100606333","piezosurgery-versus-conventional-techniques-in-orthognathic-surgery-100606333","NCT07174193","Piezosurgery Versus Conventional Techniques in Orthognathic Surgery","4.2 Inclusion criteria\n\nWe will include:\n\n* Dutch or English-speaking patients\n* Patients 18-65 years of age\n\n4.3 Exclusion criteria\n\nThe following patients will be excluded from the study:\n\n* Patients with any underlying comorbidities or medication use that may impair bone healing, i.e., radiotherapy in the head- and neck region or the use of antiresorptive drugs.\n* Patients with coagulation disorders or those using of anticoagulative medication\n* Patients with a history of facial trauma or previous facial surgery\n* Patients who smoke\n* Patients with facial cleft(s) or other craniofacial anomalies\n* Patients undergoing simultaneous genioplasty",true,"65 Years",{"count":79,"type":21},70,[24],"The goal of this randomized double-blinded controlled clinical trial is to determine whether piezosurgery can reduce complications and improve outcomes compared to conventional osteotomy techniques in patients undergoing bilateral sagittal split osteotomy (BSSO), with or without concurrent Le Fort I osteotomy (bimaxillary surgery).\n\nThe main questions this study aims to answer are:\n\n* Does piezosurgery reduce inferior alveolar nerve impairment following BSSO compared to conventional techniques?\n* Does piezosurgery affect surgical duration, intraoperative blood loss, rates of bad splits, postoperative infections, costs, and environmental sustainability compared to conventional techniques?\n\nResearchers will compare BSSO performed with piezosurgery versus BSSO performed with conventional oscillating saw and burr techniques to see if piezosurgery leads to better sensory outcomes, reduced morbidity, and improved cost-effectiveness and sustainability.\n\nParticipants will be:\n\n* Dutch or English-speaking adults aged 18-65 scheduled for BSSO or BIMAX surgery at Erasmus Medical Centre (Rotterdam) or St. Anna Hospital (Geldrop, Netherlands).\n* Exclusions include bone healing disorders, coagulation issues, facial trauma history, smoking, craniofacial anomalies, and planned simultaneous genioplasty.\n\nParticipants will:\n\n* Undergo preoperative assessment of inferior alveolar nerve function (two-point discrimination test, validated questionnaire).\n* Be randomized into:\n\n  * Intervention group: BSSO performed entirely using piezosurgery.\n  * Control group: BSSO performed with conventional burr and saw techniques.\n* Have their surgery performed by experienced maxillofacial surgeons following standardized protocols.\n* Have operative time and blood loss recorded during surgery.\n* Be followed up at 1 week, 3 months, 6 months, and 1 year for nerve function, sensory recovery, and infection assessment.\n* Complete postoperative questionnaires on sensory changes at 3 months and 1 year.\n* Have surgical outcomes evaluated by blinded examiners.\n* Contribute to a life cycle cost analysis (LCC) and life cycle assessment (LCA) comparing equipment cost, maintenance, energy use, waste generation, and environmental impact between techniques.",[28,83],"Piezoelectric Technique",[85,86],"orthognathic surgery","piezosurgery","2025-09-08",{"date":89,"type":40},"2025-09-15",{"date":91,"type":21},"2025-10-01",{"date":93,"type":21},"2027-10-01",{"name":95,"class":47},"Erasmus Medical Center",2,{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":4,"eligibilityCriteria":103,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":104,"targetDuration":4,"studyType":22,"phases":105,"briefSummary":106,"conditions":107,"keywords":111,"overallStatus":123,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":96},"100598201","impact-of-3d-printed-anatomical-model-on-patient-understanding-in-orthognathic-surgery-100598201","NCT07068412","Impact of 3D-Printed Anatomical Model on Patient Understanding in Orthognathic Surgery","Impact of 3D-Printed Anatomical Models on Patient Understanding, Anxiety, Patient-Doctor Relationship, and Overall Satisfaction During the Informed Consent Process in Orthognathic Surgery: A Randomized Clinical Trial","Inclusion Criteria:\n\n* Adult patients (aged 18 and above)\n* Scheduled for orthognathic surgery (specifically double-jaw or triple-jaw procedures)\n\nExclusion Criteria:\n\n* Pediatric patients (under 18 years old)\n* Patients undergoing re-do\u002Frevision surgery\n* Patients with psychiatric disorders\n* Patients receiving only orthodontic treatment\n* Patients undergoing single-jaw surgery",{"count":57,"type":21},[24],"The goal of this clinical trial is to learn whether using three dimensional (3D)-printed anatomical models improves the informed consent process for participants undergoing orthognathic surgery. The trial also explores how these models affect participants understanding, anxiety, satisfaction, and communication with the surgeon.\n\nThe main questions it aims to answer are:\n\n* Do 3D-printed anatomical models improve participants understanding of their jaw condition and the surgical procedure?\n* Do they reduce participants anxiety before surgery?\n* Do they enhance overall participants satisfaction and the physician-patient relationship?\n\nResearchers compares participants who received standard two dimensional (2D) imaging and verbal explanations with those who received the same information plus 3D-printed jaw models.\n\nParticipants:\n\n* Scheduled for double- or triple-jaw orthognathic surgery\n* Randomly assigned to receive either traditional 2D education or the 3D-printed model intervention\n* Complete a validated questionnaires assessing understanding, anxiety, satisfaction, and doctor-patient communication",[108,28,109,110],"Skeletal Deformities","Anxiety","Patient Education",[112,113,114,115,116,117,118,119,120,121,122],"Skeletal deformities","Skeletal class II","Skeletal class III","Orthognathic surgery","Patient understanding","Patients' satisfaction","Patient-doctor relationship","Anxiety level","anatomical models","3D printed models","Patient education","RECRUITING","2025-07-06",{"date":126,"type":40},"2025-07-16",{"date":128,"type":40},"2025-06-01",{"date":130,"type":21},"2025-08-30",{"name":132,"class":47},"King Abdulaziz University",{"id":134,"slug":135,"hasResults":11,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":139,"eligibilityCriteria":140,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":141,"enrollmentInfo":142,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":144,"conditions":145,"keywords":146,"overallStatus":123,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":96},"100584765","facial-conformation-meshes-for-orthognathic-surgery-100584765","NCT06893614","Facial Conformation Meshes for Orthognathic Surgery","Segmented 3D Facial Conformation Meshes and Regional Esthetic Subunits: Advancing Soft Tissue Prediction Planning for Orthognathic Surgery: A Retrospective Study","FEU","Inclusion Criteria:\n\n* Preoperative and at least 6 months postoperative CBCTs of Patients who suffered from class III facial deformity and had bimaxillary orthognathic surgical correction who undergone maxillary advancement and mandibular setbacks.\n\nExclusion Criteria:\n\n* CBCTs of patients with:\n\n  * Craniofacial anomalies including cleft lip\u002Fpalate,\n  * who had had previous maxillofacial operations or facial scars,\n  * Surgical Corrections that required multi-segment Le Fort I osteotomies,\n  * Simultaneous Genioplasty as part of the carried-out corrections.\n  * Significant facial Asymmetry.\n  * Missing Data","50 Years",{"count":143,"type":21},13,"This study is a retrospective analysis that evaluates the accuracy of 3D soft tissue simulation in bimaxillary orthognathic surgery for Class III dentofacial deformities. The study integrates segmented 3D facial conformation meshes and regional aesthetic subunits to enhance soft tissue prediction accuracy.\n\nKey Aspects of the Study:\n\nStudy Design: Retrospective analysis based on existing CBCT scans of patients who have undergone maxillary advancement and mandibular setback surgery.\n\nObjective: To assess the accuracy of soft tissue predictions using Dolphin software in different facial regions, particularly in midline vs. lateral regions.\n\nMethodology:\n\n.CBCT superimposition using voxel-based registration. .Soft tissue surface analysis via generic mesh conformation and dense correspondence analysis.\n\n.Error assessment in X, Y, Z dimensions rather than Euclidean distance. .Color-coded maps for visualizing prediction accuracy.\n\nClinical Relevance:\n\nThe study aims to refine 3D prediction models for orthognathic surgery planning, making them more precise and reliable.\n\nKey innovation: Modifying the aesthetic unit segmentation approach for a clinically and statistically relevant assessment of soft tissue changes.\n\nFindings will contribute to improving surgical outcome predictability and optimizing treatment planning in maxillofacial surgery.\n\nEthical Considerations:\n\nNo patient recruitment; the study relies solely on existing anonymized CBCT scans.\n\nEthical approval and waiver of informed consent will be sought from the Institutional Review Board (IRB).\n\nThis research aligns with modern advancements in 3D facial prediction technology, aiming to enhance precision and clinical applicability in orthognathic surgery.",[28],[147,148,149,150,151,152,153],"Orthognathic Surgery","Three-Dimensional Imaging.","Soft Tissue.","Cone-Beam Computed Tomography","Prognathism","Treatment Outcome","Computer Simulation","2025-03-23",{"date":156,"type":40},"2025-03-25",{"date":158,"type":40},"2025-03-12",{"date":160,"type":21},"2025-05-01",{"name":162,"class":47},"Ain Shams University",{"id":164,"slug":165,"hasResults":11,"nctId":166,"briefTitle":167,"officialTitle":168,"acronym":169,"eligibilityCriteria":170,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":171,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":173,"conditions":174,"keywords":176,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":181,"lastUpdatePostDateStruct":182,"startDateStruct":184,"completionDateStruct":185,"leadSponsor":187,"locationsCount":48},"100583665","incidence-of-body-dysmorphic-disorder-bdd-in-a-population-of-patients-undergoing-orthognathic-surgery-100583665","NCT06879275","Incidence of Body Dysmorphic Disorder (BDD) in a Population of Patients Undergoing Orthognathic Surgery","Incidence of Body Dysmorphic Disorder (BDD) in a Population of Patients Undergoing Orthognathic Surgery: a Prospective Study","IBDOS","Inclusion Criteria:\n\n* Patients who are candidates for orthognathic surgery\n* Age: 18 to 50 years;\n* Informed consent\n\nExclusion Criteria:\n\n* \\- Patients diagnosed with another psychiatric pathology\n* Patients affected by syndromes involving the cervical-facial district\n* Patients affected by clefts\n* Patients affected by OSAS and candidates for orthognathic surgery for this indication\n* Patients affected by connective tissue disorders (e.g. Ehler-Danlos, scleroderma, etc.)\n* Patients candidates for orthognathic surgery due to facial trauma",{"count":172,"type":21},90,"Assessment of the incidence of Body dismorphic disorder in a population candidated to orthognathic surgery",[28,175,151],"Psychiatric Disorders",[177,178,179,180],"orthognatic surgery","body dismorphic disorder","prognathism","aesthetic surgery","2025-03-13",{"date":183,"type":40},"2025-03-17",{"date":160,"type":21},{"date":186,"type":21},"2030-01-01",{"name":188,"class":47},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS",{"id":190,"slug":191,"hasResults":11,"nctId":192,"briefTitle":193,"officialTitle":194,"acronym":195,"eligibilityCriteria":196,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":197,"targetDuration":4,"studyType":22,"phases":199,"briefSummary":200,"conditions":201,"keywords":202,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":206,"lastUpdatePostDateStruct":207,"startDateStruct":209,"completionDateStruct":211,"leadSponsor":213,"locationsCount":4},"100557326","biodegradable-magnesium-bone-plate-and-screw-fixation-in-jaw-surgery-100557326","NCT06536660","Biodegradable Magnesium Bone Plate and Screw Fixation in Jaw Surgery","Development and Application of Biodegradable Magnesium Bone Plate and Screw Fixation in Jaw Surgery","MgJawSurgery","Inclusion Criteria:\n\n1. Participants must be 18 years of age or older.\n2. Participants must have confirmed indications for jaw surgery with internal fixation, such as alveolar onlay bone grafting, fracture fixation, orthognathic surgery, or reconstructive surgery.\n3. Participants should have adequate bone quality and sufficient bone volume to support the placement of magnesium bone plates and screws.\n4. Participants must provide written informed consent, indicating their understanding of the potential risks and benefits of magnesium bone plate and screw fixation.\n\nExclusion Criteria:\n\n1. Participants with certain medical conditions that may affect bone healing or increase the risk of complications, such as uncontrolled diabetes, severe osteoporosis, multiple myelomas, or active bone infections.\n2. Participants with medical conditions that may exacerbate or predispose them to systemic side effects of magnesium implants, thus contraindicating their use, should be excluded. These conditions include chronic kidney disease, hypermagnesemia, severe electrolyte imbalances, severe heart disease (especially in those with a history of arrhythmias or heart failure), myasthenia gravis, abnormal thyroid functions, hyperparathyroidism, and adrenocortical insufficiency.\n3. Participants with known allergies or hypersensitivity to magnesium.\n4. Participants with an ASA score of 3 or above, indicating a higher risk for general anesthesia.\n5. Participants who are pregnant or breastfeeding.\n6. Participants deemed unlikely to comply with the study protocol, such as attending follow-up appointments or adhering to post-operative care instructions.",{"count":198,"type":21},62,[24],"The purpose of this study is to evaluate the efficacy and safety of using high-purity magnesium bone plates and screws for internal fixation in jaw surgery. The investigators aim to assess whether these biodegradable magnesium devices promote normal bone healing and functional recovery while ensuring the safety of patients undergoing dentoalveolar surgery, fracture fixation, orthognathic surgery, or craniofacial reconstruction. The hypotheses are:\n\n1. High-purity magnesium bone plates and screws are effective in bone fixation, promoting normal bone healing and functional recovery in jaw surgery.\n2. High-purity magnesium bone plates and screws are safe in jaw surgery in terms of local side effects and systemic safety.\n\nParticipants will undergo jaw surgery based on the clinical indications. High-purity magnesium bone plates and screws will be used for internal fixation during the surgical procedure. Participants will be followed up at 1 week, 3 weeks, 6 weeks, 3 months, 6 months, 1 year, and 2 years after surgery to assess wound healing, functional recovery, and any side effects. If any side effects occur or deemed necessary, participants may be followed up for a longer period. During postoperative follow-up visits, X-ray or CBCT\u002FCT imaging will be conducted routinely or when clinically indicated.",[28],[203,204,205,28],"Biodegradable Magnesium Bone Plate","Screw Fixation","Jaw Surgery","2024-07-30",{"date":208,"type":40},"2024-08-05",{"date":210,"type":21},"2024-08-15",{"date":212,"type":21},"2028-08-15",{"name":214,"class":47},"The University of Hong Kong"]