[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100599024":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":33,"locations":25,"responsibleParty":39,"collaborators":25,"id":41,"slug":42,"hasResults":43,"nctId":44,"briefTitle":45,"officialTitle":45,"acronym":25,"eligibilityCriteria":46,"healthyVolunteers":43,"sex":47,"minAge":48,"maxAge":49,"enrollmentInfo":50,"targetDuration":25,"studyType":53,"phases":54,"briefSummary":56,"conditions":57,"keywords":61,"overallStatus":63,"whyStopped":25,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":25},{"fullName":5,"class":6},"Johns Hopkins University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Industry made splint","EXPERIMENTAL","Occlusal splints will be 3D printed by industrial third party",[13],"Device: Industry made occlusal splint",{"label":15,"type":10,"description":16,"interventionNames":17},"In House made splint","In house 3D printed occlusal splint",[18],"Device: Formlabs 3D printed occlusal splint",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Formlabs 3D printed occlusal splint","In house 3D printed occlusal splint with Formlabs printer",[15],null,{"type":21,"name":27,"description":27,"armGroupLabels":28,"otherNames":25},"Industry made occlusal splint",[9],[30],{"name":31,"affiliation":5,"role":32},"Robin Yang, MD, DDS","PRINCIPAL_INVESTIGATOR",[34],{"name":35,"role":36,"phone":37,"phoneExt":25,"email":38},"Thomas Ren, BS","CONTACT","8457020623","tren13@jh.edu",{"type":40,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100599024","3d-printed-occlusal-splints-for-intraoperative-use-100599024",false,"NCT07079111","3D Printed Occlusal Splints for Intraoperative Use","Inclusion Criteria:\n\n* Patients of any age who require any orthognathic surgery (including, but not limited to, facial fracture reduction and fixation, mandibular or maxillary reconstruction, cranial vault reconstruction, mandibular osteotomies, maxilla osteotomies) at Johns Hopkins Hospital.\n\nExclusion Criteria:\n\n* Patients who are non-English speaking.\n* Surgeons who do not perform orthognathic surgery with occlusal splints.","ALL","0 Years","80 Years",{"count":51,"type":52},70,"ESTIMATED","INTERVENTIONAL",[55],"NA","A 3D printed intraoperative occlusal splint is a custom-made biocompatible resin guide that allows surgeons properly align a patient's upper and lower dentition during surgery. This alignment further places maxilla and mandible into proper position. An occlusal splint contains outlines maxillary and mandibular dentition allowing the teeth to lock into place with correct alignment.\n\nAt Johns Hopkins, traditionally hand-made and industry-made 3D printed splints have been used safely. However, prior studies have demonstrated the ability of in-house 3D prints to save time and money compared to industry. In-house models are similarly produced with FDA-clear, biocompatible resin for 3D printing, and maintain equivalent safety for patients compared to industry-made models.",[58,59,60],"Malocclusion, Angle Class I","Malocclusion, Angle Class II","Malocclusion, Angle Class III",[62],"malocclusion","NOT_YET_RECRUITING","2026-04-09",{"date":66,"type":67},"2026-04-13","ACTUAL",{"date":69,"type":52},"2026-08-30",{"date":71,"type":52},"2030-08-30",{"name":5,"class":6}]