[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643395":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":35,"locations":41,"responsibleParty":77,"collaborators":25,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":25,"eligibilityCriteria":86,"healthyVolunteers":87,"sex":88,"minAge":89,"maxAge":90,"enrollmentInfo":91,"targetDuration":25,"studyType":94,"phases":95,"briefSummary":97,"conditions":98,"keywords":102,"overallStatus":44,"whyStopped":25,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},{"fullName":5,"class":6},"University of Baghdad","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Direct-Printed Aligner","EXPERIMENTAL","Participants in this group will receive clear aligners manufactured using in-office 3D printing technology. This arm tests the effectiveness of additive manufacturing and the shape-memory properties of the resin in achieving programmed tooth movements.",[13],"Device: Direct-Printed Aligner",{"label":15,"type":16,"description":17,"interventionNames":18},"Thermoformed Aligner","ACTIVE_COMPARATOR","Participants in this group will receive conventional clear aligners manufactured using the vacuum-forming (thermoforming) process. This arm serves as the gold standard to which the experimental 3D-printed aligners are compared.",[19],"Device: Thermoformed aligner",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Participants in this group will receive clear aligner therapy fabricated via direct-printing, utilizing a specialized light-curable resin (Clear-A V2, Senertek, İzmir, Turkey).",[9],null,{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Thermoformed aligner","Participants in this group will treated with clear aligners fabricated via the conventional indirect method, involving the thermoforming of thermoplastic sheets (Zendura FLX, Zendura dental, Fremont, California) over 3D-printed dental molds.",[15],[31],{"name":32,"affiliation":33,"role":34},"Noor Muhammed Garma, Assistant Professor","University of Baghdad, College of Dentistry, Department of Orthodontic.","STUDY_DIRECTOR",[36],{"name":37,"role":38,"phone":39,"phoneExt":25,"email":40},"Ali Rahman Issa, PhD student","CONTACT","009647801218939","ali.hassan1902@codental.uobaghdad.edu.iq",[42,59,69],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Specialized Dental Center for Prosthodontics and Orthodontics","RECRUITING","Baghdad","Bab Al-Muadham","10047","Iraq","IQ",{"type":51,"coordinates":52},"Point",[53,54],44.40088,33.34058,{"lat":54,"lon":53},[57],{"name":58,"role":38,"phone":39,"phoneExt":25,"email":40},"Ali Rahman Issa",{"facility":60,"status":44,"city":45,"state":25,"zip":61,"country":48,"countryCode":49,"cosmosGeoPoint":62,"geoPoint":64,"contacts":65},"Z Orchida Clinic","10013",{"type":51,"coordinates":63},[53,54],{"lat":54,"lon":53},[66],{"name":67,"role":38,"phone":39,"phoneExt":25,"email":68},"Ali Rahman isaa","ali.abdolrahman@gmail.com",{"facility":70,"status":44,"city":45,"state":25,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":71,"geoPoint":73,"contacts":74},"Orthodontic department, College of dentistry, university of Baghdad.",{"type":51,"coordinates":72},[53,54],{"lat":54,"lon":53},[75],{"name":76,"role":38,"phone":39,"phoneExt":25,"email":40},"Ali Rahman Issa, PhD. student",{"type":78,"investigatorFullName":58,"investigatorTitle":79,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Assistant Lecturer, PhD student","100643395","clinical-performance-of-direct-printed-versus-thermoformed-aligners-100643395",false,"NCT07637227","Clinical Performance of Direct-Printed Versus Thermoformed Aligners","Clinical Performance of In-Office Directly Printed Versus Thermoformed Aligners: A Randomized Clinical Trial","Inclusion Criteria:\n\n1. Adult patient with an age range of 15-30 with fully erupted all permanent dentitions excluding third molars, and a willingness to participate in the trial.\n2. Angle Class I non-extraction cases, presented with mild crowding or spacing (\\\u003C5 mm) and dental rotation \\\u003C30° .\n3. Good oral hygiene; no active caries\u002Fperiodontal disease, no history of trauma or root resorption.\n\nExclusion Criteria:\n\n1. Pregnancy, smoking, and systemic conditions affecting bone remodeling.\n2. Subject with poor oral hygiene, using simplified oral hygiene index (OHI-S ≥ 3.1 ) (Greene \\& Vermillion, 1963).\n3. Patient with malposed lower second molars (need orthodontic alignment).\n4. Allergy to materials used (resins, plastics, solvents).\n5. History of trauma, root resorption, and dilacerated roots.\n6. Previous extraction or history of previous orthodontic treatment.",true,"ALL","15 Years","30 Years",{"count":92,"type":93},34,"ESTIMATED","INTERVENTIONAL",[96],"NA","The goal of this study is to evaluate and compare the clinical effectiveness of in-office directly 3D-printed clear aligners versus conventional multilayered thermoformed aligners.\n\nThe main question it aims to answer is:\n\nDoes the use of in-office direct-printed shape-memory aligners result in superior clinical effectiveness, compared to established multilayer thermoformed aligner systems?\n\nResearchers will compare a Direct-Printed Aligner (DPA) group using Senertek Clear-A V2 resin to a Thermoformed Aligner (TFA) group using Zendura FLX multilayer sheets to see if the additive manufacturing process improves clinical outcomes and patient satisfaction.\n\nParticipants will:\n\n* Undergo initial records including intraoral digital scans, photos, and a panoramic radiograph for treatment planning.\n* Wear their assigned clear aligners (either direct-printed or thermoformed) for at least 22 hours per day, changing them every 7 days.\n* Attend follow-up appointments every 5 weeks.",[99,100,101],"Angle Class I Malocclusion","Dental Crowding","Tooth Spacing",[103,104,105,106,107,108],"In office aligners","3D printed aligners","Thermoformed Aligners","Tooth movement","Photopolymer Resin","Pain","2026-06-05",{"date":111,"type":112},"2026-06-09","ACTUAL",{"date":114,"type":93},"2026-06",{"date":116,"type":93},"2027-10",{"name":5,"class":6},3]