[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"angle-class-i-malocclusion\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:angle-class-i-malocclusion":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"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":21,"type":22},34,"ESTIMATED","INTERVENTIONAL",[25],"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.",[28,29,30],"Angle Class I Malocclusion","Dental Crowding","Tooth Spacing",[32,33,34,35,36,37],"In office aligners","3D printed aligners","Thermoformed Aligners","Tooth movement","Photopolymer Resin","Pain","RECRUITING","2026-06-05",{"date":41,"type":42},"2026-06-09","ACTUAL",{"date":44,"type":22},"2026-06",{"date":46,"type":22},"2027-10",{"name":48,"class":49},"University of Baghdad","OTHER",3]