[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100600502":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":24,"studyPopulation":17,"armGroups":25,"interventions":37,"overallOfficials":47,"centralContacts":55,"locations":61,"responsibleParty":74,"collaborators":17,"id":78,"slug":17,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":17,"eligibilityCriteria":83,"healthyVolunteers":79,"sex":84,"minAge":17,"maxAge":17,"enrollmentInfo":85,"targetDuration":17,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":94,"overallStatus":64,"whyStopped":17,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"Al-Azhar University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":17},[9,13],{"measure":10,"description":11,"timeFrame":12},"Bacterial growth measured using colony-forming unit (CFU) count on agar plates.","Saliva samples will be collected from each participant at baseline and at day 14. Samples will be cultured on standard agar plates under aerobic conditions. After incubation, bacterial colonies will be counted, and results will be expressed in colony-forming units per milliliter (CFU\u002Fml). A higher CFU value indicates greater bacterial growth.\n\nUnits:\n\nCFU\u002Fml","from day 0 (Baseline time ) to 14 days after insertion",{"measure":14,"description":15,"timeFrame":16},"Color change of 3D printed retainers measured using spectrophotometer; ΔE calculated at day 0 and day 14.","The color stability of the retainers will be assessed using a spectrophotometer (VITA Easyshade or equivalent). Color difference (ΔE) will be calculated between baseline and day 14. A ΔE \\> 3.3 is considered clinically perceptible. Scale range: 0-10; higher ΔE score indicates greater color change and worse color stability.\n\nUnits:\n\nΔE (Delta E) score","from day 0 (baseline time ) to 14 days after insertion",null,{"allocation":19,"interventionModel":20,"interventionModelDescription":17,"primaryPurpose":21,"observationalModel":17,"timePerspective":17,"maskingInfo":22},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":23,"maskingDescription":17,"whoMasked":17},"NONE","Retainers are routinely fitted at the end of active orthodontic treatment to allow the teeth to adjust to their new positions The growing demand has led to constant improvements in materials and technologies offered by a rising number of different companies.\n\nIn recent years, major technological innovations in 3D printing, especially related to computer-aided design, biomaterials and manufacturing techniques, have enabled the production of in-office direct printed Retainers (DPRs) - representing an innovation compared to the traditional thermoformed Retainers.\n\nInsufficient cleaning will lead to microbe's growth in retainers. The mostly found microbes are candida and staphylococcus that may include MRSA strains. Once the biofilms are formed in the retainer it's quite difficult to remove that biofilm which shows resistance to antimicrobials and difficult to clear.\n\northodontic retainers hinder the sterilizing effect of saliva, which further promotes the rapid division, reproduction, and growth of colonized bacteria.\n\nStaphylococcus aureus is most commonly found on the retainers and tends to cause bloodstream infections which can lead to serious other infections.\n\nWhile several studies have assessed tooth movement, and biomechanical and clinical effects according to the design of attachments, studies investigating the thickness of the CAs are limited",[26,32],{"label":27,"type":28,"description":29,"interventionNames":30},"direct 3d printed retainer of .5mm","EXPERIMENTAL","group wearing direct 3d retainer of .5 mm",[31],"Device: retainer with .5 mm thickness",{"label":33,"type":28,"description":34,"interventionNames":35},"direct 3d printed retainer of 1mm","group wearing direct 3 d retainer with thickness 1 mm",[36],"Device: retainer with 1 mm thickness",[38,43],{"type":39,"name":40,"description":41,"armGroupLabels":42,"otherNames":17},"DEVICE","retainer with .5 mm thickness","direct 3d printed retainer with .5 mm thickness",[27],{"type":39,"name":44,"description":45,"armGroupLabels":46,"otherNames":17},"retainer with 1 mm thickness","direct 3d printed retainer with 1 mm thickness,",[33],[48,52],{"name":49,"affiliation":50,"role":51},"Dr. Mustafa Mohamed Mahmoud Dawaba Associate Professor of Orthodontics","Faculty of Dental Medicine, Al-Azhar University Assiut Branch","STUDY_CHAIR",{"name":53,"affiliation":54,"role":51},"Dr. Mahmoud Mohamed Salah El-din Ibrahim Lecturer of Orthodontics","Faculty of Dental Medicine , Al-Azhar University Assiut Branch",[56],{"name":57,"role":58,"phone":59,"phoneExt":17,"email":60},"Norhan Ibrahim Eldsokee Master's Candidate, B.D.S","CONTACT","+20 01559921144","noureldsokee@gmail.com",[62],{"facility":63,"status":64,"city":65,"state":17,"zip":17,"country":66,"countryCode":67,"cosmosGeoPoint":68,"geoPoint":73,"contacts":17},"Faculty of Dental Medicine , Al-Azhar University","RECRUITING","Asyut","Egypt","EG",{"type":69,"coordinates":70},"Point",[71,72],31.18368,27.18096,{"lat":72,"lon":71},{"type":75,"investigatorFullName":76,"investigatorTitle":77,"investigatorAffiliation":5,"oldNameTitle":17,"oldOrganization":17},"PRINCIPAL_INVESTIGATOR","Norhan Ibrahim Eldsokee Khidr","Principal Investigator, Master's Candidate at Orthodontic department at Al-Azhar University, Assiut branch.","100600502",false,"NCT07098325","Biological Reaction of Direct 3d Printed Retainers","Evaluation of Biological Reaction of Direct Three Dimensional Printed Retainers","Inclusion Criteria:\n\n* -Finished fixed orthodontic therapy and seeking for retention as a part of their original treatment plan.\n* Good oral hygiene.\n* No habits (e.g., smoking)\n\nExclusion Criteria:\n\n* Medication affecting saliva.\n\n  * intrinsic tooth discoloration.\n  * Uncooperative patients.\n  * Patient with periodontitis.\n  * Learning difficulties and inability to read written instructions.","ALL",{"count":86,"type":87},26,"ESTIMATED","INTERVENTIONAL",[90],"NA","The aim of this study will be to evaluate the biological reaction of direct three dimensional printed retainers.\n\nPrimary objective is to evaluate bacterial growth and color stability between different thicknesses of 3d printed material used as a retainer .\n\nSecondary objective is to determine the optimal thickness for use in clear aligner fabrication based on biological performance.",[93],"Orthodontic Retainers",[95,96,97,98],"Different thicknesses","Direct three dimensional printed retainers","Bacterial growth","Color change","2025-07-25",{"date":101,"type":102},"2025-08-01","ACTUAL",{"date":104,"type":87},"2025-10-01",{"date":106,"type":87},"2027-06-01",{"name":5,"class":6},1]