[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100613154":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":20,"studyPopulation":13,"armGroups":21,"interventions":37,"overallOfficials":13,"centralContacts":47,"locations":57,"responsibleParty":72,"collaborators":76,"id":80,"slug":13,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":13,"eligibilityCriteria":85,"healthyVolunteers":86,"sex":87,"minAge":88,"maxAge":89,"enrollmentInfo":90,"targetDuration":13,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":99,"overallStatus":59,"whyStopped":13,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"Bezmialem Vakif University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Change in Maxillary First Molar Tipping","The angulation of the maxillary first molars will be measured using three-dimensional digital models obtained at T0, at 3 months after completion of expansion (T1), and at the 6-month retention follow-up (T2). Angular changes will be calculated through superimposition of maxillary 3D models and standardized angular measurements.","Baseline (T0), 3 months after expansion (T1), and 6-month retention period (T2)",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":13,"primaryPurpose":17,"observationalModel":13,"timePerspective":13,"maskingInfo":18},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":19,"maskingDescription":13,"whoMasked":13},"NONE","Maxillary transverse deficiency is a common craniofacial problem that often presents with posterior crossbite and dental crowding. Rapid Maxillary Expansion (RME) achieves sutural separation and bone remodeling, typically activated at 0.5 mm per day. Invisalign® Palatal Expander (IPE) is a modern digital system using 3D printing to produce removable nylon expanders adapted to palatal curvature, with 0.25 mm activations, simplifying oral hygiene and eliminating screw activation.\n\nThis controlled prospective clinical trial will recruit 60 children with maxillary transverse deficiency. Participants will be assigned to three groups: IPE (n=20), RME (n=20), and untreated control (n=20). Intraoral scans will be obtained at the end of expansion, at 3 months, and at 6 months to create three-dimensional digital models. Maxillary dental arch widths, first molar angulations, palatal surface areas, and volumes will be measured. Extraoral 3D facial scans will evaluate soft tissue changes, including nasal tip, alar width, and interzygomatic distance.\n\nStatistical analyses will be performed using SPSS, applying t-tests for intra- and inter-group comparisons. The study aims to provide comparative data on a traditional (RME) and a contemporary digital (IPE) maxillary expansion method. No prior studies have directly compared these two techniques in children.",[22,28,33],{"label":23,"type":24,"description":25,"interventionNames":26},"IPE Group","EXPERIMENTAL","Participants in this group will receive treatment with the Invisalign Palatal Expander (IPE). Three-dimensional (3D) intraoral and extraoral scans will be taken at the end of expansion, at 3 months, and at 6 months.",[27],"Device: Invisalign Palatal Expander (IPE)",{"label":29,"type":24,"description":30,"interventionNames":31},"RME Group","Participants in this group will receive treatment with an acrylic cap splint Rapid Maxillary Expansion (RME) appliance. Three-dimensional (3D) intraoral and extraoral scans will be taken at the end of expansion, at 3 months, and at 6 months.",[32],"Device: Acrylic Cap Splint Rapid Maxillary Expansion (RME) Appliance",{"label":34,"type":35,"description":36,"interventionNames":13},"Control Group","NO_INTERVENTION","Participants in this group will not receive orthodontic expansion treatment during the study period and will serve as untreated controls. 3D intraoral and extraoral scans will be obtained at the same time points as treatment groups (end of expansion period equivalent, 3 months, 6 months).",[38,43],{"type":39,"name":40,"description":41,"armGroupLabels":42,"otherNames":13},"DEVICE","Invisalign Palatal Expander (IPE)","A removable, nylon palatal expander produced via digital workflow and 3D printing. Activations are planned at 0.25 mm per activation according to manufacturer protocol. Device is fitted to palatal curvature and used until desired expansion achieved, followed by retention.",[23],{"type":39,"name":44,"description":45,"armGroupLabels":46,"otherNames":13},"Acrylic Cap Splint Rapid Maxillary Expansion (RME) Appliance","Bonded acrylic cap splint RME with a jackscrew activated typically at 0.5 mm per day until expansion goal is reached, followed by retention period. Used in pediatric orthodontic practice.",[29],[48,53],{"name":49,"role":50,"phone":51,"phoneExt":13,"email":52},"Banu Kılıç, Associate Professor","CONTACT","+90 532 243 2756","bkilic@bezmialem.edu.tr",{"name":54,"role":50,"phone":55,"phoneExt":13,"email":56},"Büşra Zeynep Yörük, Phd Student","+90 531 287 8055","dr.zeynepyoruk@gmail.com",[58],{"facility":5,"status":59,"city":60,"state":61,"zip":62,"country":63,"countryCode":13,"cosmosGeoPoint":64,"geoPoint":69,"contacts":70},"RECRUITING","Istanbul","Fatih","34093","Turkey (Türkiye)",{"type":65,"coordinates":66},"Point",[67,68],28.94966,41.01384,{"lat":68,"lon":67},[71],{"name":49,"role":50,"phone":51,"phoneExt":13,"email":52},{"type":73,"investigatorFullName":74,"investigatorTitle":75,"investigatorAffiliation":5,"oldNameTitle":13,"oldOrganization":13},"SPONSOR_INVESTIGATOR","Büşra Zeynep Yörük","Phd Student",[77],{"name":78,"class":79},"Centerdent Orthodontics & Aesthetic Dentistry Clinic","UNKNOWN","100613154",false,"NCT07262892","3D Evaluation of Maxillary Expansion Methods","Three-Dimensional Evaluation of the Effects of Different Maxillary Expansion Methods","Inclusion Criteria:\n\n* Children aged 6-12 years\n* Good oral hygiene and adequate patient cooperation\n* No previous orthodontic expansion treatment\n\nExclusion Criteria:\n\n* Systemic diseases affecting growth, bone metabolism, or craniofacial development\n* Craniofacial syndromes or congenital anomalies\n* Severe behavioral or cooperation problems\n* Previous orthodontic or orthopedic maxillary expansion\n* Patients undergoing medications that affect bone metabolism",true,"ALL","6 Years","12 Years",{"count":91,"type":92},60,"ESTIMATED","INTERVENTIONAL",[95],"NA","This controlled prospective clinical trial aims to evaluate the effectiveness of different maxillary expansion methods in children with maxillary transverse deficiency. A total of 60 participants will be included: 20 patients will receive Invisalign Palatal Expander (IPE), 20 will receive acrylic cap splint Rapid Maxillary Expansion (RME), and 20 will serve as an untreated control group. Three-dimensional (3D) intraoral and extraoral scans will be taken at the end of expansion, at 3 months, and at 6 months. Primary outcomes include maxillary arch width, first molar angulation, palatal surface area, and palatal volume. Secondary outcomes include soft tissue changes in the facial region. This study provides a direct comparison between a traditional and a modern digital expansion method, generating evidence for clinical decision-making in pediatric orthodontics.",[98],"Maxillary Transverse Deficiency",[100,101,40,102,103,104,105],"Maxillary Expansion","Rapid Maxillary Expansion (RME)","Transverse Maxillary Deficiency","Three-Dimensional Evaluation","Orthodontics","Pediatric Dentistry","2025-12-02",{"date":108,"type":109},"2025-12-04","ACTUAL",{"date":111,"type":109},"2025-11-20",{"date":113,"type":92},"2026-06",{"name":74,"class":6},1]