[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100630269":3},{"organization":4,"outcomesModule":7,"designInfo":22,"detailedDescription":21,"studyPopulation":21,"armGroups":30,"interventions":41,"overallOfficials":21,"centralContacts":21,"locations":51,"responsibleParty":72,"collaborators":21,"id":74,"slug":21,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":21,"eligibilityCriteria":79,"healthyVolunteers":75,"sex":80,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":21,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":93,"overallStatus":99,"whyStopped":21,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Mahidol University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":21},[9,13],{"measure":10,"description":11,"timeFrame":12},"Maxillary skeletal change","* Anterior and posterior midpalatal suture width\n* Anterior apical base width inferior\n* Anterior apical base width superior\n* Posterior apical base width\n* Anterior width at mid-alveolar level\n* Posterior width at alveolar crest level","T0: Baseline (Day 0) - before initiation of maxillary expansion T1: Post-expansion - after completion of 7 mm expansion with RPE or IPE T2: Post-protraction - after 6 months of active maxillary protraction",{"measure":14,"description":15,"timeFrame":12},"Maxillary dental change","* Intermolar width at occlusal surface\n* Intermolar width at palatal root apices\n* Right first molar angulation\n* Left first molar angulation",[17],{"measure":18,"description":19,"timeFrame":20},"Functional and perceptual experiences and parental involvement associated with the use of Rapid Palatal Expander (RPE) and Invisalign Palatal Expander (IPE).","The functional and perceptual experiences of pediatric patients and their parents, as well as parental involvement in appliance management, will be evaluated through semi-structured face-to-face interviews. Interviews will take place at the Orthodontic Clinic, Faculty of Dentistry, Mahidol University, using a topic guide developed from the study conceptual framework. The interviews will explore appliance-related factors, functional impacts on the child (pain, speech, mastication, and oral hygiene), emotional and perceptual responses of both children and parents, parental involvement in appliance management, treatment compliance, and perceived treatment outcomes. Each interview will last approximately 30 minutes, with audio recording and field notes used for qualitative analysis.","Single assessment at 28 days (± 5 days) after appliance insertion",null,{"allocation":23,"interventionModel":24,"interventionModelDescription":21,"primaryPurpose":25,"observationalModel":21,"timePerspective":21,"maskingInfo":26},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":27,"maskingDescription":21,"whoMasked":28},"SINGLE",[29],"OUTCOMES_ASSESSOR",[31,36],{"label":32,"type":33,"description":21,"interventionNames":34},"Invisalign Palatal Expander (IPE) group","EXPERIMENTAL",[35],"Device: Invisalign Palatal Expander (IPE)",{"label":37,"type":38,"description":21,"interventionNames":39},"Rapid Palatal Expander (RPE) group","ACTIVE_COMPARATOR",[40],"Device: Rapid Palatal Expander (RPE)",[42,47],{"type":43,"name":44,"description":45,"armGroupLabels":46,"otherNames":21},"DEVICE","Invisalign Palatal Expander (IPE)","Participants will be treated with an Invisalign palatal expander. Participants will be instructed to wear the appliance full-time, except when brushing and flossing their teeth, and to change the device daily (0.25 mm) until the planned transverse width (7 mm.) is achieved.",[32],{"type":43,"name":48,"description":49,"armGroupLabels":50,"otherNames":21},"Rapid Palatal Expander (RPE)","Participants will be treated with a bonded RPE. Their parents are instructed to activate the screw once per day (0.25 mm) until the expansion screw reaches 7 mm.",[37],[52],{"facility":53,"status":21,"city":54,"state":21,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Faculty of Dentistry, Mahidol University","Bangkok","10700","Thailand","TH",{"type":59,"coordinates":60},"Point",[61,62],100.50144,13.75398,{"lat":62,"lon":61},[65,70],{"name":66,"role":67,"phone":68,"phoneExt":21,"email":69},"Nakornnoi, DDS PhD","CONTACT","+662007813","theerasak.nak@mahidol.ac.th",{"name":71,"role":67,"phone":68,"phoneExt":21,"email":21},"Chaisomsukrudee, DDS",{"type":73,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR","100630269",false,"NCT07485478","Effects of Invisalign Palatal Expander vs Rapid Palatal Expander With Facemask in Growing Class III Patients","Effects of the Invisalign® Palatal Expander (IPE) vs. Rapid Palatal Expander With Facemask in Growing Skeletal Class III Patients: A CBCT Randomized Clinical Trial","Inclusion Criteria:\n\n* Patients aged between 8 and 12 years\n* Patients in the mixed dentition or early permanent stage have at least three stable teeth per quadrant, good oral hygiene, and healthy periodontal tissues\n* Patients with maxilla-mandibular discrepancies; skeletal class III is indicated by an ANB angle \\\u003C 0 degrees or a Wits appraisal value that is negative, and Maxillary constriction is characterized by posterior crossbite teeth or having a maxillary width below the norm value.\n\nExclusion Criteria:\n\n* Patients with craniofacial anomalies such as cleft lip and palate\n* Patient with a prior history of maxillary expansion.\n* Patients who have systemic conditions that contraindicate orthodontic treatment.","ALL","8 Years","12 Years",{"count":84,"type":85},24,"ESTIMATED","INTERVENTIONAL",[88],"NA","The goal of this clinical trial is to compare two types of palatal expanders used with a facemask in children who have skeletal Class III and a narrow upper jaw. The study will compare the Invisalign Palatal Expander (IPE) and the Rapid Palatal Expander (RPE). Researchers want to learn how these devices affect jaw bones and tooth position. They also want to learn about children's and parents' experiences during treatment.\n\nThe main questions this study aims to answer are:\n\nDo IPE and RPE widen the upper jaw differently?\n\nDo they cause different changes in tooth position?\n\nHow do children and parents describe their treatment experience?\n\nParticipants will be children aged 8 to 12 years who have skeletal Class III and a narrow upper jaw. Children with craniofacial conditions, previous upper jaw expansion, or medical conditions that prevent orthodontic treatment will not take part. Parents and children must give consent before joining the study.\n\nParticipants will:\n\nBe assigned to receive either IPE or RPE\n\nExpand the upper jaw to 7 mm (0.25 mm per day)\n\nAfter expansion, wear a facemask for at least 12 hours per day for 6 to 8 months\n\nHave cone-beam computed tomography (CBCT) scans taken before expansion, after expansion, and after facemask treatment\n\nTake part in an interview with a parent after expansion\n\nResearchers will use CBCT images to measure changes in jaw bones and tooth position. The main outcomes are changes in jaw bones and tooth position. Secondary outcomes include children's and parents' experiences during treatment.",[91,92],"Skeletal Class III Malocclusion","Transverse Maxillary Deficiency",[94,95,96,97,98],"Invisalign Palatal Expander","Rapid Palatal Expansion","Facemask","CBCT","Retrognathic maxilla","NOT_YET_RECRUITING","2026-03-16",{"date":102,"type":103},"2026-03-20","ACTUAL",{"date":105,"type":85},"2026-03",{"date":107,"type":85},"2027-10",{"name":5,"class":6},1]