[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100631401":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":26,"studyPopulation":16,"armGroups":27,"interventions":40,"overallOfficials":50,"centralContacts":58,"locations":65,"responsibleParty":82,"collaborators":16,"id":86,"slug":16,"hasResults":87,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":91,"eligibilityCriteria":92,"healthyVolunteers":87,"sex":93,"minAge":94,"maxAge":95,"enrollmentInfo":96,"targetDuration":16,"studyType":99,"phases":100,"briefSummary":102,"conditions":103,"keywords":107,"overallStatus":114,"whyStopped":16,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},{"fullName":5,"class":6},"Al-Azhar University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":16},[9],{"measure":10,"description":11,"timeFrame":12},"Maxillary Arch Width Changes","Measured on dental castes at the level of inter molar \u002F inter canine width and Cone-beam computed tomography (CBCT) for upper arch","Baseline and 6 months",[14],{"measure":15,"description":16,"timeFrame":17},"Treatment duration",null,"At the time of complete cross-bite correction (average of 6 months)",{"allocation":19,"interventionModel":20,"interventionModelDescription":21,"primaryPurpose":22,"observationalModel":16,"timePerspective":16,"maskingInfo":23},"RANDOMIZED","PARALLEL","A randomized controlled clinical trial with two parallel groups. Patients are randomly assigned to either receive the Quad Helix appliance (Group A) or the Rapid Maxillary Expander (Group B)","TREATMENT",{"masking":24,"maskingDescription":25,"whoMasked":16},"NONE","It is an open-label study where both the participants and investigators are aware of the assigned intervention due to the nature of the orthodontic appliances used","The study involves 20 orthodontic patients aged 9-12 years with posterior cross-bite. Group A will receive the Quad Helix appliance, while Group B will receive Rapid Maxillary Expanders. Evaluation will be based on orthodontic study models, clinical photographs, and various radiographs including CBCT. Treatment will continue until complete correction is achieved, followed by a 3-month passive retention period.",[28,34],{"label":29,"type":30,"description":31,"interventionNames":32},"Group A:Quad Helix Appliance","EXPERIMENTAL","Participants in this group will receive treatment using a fixed Quad Helix (QH) appliance to correct posterior cross-bite. The appliance is fabricated using stainless steel wire and soldered to bands on the upper first permanent molars.",[33],"Device: Quad Helix(QH) Appliance",{"label":35,"type":36,"description":37,"interventionNames":38},"Group B: Rapid maxillary expanders","ACTIVE_COMPARATOR","Participants in this group will receive treatment using fixed Rapid Maxillary Expanders (RME) bonded on the upper first permanent molars and pre-molars",[39],"Device: Rapid Maxillary Expanders",[41,46],{"type":42,"name":43,"description":44,"armGroupLabels":45,"otherNames":16},"DEVICE","Quad Helix(QH) Appliance","It is a fixed orthodontic appliance fabricated using stainless-steel wire and soldered to bands on upper first permanent molars.",[29],{"type":42,"name":47,"description":48,"armGroupLabels":49,"otherNames":16},"Rapid Maxillary Expanders","It is a fixed expansion device bonded on the upper first permanent molars and pre-molars. Activation is done at a rate of 0.25 mm twice daily (two turns per day)",[35],[51,55],{"name":52,"affiliation":53,"role":54},"Al Dany Atwa Mohamed, Professor","Faculty of dental medicine(boys) Cairo ,Al Azhar University","STUDY_CHAIR",{"name":56,"affiliation":53,"role":57},"Mahmoud Mohamed Fathy Abo ELMahasen, Associated Professor","STUDY_DIRECTOR",[59],{"name":60,"role":61,"phone":62,"phoneExt":63,"email":64},"Moustafa Galal Borham Moustafa Saad, Bachelor of dental Science","CONTACT","+201026896894","+201155874709","moustafagalal.1.209@azhar.edu.eg",[66],{"facility":67,"status":16,"city":68,"state":69,"zip":70,"country":71,"countryCode":72,"cosmosGeoPoint":73,"geoPoint":78,"contacts":79},"Faculty of Dental medicine (boys) ,Cairo,Al-Azhar University","Cairo","Cairo Governorate","00000","Egypt","EG",{"type":74,"coordinates":75},"Point",[76,77],31.24967,30.06263,{"lat":77,"lon":76},[80],{"name":81,"role":61,"phone":62,"phoneExt":63,"email":64},"Moustafa G Saad, BDS",{"type":83,"investigatorFullName":84,"investigatorTitle":85,"investigatorAffiliation":5,"oldNameTitle":16,"oldOrganization":16},"PRINCIPAL_INVESTIGATOR","Moustafa Galal Borham Moustafa Saad","Dentist at orthodontic Department, Faculty of dental medicine, Al Azhar University","100631401",false,"NCT07500194","Quad Helix vs RME for Posterior Cross-bite in Egyptian Children","Quad Helix Versus Rapid Maxillary Expanders in the Treatment of Posterior Cross-bite During Mixed Dentition in a Sample of Egyptian Children: A Randomized Clinical Study.","Expansion","Inclusion Criteria:\n\n1. Children aged 9-12 years in the mixed dentition stage\n2. Presence of posterior cross-bite due to transverse maxillary deficiency\n3. No previous history of orthodontic treatment\n4. Good oral hygiene and cooperative behavior\n5. No significant antero-posterior or vertical skeletal discrepancies\n\nExclusion Criteria:\n\n1. Patient with craniofacial anomalies\n2. Presence of systemic diseases or syndromes affecting bone metabolism\n3. Extensive dental caries or untreated periodontal disease\n4. History of trauma or surgery affecting the maxilla or mandible","ALL","9 Years","12 Years",{"count":97,"type":98},20,"ESTIMATED","INTERVENTIONAL",[101],"NA","This randomized clinical trial aims to evaluate and compare the effectiveness of the Quad Helix (QH) appliance versus Rapid Maxillary Expanders (RME) in treating posterior cross-bite in Egyptian children during the mixed dentition stage. The study will also assess patient comfort and pain levels associated with each appliance.",[104,105,106],"Posterior Crossbite","Maxillary Expansion","Transverse Maxillary Deficiency",[108,109,110,111,112,113],"Quad Helix","Rapid Maxillary Expansion","Posterior cross-bite","Mixed Dentition","Egyptian children","Randomized clinical trials","NOT_YET_RECRUITING","2026-03-24",{"date":117,"type":118},"2026-03-30","ACTUAL",{"date":117,"type":98},{"date":121,"type":98},"2028-03-31",{"name":5,"class":6},1]