[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100547029":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":11,"locations":11,"responsibleParty":27,"collaborators":11,"id":29,"slug":30,"hasResults":31,"nctId":32,"briefTitle":33,"officialTitle":34,"acronym":11,"eligibilityCriteria":35,"healthyVolunteers":31,"sex":36,"minAge":37,"maxAge":38,"enrollmentInfo":39,"targetDuration":11,"studyType":42,"phases":43,"briefSummary":45,"conditions":46,"keywords":11,"overallStatus":49,"whyStopped":11,"lastUpdateSubmitDate":50,"lastUpdatePostDateStruct":51,"startDateStruct":54,"completionDateStruct":56,"leadSponsor":58,"locationsCount":11},{"fullName":5,"class":6},"Azienda Ospedaliero-Universitaria Careggi","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Customized facemask","EXPERIMENTAL",null,[13],"Device: Customized facemask",{"label":15,"type":16,"description":11,"interventionNames":17},"Standard facemask","ACTIVE_COMPARATOR",[18],"Device: Standard facemask",[20,24],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":11},"DEVICE","The customized face mask will be fabricated from a 3D digital image of the patient's face obtained by means of a 3D scanner. Such a scanner consists of 6 digital SLR cameras and software capable of processing a 3-D image of the patient's face exportable as an stl file.",[9],{"type":21,"name":15,"description":25,"armGroupLabels":26,"otherNames":11},"The standard facemask is the commercially available Petit standard facemask",[15],{"type":28,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100547029","comparison-of-customized-and-standard-facemasks-for-early-treatment-of-class-iii-malocclusion-100547029",false,"NCT06402656","Comparison of Customized and Standard Facemasks for Early Treatment of Class III Malocclusion","Comparison of Customized and Standard Facemasks for Early Treatment of Class III Malocclusion: Randomized Crossover Study","Inclusion Criteria:\n\n* Age between 5 and 12 years;\n* Class III malocclusion, for which early orthopedic treatment with rapid maxillary expander and facemask is indicated.\n* signing of informed consent\n\nExclusion Criteria:\n\n* Cleft lip and\u002For palate.\n* Craniofacial syndromes.","ALL","5 Years","12 Years",{"count":40,"type":41},24,"ESTIMATED","INTERVENTIONAL",[44],"NA","The aim of the study is to compare a customized facemask for the treatment of Class III malocclusion in the prepubertal growing patient (patients between the ages of 5 and 12 years) versus a standard commercial facemask. Specifically, preference, pain, difficulty in sleeping, time of use, and possible complications for the two types of facemasks will be analyzed.\n\nThis is a single-center, national, controlled, superiority, randomized, crossover, open-label study.\n\nEach patient will be treated with both the customized facemask and the standard commercial facemask. Each patient will wear one type of facemask for 2 months and the other type of facemask for the next 2 months. After 2 weeks and at the end of therapy with each of the facemask types, the patient, with the possible help of the parents, will have to answer a questionnaire about pain and difficulty sleeping and report any complications. In addition, after completing both phases (fourth month), the patient should indicate a preference for one of the two types of mask with which to complete therapy for an additional 6 months.",[47,48],"Malocclusion, Angle Class III","Extraoral Traction Appliances","NOT_YET_RECRUITING","2024-07-30",{"date":52,"type":53},"2024-07-31","ACTUAL",{"date":55,"type":41},"2024-09-01",{"date":57,"type":41},"2026-01-01",{"name":5,"class":6}]