[{"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":11,"hasResults":30,"nctId":31,"briefTitle":32,"officialTitle":33,"acronym":11,"eligibilityCriteria":34,"healthyVolunteers":30,"sex":35,"minAge":36,"maxAge":37,"enrollmentInfo":38,"targetDuration":11,"studyType":41,"phases":42,"briefSummary":44,"conditions":45,"keywords":11,"overallStatus":48,"whyStopped":11,"lastUpdateSubmitDate":49,"lastUpdatePostDateStruct":50,"startDateStruct":53,"completionDateStruct":55,"leadSponsor":57,"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",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":39,"type":40},24,"ESTIMATED","INTERVENTIONAL",[43],"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.",[46,47],"Malocclusion, Angle Class III","Extraoral Traction Appliances","NOT_YET_RECRUITING","2024-07-30",{"date":51,"type":52},"2024-07-31","ACTUAL",{"date":54,"type":40},"2024-09-01",{"date":56,"type":40},"2026-01-01",{"name":5,"class":6}]