[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"extraoral-traction-appliances\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:extraoral-traction-appliances":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":4},"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":20,"type":21},24,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28],"Malocclusion, Angle Class III","Extraoral Traction Appliances","NOT_YET_RECRUITING","2024-07-30",{"date":32,"type":33},"2024-07-31","ACTUAL",{"date":35,"type":21},"2024-09-01",{"date":37,"type":21},"2026-01-01",{"name":39,"class":40},"Azienda Ospedaliero-Universitaria Careggi","OTHER"]