[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100525520":3},{"organization":4,"armGroups":7,"interventions":42,"overallOfficials":49,"centralContacts":54,"locations":62,"responsibleParty":83,"collaborators":48,"id":85,"slug":86,"hasResults":87,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":48,"eligibilityCriteria":91,"healthyVolunteers":92,"sex":93,"minAge":94,"maxAge":95,"enrollmentInfo":96,"targetDuration":48,"studyType":99,"phases":100,"briefSummary":102,"conditions":103,"keywords":48,"overallStatus":65,"whyStopped":48,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},{"fullName":5,"class":6},"Children's Hospital Los Angeles","OTHER",[8,14,18,22,26,29,32,36,39],{"label":9,"type":10,"description":11,"interventionNames":12},"Orthognathic Surgery Manual Toothbrush","EXPERIMENTAL","1. Patient of record of the Craniofacial and Special Care Orthodontic Clinic at Children's Hospital Los Angeles\n2. Between the ages of 6 and 20 years\n3. Physical status of ASA I or II\n4. Diagnosis of craniofacial and\u002For isolated, complete or incomplete, bilateral or unilateral cleft lip and palate\n5. Intervention: Manual toothbrush.",[13],"Device: Toothbrush",{"label":15,"type":10,"description":16,"interventionNames":17},"Orthognathic Surgery Sonic toothbrush","1. Patient of record of the Craniofacial and Special Care Orthodontic Clinic at Children's Hospital Los Angeles\n2. Between the ages of 6 and 20 years\n3. Physical status of ASA I or II\n4. Diagnosis of craniofacial and\u002For isolated, complete or incomplete, bilateral or unilateral cleft lip and palate\n5. Intervention:Sonic toothbrush without activation of the dual light feature.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Orthognathic Surgery Sonic and dual light toothbrush","1. Patient of record of the Craniofacial and Special Care Orthodontic Clinic at Children's Hospital Los Angeles\n2. Between the ages of 6 and 20 years\n3. Physical status of ASA I or II\n4. Diagnosis of craniofacial and\u002For isolated, complete or incomplete, bilateral or unilateral cleft lip and palate\n5. Intervention:Sonic toothbrush with activation of the dual light feature",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"Bone Graft Manual Toothbrush","1. Patient of record of the Craniofacial and Special Care Orthodontic Clinic at Children's Hospital Los Angeles\n2. Between the ages of 6 and 20 years\n3. Physical status of ASA I or II\n4. Diagnosis of craniofacial and\u002For isolated, complete or incomplete, bilateral or unilateral cleft lip and palate\n5. Intervention:Manual toothbrush.",[13],{"label":27,"type":10,"description":16,"interventionNames":28},"Bone Graft Sonic Toothbrush",[13],{"label":30,"type":10,"description":20,"interventionNames":31},"Bone Graft Sonic and Dual-light Toothbrush",[13],{"label":33,"type":10,"description":34,"interventionNames":35},"No surgery, Manual Toothbrush","1. Patient of record of the Craniofacial and Special Care Orthodontic Clinic at Children's Hospital Los Angeles\n2. Between the ages of 6 and 20 years\n3. Physical status of ASA I or II\n4. Diagnosis of craniofacial and\u002For isolated, complete or incomplete, bilateral or unilateral cleft lip and palate 5, Intervention:Manual toothbrush.",[13],{"label":37,"type":10,"description":16,"interventionNames":38},"No Surgery, Sonic Toothbrush",[13],{"label":40,"type":10,"description":20,"interventionNames":41},"No Surgery, Sonic and Dual-light Toothbrush",[13],[43],{"type":44,"name":45,"description":46,"armGroupLabels":47,"otherNames":48},"DEVICE","Toothbrush","We will test three toothbrushes in patients undergoing surgery and a control no surgery group. These toothbrushes are manual toothbrushes, sonic toothbrushes, and sonic and dual light toothbrushes.",[23,27,30,37,40,33,9,19,15],null,[50],{"name":51,"affiliation":52,"role":53},"Stephen Yen, DMD, PhD","Children's Hospital Los Angeles and USC","PRINCIPAL_INVESTIGATOR",[55,59],{"name":51,"role":56,"phone":57,"phoneExt":48,"email":58},"CONTACT","3233612130","syen@chla.usc.edu",{"name":60,"role":56,"phone":57,"phoneExt":48,"email":61},"Jose Polido, DDS","jpolido@chla.usc.edu",[63],{"facility":64,"status":65,"city":66,"state":67,"zip":68,"country":69,"countryCode":70,"cosmosGeoPoint":71,"geoPoint":76,"contacts":77},"Chilldren's Hospital Los Angeles","RECRUITING","Los Angeles","California","90027","United States","US",{"type":72,"coordinates":73},"Point",[74,75],-118.24368,34.05223,{"lat":75,"lon":74},[78,81],{"name":79,"role":56,"phone":80,"phoneExt":48,"email":58},"Stephen Yen","323-361-2130",{"name":82,"role":56,"phone":57,"phoneExt":48,"email":61},"Jose Polido",{"type":53,"investigatorFullName":79,"investigatorTitle":84,"investigatorAffiliation":5,"oldNameTitle":48,"oldOrganization":48},"Associate Professor","100525520","effectiveness-of-dual-light-electric-toothbrush-vs-manual-toothbrush-in-orthodontic-patients-undergoing-oral-surgery-100525520",false,"NCT06122805","Effectiveness of Dual Light Electric Toothbrush vs. Manual Toothbrush in Orthodontic Patients Undergoing Oral Surgery","Effectiveness of Dual Light Therapy Electric Toothbrush vs.Manual Toothbrush on Periodontal Health of Orthodontic Patients Undergoing Oral Surgery","Inclusion Criteria:\n\n* Patient of record of the Craniofacial and Special Care Orthodontic Clinic at Children's Hospital Los Angeles\n* Between the ages of 6 and 20 years\n* Physical status of ASA I or II\n* Diagnosis of craniofacial and\u002For isolated, complete or incomplete, bilateral or unilateral cleft lip and palate\n\nExclusion Criteria:\n\n* physical inability to brush teeth\n* cognitive inability to comprehend and follow directions.",true,"ALL","6 Years","20 Years",{"count":97,"type":98},198,"ESTIMATED","INTERVENTIONAL",[101],"NA","The study is a randomized clinical trial to compare the effectiveness of a dual light ultrasonic toothbrush on periodontal health in orthodontic patients undergoing surgery.\n\nPatients with cleft lip and palate undergo bone graft and orthognathic surgery. The study will compare the periodontal outcomes in patients who use these toothbrushes during the post-surgical period.",[104,105,106],"Toothbrushing","Gingivitis","Cleft Lip and Palate","2024-05-09",{"date":109,"type":110},"2024-05-13","ACTUAL",{"date":112,"type":110},"2024-03-11",{"date":114,"type":98},"2027-11-30",{"name":5,"class":6},1]