[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100564334":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":37,"centralContacts":41,"locations":50,"responsibleParty":67,"collaborators":70,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":11,"eligibilityCriteria":80,"healthyVolunteers":76,"sex":81,"minAge":82,"maxAge":11,"enrollmentInfo":83,"targetDuration":11,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":92,"overallStatus":94,"whyStopped":11,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"The University of Texas Health Science Center, Houston","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Group A","EXPERIMENTAL",null,[13],"Device: Surgically facilitated orthodontics therapy (SFOT) using allograft",{"label":15,"type":10,"description":11,"interventionNames":16},"Group B",[17],"Device: Surgically facilitated orthodontics therapy (SFOT) using xenograft",{"label":19,"type":20,"description":11,"interventionNames":21},"Control group","ACTIVE_COMPARATOR",[22],"Device: Usual care",[24,29,33],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"DEVICE","Surgically facilitated orthodontics therapy (SFOT) using allograft","Participants will receive Surgically facilitated orthodontics therapy (SFOT) along with bone grafting using particulate allograft and collagen membrane, prior to orthodontics treatment.",[9],{"type":25,"name":30,"description":31,"armGroupLabels":32,"otherNames":11},"Surgically facilitated orthodontics therapy (SFOT) using xenograft","Participants will receive SFOT using particulate xenograft and collagen membrane, prior to orthodontics treatment.",[15],{"type":25,"name":34,"description":35,"armGroupLabels":36,"otherNames":11},"Usual care","Participants will have conventional orthodontics treatment with Invisalign aligners, without any surgical intervention",[19],[38],{"name":39,"affiliation":5,"role":40},"Sahar Dowlatshahi, DDS, MMSc","PRINCIPAL_INVESTIGATOR",[42,46],{"name":39,"role":43,"phone":44,"phoneExt":11,"email":45},"CONTACT","(713) 486-4074","Sahar.Dowlatshahi@uth.tmc.edu",{"name":47,"role":43,"phone":48,"phoneExt":11,"email":49},"Nikola Angelov","(713) 486-4073","Nikola.Angelov@uth.tmc.edu",[51],{"facility":52,"status":11,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"The University of Texas Health Science Center at Houston","Houston","Texas","77479","United States","US",{"type":59,"coordinates":60},"Point",[61,62],-95.36327,29.76328,{"lat":62,"lon":61},[65,66],{"name":39,"role":43,"phone":44,"phoneExt":11,"email":45},{"name":47,"role":43,"phone":48,"phoneExt":11,"email":49},{"type":40,"investigatorFullName":68,"investigatorTitle":69,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"Sahar Dowlatshahi","Assistant Professor",[71],{"name":72,"class":73},"American Academy of Periodontology Foundation","UNKNOWN","100564334","effect-of-different-grafting-material-following-surgically-facilitated-orthodontics-therapy-100564334",false,"NCT06627829","Effect of Different Grafting Material Following Surgically Facilitated Orthodontics Therapy","Effect of Different Grafting Material Following Surgically Facilitated Orthodontics Therapy: a Randomized Controlled Clinical Trial","Inclusion Criteria:\n\n* American Society of Anesthesiologists (ASA) I\u002FII\n* Periodontal diagnosis of clinical gingival health or gingivitis on intact\u002Freduced periodontium per 2017 American Academy of Periodontology (AAP) classification\n* No history of periodontitis.\n* Class I malocclusion\n* Crowding of 4 mm or less on mandibular anterior incisors\n* Incisor mandibular plane angle between 90-100 degrees\n* No extractions indicated as part of the orthodontic treatment plan\n* Keratinized tissue of at least 3mm\n\nExclusion Criteria:\n\n* Patients who are current smokers\n* Pregnancy\n* Uncontrolled diabetes or other metabolic systemic conditions\n* Presence of open bite or deep bite\n* Spacing\n* Excessive retroclined mandibular incisors\n* Any contraindication to treatment or the material used if in the experimental groups","ALL","18 Years",{"count":84,"type":85},24,"ESTIMATED","INTERVENTIONAL",[88],"NA","The purpose of this study is to quantitatively investigate the radiographic changes of alveolar bone, and gingival tissue changes of the mandibular anterior teeth in experimental group A receiving SFOT using freeze-dried allograft with a collagen membrane, experimental group B receiving SFOT using particulate xenograft covered by a collagen membrane and control group receiving only orthodontics therapy.",[91],"Malocclusion, Angle Class I",[93],"orthodontic treatment","NOT_YET_RECRUITING","2024-10-02",{"date":97,"type":98},"2024-10-04","ACTUAL",{"date":100,"type":85},"2025-01-06",{"date":102,"type":85},"2027-01-06",{"name":5,"class":6},1]