[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100564334":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":37,"centralContacts":41,"locations":50,"responsibleParty":66,"collaborators":69,"id":73,"slug":11,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":11,"eligibilityCriteria":78,"healthyVolunteers":74,"sex":79,"minAge":80,"maxAge":11,"enrollmentInfo":81,"targetDuration":11,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":92,"whyStopped":11,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"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,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"The University of Texas Health Science Center at Houston","Houston","Texas","77479","United States",{"type":58,"coordinates":59},"Point",[60,61],-95.36327,29.76328,{"lat":61,"lon":60},[64,65],{"name":39,"role":43,"phone":44,"phoneExt":11,"email":45},{"name":47,"role":43,"phone":48,"phoneExt":11,"email":49},{"type":40,"investigatorFullName":67,"investigatorTitle":68,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"Sahar Dowlatshahi","Assistant Professor",[70],{"name":71,"class":72},"American Academy of Periodontology Foundation","UNKNOWN","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":82,"type":83},24,"ESTIMATED","INTERVENTIONAL",[86],"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.",[89],"Malocclusion, Angle Class I",[91],"orthodontic treatment","NOT_YET_RECRUITING","2024-10-02",{"date":95,"type":96},"2024-10-04","ACTUAL",{"date":98,"type":83},"2025-01-06",{"date":100,"type":83},"2027-01-06",{"name":5,"class":6},1]