[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100652793":3},{"organization":4,"armGroups":7,"interventions":29,"overallOfficials":45,"centralContacts":49,"locations":35,"responsibleParty":55,"collaborators":35,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":35,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":35,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":79,"overallStatus":83,"whyStopped":35,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":35},{"fullName":5,"class":6},"Sana'a University","OTHER",[8,15,19,25],{"label":9,"type":10,"description":11,"interventionNames":12},"Clear Aligners with Laser Frenectomy","EXPERIMENTAL","Participants receive clear aligner therapy for diastema and generalized space closure combined with adjunctive diode laser frenectomy.",[13,14],"Device: Clear Aligners","Procedure: Laser Frenectomy",{"label":16,"type":10,"description":17,"interventionNames":18},"Clear Aligners without Laser Frenectomy","Participants receive clear aligner therapy alone for diastema and generalized space closure without frenectomy.",[13],{"label":20,"type":21,"description":22,"interventionNames":23},"Fixed Appliances with Laser Frenectomy","ACTIVE_COMPARATOR","Participants receive conventional fixed orthodontic appliances (MBT 0.022-inch) combined with adjunctive diode laser frenectomy.",[24,14],"Device: Fixed Orthodontic Appliance",{"label":26,"type":21,"description":27,"interventionNames":28},"Fixed Appliances without Laser Frenectomy","Participants receive conventional fixed orthodontic appliances (MBT 0.022-inch) alone without frenectomy.",[24],[30,36,40],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"DEVICE","Clear Aligners","Custom thermoplastic aligners worn 20-22 hours daily with sequential staged movements for space closure.",[9,16],null,{"type":31,"name":37,"description":38,"armGroupLabels":39,"otherNames":35},"Fixed Orthodontic Appliance","Metal brackets with MBT 0.022-inch slot prescription and sequential archwires for controlled space closure.",[20,26],{"type":41,"name":42,"description":43,"armGroupLabels":44,"otherNames":35},"PROCEDURE","Laser Frenectomy","Surgical ablation and tissue excision of the labial frenum performed using a soft-tissue diode laser.",[9,20],[46],{"name":47,"affiliation":5,"role":48},"Ghamdan A Al-Harazi, PhD","STUDY_DIRECTOR",[50],{"name":51,"role":52,"phone":53,"phoneExt":35,"email":54},"Seham Abdulghani Hamood Alokam, BDS, MSc","CONTACT","00967738718234","SEHAM.AL_OKAM@su.edu.ye",{"type":56,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":35,"oldOrganization":35},"PRINCIPAL_INVESTIGATOR","Seham Abdulghani Hamood Alokam","PhD Researcher, Department of Orthodontics","100652793","diastema-closure-and-stability-clear-aligners-vs-fixed-appliances-with-laser-frenectomy-100652793",false,"NCT07778095","Diastema Closure and Stability: Clear Aligners vs Fixed Appliances With Laser Frenectomy","Closure and Stability of Diastema Associated With Generalized Interdental Spacing Using Clear Aligners Versus Fixed Appliances With Adjunctive Frenectomy: A 2x2 Factorial RCT","Inclusion Criteria:\n\n* Adult patients aged 18 to 35 years.\n* Presence of maxillary median diastema associated with generalized interdental spacing (width \\>= 3 mm).\n* Fully erupted permanent teeth (excluding third molars).\n* Good periodontal health with probing depths \\\u003C= 3 mm and no bone loss.\n* High motivation and commitment to follow treatment protocols and compliance.\n* Written informed consent provided.\n\nExclusion Criteria:\n\n* Previous orthodontic treatment.\n* Severe skeletal malocclusion or craniofacial anomalies.\n* Active periodontal disease, poor oral hygiene, or untreated caries.\n* Missing or impacted permanent teeth in the maxillary arch (excluding third molars).\n* Systemic diseases or long-term medication use affecting bone metabolism or tooth movement (e.g., bisphosphonates, systemic corticosteroids).\n* Pregnant or lactating females.\n* Heavy smokers or individuals with severe parafunctional","ALL","18 Years","35 Years",{"count":70,"type":71},48,"ESTIMATED","INTERVENTIONAL",[74],"NA","This study is a prospective 2x2 factorial randomized clinical trial designed to evaluate and compare the closure efficiency and post-treatment stability of diastema associated with generalized interdental spacing (width \\>= 3 mm) treated with clear aligners versus fixed orthodontic appliances, with and without adjunctive laser frenectomy. Participants are randomized into four treatment arms to assess the main effects and interaction effects of appliance modality and laser frenectomy. Stability and relapse rates are systematically tracked across active treatment, a 6-month retention period, and post-retention follow-up intervals at 6 and 8 months.",[77,78],"Diastema","Generalized Interdental Spaces",[77,80,32,81,42,82],"Generalized Interdental Spacing","Fixed Orthodontic Appliances","Treatment Stability","NOT_YET_RECRUITING","2026-08-20",{"date":86,"type":87},"2026-08-21","ACTUAL",{"date":89,"type":71},"2026-11",{"date":91,"type":71},"2029-01",{"name":5,"class":6}]