[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100639211":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":29,"locations":11,"responsibleParty":35,"collaborators":11,"id":37,"slug":38,"hasResults":39,"nctId":40,"briefTitle":41,"officialTitle":42,"acronym":11,"eligibilityCriteria":43,"healthyVolunteers":39,"sex":44,"minAge":45,"maxAge":46,"enrollmentInfo":47,"targetDuration":11,"studyType":50,"phases":51,"briefSummary":53,"conditions":54,"keywords":57,"overallStatus":65,"whyStopped":11,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":11},{"fullName":5,"class":6},"3D-Aligners","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Nickle-titanium group","EXPERIMENTAL",null,[13],"Other: Nickel-Titanium separators",{"label":15,"type":16,"description":11,"interventionNames":17},"elastomeric group","ACTIVE_COMPARATOR",[18],"Other: Elastomeric separators",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"OTHER","Elastomeric separators","application of the elastomeric separators before application of the orthodontic bands on the first molars",[15],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"Nickel-Titanium separators","application of the Nickel-Titanium separators before application of the orthodontic bands on the first molars",[9],[30],{"name":31,"role":32,"phone":33,"phoneExt":11,"email":34},"Aghiad Abdalrazzak","CONTACT","+963931647613","aghiad900@gmail.com",{"type":36,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100639211","treatment-outcome-of-elastomeric-and-nickel-titanium-separators-in-tooth-separation-100639211",false,"NCT07591454","Treatment Outcome of Elastomeric and Nickel-Titanium Separators in Tooth Separation","Comparison Between The Efficiency Of Elastomeric And Nickel-Titanium Separators In Tooth Separation, Pain Perception, And Gingival Inflammation - A Randomized Controlled Trial","Inclusion Criteria:\n\n* Class I skeletal and dental malocclusion.\n* No history of previous orthodontic treatment.\n* All permanent teeth in both arches, except third molars.\n* Good oral hygiene and periodontal health.\n* Good interproximal tooth contacts at the site of separator placement as\n* checked by interdental floss.\n* No caries or restorations on the proximal surfaces of first and second permanent molars, and second premolars.\n\nExclusion Criteria:\n\n* Patients presenting with restorations or carious lesions on the proximal surfaces of the first or second molars or the second premolars.\n* Patients with uncontrolled gingival or periodontal inflammation.\n* Patients with a history of previous orthodontic treatment.\n* Patients are skeletally classified as Class II or Class III.\n* Patients are currently using opioid analgesics or have chronic pain conditions requiring regular analgesic intake.","ALL","16 Years","25 Years",{"count":48,"type":49},30,"ESTIMATED","INTERVENTIONAL",[52],"NA","Patients seeking fixed orthodontic treatment that requires band placement will be enrolled in this study. This trial aims to compare the efficiency of rectangular cross-section nickel-titanium separators with elastomeric separators in creating sufficient interdental space for orthodontic band placement. In addition, the impact of both separator types on pain perception and gingival health during a 3-day placement period will be evaluated. Participants will be allocated to two groups in a split-mouth design. On the experimental side, nickel-titanium separators will be used, while elastomeric separators will be used as the control on the other side. Outcomes will include separation efficacy, pain perception over time, gingival inflammation, analgesic consumption, and separator loss.",[55,56],"Dental Crowding","Malocclusion, Angle Class I",[58,59,60,61,62,63,64],"Orthodontic separators","Nickel-Titanium","Elastomeric","Tooth separation","Pain perception","VAS","Gingival inflammation","NOT_YET_RECRUITING","2026-05-13",{"date":68,"type":69},"2026-05-15","ACTUAL",{"date":71,"type":49},"2026-06-01",{"date":73,"type":49},"2027-02-01",{"name":5,"class":6}]