[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100633850":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":40,"centralContacts":45,"locations":55,"responsibleParty":72,"collaborators":31,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":82,"sex":83,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":31,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":97,"overallStatus":103,"whyStopped":31,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"Islamabad Medical and Dental College","OTHER",[8,14,20],{"label":9,"type":6,"description":10,"interventionNames":11},"Elastomeric Separator Group","Participants will receive elastomeric separators placed on the mesial and distal surfaces of maxillary first molars to achieve interproximal separation prior to banding.",[12,13],"Device: Elastomeric Separator","Device: Tie wire separator",{"label":15,"type":16,"description":17,"interventionNames":18},"Kesling Separator Group","ACTIVE_COMPARATOR","participants will receive Kesling (spring-type) separators placed on the mesial and distal surfaces of maxillary first molars to achieve interproximal separation prior to banding.",[12,19],"Device: Kesling Separator",{"label":21,"type":22,"description":23,"interventionNames":24},"Tie Wire Separator Group","EXPERIMENTAL","Participants will receive customized ligature tie wire separators placed on the mesial and distal surfaces of maxillary first molars to achieve interproximal separation prior to banding.",[19,13],[26,32,36],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DEVICE","Elastomeric Separator","Elastomeric separators are polyurethane O-shaped orthodontic modules placed interdentally between the mesial and distal surfaces of maxillary first molars. They exert continuous elastic force to create interproximal space prior to molar band placement. In this study, separators will be placed bilaterally and left in situ for 48-72 hours before removal and clinical assessment of separation, pain, and plaque accumulation.",[9,15],null,{"type":27,"name":33,"description":34,"armGroupLabels":35,"otherNames":31},"Kesling Separator","Kesling separators are spring-type orthodontic separators fabricated from 0.020-inch stainless steel Australian wire with a helical loop design. The appliance has two arms, one engaging the lingual embrasure and the other positioned beneath the interproximal contact point, providing controlled separation force in areas with tight contact. In this study, Kesling separators will be placed bilaterally on the mesial and distal surfaces of maxillary first molars and left in situ for 48-72 hours prior to removal and clinical evaluation of separation, pain, and plaque accumulation.",[15,21],{"type":27,"name":37,"description":38,"armGroupLabels":39,"otherNames":31},"Tie wire separator","Tie wire separators are orthodontic separators fabricated using 0.010-0.012 inch stainless steel ligature wire twisted and adapted interproximally around the contact area of posterior teeth. The wire is tightened and positioned to exert gradual separating force between the mesial and distal surfaces of maxillary first molars, facilitating creation of interproximal space for band placement. In this study, tie wire separators will be placed bilaterally and maintained in situ for 48-72 hours prior to removal and assessment of tooth separation, pain, and plaque accumulation.",[9,21],[41],{"name":42,"affiliation":43,"role":44},"Prof Dr Haroon Shahid Qazi, BDS, MS, MCPS( HPE)","Islamabad medical & dental College","STUDY_CHAIR",[46,51],{"name":47,"role":48,"phone":49,"phoneExt":31,"email":50},"Dr Sofia Riaz, BDS, MDS","CONTACT","+92 346 5001484","sofia.riaz@iideas.edu.pk",{"name":52,"role":48,"phone":53,"phoneExt":31,"email":54},"Prof. Dr Haroon Shahid Qazi, BDS, MS, MCPS(HPE)","+92 3005001774","haroon77@gmail.com",[56],{"facility":57,"status":31,"city":58,"state":59,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"Islamabad Dental Hospital","Islamabad","Federal","45720","Pakistan","PK",{"type":64,"coordinates":65},"Point",[66,67],73.04329,33.72148,{"lat":67,"lon":66},[70],{"name":47,"role":48,"phone":71,"phoneExt":31,"email":50},"+92 3465001484",{"type":73,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100633850","comparison-of-three-orthodontic-separators-for-pain-plaque-and-tooth-separation-100633850",false,"NCT07532044","Comparison of Three Orthodontic Separators for Pain, Plaque, and Tooth Separation","Separation Effect, Plaque Score, Pain Perception, And Impact On Quality Of Life When Comparing Three Types Of Orthodontic Separators: A Randomized Controlled Trial","SEP-ORTHO","Inclusion Criteria:\n\n* Patients requiring fixed orthodontic appliance therapy with maxillary first molar banding\n* Age between 12 and 25 years\n* Good oral hygiene (Plaque Index score 0-1)\n* Good general oral health\n* No previous orthodontic treatment\n* No history of dental extractions\n* Presence of tight interproximal contacts at the site of separator placement (no spacing)\n\nExclusion Criteria:\n\n* Presence of interproximal restorations\n* Presence of interproximal caries\n* Missing maxillary second premolar, first molar, or second molar\n* Unerupted maxillary second molars\n* Systemic diseases affecting oral health (e.g., diabetes mellitus)\n* Regular use of medications affecting pain perception (e.g., analgesics, corticosteroids)\n* Loss of separators before follow-up appointment\n* Failure to return within 72 hours for evaluation",true,"ALL","12 Years","25 Years",{"count":87,"type":88},144,"ESTIMATED","INTERVENTIONAL",[91],"NA","Orthodontic separators are small devices placed between teeth before fitting braces to create space for bands. This procedure may cause pain, discomfort, and changes in oral hygiene, which can affect plaque buildup and daily activities.\n\nThis study aims to compare three commonly used types of orthodontic separators-elastomeric, Kesling, and customized tie wire separators-in terms of the amount of tooth separation achieved, pain experienced by patients, and plaque accumulation.\n\nIn addition, the study will assess how these separators affect patients' quality of life, including eating, speaking, and daily comfort.\n\nParticipants will be assigned to one of the three separator types and will be evaluated after 48 to 72 hours. The findings of this study may help identify the most effective and comfortable separator, improving patient care and treatment experience in orthodontics.",[94,95,96],"Orthodontic Pain (D013850)","Malocclusion","Orthodontic Treatment",[98,99,100,101,102],"Orthodontic separators","Pain perception","Plaque index","Quality of life","Tooth separation","NOT_YET_RECRUITING","2026-05-05",{"date":106,"type":107},"2026-05-08","ACTUAL",{"date":109,"type":88},"2026-04-10",{"date":111,"type":88},"2028-04-10",{"name":5,"class":6},1]