[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658431":3},{"organization":4,"outcomesModule":7,"designInfo":31,"detailedDescription":39,"studyPopulation":30,"armGroups":40,"interventions":53,"overallOfficials":30,"centralContacts":62,"locations":68,"responsibleParty":81,"collaborators":30,"id":85,"slug":86,"hasResults":87,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":91,"eligibilityCriteria":92,"healthyVolunteers":87,"sex":93,"minAge":94,"maxAge":95,"enrollmentInfo":96,"targetDuration":30,"studyType":99,"phases":100,"briefSummary":102,"conditions":103,"keywords":106,"overallStatus":109,"whyStopped":30,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},{"fullName":5,"class":6},"Cairo University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":30},[9,13],{"measure":10,"description":11,"timeFrame":12},"Amount of Space Regained","The amount of space regained following application of the space regainer, measured on dental casts using a digital caliper. Measured by mm","Baseline (T0) to completion of space regaining, up to 6 months.",{"measure":14,"description":15,"timeFrame":12},"Rate of Space Regaining","The rate of space regaining assessed through serial space measurements during follow-up visits. MEASURING UNIT IS mm\u002Fmonth",[17,21,24,27],{"measure":18,"description":19,"timeFrame":20},"Patient Discomfort","Patient discomfort associated with the use of the space regainer, assessed by clinical evaluation. Binary (Present\u002FAbsent) the measuring unit","Baseline (T0) to completion of space regaining, up to 6 months",{"measure":22,"description":23,"timeFrame":12},"Gingival Inflammation Around Appliance","Gingival inflammation around the appliance assessed using a periodontal probe and Gingival Index. Ordinal score (0-3) is the measurment unit",{"measure":25,"description":26,"timeFrame":12},"Plaque Accumulation","Plaque accumulation around the appliance assessed using a periodontal probe and Plaque Index. Measurement Unit:\n\nOrdinal score (0-3)",{"measure":28,"description":29,"timeFrame":12},"Appliance Breakage\u002FFailure","Occurrence of appliance breakage or failure during the treatment period, assessed by clinical evaluation. Measurement Unit:\n\nBinary (Present\u002FAbsent)",null,{"allocation":32,"interventionModel":33,"interventionModelDescription":30,"primaryPurpose":34,"observationalModel":30,"timePerspective":30,"maskingInfo":35},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":36,"maskingDescription":30,"whoMasked":37},"SINGLE",[38],"OUTCOMES_ASSESSOR","Premature loss of a primary second molar may result in mesial drifting, tipping, or rotation of the adjacent permanent first molar and subsequent loss of arch space. Active space regainers are used to recover the lost space and help restore the arch length.\n\nIn this study, children aged 7-9 years presenting with unilateral space loss of 2-4 mm following premature loss of a primary second molar will be enrolled. Eligible participants will be randomly allocated in a 1:1 ratio to receive either a Banded Helical space regainer or a Gerber unilateral space regainer.\n\nThe amount of space regained will be measured on dental casts using a digital caliper, and the rate of space regaining will be assessed through serial measurements during monthly follow-up visits. Secondary outcomes will include patient discomfort, gingival inflammation around the appliance, plaque accumulation, and appliance breakage or failure.\n\nParticipants will be assessed at baseline and followed monthly until completion of space regaining, for a maximum of 6 months. The study is designed as a pilot randomized controlled clinical trial and will be conducted in the outpatient clinics of the Department of Pediatric Dentistry and Dental Public Health, Faculty of Dentistry, Cairo University.",[41,47],{"label":42,"type":43,"description":44,"interventionNames":45},"Banded Helical Space Regainer","EXPERIMENTAL","Participants assigned to this arm will receive a Banded Helical Space Regainer for management of unilateral space loss following premature loss of a primary second molar. The appliance consists of an orthodontic band cemented on the molar and a helical loop incorporated into the wire design, activated to deliver force for space regaining",[46],"Device: Banded Helicle Space Regainer",{"label":48,"type":49,"description":50,"interventionNames":51},"Gerber Space Regainer","ACTIVE_COMPARATOR","Participants assigned to this arm will receive a Gerber unilateral space regainer for management of unilateral space loss following premature loss of a primary second molar. The appliance consists of a band placed on the permanent molar, a U-shaped wire component, and an open coil spring mechanism that delivers continuous distalizing force.",[52],"Device: Gerber Space Regainer",[54,59],{"type":55,"name":56,"description":57,"armGroupLabels":58,"otherNames":30},"DEVICE","Banded Helicle Space Regainer","The Banded Helical Space Regainer consists of an orthodontic band cemented on the molar and a helical loop incorporated into the wire design. The appliance is activated to deliver force for space regaining.",[42],{"type":55,"name":48,"description":60,"armGroupLabels":61,"otherNames":30},"The Gerber unilateral space regainer consists of a band placed on the permanent molar, a U-shaped wire component, and an open coil spring mechanism that delivers continuous distalizing force.",[48],[63],{"name":64,"role":65,"phone":66,"phoneExt":30,"email":67},"Karmiena Wafeek Guirges, B.D.S. 2022","CONTACT","+201206960584","karrmiena.guirges@dentistry.cu.edu.eg",[69],{"facility":70,"status":30,"city":71,"state":72,"zip":30,"country":73,"countryCode":74,"cosmosGeoPoint":75,"geoPoint":80,"contacts":30},"Faculty of dentistry , cairo university","Giza","Giza Governorate","Egypt","EG",{"type":76,"coordinates":77},"Point",[78,79],31.20861,30.00944,{"lat":79,"lon":78},{"type":82,"investigatorFullName":83,"investigatorTitle":84,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"PRINCIPAL_INVESTIGATOR","Karmiena Wafeek Guirges","Resident in Pediatric Dentistry","100658431","banded-helical-vs-gerber-space-regainers-for-unilateral-space-loss-in-children-100658431",false,"NCT07853313","Banded Helical vs Gerber Space Regainers for Unilateral Space Loss in Children","Effectiveness of Banded Helical Regainer Versus Gerber's Space Regainer for Management of Unilateral Space Loss in Children: A Pilot Randomized Controlled Trial","BHR-GSR","Inclusion Criteria:\n\n* Children aged 7-9 years.\n* Premature loss of a mandibular primary second molar.\n* Unilateral space loss in the mandibular arch.\n* Presence of the required abutment teeth for appliance placement.\n* Healthy children with no systemic conditions that may affect the study outcomes.\n\nExclusion Criteria:\n\n* Bilateral space loss.\n* Presence of pathological conditions affecting the teeth or supporting tissues.\n* Previous orthodontic treatment.\n* Medical conditions or medications that may affect tooth movement or periodontal health.\n* Poor oral hygiene, if defined according to the study's eligibility criteria.","ALL","7 Years","9 Years",{"count":97,"type":98},28,"ESTIMATED","INTERVENTIONAL",[101],"NA","This pilot randomized controlled clinical trial will evaluate and compare Banded Helical and Gerber space regainers in children aged 7-9 years with unilateral space loss following premature loss of a primary second molar. The study will assess the effectiveness of the two appliances in regaining lost space and evaluate treatment duration, patient discomfort, gingival inflammation, plaque accumulation, and appliance failure.",[104,105],"Premature Loss of Primary Second Molars","Unilateral Space Loss",[107,42,48,108],"Space Regainer","Pediatric Dentistry","NOT_YET_RECRUITING","2026-10-09",{"date":112,"type":113},"2026-10-13","ACTUAL",{"date":115,"type":98},"2026-11-01",{"date":117,"type":98},"2028-03-31",{"name":5,"class":6},1]