[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100569365":3},{"organization":4,"outcomesModule":7,"designInfo":36,"detailedDescription":46,"studyPopulation":28,"armGroups":47,"interventions":60,"overallOfficials":28,"centralContacts":68,"locations":78,"responsibleParty":93,"collaborators":97,"id":103,"slug":28,"hasResults":104,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":28,"eligibilityCriteria":108,"healthyVolunteers":109,"sex":110,"minAge":111,"maxAge":28,"enrollmentInfo":112,"targetDuration":28,"studyType":115,"phases":116,"briefSummary":118,"conditions":119,"keywords":121,"overallStatus":81,"whyStopped":28,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":136},{"fullName":5,"class":6},"University of Jordan","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":28},[9],{"measure":10,"description":11,"timeFrame":12},"Marginal bone level changes","Marginal bone level changes by standardized periapical radiographs.","Baseline (day of implant placement), at definitive loading (more than 8 weeks post-placement for the conventional loading group, within 1 week post-placement for the immediate loading group), and at 1-year follow-up post-loading.",[14,18,22,26,29,33],{"measure":15,"description":16,"timeFrame":17},"Implant failure rate","defined as implant removal","1 year",{"measure":19,"description":20,"timeFrame":21},"Implant stability","Osstell readings","Baseline (day of implant placement), at definitive loading (more than 8 weeks post-placement for the conventional loading group, within 1 week post-placement for the immediate loading group)",{"measure":23,"description":24,"timeFrame":25},"Midfacial mucosal level","as measured by periodontal probe","at time of delivery of definitive prosthesis (more than 8 weeks post-placement for the conventional loading group, within 1 week post-placement for the immediate loading group) and one-year follow-up",{"measure":27,"description":28,"timeFrame":25},"Pink and white esthetic scores",null,{"measure":30,"description":31,"timeFrame":32},"Patient Satisfaction","To be assesses by oral health impact profile-14 (OHIP-14), The scale includes 14 items covering various aspects of oral health-related quality of life, Score Range: from 0 to 56, Higher OHIP-14 scores indicate a worse outcome, representing a greater negative impact of oral health issues on quality of life, while lower scores suggest a better outcome or less impact on the individual's daily life.","after 6 months and 1 year of placements",{"measure":34,"description":35,"timeFrame":17},"Biological, estehtic and technical complications","(infection, implant mobility, or prosthesis-related issues) assessed by expert prosthodontist who is blind to the nature of intervention",{"allocation":37,"interventionModel":38,"interventionModelDescription":28,"primaryPurpose":39,"observationalModel":28,"timePerspective":28,"maskingInfo":40},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":41,"maskingDescription":28,"whoMasked":42},"TRIPLE",[43,44,45],"CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","Study design:\n\nThis study is designed as a parallel group randomized controlled trial with an allocation ratio of 1:1.\n\nThe (PICO) study design: population will be patients from Jordan University Hospital aged 18 years or older, requiring single tooth replacement (molar or premolar) with dental implants, with sufficient bone volume and controlled oral hygiene. The intervention group will receive immediate loading of early placed implants (within 1 week), while the comparator group will receive conventional loading (after more than 8 weeks). The primary outcome is changes in marginal bone levels, and the secondary outcomes include implant primary osseointegration, stability, patient satisfaction, and various complications.\n\nBoth groups will receive early placed implants after 8-12 weeks of healing (Type 2-3A placement). The surgical procedure will follow standardized protocols, with no variations between groups other than the loading time.\n\nBlinded assessors will perform radiographic and clinical evaluations at designated follow-up visits: at implant placement, definitive loading, 6 months, and 1 year. Ethical approval is obtained prior to study commencement, and all participants will provide informed consent.",[48,55],{"label":49,"type":50,"description":51,"interventionNames":52},"Conventional loading of early placed implants","ACTIVE_COMPARATOR","Early placed implants ( within 16 weeks of healing after Extraction of a tooth) will be conventionally loaded ( at least 8 weeks after implant placement )",[53,54],"Device: Immediate loading of early placed implants","Device: Conventional loading of early placed implants",{"label":56,"type":57,"description":58,"interventionNames":59},"Immediate loading of early placed implants","EXPERIMENTAL","Early placed implants (within 16 weeks of tooth extraction) will be loaded immediately with provisional screw retained crown",[53,54],[61,65],{"type":62,"name":56,"description":63,"armGroupLabels":64,"otherNames":28},"DEVICE","Implants with active thread design will be used. The implants placed will be randomly allocated into either immediate loading or conventional loading group.",[49,56],{"type":62,"name":49,"description":66,"armGroupLabels":67,"otherNames":28},"Definitive loading of early placed implants upon successful osteointegration (after 8 weks)",[49,56],[69,74],{"name":70,"role":71,"phone":72,"phoneExt":28,"email":73},"Mohammad A AL-Rababáh","CONTACT","00962792131548","malrababah@ju.edu.jo",{"name":75,"role":71,"phone":76,"phoneExt":28,"email":77},"Dareen M Abu Mahfouz","00962799435925","dareen_abumahfouz@hotmail.com",[79],{"facility":80,"status":81,"city":82,"state":28,"zip":28,"country":83,"countryCode":84,"cosmosGeoPoint":85,"geoPoint":90,"contacts":91},"Jordan University Hospital","RECRUITING","Amman","Jordan","JO",{"type":86,"coordinates":87},"Point",[88,89],35.94503,31.95522,{"lat":89,"lon":88},[92],{"name":70,"role":71,"phone":72,"phoneExt":28,"email":73},{"type":94,"investigatorFullName":95,"investigatorTitle":96,"investigatorAffiliation":5,"oldNameTitle":28,"oldOrganization":28},"PRINCIPAL_INVESTIGATOR","Mohammad AL-Rababáh","Associate Professor",[98,101],{"name":99,"class":100},"Straumann Group","UNKNOWN",{"name":102,"class":100},"MegaGen","100569365",false,"NCT06693297","Immediate Versus Conventional Loading of Early Placed Dental Implant Supporting Single Crowns","Immediate Versus Conventional Loading of Early Placed Dental Implant Supporting Single Crowns: a Randomized Controlled Trial","Inclusion Criteria:\n\n1. aged 18 years or older\n2. requiring single tooth replacement with dental implants in presence of four bone walls (mandible or maxilla)\n3. having adequate bone volume\n4. controlled oral hygiene\n5. having agreed to take part in the study and willing to comply with the study protocol and follow-up visits\n\nExclusion Criteria:\n\n1. Any systemic condition that might jeopardize implant surgery\n2. history of radiation therapy to the head and neck region\n3. history of bisphosphonate therapy or other medications that may affect bone metabolism\n4. smoking more than 10 cigarettes\u002Fday\n5. history of bruxism or parafunctional habits\n6. localized\u002Fgeneralized periodontitis\n7. patients in need of bone grafting\n8. any known allergy or hypersensitivity to implant materials",true,"ALL","18 Years",{"count":113,"type":114},40,"ESTIMATED","INTERVENTIONAL",[117],"NA","This study focuses on examining the efficacy and clinical performance of immediate loading of early placed single implants.\n\nThe aim of the randomized controlled trial is to compare between two loading protocols (immediate versus conventional) of early placed implants (Type 2-3A) in terms of clinical, radiographic, and patient-reported outcomes.\n\nNull hypothesis: There will be no significant differences in implant survival\u002Fsuccess, stability, radiographic marginal bone level, and patient reported outcomes between immediately or conventionally loaded and early placed implants.",[120],"Dental Implant",[122,123,124,125,126],"dental implant","thread design","immediate loading","conventional loading","early placement","2024-11-14",{"date":129,"type":130},"2024-11-18","ACTUAL",{"date":132,"type":130},"2024-09-25",{"date":134,"type":114},"2026-09",{"name":5,"class":6},1]