[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100588485":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":26,"locations":26,"responsibleParty":32,"collaborators":26,"id":36,"slug":37,"hasResults":38,"nctId":39,"briefTitle":40,"officialTitle":41,"acronym":26,"eligibilityCriteria":42,"healthyVolunteers":43,"sex":44,"minAge":45,"maxAge":46,"enrollmentInfo":47,"targetDuration":26,"studyType":50,"phases":51,"briefSummary":53,"conditions":54,"keywords":26,"overallStatus":56,"whyStopped":26,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":26},{"fullName":5,"class":6},"Cairo University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Full Digital Workflow","EXPERIMENTAL","Study Group (Computer-Guided Autogenous Cortical Shell Technique)\n\nBone harvesting and fixation are done using patient-specific guides , chin harvesting guide and bone block fixation guide. Uses a 3D-printed, patient-specific surgical guide for precise bone harvesting and placement.\n\nPiezo drill cuts are guided to ensure accurate osteotomy and graft positioning. The labial cortical shell is fixated using pre-planned screw holes for better stability.\n\nBone particulate grafting (autogenous + xenograft, 50:50) is packed into the defect.\n\nEnhances accuracy, reduces surgical time, and minimizes complications",[13],"Device: Computer-Guided Autogenous Cortical Shell Technique (Study Group)",{"label":15,"type":16,"description":17,"interventionNames":18},"Free Hand Protocol","ACTIVE_COMPARATOR","Control Group (Free-Hand Autogenous Cortical Shell Technique)\n\nBone harvesting and fixation are done manually, relying on the surgeon's experience.\n\nOsteotomy is performed free-hand, increasing the risk of inaccurate graft placement.\n\nThe labial cortical shell is manually fixated, potentially leading to misalignment.\n\nBone particulate grafting (autogenous + xenograft, 50:50) is used, similar to the study group.\n\nHigher risk of human error, longer surgical time, and greater variability in outcomes",[19],"Procedure: Free-Hand Autogenous Cortical Shell Technique (Control group)",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Computer-Guided Autogenous Cortical Shell Technique (Study Group)","This study utilizes two patient-specific 3D-printed surgical guides to enhance precision in bone harvesting and fixation for horizontal ridge augmentation in the anterior mandible.\n\nChin Harvesting Guide\n\nThis tooth-supported guide is placed on the exposed mandibular symphysis to ensure accurate osteotomy cuts for harvesting a cortical bone shell.\n\nIt directs piezo drill cuts (superior, inferior, and vertical) to minimize errors and prevent damage to vital structures.\n\nBone Block Fixation Guide\n\nAfter harvesting, this guide helps in precise fixation of the cortical shell onto the recipient site.\n\nIt includes pre-planned screw holes to ensure stable positioning of the graft and improve surgical accuracy.\n\nThese guides enhance precision, reduce surgical time, and improve graft stability, making the computer-guided technique superior to the traditional free-hand method.",[9],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"PROCEDURE","Free-Hand Autogenous Cortical Shell Technique (Control group)","In this group, horizontal ridge augmentation of the anterior mandible is performed using a free-hand technique without computer-guided assistance. Autogenous cortical bone is harvested from the mandibular symphysis using a conventional osteotomy performed manually. The harvested cortical shell is adapted and fixated at the recipient site using titanium mini screws, based on the surgeon's clinical judgment and intraoperative assessment. Bone particulate grafting using a 1:1 ratio of autogenous bone and xenograft material is packed into the defect to enhance volume stability. This approach may result in increased variability in graft positioning, longer surgical time, and higher dependence on surgeon experience.",[15],{"type":33,"investigatorFullName":34,"investigatorTitle":35,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Mayar Momen El Khawass","Doctor","100588485","radiographic-assessment-of-guided-cortical-shell-technique-for-horizontal-ridge-augmentation-100588485",false,"NCT06942013","Radiographic Assessment of Guided Cortical Shell Technique for Horizontal Ridge Augmentation","Radiographic Assessment of Cortical Shell Technique For Horizontal Ridge Augmentation In The Anterior Mandible Using Full Digital Workflow Versus Free Hand Protocol: A Randomized Clinical Trial","Inclusion Criteria:\n\n* • Anterior mandible with horizontal deficient alveolar ridge that is from 2 to 4 mm measured from the crest of the alveolar ridge buccolingually.\n\n  * Class IV and V according to Cawood and Howell classification.\n  * No sex predilection.\n  * Patients free from any systemic conditions and bone metabolism diseases that might interfere with the surgical intervention, soft tissue or hard tissue healing.\n  * The minimum number of missing teeth in the anterior mandible alveolar ridge is two adjacent teeth.\n  * Normal vertical dimension with normal inter-arch space.\n\nExclusion Criteria:\n\n* • Intra-bony lesions (e.g. cysts) or infections (e.g. abscess) that may retard the osteotomy healing.\n\n  * General contraindications to implant surgery.\n  * Subjected to irradiation in the head and neck area less than 1 year before implantation.\n  * Untreated periodontitis.\n  * Poor oral hygiene and motivation.\n  * Uncontrolled diabetes.\n  * Pregnant or nursing females.\n  * Immunosuppressed or immunocompromised\n  * Heavy smokers\n  * Patients who undergo medication interfere with bone healing\n  * Previous grafting procedures in the edentulous area.",true,"ALL","20 Years","60 Years",{"count":48,"type":49},20,"ESTIMATED","INTERVENTIONAL",[52],"NA","The protocol outlines a randomized clinical trial comparing two surgical techniques for horizontal ridge augmentation in the anterior mandible:\n\nComputer-Guided Autogenous Cortical Shell Technique (using a patient-specific guide for precise placement).\n\nFree-Hand Autogenous Cortical Shell Technique (traditional approach without a guiding template).\n\nKey Points:\n\nThe study aims to determine which method provides better accuracy and bone volume stability.\n\nCone Beam CT scans (CBCT) will assess horizontal bone gain preoperatively and six months postoperatively.\n\nThe trial is conducted at Cairo University's Faculty of Dentistry. Participants: Patients with pure horizontal bone loss in the anterior mandible.\n\nOutcomes:\n\nPrimary: Bone width gain in millimeters. Secondary: Accuracy of augmentation and surgical time.\n\nMethodology:\n\nThe study group will use computer-designed surgical osteotomy guides to harvest and place bone grafts with improved precision.\n\nThe control group will rely on the conventional free-hand approach. Both groups will undergo bone grafting using autogenous cortical bone shells.\n\nData Collection \\& Analysis:\n\nParticipants will be randomized and blinded. Data will be analyzed using statistical methods to compare effectiveness.",[55],"Horizontal Ridge Deficiency","NOT_YET_RECRUITING","2025-04-20",{"date":59,"type":60},"2025-04-24","ACTUAL",{"date":62,"type":49},"2025-05-01",{"date":64,"type":49},"2026-09-01",{"name":5,"class":6}]