[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100566920":3},{"organization":4,"outcomesModule":7,"designInfo":37,"detailedDescription":36,"studyPopulation":36,"armGroups":45,"interventions":61,"overallOfficials":36,"centralContacts":70,"locations":76,"responsibleParty":100,"collaborators":36,"id":103,"slug":104,"hasResults":105,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":36,"eligibilityCriteria":109,"healthyVolunteers":110,"sex":111,"minAge":112,"maxAge":113,"enrollmentInfo":114,"targetDuration":36,"studyType":117,"phases":118,"briefSummary":120,"conditions":121,"keywords":124,"overallStatus":127,"whyStopped":36,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":137},{"fullName":5,"class":6},"Universidad de Especialidades Espiritu Santo","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":36},[9],{"measure":10,"description":11,"timeFrame":12},"Horizontal Bone Gain (mm) Measured by CBCT","Participant-level horizontal bone gain at 6 months after surgery, measured on cone-beam computed tomography (CBCT) scans using standardized reference points. When two eligible posterior mandibular sites are treated in the same participant, the participant-level mean will be used for the primary analysis.","6 after surgery",[14,18,22,26,29,32],{"measure":15,"description":16,"timeFrame":17},"Surgical Duration (minutes)","Total surgical time for each bone augmentation procedure, measured from the first anesthetic injection to the final suture. Timing will be recorded using a standardized chronometer to compare operative efficiency across autogenous, xenogeneic, and allogeneic cortical shell techniques.","Day 0 (intraoperative measurement)",{"measure":19,"description":20,"timeFrame":21},"Relative Radiographic Density Using CBCT Gray Value Units","Relative radiographic density within the grafted area will be assessed using device-specific CBCT gray value measurements under standardized acquisition parameters. These values will not be interpreted as calibrated Hounsfield Units. Measurements will be performed by calibrated examiners.","3, 6, and 12 months after surgery",{"measure":23,"description":24,"timeFrame":25},"Postoperative Inflammation (mm Facial Measurement)","Postoperative swelling will be assessed by measuring the linear distance from the lip commissure to the tragus with a flexible tape. Measurements will be taken bilaterally under standardized conditions by the same examiner to evaluate differences among groups.","Preoperative, immediate postoperative, days 3, 7, and 14",{"measure":27,"description":28,"timeFrame":21},"Volumetric Bone Gain (mm³)","Three-dimensional volumetric changes of the augmented area will be calculated by superimposing pre- and postoperative CBCT-derived meshes using surface registration software. The difference in total reconstructed volume (ΔVolume) will quantify the amount of new bone formation across techniques.",{"measure":30,"description":31,"timeFrame":21},"Morphometric Surface Deviation (mm)","Surface deviation between pre- and postoperative 3D models will be analyzed using color-coded distance maps and point-to-surface metrics (mean absolute distance, RMS error, and 95th-percentile distance). This quantifies contour stability and remodeling patterns for each graft material.",{"measure":33,"description":34,"timeFrame":35},"Secondary Horizontal Bone Gain at 3 and 12 Months","Horizontal bone gain measured on CBCT scans at 3 and 12 months after surgery will be analyzed as a secondary longitudinal outcome.","3 and 12 months after surgery",null,{"allocation":38,"interventionModel":39,"interventionModelDescription":40,"primaryPurpose":41,"observationalModel":36,"timePerspective":36,"maskingInfo":42},"RANDOMIZED","PARALLEL","A randomized, statistician-blinded, parallel-group clinical trial will be conducted in 78 participants presenting with posterior mandibular bone atrophy. Participants will be allocated in a 1:1:1 ratio to receive autogenous, xenogeneic, or allogeneic cortical shell augmentation. Each participant will receive only one allocated intervention, and the unit of analysis for the primary endpoint will be the participant.","TREATMENT",{"masking":43,"maskingDescription":44,"whoMasked":36},"NONE","This is an open-label surgical trial. Due to the nature of the interventions, participants, surgeons, and investigators cannot be blinded. The statistician responsible for the primary analysis will remain blinded to group allocation until completion of the primary analysis.",[46,52,57],{"label":47,"type":48,"description":49,"interventionNames":50},"Autogenous Cortical Shell Graft","ACTIVE_COMPARATOR","Thin cortical bone plates harvested from the mandibular ramus will be fixed to the recipient ridge with titanium microscrews to form a cortical shell. The internal space will be filled with a 1:1 mixture of autogenous bone chips and xenogeneic particulate graft. This conventional technique represents the control group for comparison with xenogeneic and allogeneic materials.",[51],"Procedure: Cortical Shell Bone Grafting",{"label":53,"type":54,"description":55,"interventionNames":56},"Xenogeneic Cortical Shell Graft","EXPERIMENTAL","Prefabricated bovine cortical laminae will be rehydrated, trimmed to contour, and fixed with titanium microscrews to the mandibular ridge. The enclosed space will be filled with a 1:1 mixture of autogenous bone chips and xenogeneic particulate graft to promote bone regeneration.",[51],{"label":58,"type":54,"description":59,"interventionNames":60},"Allogenic Cortical Shell Graft","A allogenic cortical sheets be rehydrated, adapted to the defect site, and fixed with titanium microscrews. The internal space will be filled with a 1:1 mixture of autogenous bone chips and xenogeneic particulate graft, following the same standardized protocol as the other groups.",[51],[62],{"type":63,"name":64,"description":65,"armGroupLabels":66,"otherNames":67},"PROCEDURE","Cortical Shell Bone Grafting","Surgical reconstruction of atrophic posterior mandibular ridges using thin cortical plates fixed with titanium microscrews to form a biologic shell. The inner space is filled with a 1:1 mixture of autogenous bone chips and biomaterial. Depending on the study group, the cortical plates are autogenous (from the mandibular ramus), xenogeneic (bovine origin), or allogeneic (human donor).",[58,47,53],[68,69],"Shell technique","3D Onlay bone graft",[71],{"name":72,"role":73,"phone":74,"phoneExt":36,"email":75},"Antonio G Lanata-Flores","CONTACT","+593983820084","alanataf@uees.edu.ec",[77],{"facility":78,"status":36,"city":79,"state":80,"zip":81,"country":82,"countryCode":83,"cosmosGeoPoint":84,"geoPoint":89,"contacts":90},"Universidad Espíritu Santo","Samborondón","Guayas","092301","Ecuador","EC",{"type":85,"coordinates":86},"Point",[87,88],-79.72566,-1.96071,{"lat":88,"lon":87},[91,94,97],{"name":92,"role":73,"phone":93,"phoneExt":36,"email":75},"Antonio Gabriel Lanata-Flores, Phd","+593(04)5000950",{"name":95,"role":73,"phone":36,"phoneExt":36,"email":96},"Estefania Ayala, Phd","payalaa@uees.edu.ec",{"name":98,"role":99,"phone":36,"phoneExt":36,"email":36},"Antonio Lanata-Flores, Phd","PRINCIPAL_INVESTIGATOR",{"type":99,"investigatorFullName":101,"investigatorTitle":102,"investigatorAffiliation":5,"oldNameTitle":36,"oldOrganization":36},"Antonio Lanata Flores","Assistant Professor","100566920","bone-augmentation-techniques-in-the-mandible-posterior-region-100566920",false,"NCT06661447","Bone Augmentation Techniques in the Mandible Posterior Region","Comparison of Bone Augmentation Techniques in the Mandibular Posterior Region: A Randomized Clinical Trial","Inclusion Criteria:\n\nPosterior mandibular edentulism requiring horizontal ridge augmentation (Cawood \\& Howell Classes IV-VI).\n\nOne or two eligible posterior mandibular sites suitable for cortical shell augmentation.\n\nAdequate residual bone height to allow safe fixation above the mandibular canal.\n\nGood general health (ASA I or II). Plaque index \\\u003C 20% and absence of active periodontal infection. Ability and willingness to attend scheduled follow-up visits (up to 12 months). Written informed consent provided prior to any study-related procedure.\n\nExclusion Criteria:\n\nUncontrolled systemic diseases affecting bone healing (e.g., uncontrolled diabetes mellitus, immunosuppressive disorders).\n\nCurrent heavy smoking (\\>5 cigarettes\u002Fday). Pregnancy or lactation. Current use of medications known to affect bone metabolism or healing (e.g., bisphosphonates, long-term corticosteroids, anticoagulants).\n\nActive periodontal disease or untreated oral infection. History of chemotherapy or radiotherapy to the head and neck region.",true,"ALL","18 Years","64 Years",{"count":115,"type":116},78,"ESTIMATED","INTERVENTIONAL",[119],"NA","This study will compare three methods to rebuild lost bone in the back part of the lower jaw (posterior mandible) before dental implant placement. Seventy-eight adults will be randomly assigned to receive one of three \"cortical shell\" techniques using either the patient's own bone (autogenous) or prefabricated bone plates from animal (xenogeneic) or human donors (allogeneic). In all groups, the space inside the shell will be filled with a mixture of small bone chips and bone substitute material. The main outcome is the increase in jawbone width measured on 3D cone-beam CT scans at 6 months after surgery. Additional scans and clinical assessments up to 12 months will evaluate healing, bone stability, and postoperative recovery.",[122,123],"Bone Substitutes","Alveolar Bone Grafting",[125,122,126],"Alveolar Bone Atrophy","Bone Resorption","NOT_YET_RECRUITING","2026-07-14",{"date":130,"type":131},"2026-07-16","ACTUAL",{"date":133,"type":116},"2026-08-01",{"date":135,"type":116},"2027-04-01",{"name":5,"class":6},1]