Nctid:
NCT06615362
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"TRIPLE", "whoMasked"=>["PARTICIPANT", "INVESTIGATOR", "OUTCOMES_ASSESSOR"]}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL", "interventionModelDescription"=>"Two arms: one arm Autogenous Dentin Derived Barrier Membrane ,second arm Collagen Membrane ."}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>20}}, "statusModule"=>{"overallStatus"=>"ACTIVE_NOT_RECRUITING", "startDateStruct"=>{"date"=>"2022-04-10", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2024-10-10", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-24", "studyFirstSubmitDate"=>"2024-09-07", "studyFirstSubmitQcDate"=>"2024-09-24", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-26", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-26", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-04-10", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"All patients were evaluated radiographically immediately postoperative,and after 12 months", "timeFrame"=>"1 year", "description"=>"Radiographic Evaluation Cone Beam Computed Tomography scan was taken to measure Marginal Bone loss and Relative bone density"}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["TOOTH EXTRACTION", "IMMEDIATE IMPLANT"]}, "descriptionModule"=>{"briefSummary"=>"Autogenous Dentin Derived Barrier Membrane versus Collagen Membrane", "detailedDescription"=>"Autogenous Dentin Derived Barrier Membrane versus Collagen Membrane for Guided Bone Regeneration in Immediate Implant"}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT"], "maximumAge"=>"50 years", "minimumAge"=>"18 years", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\n1. Patient's age ranges from 18-50 years.\n2. Adequate inter-arch relation and inter-occlusal space that could accommodate the implant abutment and the future restoration\n3. Non-restorable tooth that needs dental extraction \\& guided bone regeneration for immediate implant.\n4. Presence of alveolar bone defect with vertical loss of buccal bone more than a third implant thread.\n5. Co-operative patients willing to complete the follow-up periods.\n\nExclusion Criteria:\n\n1. Any pathological condition at site of surgery.\n2. Patients with systemic diseases that contra-indicate the surgical procedure.\n3. Heavy smoking.\n4. Parafunctional habits such as bruxism and clenching.\n5. Pregnant patients. -"}, "identificationModule"=>{"nctId"=>"NCT06615362", "acronym"=>"DDBM dental", "briefTitle"=>"Autogenous Dentin Derived Barrier Membrane Versus Collagen Membrane", "organization"=>{"class"=>"OTHER", "fullName"=>"Mansoura University"}, "officialTitle"=>"Autogenous Dentin Derived Barrier Membrane Versus Collagen Membrane for Guided Bone Regeneration in Immediate Implant", "orgStudyIdInfo"=>{"id"=>"A04010222"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Autogenous Dentin Derived Barrier Membrane", "description"=>"Autogenous Dentin Derived Barrier Membrane + Xenogeneic bone graft material+ immediate implant", "interventionNames"=>["Procedure: preparation of dentin membrane from hopeless tooth for Guided Bone Regeneration in Immediate Implant"]}, {"type"=>"EXPERIMENTAL", "label"=>"Collagen Membrane", "description"=>"Collagen Membrane + Xenogeneic bone graft material + immediate implant", "interventionNames"=>["Procedure: Collagen Membrane for Guided Bone Regeneration in Immediate Implant"]}], "interventions"=>[{"name"=>"preparation of dentin membrane from hopeless tooth for Guided Bone Regeneration in Immediate Implant", "type"=>"PROCEDURE", "description"=>"tooth extraction , preparation of dentin membrane ,immediate implantation ,Xenogeneic bone graft material, application of dentin derived barrier membrane", "armGroupLabels"=>["Autogenous Dentin Derived Barrier Membrane"]}, {"name"=>"Collagen Membrane for Guided Bone Regeneration in Immediate Implant", "type"=>"PROCEDURE", "description"=>"like group one but with application of collagen membrane", "armGroupLabels"=>["Collagen Membrane"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"002", "city"=>"Mansoura", "state"=>"Eygpt", "country"=>"Egypt", "facility"=>"Mansoura University, faculty of dentistry ,Department of Oral and Maxillofacial", "geoPoint"=>{"lat"=>31.03637, "lon"=>31.38069}}, {"city"=>"Mansoura", "state"=>"Eygpt", "country"=>"Egypt", "facility"=>"Elhussein Farag", "geoPoint"=>{"lat"=>31.03637, "lon"=>31.38069}}], "overallOfficials"=>[{"name"=>"Heba Elsheikh Assistant professor, Assistant professor", "role"=>"STUDY_CHAIR", "affiliation"=>"Mansoura University, faculty of dentistry ,Department of Oral and Maxillofacial"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Mansoura University", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
