Nctid:
NCT06222970
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M21860", "name"=>"Pharmaceutical Solutions", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Pharmaceutical Solutions", "abbrev"=>"PhSol"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"PROSPECTIVE", "observationalModel"=>"COHORT"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>40}, "targetDuration"=>"6 Months", "patientRegistry"=>true}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2020-05-04", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2024-12", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-01-26", "studyFirstSubmitDate"=>"2024-01-15", "studyFirstSubmitQcDate"=>"2024-01-15", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-30", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-25", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2023-09-18", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Bone gain", "timeFrame"=>"6 months", "description"=>"Measurement of bone height and width"}]}, "oversightModule"=>{"isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Maxillary Deficiency"]}, "descriptionModule"=>{"briefSummary"=>"Maxillary sinus augmentation is one of the most performed procedures to increase the bone quantity of the atrophic maxilla in order to allow implant placement. The aim of the present case series was to describe a surgical protocol to perform maxillary sinus augmentation with the \"bone lid technique\", and its outcomes in a cohort of patients eligible for the procedure."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"patients referred to the Unit of Dentistry and Oral Surgery, University Hospital of Pisa, with a severe bone atrophy of the maxillary posterior areas that required bone grafting through a lateral approach of the maxillary sinus", "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Partially or fully edentulous patients requiring an implant-prosthetic rehabilitation of the premolar or molar maxillary areas with a residual ridge height lower than 4 mm.\n* Patients needing for a unilateral or bilateral sinus lift with a lateral wall approach.\n\nExclusion Criteria:\n\n* Patients under treatment with immunosuppressive agents\n* Patients under treatment with medications that could impair bone metabolism.\n* Patients pregnant or breastfeeding.\n* Patients who had received irradiation treatment to the head and neck area.\n* Patients with uncontrolled diabetes.\n* Patients with uncontrolled periodontal disease."}, "identificationModule"=>{"nctId"=>"NCT06222970", "acronym"=>"SINUSLID_2023", "briefTitle"=>"Maxillary Sinus Augmentation Via the \"Bone Lid Technique\"", "organization"=>{"class"=>"OTHER", "fullName"=>"University of Pisa"}, "officialTitle"=>"Maxillary Sinus Augmentation Via the \"Bone Lid Technique\"", "orgStudyIdInfo"=>{"id"=>"SINUSLID_2023"}}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Bone lid repositioning in course of sinus lift", "type"=>"PROCEDURE", "description"=>"A full-thickness flap was elevated to access the lateral maxillary bone wall. Subsequently, a lateral access window was prepared using a piezoelectric device with specific bone tips, delimitating a trapezoidal bone lid.\n\nOnce the antrostomy was completed, the bone lid was gently removed with a Lucas surgical curette and anatomical tweezers, with great care to avoid damages to the Schneiderian membrane. The Schneiderian membrane was detached from the bone layer using specific sinus curettes. In case of sinus membrane perforation, the membrane was raised in all directions. All clinical cases received a cortical bone lamina to avoid graft particles displacement in the maxillary sinus. The elevated space was filled with chips of cortico-spongious bone. The antrostomy was then covered with the bone lid (osteotomy window), previously removed and preserved in physiological solution and fixed in the original anatomical position with a surgical glue. The flap was then repositioned and sutured."}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"56126", "city"=>"Pisa", "status"=>"RECRUITING", "country"=>"Italy", "contacts"=>[{"name"=>"Antonio Barone, Professor", "role"=>"CONTACT", "email"=>"antonio.barone@unipi.it", "phone"=>"050993327"}], "facility"=>"U.O. Odontostomatologia e Chirurgia del Cavo Orale", "geoPoint"=>{"lat"=>43.70853, "lon"=>10.4036}}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO", "description"=>"data will be published after anonymization and/or as aggregated data"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"University of Pisa", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Full Professor of Oral Surgery and Implantology, Principal Investigator", "investigatorFullName"=>"Antonio Barone", "investigatorAffiliation"=>"University of Pisa"}}}}
