Nctid:
NCT06615544
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000003731", "term"=>"Dental Caries"}], "ancestors"=>[{"id"=>"D000017001", "term"=>"Tooth Demineralization"}, {"id"=>"D000014076", "term"=>"Tooth Diseases"}, {"id"=>"D000009057", "term"=>"Stomatognathic Diseases"}], "browseLeaves"=>[{"id"=>"M6928", "name"=>"Dental Caries", "asFound"=>"Caries,Dental", "relevance"=>"HIGH"}, {"id"=>"M19339", "name"=>"Tooth Demineralization", "relevance"=>"LOW"}, {"id"=>"M16831", "name"=>"Tooth Diseases", "relevance"=>"LOW"}, {"id"=>"M12017", "name"=>"Stomatognathic Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Mouth and Tooth Diseases", "abbrev"=>"BC07"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"NA", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"SINGLE_GROUP"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>45}}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-10", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2031-04", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-24", "studyFirstSubmitDate"=>"2024-09-24", "studyFirstSubmitQcDate"=>"2024-09-24", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-26", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-26", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-08", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Postoperative hypersensitivity", "timeFrame"=>"1 month", "description"=>"will be assessed according to FDI criteria (grade 1-5, lower scores mean a better outcome)"}], "secondaryOutcomes"=>[{"measure"=>"Fracture rate", "timeFrame"=>"5 years", "description"=>"will be assessed according to FDI criteria (grade 1-5, lower scores mean a better outcome)"}, {"measure"=>"Marginal quality", "timeFrame"=>"5 years", "description"=>"will be assessed according to FDI criteria (grade 1-5, lower scores mean a better outcome)"}]}, "oversightModule"=>{"isUsExport"=>false, "oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Class I Dental Restorations", "Class II Dental Restorations", "Insufficient Dental Restoration", "Caries, Dental"]}, "descriptionModule"=>{"briefSummary"=>"The overall aim of this study is to evaluate the clinical performance and safety of the new dental dual-cure adhesive for luting indirect ceramic restorations (inlays and onlays). The primary aim is to determine the rate of postoperative hypersensitivity occurrence after using the new adhesive for the placement of indirect restorations. The secondary objective of this study is to assess the long-term clinical performance of the new adhesive in terms of marginal quality, retention/fracture rate of the ceramic restorations, and vitality/fracture rate of the restored teeth."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"65 years", "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Age: 18-65 years\n* Informed consent signed and understood by the subject\n* Indication for indirect restorations (inlay, onlay) in molar or premolar\n* The occlusal area of the restoration must cover at least 1/3 of the occlusal area of the tooth.\n* visual analogue scale (VAS)\\<4 (0=no pain, 10=maximum conceivable pain)\n* Max. 2 restorations per participant in different quadrants.\n* Vital tooth\n* Healthy periodontium, no active periodontitis\n* Contact with adjacent teeth (at least at one side) and opposing teeth present with at least one contact point.\n* Sufficient language skills\n\nExclusion Criteria:\n\n* Insufficient isolation\n* Participants with a proven allergy to one of the ingredients of the materials used\n* Participants with proven allergy to local anaesthetics\n* High caries activity/ poor oral hygiene\n* Participants with severe systemic diseases\n* Pregnancy\n* Tooth with irreversible pulpitis\n* Indication for direct pulp capping\n* Bleaching of teeth within the last 14 days\n* Usage of peroxide-based disinfectants within the last 14 days"}, "identificationModule"=>{"nctId"=>"NCT06615544", "briefTitle"=>"Clinical Evaluation of a New Dual-cure Universal Adhesive", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"Ivoclar Vivadent AG"}, "officialTitle"=>"Clinical Evaluation of a New Dual-cure Universal Adhesive for Indirect Restorative Treatment", "orgStudyIdInfo"=>{"id"=>"OTCS187092274"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"New dual-cure adhesive", "description"=>"The newly developed dual-cure adhesive will be used for the placement of indirect restorations.", "interventionNames"=>["Device: Placement of indirect dental restoration"]}], "interventions"=>[{"name"=>"Placement of indirect dental restoration", "type"=>"DEVICE", "description"=>"The newly developed dual-cure adhesive will be used for the placement of indirect restorations.", "armGroupLabels"=>["New dual-cure adhesive"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"9494", "city"=>"Schaan", "country"=>"Liechtenstein", "contacts"=>[{"name"=>"Lukas Enggist, Dr. med. dent.", "role"=>"CONTACT", "email"=>"Lukas.Enggist@ivoclar.com", "phone"=>"+423 235 3401"}], "facility"=>"Ivoclar Vivadent AG", "geoPoint"=>{"lat"=>47.16498, "lon"=>9.50867}}], "centralContacts"=>[{"name"=>"Patrizia Elkuch-Hoch", "role"=>"CONTACT", "email"=>"Patrizia.Elkuch-Hoch@ivoclar.com", "phone"=>"+423 235 3780"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Ivoclar Vivadent AG", "class"=>"INDUSTRY"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
