Nctid:
NCT06612021
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"=>"Dental Caries", "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"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"TRIPLE", "whoMasked"=>["PARTICIPANT", "CARE_PROVIDER", "OUTCOMES_ASSESSOR"]}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>64}}, "statusModule"=>{"overallStatus"=>"ACTIVE_NOT_RECRUITING", "startDateStruct"=>{"date"=>"2023-07-14", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2024-11-01", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-21", "studyFirstSubmitDate"=>"2023-08-25", "studyFirstSubmitQcDate"=>"2024-09-21", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-25", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-25", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-10-14", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"marginal staining of restoration", "timeFrame"=>"baseline ,6 months & 12 months", "description"=>"marginal staining using USPHS criteria Alpha: No staining in the margin Bravo: superficial staining on the margin Charlie: deep staining on the margin"}], "secondaryOutcomes"=>[{"measure"=>"caries recurrence", "timeFrame"=>"baseline ,6 months ,12 months", "description"=>"caries recurrence using USPHS criteria Alpha: no recurrent caries Charlie: Caries recurrence"}, {"measure"=>"marginal adaptation of restoration", "timeFrame"=>"baseline ,6 months and 12 months", "description"=>"marginal adaptation using USPHS criteria ALPHA: Marginal continuity BRAVO: slightly detectable marginal discontinuity that does not require replacement CHARLIE: Detectable crevice or ledge at margin that requires replacement"}]}, "oversightModule"=>{"isUsExport"=>false, "oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["HEMA free", "HEMA containing adhesive", "Giomers", "Giomer", "USPHS criteria"], "conditions"=>["Dental Caries"]}, "descriptionModule"=>{"briefSummary"=>"The aim of study is to evaluate the clinical performance of posterior restorations using HEMA free universal adhesive versus HEMA containing universal adhesive over one year using USPHS criteria.", "detailedDescription"=>"The study is intended to evaluate the HEMA free universal adhesive versus HEMA containing universal adhesive when both used in conjunction with giomer aesthetic restorations in occlusal cavities in posterior teeth ICDAS III and IV.\n\nThe restorations will be evaluated at baseline, 6 and 12 months according to modified USPHS criteria in terms of marginal staining, marginal adaptation and caries recurrence.\n\nPatients will be recruited from outpatient clinic of conservative dentistry department, cairo university according to inclusion and exclusion criteria. patient will be randomly allocated to intervention or control group."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT"], "maximumAge"=>"35 years", "minimumAge"=>"19 years", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria of participants:\n\n* Patients with occlusal caries in molars classified as ICDAS III or IV.\n* 19-35 years.\n* Males or Females.\n* Co-operative patients approving to participate in the trial.\n\nExclusion criteria of participants:\n\n* Pregnancy.\n* Disabilities.\n* Systemic disease or severe medical complications.\n* Allergic history concerning methacrylate.\n* Rampant caries.\n* Heavy smoking.\n* Xerostomia.\n* Lack of compliance.\n* Evidence of severe bruxism, clenching, or tempromandibular joint disorders."}, "identificationModule"=>{"nctId"=>"NCT06612021", "briefTitle"=>"Hema Free Versus Hema Containing Adhesives in Posterior Restorations", "organization"=>{"class"=>"OTHER", "fullName"=>"Cairo University"}, "officialTitle"=>"Clinical Performance of Posterior Restorations Using Hema Free Universal Adhesive Versus Hema Containing Universal Adhesive Over One Year Using USPHS Criteria: Randomized Controlled Trial", "orgStudyIdInfo"=>{"id"=>"2255874"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"HEMA free universal adhesive group", "interventionNames"=>["Procedure: Beautibond universal adhesive"]}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"HEMA containing universal adhesive group", "interventionNames"=>["Procedure: Tetric N universal bond"]}], "interventions"=>[{"name"=>"Beautibond universal adhesive", "type"=>"PROCEDURE", "description"=>"HEMA free universal adhesive", "armGroupLabels"=>["HEMA free universal adhesive group"]}, {"name"=>"Tetric N universal bond", "type"=>"PROCEDURE", "description"=>"HEMA containing universal bond", "armGroupLabels"=>["HEMA containing universal adhesive group"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"11555", "city"=>"Cairo", "state"=>"Manyal", "country"=>"Egypt", "facility"=>"Faculty of dentistry Cairo university", "geoPoint"=>{"lat"=>30.06263, "lon"=>31.24967}}], "overallOfficials"=>[{"name"=>"Alaa F Abdelsalam, phD", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"lecturer of conservative dentistry, Cairo university"}, {"name"=>"Hadier M Gad, PhD", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Lecturer of conservative dentistry, Cairo university"}, {"name"=>"Manar A Elmokanen, PhD", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Lecturer of conservative dentistry, Cairo University"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Cairo University", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"lecturer of conservative dentistry", "investigatorFullName"=>"Alaa Fathi Abdelsalam", "investigatorAffiliation"=>"Cairo University"}}}}
