Nctid:
NCT06617221
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"DOUBLE", "whoMasked"=>["PARTICIPANT", "OUTCOMES_ASSESSOR"]}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>24}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"2021-01-01", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2023-06-01", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2024-09-27", "studyFirstSubmitDate"=>"2024-09-25", "studyFirstSubmitQcDate"=>"2024-09-25", "lastUpdatePostDateStruct"=>{"date"=>"2024-10-01", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-27", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2023-03-01", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"clinical and radiographic ridge alterations", "timeFrame"=>"four months", "description"=>"Using a standardized stent with reference points , the following horizontal clinical measurements were obtained before extraction through the stent holes: buccal soft tissue thickness at 4, 7, and 10 mm apical to the gingival margin and palatal or lingual soft tissue thickness at similar sites. Vertical measurements were obtained an incisal or occlusal hole to the buccal aspect of the ridge (inciso-buccal) and the palatal/ lingual aspect (inciso-palatal). Radiographic width of the alveolar ridge was measure at the same reference points.\n\ntheses measurements were taken at baseline (before extraction) and at 4 months after extraction and socket graft"}]}, "oversightModule"=>{"isUsExport"=>false, "oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Extraction Socket Healing", "Socket Preservation", "Alveolar Ridge Preservation"]}, "referencesModule"=>{"references"=>[{"pmid"=>"38660739", "type"=>"BACKGROUND", "citation"=>"Jafarian J, Shahrabi-Farahani S, Ferreira CF, Stewart CW, Luepke P. Histological Evaluation of Alveolar Ridge Preservation Using Different Bone Grafts: Clinical Study Analysis Part II. J Oral Implantol. 2024 Jun 1;50(3):260-265. doi: 10.1563/aaid-joi-D-23-00060."}, {"pmid"=>"34114665", "type"=>"BACKGROUND", "citation"=>"Jones K, Williams C, Yuan T, Digeorge-Foushee AM, Chambers Wilson R, Burton T, Hamlin N, Martinez L. Comparative in vitro study of commercially available products for alveolar ridge preservation. J Periodontol. 2022 Mar;93(3):403-411. doi: 10.1002/JPER.21-0087. Epub 2021 Jul 12."}]}, "descriptionModule"=>{"briefSummary"=>"The goal of this clinical trial is to determine whether a graft material introduced recently (test) to be used in extraction sockets is as good as a previously known graft material (control) in adults undergoing tooth extraction of a single-rooted tooth.\n\nThe main question it aims to answer is:\n\nIs this graft material able to maintain good bone volume and composition after extraction?\n\nResearchers will compare this new graft to a well-studied graft material.\n\nParticipants will be randomly assigned to one of the groups and will receive the allocated graft after tooth extraction. The dimension of the alveolar ridge, which supports teeth in the jaw, will be measured before extraction and four months after healing. A cone beam CT Scan will also be obtained.", "detailedDescription"=>"Alveolar ridge resorption after tooth extraction poses a substantial obstacle for subsequent implant placement, frequently necessitating ridge augmentation treatments. Alveolar ridge preservation (ARP) is intended to reduce these dimensional alterations. Various grafting materials have been used for ARP, with varying success rates in maintaining ridge dimensions. This study compares the clinical and radiological outcomes of a composite graft plug of bioactive resorbable calcium apatite crystals embedded in a collagen matrix to a typical allograft.\n\nThis randomized controlled clinical experiment comprised 26 people needing a single-rooted tooth extracted. They were divided into two groups: composite plug and allograft. Clinical measures of soft tissue were collected at baseline and four months after extraction using a stent with reference points. At baseline and four months after extraction, radiographic examinations were performed using cone beam computed tomography (CBCT)."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* 18 years or older\n* planned for extraction and alveolar ridge preservation of a single-rooted tooth - -- healthy or have well-controlled systemic disease\n* good oral hygiene\n* healthy periodontium or at least at the extraction area.\n\nExclusion Criteria:\n\n* smoking ≥10 cigarettes per day\n* generalized periodontitis\n* poor oral hygiene\n* uncontrolled systemic diseases such as diabetes\n* pregnancy\n* history of anti-resorptive therapy such as bisphosphonate"}, "identificationModule"=>{"nctId"=>"NCT06617221", "briefTitle"=>"Alveolar Ridge Preservation Using a Composite Graft Plug: Radiographic and Clinical Assessment", "organization"=>{"class"=>"OTHER", "fullName"=>"King Abdulaziz University"}, "officialTitle"=>"Alveolar Ridge Preservation Using a Composite Graft Plug: Radiographic and Clinical Assessment", "orgStudyIdInfo"=>{"id"=>"REC 4350-444"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Composite graft plug", "description"=>"composite graft plug was placed in the socket after extraction", "interventionNames"=>["Biological: Composite graft plug"]}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"Allograft", "description"=>"allograft was placed in the socket after extraction", "interventionNames"=>["Biological: Allograft"]}], "interventions"=>[{"name"=>"Composite graft plug", "type"=>"BIOLOGICAL", "description"=>"after tooth extraction the socket was grafted with a composite graft plug", "armGroupLabels"=>["Composite graft plug"]}, {"name"=>"Allograft", "type"=>"BIOLOGICAL", "description"=>"after tooth extraction the socket was grafted with allograft", "armGroupLabels"=>["Allograft"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"21589", "city"=>"Jeddah", "state"=>"Makkah", "country"=>"Saudi Arabia", "facility"=>"King Abdulaziz University", "geoPoint"=>{"lat"=>21.54238, "lon"=>39.19797}}]}, "ipdSharingStatementModule"=>{"infoTypes"=>["STUDY_PROTOCOL", "SAP", "CSR"], "ipdSharing"=>"YES", "description"=>"Age, Medical condition, gender"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"King Abdulaziz University", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Assistant professor", "investigatorFullName"=>"Arwa Abubakr Badahdah", "investigatorAffiliation"=>"King Abdulaziz University"}}}}
