Nctid:
NCT06614426
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-03"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000057873", "term"=>"Peri-Implantitis"}], "ancestors"=>[{"id"=>"D000010510", "term"=>"Periodontal Diseases"}, {"id"=>"D000009059", "term"=>"Mouth Diseases"}, {"id"=>"D000009057", "term"=>"Stomatognathic Diseases"}], "browseLeaves"=>[{"id"=>"M28893", "name"=>"Peri-Implantitis", "asFound"=>"Peri-implantitis", "relevance"=>"HIGH"}, {"id"=>"M13419", "name"=>"Periodontal Diseases", "relevance"=>"LOW"}, {"id"=>"M12019", "name"=>"Mouth 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"=>"DOUBLE", "whoMasked"=>["INVESTIGATOR", "OUTCOMES_ASSESSOR"]}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>57}}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-11-01", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2026-12-30", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-25", "studyFirstSubmitDate"=>"2024-09-18", "studyFirstSubmitQcDate"=>"2024-09-25", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-26", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-26", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2026-11-30", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Probing pocket depth", "timeFrame"=>"Baseline (prior to surgical intervention), 3, 6, 12 and 24 months", "description"=>"- Probing pocket depth: measured at baseline (prior to surgical intervention), 3, 6, 12 and 24 months using a manual periodontal probe."}], "secondaryOutcomes"=>[{"measure"=>"Presence or absence of plaque, bleeding on probing and suppuration", "timeFrame"=>"Baseline (prior to surgical intervention), 3, 6, 12 and 24 months", "description"=>"Presence or absence of plaque, bleeding on probing and suppuration: measured at baseline (prior to surgical intervention), 3, 6, 12 and 24 months using a manual periodontal probe"}, {"measure"=>"Peri-implant marginal bone level", "timeFrame"=>"Baseline (prior to surgical intervention), 12 and 24 months", "description"=>"- Peri-implant marginal bone level: measured at baseline (prior to surgical intervention), 12 and 24 months using standardized peri-apical radiographs."}, {"measure"=>"Peri-implant soft tissue level", "timeFrame"=>"Baseline (prior to surgical intervention), 3, 6, 12 and 24 months", "description"=>"- Peri-implant soft tissue level: measured at baseline (prior to surgical intervention), 3, 6, 12 and 24 months using a manual periodontal probe."}, {"measure"=>"Peri-implant soft tissue thickness (Phenotype)", "timeFrame"=>"Baseline (prior to surgical intervention), 3, 6, 12 and 24 months", "description"=>"- Peri-implant soft tissue thickness (Phenotype): measured at baseline (prior to surgical intervention), 3, 6, 12 and 24 months using an endodontic spreader at 3 points."}]}, "oversightModule"=>{"isUsExport"=>false, "oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Peri Implantitis"]}, "referencesModule"=>{"references"=>[{"pmid"=>"25909530", "type"=>"BACKGROUND", "citation"=>"Hamzacebi B, Oduncuoglu B, Alaaddinoglu EE. Treatment of Peri-implant Bone Defects with Platelet-Rich Fibrin. Int J Periodontics Restorative Dent. 2015 May-Jun;35(3):415-22. doi: 10.11607/prd.1861."}]}, "descriptionModule"=>{"briefSummary"=>"The aim of this study is to evaluate the efficacy of implant surface decontamination using electrolysis cleaning system. And to evaluate the adjunctive use of L-PRF in promoting soft tissue healing and long-term stability of the peri-implant marginal bone in the surgical treatment of peri-implantitis.", "detailedDescription"=>"Research design\n\n* Prospective, in which participants will be recruited and then followed up throughout a specified period of time.\n* Randomized, parallel designed, concurrent controlled trial with participants randomly allocated to either control or test groups.\n* Single-blinded as the outcome accessors will be blinded to the intervention.\n\nMaterials and Methods:\n\nPatients attending Dubai Dental Hospital and requiring treatment of peri-implantitis will be invited to take part in this randomized controlled trial based on the following inclusion and exclusion criteria:\n\nInclusion criteria:\n\n* Aged 18 or over.\n* Require treatment of peri-implantitis (defined as the presence of bleeding and/or suppuration on gentle probing, probing depths of ≥ 6 mm, presence of bone loss beyond crestal bone level changes resulting from initial bone remodeling).\n* Screw retained implant crown.\n* Good compliance and commitment to attend follow-up review appointments.\n* Willing to provide informed consent.\n\nExclusion criteria\n\n* History of surgical therapy of peri-implantitis.\n* Peri-implant defects indicated for regenerative procedure (i.e. contained bony defect).\n* Cement retained implant crown.\n* Systemic/local antibiotics during the previous 6 months.\n* Bone metabolic disease and/or taking medications that affect bone metabolism.\n* History of malignancy, radiotherapy or chemotherapy.\n* Pregnant or lactating women.\n* Smokers\n\nThe study will be conducted following the ethical standards of the Declaration of Helsinki in 1975, as revised in 2013 and the CONSORT statement will be used as a guideline in reporting this study.\n\nRandomization, allocation concealment and blinding:\n\nThe participants will be randomly allocated to three equally sized groups using computer-generated numbers:\n\nControl group (C): Conventional open flap debridement Test group 1 (T1): Open flap debridement using (GalvoSurge® - Straumann) Test group 2 (T2): Open flap debridement using (GalvoSurge® - Straumann) combined with L-PRF application"}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Aged 18 or over.\n* Require treatment of peri-implantitis (defined as the presence of bleeding and/or suppuration on gentle probing, probing depths of ≥ 6 mm, presence of bone loss beyond crestal bone level changes resulting from initial bone remodeling).\n* Screw retained implant crown.\n* Good compliance and commitment to attend follow-up review appointments.\n* Willing to provide informed consent.\n\nExclusion Criteria:\n\n* History of surgical therapy of peri-implantitis.\n* Peri-implant defects indicated for regenerative procedure (i.e. contained bony defect).\n* Cement retained implant crown.\n* Systemic/local antibiotics during the previous 6 months.\n* Bone metabolic disease and/or taking medications that affect bone metabolism.\n* History of malignancy, radiotherapy or chemotherapy.\n* Pregnant or lactating women.\n* Smokers"}, "identificationModule"=>{"nctId"=>"NCT06614426", "briefTitle"=>"Surgical Treatment of Peri-implantitis Defects", "organization"=>{"class"=>"OTHER", "fullName"=>"Mohammed Bin Rashid University of Medicine and Health Sciences"}, "officialTitle"=>"The Efficacy of Electrolysis Decontamination with or Without Leukocyteplatelet Rich Fibrin (L-PRF) in the Surgical Treatment of Peri-implantitis Defects: a Randomized Controlled Trial", "orgStudyIdInfo"=>{"id"=>"MBRU IRB-2024-563"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"ACTIVE_COMPARATOR", "label"=>"Control group (C): Conventional open flap debridement", "description"=>"Conventional open flap debridement", "interventionNames"=>["Procedure: Control group (C)"]}, {"type"=>"EXPERIMENTAL", "label"=>"Test group 1 (T1): Open flap debridement using electrolysis decontamination", "description"=>"Open flap debridement using (GalvoSurge® - Straumann)", "interventionNames"=>["Procedure: Test group 1 (T1)"]}, {"type"=>"EXPERIMENTAL", "label"=>"Test group 2 (T2): Open flap debridement using electrolysis decontamination combined with L-PRF", "description"=>"Open flap debridement using (GalvoSurge® - Straumann) combined with L-PRF application", "interventionNames"=>["Procedure: Test group 2 (T2)"]}], "interventions"=>[{"name"=>"Test group 1 (T1)", "type"=>"PROCEDURE", "description"=>"Test group 1 (T1): Open flap debridement using electrolysis decontamination", "armGroupLabels"=>["Test group 1 (T1): Open flap debridement using electrolysis decontamination"]}, {"name"=>"Test group 2 (T2)", "type"=>"PROCEDURE", "description"=>"Test group 2 (T2): Open flap debridement using electrolysis decontamination combined with L-PRF application", "armGroupLabels"=>["Test group 2 (T2): Open flap debridement using electrolysis decontamination combined with L-PRF"]}, {"name"=>"Control group (C)", "type"=>"PROCEDURE", "description"=>"Conventional open flap debridement", "armGroupLabels"=>["Control group (C): Conventional open flap debridement"]}]}, "contactsLocationsModule"=>{"centralContacts"=>[{"name"=>"Abeer Hakam", "role"=>"CONTACT", "email"=>"abeer.hakam@dubaihealth.ac.ae", "phone"=>"3053353797"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"UNDECIDED"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Abeer Hakam", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR_INVESTIGATOR", "investigatorTitle"=>"Assistant professor", "investigatorFullName"=>"Abeer Hakam", "investigatorAffiliation"=>"Mohammed Bin Rashid University of Medicine and Health Sciences"}}}}
