[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100655649":3},{"organization":4,"outcomesModule":7,"designInfo":37,"detailedDescription":45,"studyPopulation":36,"armGroups":46,"interventions":56,"overallOfficials":36,"centralContacts":69,"locations":36,"responsibleParty":79,"collaborators":36,"id":83,"slug":84,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":85,"sex":91,"minAge":92,"maxAge":36,"enrollmentInfo":93,"targetDuration":36,"studyType":96,"phases":97,"briefSummary":99,"conditions":100,"keywords":102,"overallStatus":107,"whyStopped":36,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":36},{"fullName":5,"class":6},"George Eastman Dental Hospital, Italy","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":36},[9],{"measure":10,"description":11,"timeFrame":12},"Change in Probing pocket depth","distance (mm) between marginal mucosa and bottom of probable pocket","from baseline to 12, 24 months post-surgery",[14,18,22,26,29,32],{"measure":15,"description":16,"timeFrame":17},"change in recession","change between baseline and 24 months (mm)","baseline to 12 and 24 months post-op",{"measure":19,"description":20,"timeFrame":21},"change in CAL","change in CAL between baseline and 24 months (mm)","between baseline and 24 months",{"measure":23,"description":24,"timeFrame":25},"Suppuration on probing (SoP)","Dichotomic variable","baseline, 12, 24 months",{"measure":27,"description":28,"timeFrame":25},"Bleeding on probing","Dichotomic variable (yes\u002F no)",{"measure":30,"description":31,"timeFrame":25},"Keratinized mucosa (KM)","continuous, measured in mm, from the margin of the mucosa to the mucogingival junction",{"measure":33,"description":34,"timeFrame":35},"Treatment Success","Composite outcome comprising implant not lost, no more than 1 mm of buccal recession, no more than 5 mm of PPD, no SOP, no more than 1 bleeding spot on probing, no loss of crestal bone (mm)","24 months",null,{"allocation":38,"interventionModel":39,"interventionModelDescription":36,"primaryPurpose":40,"observationalModel":36,"timePerspective":36,"maskingInfo":41},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":42,"maskingDescription":36,"whoMasked":43},"SINGLE",[44],"OUTCOMES_ASSESSOR","Implants diagnosed with peri-implantitis and amenable for bone reconstructive treatment will be enrolled in the study. All implants will receive reconstructive therapy by means of a collagenated bone graft, however the method of decontamination will be randomized between electrolytic cleaning or titanium rotating brushes. In both cases, titanium curettes will be used to remove hard deposits on the implant surface and degranulation will be completed with curettes.",[47,53],{"label":48,"type":49,"description":50,"interventionNames":51},"Test: Electrolytic decontamination","EXPERIMENTAL","Electrolytic decontamination with GalvoSurge (Straumann AG)",[52],"Procedure: test device GalvoSurge",{"label":54,"type":49,"description":55,"interventionNames":36},"Control: Mechanical decontamination with rotating titanium brush","Mechanical rotating brush used with titanium curettes to remove hard tissue deposits from the implant surface",[57,64],{"type":58,"name":59,"description":60,"armGroupLabels":61,"otherNames":62},"PROCEDURE","test device GalvoSurge","Electrolytic decontamination",[48],[63],"electrolytic decontamination",{"type":58,"name":65,"description":66,"armGroupLabels":36,"otherNames":67},"Mechanical decontamination with titanium brush","Reconstructive treatment of peri-implantitis after removal of hard and soft tissue deposits from the implant surface followed by mechanical decontamination with titanium brush",[68],"tibrush",[70,75],{"name":71,"role":72,"phone":73,"phoneExt":36,"email":74},"Lucrezia Paterno Holtzman, DDS, MS","CONTACT","+393398035371","lucreziaph@gmail.com",{"name":76,"role":72,"phone":36,"phoneExt":77,"email":78},"Luca Cordaro, DDS MD","+390647746017","lucacordaro@usa.net",{"type":80,"investigatorFullName":81,"investigatorTitle":82,"investigatorAffiliation":5,"oldNameTitle":36,"oldOrganization":36},"PRINCIPAL_INVESTIGATOR","Lucrezia Paternò Holtzman","PhD candidate","100655649","early-phase-1-reconstructive-treatment-of-peri-implantitis-with-electrolytic-decontamination-versus-titanium-brushes-100655649",false,"NCT07814391","Reconstructive Treatment of Peri-implantitis With Electrolytic Decontamination Versus Titanium Brushes","Reconstructive Treatment of Peri-implantitis With Electrolytic Decontamination Versus Titanium Brushes: a Randomized Controlled Trial","Galvo vs mech","Inclusion Criteria:\n\n* Implants with peri-implantitis (defined according to 2017 World Workshop definitions)\n* contained defects with infra osseous component amenable to reconstructive treatment\n* fixed and removable superstructures\n* patients with no systemic conditions affecting healing (uncontrolled diabetes mellitus, chronic corticosteroid use, autoimmune conditions affecting connective tissue)\n* smoking more than 10 cigarettes\n\nExclusion Criteria:\n\n* mobile implants\n* non removable crowns (both cement or screw retained) that cannot be removed prior to surgery","ALL","18 Years",{"count":94,"type":95},38,"ESTIMATED","INTERVENTIONAL",[98],"EARLY_PHASE1","Implants diagnosed with peri-implantitis and amenable for bone reconstructive treatment will be enrolled in the study. The implants will randomly be treated with either an electrolytic or a mechanical cleaning of the implant surface (with titanium brushes). In all cases, a bone graft will be used to rebuild missing bone.",[101],"Peri-Implantitis and Peri-implant Mucositis",[103,104,105,106],"electrolytic cleaning","reconstructive treatment","demineralized bovine bone mineral (DBBM)","titanium brush","NOT_YET_RECRUITING","2026-09-04",{"date":110,"type":111},"2026-09-11","ACTUAL",{"date":113,"type":95},"2027-01",{"date":115,"type":95},"2027-04",{"name":5,"class":6}]