[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100599253":3},{"organization":4,"outcomesModule":7,"designInfo":21,"detailedDescription":20,"studyPopulation":20,"armGroups":29,"interventions":40,"overallOfficials":20,"centralContacts":45,"locations":20,"responsibleParty":51,"collaborators":20,"id":55,"slug":20,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":20,"eligibilityCriteria":60,"healthyVolunteers":61,"sex":62,"minAge":63,"maxAge":20,"enrollmentInfo":64,"targetDuration":20,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":20,"overallStatus":73,"whyStopped":20,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":20},{"fullName":5,"class":6},"Universita degli Studi di Genova","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":20},[9],{"measure":10,"description":11,"timeFrame":12},"Perimplant tissue inflammation","Evaluation of density and distribution of inflammatory cells (lymphocytes, plasma cells, granulocytes, macrophages) in the peri-epithelial connective tissue will be evaluated and a score will be used; 0 Massive infiltrate, diffusely present throughout the section; dense cellular aggregates; severely disturbed connective architecture.\n\n1\\. Intense infiltrate, present in most of the section but not fully diffuse; clearly visible focal aggregates.\n\n2 Moderate infiltrate, 3 Minimal infiltrate; isolated low-density cellular foci; connective tissue mostly unaffected.\n\n4 No recognizable inflammatory infiltrate; only resident normal cells present.","3 months after implant insertion",[14,17],{"measure":15,"description":16,"timeFrame":12},"Connective tissue maturation","Organization and maturation of collagen fibers in the subepithelial connective tissue. Score:\n\n0 Immature, disorganized tissue; sparse, wavy, randomly oriented collagen fibers; abundant amorphous matrix; numerous active fibroblasts.\n\n1. Partial organization: more collagen fibers but still irregularly arranged; thin, wavy fibers; abundant amorphous matrix persists.\n2. Intermediate organization: initial fiber parallelism; collagen bundles alternating with matrix; fibers still partially wavy.\n3. Well organized: parallel collagen bundles along the epithelial plane; reduced interstitial spaces; reduced amorphous matrix; fewer fibroblasts.\n4. Complete maturation: dense, regular collagen bundles; consistent and continuous orientation; dense, stable, poorly cellular connective tissue.",{"measure":18,"description":19,"timeFrame":12},"Epithelial regeneration","Evaluation of thickness, continuity, and maturation of the overlying epithelium.\n\nScores:\n\n0 Epithelium absent or severely discontinuous; ulcerated or completely denuded areas.\n\n1. Partial regeneration: covered zones alternating with denuded or de-epithelialized areas.\n2. Almost complete: continuous epithelium but with reduced thickness and\u002For not fully stratified cellular structure.\n3. Complete but thin: stratified epithelium present, with fewer cell layers than normal.\n4. Complete, stratified epithelium; well-developed with multiple layers, perfect continuity, and regular morphology.",null,{"allocation":22,"interventionModel":23,"interventionModelDescription":20,"primaryPurpose":24,"observationalModel":20,"timePerspective":20,"maskingInfo":25},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":26,"maskingDescription":20,"whoMasked":27},"SINGLE",[28],"PARTICIPANT",[30,36],{"label":31,"type":32,"description":33,"interventionNames":34},"Treated abutments","EXPERIMENTAL","abutment allocated to the test group were placed in an Argon plasma reactor (Plasmapp, South Korea) for decontamination and activation",[35],"Device: the test group were placed in an Argon plasma reactor",{"label":37,"type":38,"description":39,"interventionNames":20},"Non treated abutment","NO_INTERVENTION","Abutment without any surface treatment",[41],{"type":42,"name":43,"description":43,"armGroupLabels":44,"otherNames":20},"DEVICE","the test group were placed in an Argon plasma reactor",[31],[46],{"name":47,"role":48,"phone":49,"phoneExt":20,"email":50},"Luigi Canullo","CONTACT","+393476201976‬","luigicanullo@yahoo.com",{"type":52,"investigatorFullName":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"SPONSOR_INVESTIGATOR","Paolo Pesce","Professor","100599253",false,"NCT07082088","Abutment Hydrophilicity on Soft Tissue Morphogenesis","Effect of Abutment Hydrophilicity on Soft Tissue Morphogenesis: Histological CCT","Inclusion Criteria:\n\n* presence of at least 4 mm of keratinized mucosa around the implants\n* patients aged 18 years or older\n* medically healthy patients (ASA I), or patients with mild systemic disease (ASA II)\n* partially edentulous state\n* healthy periodontal condition (also including periodontal health on reduced periodontium) according to the referent case definition\n\nExclusion Criteria:\n\n* ASA physical status 3\n* severe smokers (\\> 10 cig\u002Fday)\n* patients undergoing bisphosphonate therapy\n* pregnant or lactating women\n* estrogen-related hormonal disorders or hormonal substitution therapy\n* untreated periodontitis (pocket depth 4mm with positive bleeding on probing)\n* multiple gingival recession\n* patients with a history of head and neck cancers and radiotherapy in this region.",true,"ALL","18 Years",{"count":65,"type":66},40,"ESTIMATED","INTERVENTIONAL",[69],"NA","The goal of this clinical trial is to evaluate the effect of abutment surface bioactivation via argon plasma treatment on peri-implant soft tissue healing and integration in adult patients undergoing implant therapy.\n\nThe main questions it aims to answer are:\n\nDoes argon plasma treatment of healing abutments improve the quality and organization of peri-implant connective tissue compared to untreated abutments?\n\nDoes the treatment influence histological parameters such as epithelial regeneration, vascularization, inflammatory infiltrate, and keratin layer thickness?\n\nResearchers will compare plasma-treated healing abutments to untreated machined-surface abutments to determine whether the bioactivated surface improves soft tissue morphogenesis.\n\nParticipants will:\n\nUndergo implant placement with immediate connection of either a treated or untreated healing abutment.\n\nHave plaque and bleeding indices recorded at 3 months.\n\nUndergo a soft tissue biopsy at 3 months for histological analysis (including evaluation of inflammation, connective tissue, epithelial morphology, vascularization, and keratinization).",[72],"Missing Tooth\u002FTeeth","NOT_YET_RECRUITING","2025-07-15",{"date":76,"type":77},"2025-07-24","ACTUAL",{"date":79,"type":66},"2025-07-31",{"date":81,"type":66},"2025-10-30",{"name":53,"class":6}]