[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100574674":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":26,"responsibleParty":40,"collaborators":44,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":26,"eligibilityCriteria":53,"healthyVolunteers":49,"sex":54,"minAge":55,"maxAge":26,"enrollmentInfo":56,"targetDuration":26,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":26,"overallStatus":65,"whyStopped":26,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":26},{"fullName":5,"class":6},"University of Turin, Italy","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"3-month frequency of supportive peri-implant care (SPIC)","EXPERIMENTAL","SPIC provided at a 3-month frequency starting from the 1-month re-evaluation after surgical treatment of peri-implantitis.",[13],"Procedure: 3-month supportive peri-implant care (SPIC)",{"label":15,"type":16,"description":17,"interventionNames":18},"6-month frequency of supportive peri-implant care (SPIC)","ACTIVE_COMPARATOR","SPIC provided at a 6-month frequency starting from the 1-month re-evaluation after surgical treatment of peri-implantitis.",[19],"Procedure: 6-month supportive peri-implant care (SPIC)",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","3-month supportive peri-implant care (SPIC)","SPIC including update on smoking status, evaluation of the patient's adherence to self-performed oral hygiene procedures, full-mouth supra-gingival instrumentation around teeth, repeated sub-gingival instrumentation on sites presenting a PPD \\>4 mm with BoP\u002FSoP or a PPD≥6 mm, supra-marginal instrumentation around implants, using an erythritol air abrasive system and interdental brushes, sub-marginal instrumentation on implants with BoP after deep probing by an erythritol air abrasive system and\u002For ultrasonic scaler provided at a 3-month frequency after surgical treatment of peri-implantitis.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"6-month supportive peri-implant care (SPIC)","SPIC including update on smoking status, evaluation of the patient's adherence to self-performed oral hygiene procedures, full-mouth supra-gingival instrumentation around teeth, repeated sub-gingival instrumentation on sites presenting a PPD \\>4 mm with BoP\u002FSoP or a PPD≥6 mm, supra-marginal instrumentation around implants, using an erythritol air abrasive system and interdental brushes, sub-marginal instrumentation on implants with BoP after deep probing by an erythritol air abrasive system and\u002For ultrasonic scaler provided at a 6-month frequency after surgical treatment of peri-implantitis.",[15],[32,37],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Giacomo Baima, PhD","CONTACT","011 6331546","giacomo.baima@unito.it",{"name":38,"role":34,"phone":26,"phoneExt":26,"email":39},"Mario Romandini","mario.romandini@gmail.com",{"type":41,"investigatorFullName":42,"investigatorTitle":43,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Giacomo Baima","Co-Principal Investigator (together with Mario Romandini)",[45],{"name":46,"class":6},"Ege University","100574674","spic-frequency-after-surgical-treatment-of-peri-implantitis-100574674",false,"NCT06762353","SPIC Frequency After Surgical Treatment of Peri-implantitis","Supportive Peri-implant Care Frequency After Surgical Treatment of Peri-implantitis - a Multi-center Randomized Clinical Trial","Any patient aged 18 years or more, who has at least one implant affected by severe peri-implantitis, and able to sign an informed consent form will be potentially eligible for this trial. Severe peri-implantitis will be defined as the presence of a peri-implant probing pocket depth \\[PPD\\] ≥ 6 mm in at least 1 site of the implant, bleeding and\u002For suppuration on deep probing \\[dBoP and\u002For dSoP, respectively\\] and radiographically documented marginal bone loss \\> 3 mm (Carcuac et al. 2016; Romandini et al. 2022) on implants in function by at least 12-months. In the absence of baseline radiographs, implants had to present a bone level \\>3 mm (Romandini et al. 2021b).\n\nPatients fulfilling the above-mentioned inclusion criteria will not be included in the study if they appear to be unable to attend the study-related procedures (including the long-term follow-up visits) or if one or more of the following systemic or local exclusion criteria are detected during the enrolment phase.\n\nSystemic primary exclusion criteria:\n\n* systemic diseases (e.g. uncontrolled diabetes mellitus) or chronic use of medications (e.g. corticosteroids, bisphosphonates) likely to influence the outcome of therapy or which contraindicates the study procedures;\n* smoking \\>10 cigarettes;\n* pregnant or nursing women.\n\nLocal primary exclusion criteria:\n\n* history of peri-implantitis treatment on the eligible implants in the previous 6 months;\n* hopeless implants (\\>80% of bone loss\u002Flevel).\n\nA secondary inclusion criterion will be applied 1-month after surgery:\n\n\\- absence of peri-implant abscess on the implants to be included.","ALL","18 Years",{"count":57,"type":58},152,"ESTIMATED","INTERVENTIONAL",[61],"NA","The leading hypothesis behind this study is that a 3-month frequency of supportive peri-implant care (SPIC) recalls after surgical therapy of implants affected by severe peri-implantitis yields better results when compared to a 6-month frequency. Thus, the primary aim of this randomized clinical trial is to compare 2 different frequencies of SPIC recalls (3 and 6 months) after surgical treatment of severe peri-implantitis in terms of treatment success (absence of implant loss, probing pocket depth (PPD) ≤ 5 mm at all aspects, bleeding on deep probing ≤1 site\u002Fimplant, no suppuration at all aspects, bone loss \\\u003C0.5 mm) at early follow-up (1-year) and implant survival at the 5-year examination. Secondarily, this randomized clinical trial aims to assess the effects of the 2 different frequencies over clinical attachment levels around remaining teeth.",[64],"Peri-Implantitis","NOT_YET_RECRUITING","2024-12-31",{"date":68,"type":69},"2025-01-07","ACTUAL",{"date":71,"type":58},"2025-01-20",{"date":73,"type":58},"2031-09-15",{"name":5,"class":6}]