[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100448702":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":35,"locations":43,"responsibleParty":62,"collaborators":64,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":25,"eligibilityCriteria":73,"healthyVolunteers":74,"sex":75,"minAge":76,"maxAge":25,"enrollmentInfo":77,"targetDuration":25,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":88,"overallStatus":46,"whyStopped":25,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"University Hospital, Basel, Switzerland","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Pagalinor®2 (PA) test arm","EXPERIMENTAL","All patients will wear both the test and control ring material for a within-subject comparison. Ideally, biofilm sampling can be performed in a split mouth design (randomly allocated materials within subjects) with one patient having two implants for placing the test and the control material at the same time. In addition, patients providing one implant, will receive test and control push-on rings in a randomly assigned order, so that both materials are assessed in a consecutive manner.",[13],"Device: Rings made of PA (test)",{"label":15,"type":16,"description":11,"interventionNames":17},"Titanium-6Aluminum- 7Niobium alloy (TAN) control arm","ACTIVE_COMPARATOR",[18],"Device: Rings made of TAN (control)",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Rings made of PA (test)","Rings made of PA (test) 0.2mm in thickness are pushed on the conical titanium base (abutment) of implant crowns and are removed and replaced after 48h, 2 weeks and 3 months for quantification of the bacterial biofilm. Test rings are applied in a split-mouth design provided that 2 implants are present (total of 4 months study period), or one after the other when only 1 implant is present (total of 8 months study period).",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Rings made of TAN (control)","Rings made of TAN (control) 0.2mm in thickness are pushed on the conical titanium base (abutment) of implant crowns and are removed and replaced after 48h, 2 weeks and 3 months for quantification of the bacterial biofilm. Control rings are applied in a split-mouth design provided that 2 implants are present (total of 4 months study period), or one after the other when only 1 implant is present (total of 8 months study period).",[15],[31],{"name":32,"affiliation":33,"role":34},"Nicola U. Zitzmann, Prof. Dr.","University Center for Dental Medicine Basel","PRINCIPAL_INVESTIGATOR",[36,40],{"name":32,"role":37,"phone":38,"phoneExt":25,"email":39},"CONTACT","+41 61 267 26 36","n.zitzmann@unibas.ch",{"name":41,"role":37,"phone":38,"phoneExt":25,"email":42},"Lucia K. Zaugg, Dr. med. dent.","lucia.zaugg@unibas.ch",[44],{"facility":45,"status":46,"city":47,"state":25,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"UZB (University Center for Dental Medicine Basel)","RECRUITING","Basel","4058","Switzerland","CH",{"type":52,"coordinates":53},"Point",[54,55],7.57327,47.55839,{"lat":55,"lon":54},[58,59,60,61],{"name":32,"role":37,"phone":38,"phoneExt":25,"email":39},{"name":41,"role":37,"phone":38,"phoneExt":25,"email":42},{"name":32,"role":34,"phone":25,"phoneExt":25,"email":25},{"name":41,"role":34,"phone":25,"phoneExt":25,"email":25},{"type":63,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[65],{"name":66,"class":6},"ITI International Team for Implantology, Switzerland","100448702","investigation-of-biofilm-formation-on-temporary-push-on-rings-of-implant-crowns-100448702",false,"NCT05122897","Investigation of Biofilm Formation on Temporary push-on Rings of Implant Crowns","Temporary push-on Rings of Antimicrobial Alloys for Transmucosal Implant Abutment Systems: a Randomized Clinical Study on Early and Mature Biofilm Formation","Inclusion Criteria:\n\n* Informed Consent signed by the subject\n* Presence of one or more bone level titanium implant prior to insertion of the final restoration\n* No systemic illness\n* No heavy smoking (smoking \\\u003C10 cigarettes\u002Fday)\n* No pregnancy\n* No active periodontitis (probing pocket depth ≤4 mm)\n* No pharmacological treatment or antibiotic therapy during or up to three months before the study\n\nExclusion Criteria:\n\n* Systemic illness (e.g. Diabetes)\n* Heavy smoking (smoking \\>10 cigarettes\u002Fday)\n* Known or suspected non-compliance, drug or alcohol abuse\n* Pregnancy\n* Active periodontitis (probing pocket depth \\>4 mm)\n* Pharmacological treatment or antibiotic therapy during or up to three months before the study",true,"ALL","18 Years",{"count":78,"type":79},33,"ESTIMATED","INTERVENTIONAL",[82],"NA","This in-vivo study investigates early (48h), mature (2 weeks) and long-term (3 months) biofilm formation and composition on temporary push-on cones (exchangeable conical rings) made of noble-alloy-based materials (Pagalinor, PA) in comparison to Titanium-6Aluminum-7Niobium alloy (TAN) presently used in the transmucosal portion of dental implant abutments.",[85,86,87],"Dental Plaque","Oral Biofilm","Peri-implantitis",[89,90,91,92,93,94],"Titanium-6Aluminum-7Niobium alloy","Pagalinor","transmucosal implant abutment","implant crowns","temporary push-on rings","Variobase abutments","2025-07-21",{"date":97,"type":98},"2025-07-25","ACTUAL",{"date":100,"type":98},"2022-01-11",{"date":102,"type":79},"2026-02",{"name":5,"class":6},1]