[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100572749":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":26,"centralContacts":31,"locations":41,"responsibleParty":59,"collaborators":25,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":66,"acronym":25,"eligibilityCriteria":67,"healthyVolunteers":64,"sex":68,"minAge":69,"maxAge":25,"enrollmentInfo":70,"targetDuration":25,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":79,"overallStatus":83,"whyStopped":25,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"University of Oslo","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Test. Increased treatment frequency","EXPERIMENTAL","Submucosal instrumentation will be performed at baseline, 3 weeks, 6 weeks, 9 weeks, 12 weeks, 16 weeks, 24 weeks and 36 weeks",[13],"Procedure: Submocosal instrumentation using a ultrasonic device (PEEK). Submucosal cleaning",{"label":15,"type":16,"description":17,"interventionNames":18},"Control. Conventional frequency","ACTIVE_COMPARATOR","Submucosal instrumentation will be performed at baseline, 12 weeks, 24 weeks and 36 weeks",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","Submocosal instrumentation using a ultrasonic device (PEEK). Submucosal cleaning","The treatment under study is professional non-surgical, submucosal debridement with ultrasonic instruments with PolyEther Ether Ketone (PEEK)",[15,9],null,[27],{"name":28,"affiliation":29,"role":30},"Carl Hjortsjø, Ph.D","Institute for Clinical Dentistry, Dental Faculty, University of Oslo","PRINCIPAL_INVESTIGATOR",[32,37],{"name":33,"role":34,"phone":35,"phoneExt":25,"email":36},"Odd Carsten Koldsland, Ph.D","CONTACT","+47 93098618","oddcko@odont.uio.no",{"name":38,"role":34,"phone":39,"phoneExt":25,"email":40},"Anders Verket, Ph.D","004793667661","anderver@odont.uio.no",[42],{"facility":43,"status":25,"city":44,"state":25,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Faculty of Dentistry, University of Oslo","Oslo","0455","Norway","NO",{"type":49,"coordinates":50},"Point",[51,52],10.74609,59.91273,{"lat":52,"lon":51},[55,57,58],{"name":33,"role":34,"phone":56,"phoneExt":25,"email":36},"004793098618",{"name":38,"role":34,"phone":39,"phoneExt":25,"email":40},{"name":28,"role":30,"phone":25,"phoneExt":25,"email":25},{"type":30,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Odd Carsten Koldsland","Associate Professor","100572749","spit-frequency-iiperi-implantitis-100572749",false,"NCT06737315","SPiT-frequency II_Peri-implantitis","Inclusion Criteria:\n\n* \\- Subject must be ≥ 20 years, diagnosed with peri-implantitis as defined by the World Workshop 2017 criteria (Berglundh et al., 2018) with a bone level \\> 3 mm from the expected initial bone level Peri-implantitis: Bleeding after gentle probing at an implant and radiographic bone level \\> 3 mm\n\nExclusion Criteria:\n\n* \\- Previous radiotherapy in the affected area, current use of chemotherapy, systemic long-term corticosteroid treatment.\n\n  * No pregnant or nursing subjects.\n  * \\> class 2 according to the ASA (American Society of Anesthesiologists) physical status classification.\n  * HIV positive or other disease severely affecting the immune system\n  * If examiners\u002Foperators agree the placement of the implant (angle, position, proximity to adjacent implant or tooth) or suprastructure was suboptimal and considered to play a major role in the development of inflammation.\n  * Anatomical abnormalities.","ALL","20 Years",{"count":71,"type":72},60,"ESTIMATED","INTERVENTIONAL",[75],"NA","This is an interventional clinical study on the peri-implant treatment necessary to improve the clinical conditions surrounding dental implants registered with peri-implant inflammation. The focus of this double-armed, examiner blinded, controlled, randomized clinical trial is to examine the effect of short-term increased frequency of a Non-surgical protocol on implants diagnosed with peri-implantitis.\n\nThe study is a part of a project assessing the frequency of supportive peri-implant therapy. The current is on non-surgical treatment of peri-implantitis (inflammation and exposed implant surface). The other study is a RCT on treatment of peri-implant mucositis (inflammation and no attachment loss at the implants) and secondary prevention of peri-implant mucositis (REK 790097). Exposure of rough surface may dramatically change the frequency of maintenance needed to improve the inflammatory condition. Thus, a segregation between adequate and low bone level at the implant is necessary.\n\nSubjects with more than one implant and both diagnoses, may be enrolled in both studies, following the frequency of treatment randomized in the peri-implant mucositis study",[78],"Peri-Implantitis and Peri-implant Mucositis",[80,81,82],"Peri-implantitis","Non-surgical treatment","Frequency","NOT_YET_RECRUITING","2024-12-11",{"date":86,"type":87},"2024-12-17","ACTUAL",{"date":89,"type":72},"2025-01-01",{"date":91,"type":72},"2028-01-19",{"name":5,"class":6},1]