[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100571046":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":34,"locations":40,"responsibleParty":58,"collaborators":26,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":62,"sex":68,"minAge":69,"maxAge":26,"enrollmentInfo":70,"targetDuration":26,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":79,"overallStatus":83,"whyStopped":26,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"University of Santiago de Compostela","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Azithromycin 500 mg","ACTIVE_COMPARATOR","Systemic antibiotic: Azithromycin 500 mg every 24 hours for 3 days",[13],"Drug: Azithromcyin",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Same shape, size and dosage as test",[19],"Other: Placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Azithromcyin","Immediately after the end of non surgical treatment of periimplantitis and depending on the result of randomization, the exact number of tablets of the placebo to be taken during the following days will be given to the patient.",[9],null,{"type":6,"name":15,"description":24,"armGroupLabels":28,"otherNames":26},[15],[30],{"name":31,"affiliation":32,"role":33},"Juan Blanco Carrión","Universidade de Santiago de Compostela","PRINCIPAL_INVESTIGATOR",[35],{"name":36,"role":37,"phone":38,"phoneExt":26,"email":39},"Antonio Liñares González","CONTACT","+34 626492454","antonio@antoniolinares.com",[41],{"facility":42,"status":26,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Department of Surgery and Medical-Surgical Specialties, Teaching and Research Unit in Periodontology. Faculty of Medicine and Dentistry, University of Santiago de Compostela.","Santiago de Compostela","A Coruña","15782","Spain","ES",{"type":49,"coordinates":50},"Point",[51,52],-8.54569,42.88052,{"lat":52,"lon":51},[55,57],{"name":36,"role":37,"phone":56,"phoneExt":26,"email":39},"626492454",{"name":31,"role":37,"phone":26,"phoneExt":26,"email":26},{"type":33,"investigatorFullName":31,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Associate Professor","100571046","phase-4-non-surgical-treatment-of-peri-implantitis-with-systemic-azithromycin-or-placebo-100571046",false,"NCT06715150","Non-Surgical Treatment of Peri-implantitis with Systemic Azithromycin or Placebo","NON-SURGICAL TREATMENT of PERI-IMPLANTITIS with or WITHOUT SYSTEMIC AZITHROMYCIN: a RANDOMIZED CLINICAL TRIAL in HUMANS","NSTP","Inclusion Criteria:\n\n* older than 18 years;\n* absence of systemic pathology contraindicating treatment;\n* presence of at least 1 implant diagnosed with peri-implantitis: presence of bleeding on probing, probing depth ≥6 mm, and radiographic bone level ≥3 mm apical to the most coronal portion of the intraosseous part of the implant;\n* absence of implant mobility;\n* patients without periodontitis or with treated periodontitis;\n* patients who understand the treatment and are willing to comply with it by providing written informed consent.\n\nExclusion Criteria:\n\n* smokers ≥10 cigarettes\u002Fday;\n* diabetic patients (HbA1c level ≥6,5%);\n* pregnant or breastfeeding women;\n* use of antibiotics, corticosteroids, and\u002For immunosuppressive treatment in the 3 months prior to the start of the study;\n* allergy to azithromycin;\n* patients with a history of bisphosphonate treatment;\n* chronic consumption of non-steroidal anti-inflammatory drugs;\n* bone loss exceeding the apex of the implant;\n* prosthesis that does not allow access to peri-implantitis treatment","ALL","18 Years",{"count":71,"type":72},52,"ESTIMATED","INTERVENTIONAL",[75],"PHASE4","The primary objective of this study is to evaluate the change in probing depth in patients with peri-implantitis, assessing the influence of systemic antibiotic (azithromycin) adjunctive to non-surgical treatment at 12 months. The secondary objective is to assess clinical, radiographic, microbiological, and systemic changes at 3, 6, and 12 months.\n\nThis study is designed as a placebo-controlled, randomized, triple-blind clinical trial in subjects diagnosed with peri-implantitis.\n\nThe treatment will consist of debridement of the implant surface and curettage of the pocket epithelium. The control group will receive placebo (1 placebo tablet per day for 3 days), and the test group will receive systemic azithromycin 500 mg per day for 3 days (1 tablet of 500 mg azithromycin per day for 3 days).",[78],"Peri-implantitis",[80,81,82],"Non-surgical treatment","Azithromycin","Systemic antibiotic","NOT_YET_RECRUITING","2024-12-04",{"date":86,"type":87},"2024-12-10","ACTUAL",{"date":89,"type":72},"2025-01-10",{"date":91,"type":72},"2027-01-10",{"name":5,"class":6},1]