[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100614129":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":26,"responsibleParty":45,"collaborators":47,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":53,"sex":59,"minAge":60,"maxAge":26,"enrollmentInfo":61,"targetDuration":26,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":73,"overallStatus":75,"whyStopped":26,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":26},{"fullName":5,"class":6},"University of Sao Paulo General Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm 1 - Antibiotic Prophylaxis","ACTIVE_COMPARATOR","Single 2 g oral dose administered 30-60 minutes before tooth extraction",[13],"Drug: Amoxicillin",{"label":15,"type":16,"description":17,"interventionNames":18},"Arm 2 - No Antibiotic Prophylaxis","PLACEBO_COMPARATOR","Four matching placebo tablets administered 30-60 minutes before extraction",[19],"Other: Placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Amoxicillin","Amoxicillin 2 g a single prophylactic dose prior to simple extraction.",[9],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Placebo","Matching placebo tablets administered as a single dose prior to extraction",[15],[32],{"name":33,"affiliation":34,"role":35},"Eloisa Bonfá, Full Professor","Hospital das Clínicas da Faculdade de Medicina da USP - HCFMUSP","PRINCIPAL_INVESTIGATOR",[37,41],{"name":33,"role":38,"phone":39,"phoneExt":26,"email":40},"CONTACT","+55 11 30617492","eloisa.bonfa@hc.fm.usp.br",{"name":42,"role":38,"phone":43,"phoneExt":26,"email":44},"Luciana PC Seguro, PhD","+55 11 999916381","luciana.seguro@hc.fm.usp.br",{"type":46,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[48],{"name":49,"class":50},"Fundação de Amparo à Pesquisa do Estado de São Paulo","OTHER_GOV","100614129","phase-4-antibiotic-prophylaxis-after-simple-tooth-extraction-in-immunosuppressed-patients-with-autoimmune-rheumatic-diseases-100614129",false,"NCT07275580","Antibiotic Prophylaxis After Simple Tooth Extraction in Immunosuppressed Patients With Autoimmune Rheumatic Diseases","Effectiveness of Short-Course Antibiotic Prophylaxis After Simple Tooth Extraction in Immunosuppressed Patients With Autoimmune Rheumatic Diseases","PRO-EXOD","Inclusion Criteria:\n\n* Age ≥18 years\n* Confirmed diagnosis of an ARD: SLE, RA, JIA, AS, PsA, IIM, systemic vasculitis, primary Sjögren's syndrome, or SSc\n* Under immunosuppressive or biologic therapy ≥3 months\n* Indication for simple extraction of tooth with chronic odontogenic focus\n* Provided informed consent\n\nExclusion Criteria:\n\n* Individuals who do not agree to participate in the study will be excluded.\n* Patients who require more technically complex extractions, such as impacted or impacted third molars.\n* Patients with local and systemic changes that require more extensive antibiotic coverage, such as cases with clinical signs of acute infections, anticoagulated patients, heart patients, patients who have undergone radiotherapy or are undergoing treatment for neoplasms.\n* Patients allergic to amoxicillin.","ALL","18 Years",{"count":62,"type":63},352,"ESTIMATED","INTERVENTIONAL",[66],"PHASE4","This randomized, double-blind, placebo-controlled clinical trial aims to evaluate whether single-dose amoxicillin prophylaxis administered prior to simple tooth extraction reduces postoperative infection rates in immunosuppressed patients with autoimmune rheumatic diseases (ARDs).\n\nAlthough antibiotic prophylaxis is not recommended for healthy individuals undergoing simple extractions, immunosuppressed ARD patients frequently receive antibiotics despite limited evidence supporting this practice.\n\nSecondary objectives include assessing infection severity, postoperative complications, and the impact of ARD diagnosis and immunosuppressive treatment on infection risk.",[69,70,71,72],"Autoimmune Rheumatic Diseases","Tooth Extraction","Infection Prevention","Antibiotic Prophylaxis",[69,70,71,23,74],"Antibiotic Stewardship","NOT_YET_RECRUITING","2026-04-14",{"date":78,"type":79},"2026-04-15","ACTUAL",{"date":81,"type":63},"2026-06-01",{"date":83,"type":63},"2029-12-30",{"name":5,"class":6}]