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Antibiotic Prophylaxis After Simple Tooth Extraction in Immunosuppressed Patients With Autoimmune Rheumatic Diseases

Study acronym: PRO-EXOD
StatusNot Yet Recruiting
PhasePhase 4
Started2026-08-20
View on ClinicalTrials.gov ↗

Amendment history

2026-08-03
Study Status, Study Description, Conditions, Arms and Interventions, Outcome Measures, Eligibility, References v2
Start date2026-06-01→2026-08-20
Eligibility criteria+545 characters
[...] IM, systemic vasculitis, primary Sjögren's syndrome, or SSc UnderUse immunosuppressiveof prednisone and/or at least one synthetic immunosuppressant (methotrexate, azathioprine, mycophenolate mofetil, leflunomide, cyclophosphamide, cyclosporine, or biologictacrolimus), therapyimmunobiological ≥3agent monthsor immunomodulator (chloroquine, sulfasalazine), with no plans to switch medications. Indication for simple tooth extraction of tooth with chronic odontogenic focus Provided informed consent Ex [...] gree to participate in the study will be excluded. Patients whorequiring requireextractions that are [...]
Secondary endpoints4 entries, revised
Influenceimpact of ARDdemographic Diagnosisdata, different ARDs; disease activity, and Immunosuppressivetreatment Oral Regimen DiseaseHealth Activityin Flaresthe different ARDs
Study description-17 characters
[...] ance, adverse reactions, and microbiome disruption. However, immunosuppressed patients with ARDs often receive prophylaxis due to theoret [...]
2026-04-14
Study Status v1
Primary completion date2029-01-17→2029-06-01
Completion date2029-02-10→2029-12-30
Start date2026-01-10→2026-06-01
2025-11-27
Original filing
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 inpatients with autoimmune rheumatic diseases (ARDs). Although antibiotic prophylaxis is not recommended for healthy individuals undergoing simple extractions, immunosuppressed ARD patients frequently receive antibiotics despite limited evidence supporting this practice. Secondary objectives include assessing infection severity, postoperative complications, and the impact of ARD diagnosis and immunosuppressive treatment on infection risk.
Trial Details
NCT Number NCT07275580
Lead Sponsor University of Sao Paulo General Hospital
Collaborators: Fundação de Amparo à Pesquisa do Estado de São Paulo
Conditions Autoimmune Rheumatic Diseases, Tooth Extraction, Infection Prevention, Antibiotic Prophylaxis
Enrollment 352 participants
Start Date 2026-08-20
Primary Completion 2029-06-01 (estimated)
Study Completion 2029-12-30 (estimated)
Updated on ClinicalTrials.gov 2026-08-06