Clinical Trial

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

Study acronym: PRO-EXOD
Not Yet Recruiting Phase 4
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Summary
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-11-27.
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