RECRUITING Phase 4 ClinicalTrials.gov

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

Sponsor: University of Sao Paulo General Hospital • ClinicalTrials.gov ID: NCT07275580

Registry updated: 2026-10-15

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Description

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.

Interventions

Amoxicillin (Drug)
Amoxicillin 2 g a single prophylactic dose prior to simple extraction.
Placebo (Other)
Matching placebo tablets administered as a single dose prior to extraction

Eligibility criteria

Inclusion Criteria: * Age ≥18 years * Confirmed diagnosis of an ARD: SLE, RA, JIA, AS, PsA, IIM, systemic vasculitis, primary Sjögren's syndrome, or SSc * Use of prednisone and/or at least one synthetic immunosuppressant (methotrexate, azathioprine, mycophenolate mofetil, leflunomide, cyclophosphamide, cyclosporine, or tacrolimus), immunobiological agent or immunomodulator (chloroquine, sulfasalazine), with no plans to switch medications. * Indication for simple tooth extraction with chronic odontogenic focus * Provided informed consent Exclusion Criteria: * Individuals who do not agree to participate in the study will be excluded. * Patients requiring extractions that are more complex from a technical standpoint, such as impacted third molars. * Patients with local or systemic conditions requiring more extensive antibiotic coverage, such as cases with clinical signs of acute infections, patients on anticoagulant therapy, patients with heart disease, patients who have undergone radiation therapy, or patients currently being treated for neoplasms; * Patients allergic to amoxicillin. * Patients currently receiving any antibiotic prophylaxis or treatment; * Patients who have undergone corticosteroid pulse therapy within the last month; * Patients taking drugs with antiresorptive effects on bone, such as oral or injectable bisphosphonates and denosumab.

Conditions

Autoimmune Rheumatic Diseases Tooth Extraction Infection Prevention Antibiotic Prophylaxis

Locations

Rheumatology Division, Faculdade de Medicina da USP, São Paulo, SP, São Paulo, Sao paulo 01246-903 — São Paulo, São Paulo, Brazil

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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