Antibiotic Prophylaxis Before Simple Tooth Extraction in Immunosuppressed Patients with Autoimmune Rheumatic Diseases

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double-blind, placebo-controlled Phase 4 trial evaluating the need for antibiotic prophylaxis before simple tooth extractions in adults with autoimmune rheumatic diseases who are immunosuppressed. Participants receive either amoxicillin or placebo prior to extraction, and postoperative infection rates, infection severity, and other complications are monitored. The study also explores how the type of ARD and immunosuppressive treatment may influence infection risk. The trial aims to provide evidence to guide antibiotic stewardship in this specific patient population.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

• Principal investigator: Eloisa Bonfá, Full Professor — Hospital das Clínicas da Faculdade de Medicina da USP - HCFMUSP
• Study coordinator: Eloisa Bonfá, Full Professor
• Email: eloisa.bonfa@hc.fm.usp.br
• Phone: +55 11 30617492

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.