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

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.

Simple tooth extractions are common procedures, and postoperative infection rates are low in the general population. Current guidelines discourage prophylactic antibiotic use to reduce microbial resistance, adverse reactions, and microbiome disruption.

However, patients with ARDs often receive prophylaxis due to theoretical risks of delayed healing and increased susceptibility to infection. Evidence in other immuno-compromised populations suggests that simple extractions may be safe without antibiotics, but no prospective trials have evaluated this issue specifically in ARD patients.

This study is the first prospective, randomized, double-blind, placebo-controlled trial designed to determine whether antibiotic prophylaxis is necessary in this population.

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.