Last updated 5 days ago

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

352 patients around the world
Available in Brazil
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.
University of Sao Paulo General Hospital
1Research sites
352Patients around the world

This study is for people with

Autoimmune diseases
Autoimmune Rheumatic Diseases

Requirements for the patient

From 18 Years
All Gender

Medical requirements

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.
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.

Sites

Hospital das Clínicas da FMUSP - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo - HCFMUSP
Recruiting
Av. Dr. Enéas Carvalho de Aguiar, 155 - Cerqueira César, São Paulo - SP, 05403-000, Brazil
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