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.
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
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.
Parallel
Amoxicillin
DrugAmoxicillin 2 g a single prophylactic dose prior to simple extraction.
Placebo
Other interventionMatching placebo tablets administered as a single dose prior to extraction
Frequency of postoperative infections
Proportion of participants developing postoperative infection, defined as purulent/serous exudate, fever, or clinical signs of local infection.
Incidence of Postoperative Complications
Presence of alveolitis, fever, edema, erythema, trismus, exudate, and pain between the two groups
Severity and Duration of Infection
To compare the duration and severity of the infection and any possible differences between the two groups
impact of demographic data, different ARDs; disease activity, and treatment
Compare the potential impact of demographic data, different ARDs; and treatment on the frequency and severity of infection in the two groups;
Oral Health in the different ARDs
Characterize oral health in the different ARDs using the decayed, missing, or filled teeth index (DMF) and the simplified periodontal screening and recording (PSR).
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University of Sao Paulo General Hospital
Lead sponsor
Fundação de Amparo à Pesquisa do Estado de São Paulo
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
