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 in immunosuppressed patients 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
Under immunosuppressive or biologic therapy ≥3 months
Indication for simple extraction of tooth with chronic odontogenic focus
Individuals who do not agree to participate in the study will be excluded.
Patients who require more technically complex extractions, such as impacted or impacted third molars.
Patients with local and systemic changes that require more extensive antibiotic coverage, such as cases with clinical signs of acute infections, anticoagulated patients, heart patients, patients who have undergone radiotherapy or are undergoing treatment 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 (\>37.8°C), or clinical signs of local infection.
Severity and Duration of Infection
Presence and duration of purulent/serous exudate, fever (\>37.8°C), or clinical signs of local infection and systemic symptoms
Incidence of Postoperative Complications
Presence of alveolitis, fever, edema, erythema, trismus, exudate, and pain
Influence of ARD Diagnosis and Immunosuppressive Regimen
Infection rate and severity related to ARD Diagnosis and Immunosuppressive Regimen
Disease Activity Flares
Disease Activity Flares according to specific ARD definitions of exacerbation, as follows: Systemic Lupus Erythematosus(SLE): Increase \>3 points in SLE Disease Activity Index 2000(SLEDAI-2K) Rheumatoid Arthritis(RA): Increase in Disease Activity Score-C-reactive protein(DAS28-CRP)\>1.2, or \>0.6 if baseline DAS28-CRP\>3.2 Juvenile Idiopathic Arthritis(JIA): Increase in JIA Disease Activity Score(JADAS-27) \>5 points, or worsening ≥2 active joints Ankylosing Spondylitis(AS): Increase in AS Disease Activity Score(ASDAS) \>0.9. Psoriatic Arthritis(PsA): Worsening in Disease Activity Index for PsA(DAPSA) Systemic Vasculitis: Increase in Birmingham Vasculitis Activity Score(BVAS). Primary Sjögren's Syndrome: EULAR Sjögren's Syndrome Disease Activity Index(ESSDAI) Systemic Sclerosis (SSc): Increase in modified Rodnan skin score, new digital ulcers, worsening dyspnea, or increase in EULAR Systemic Sclerosis Impact of Disease Index (ScleroID) Inflammatory Myopathies (IIM): muscle weakness, CK
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University of Sao Paulo General Hospital
Lead sponsor
Fundação de Amparo à Pesquisa do Estado de São Paulo
Collaborator
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