Antibiotic Prophylaxis, Autoimmune Rheumatic Diseases, Infection Prevention, Tooth Extraction
Conditions
Keywords
Autoimmune Rheumatic Diseases, Tooth Extraction, Infection Prevention, Amoxicillin, Antibiotic Stewardship, hydroxychroloquine, immunosupressive therapy
Brief summary
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.
Detailed description
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.
Interventions
DRUGAmoxicillin
Amoxicillin 2 g a single prophylactic dose prior to simple extraction.
OTHERPlacebo
Matching placebo tablets administered as a single dose prior to extraction
Sponsors
University of Sao Paulo General Hospital
Fundação de Amparo à Pesquisa do Estado de São Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of postoperative infections | 7 days post-extraction | Proportion of participants developing postoperative infection, defined as purulent/serous exudate, fever, or clinical signs of local infection. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Postoperative Complications | 7 days post-extraction | Presence of alveolitis, fever, edema, erythema, trismus, exudate, and pain between the two groups |
| Severity and Duration of Infection | 7 days post-extraction | 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 | 7 days post-extraction | 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 | Day 1 | Characterize oral health in the different ARDs using the decayed, missing, or filled teeth index (DMF) and the simplified periodontal screening and recording (PSR). |
Contacts
CONTACTEloisa Bonfá, Full Professor
CONTACTLuciana PC Seguro, PhD
PRINCIPAL_INVESTIGATOREloisa Bonfá, Full Professor
Hospital das Clínicas da Faculdade de Medicina da USP - HCFMUSP
Outcome results
None listed