NCT07275580 Antibiotic Prophylaxis After Simple Tooth Extraction in Immunosuppressed Patients With Autoimmune Rheumatic Diseases
| NCT ID | NCT07275580 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Sao Paulo General Hospital |
| Condition | Autoimmune Rheumatic Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 352 participants |
| Start Date | 2026-10-07 |
| Primary Completion | 2029-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 352 participants in total. It began in 2026-10-07 with a primary completion date of 2029-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Eloisa Bonfá, Full Professor
PRINCIPAL INVESTIGATOR
Hospital das Clínicas da Faculdade de Medicina da USP - HCFMUSP
Frequently Asked Questions
Who can join the NCT07275580 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Autoimmune Rheumatic Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07275580 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07275580 currently recruiting?
Yes, NCT07275580 is actively recruiting participants. Contact the research team at eloisa.bonfa@hc.fm.usp.br for enrollment information.
Where is the NCT07275580 trial being conducted?
This trial is being conducted at São Paulo, Brazil.
Who is sponsoring the NCT07275580 clinical trial?
NCT07275580 is sponsored by University of Sao Paulo General Hospital. The principal investigator is Eloisa Bonfá, Full Professor at Hospital das Clínicas da Faculdade de Medicina da USP - HCFMUSP. The trial plans to enroll 352 participants.