drugset / Trial / NCT07275580
Antibiotic Prophylaxis After Simple Tooth Extraction in Immunosuppressed Patients With Autoimmune Rheumatic Diseases
Phase 4
Not yet recruiting
352 enrolled
University of Sao Paulo General Hospital
Fundação de Amparo à Pesquisa do Estado de São Paulo · collab
RandomizedParallel-groupQuadruple-blindPrevention
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 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.
Timeline
- Start
- 2026-06-01
- Primary completion
- 2029-06-01
- Completion
- 2029-12-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Amoxicillin | Other / unclassified | 2 g | Oral |