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NOT YET RECRUITING
NCT07275580
PHASE4

Antibiotic Prophylaxis After Simple Tooth Extraction in Immunosuppressed Patients With Autoimmune Rheumatic Diseases

Sponsor: University of Sao Paulo General Hospital

View on ClinicalTrials.gov

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.

Official title: Effectiveness of Short-Course Antibiotic Prophylaxis After Simple Tooth Extraction in Immunosuppressed Patients With Autoimmune Rheumatic Diseases

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

352

Start Date

2026-01-10

Completion Date

2029-02-10

Last Updated

2025-12-10

Healthy Volunteers

No

Interventions

DRUG

Amoxicillin

Amoxicillin 2 g a single prophylactic dose prior to simple extraction.

OTHER

Placebo

Matching placebo tablets administered as a single dose prior to extraction