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

NCT07275580 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: 69108723.1.0000.0068
• Study Type: interventional
• Target: 352
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

Autoimmune Rheumatic Diseases; Tooth Extraction; Infection Prevention; Antibiotic Prophylaxis

Keywords

Autoimmune Rheumatic Diseases; Tooth Extraction; Infection Prevention; Amoxicillin; Antibiotic Stewardship

Outcome Measures

Primary Outcomes (1)

• 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.

  7 days post-extraction

Secondary Outcomes (4)

• Severity and Duration of Infection

  7 days

• Incidence of Postoperative Complications

  7 days

• Influence of ARD Diagnosis and Immunosuppressive Regimen

  7 days

• Disease Activity Flares

  Day 1 through Day 30

Study Arms (2)

Arm 1 - Antibiotic Prophylaxis

ACTIVE COMPARATOR

Single 2 g oral dose administered 30-60 minutes before tooth extraction

Drug: Amoxicillin

Arm 2 - No Antibiotic Prophylaxis

PLACEBO COMPARATOR

Four matching placebo tablets administered 30-60 minutes before extraction

Other: Placebo

Interventions

Amoxicillin DRUG

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

Arm 1 - Antibiotic Prophylaxis

Placebo OTHER

Matching placebo tablets administered as a single dose prior to extraction

Arm 2 - No Antibiotic Prophylaxis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Provided informed consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

MeSH Terms

Interventions

Amoxicillin

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Eloisa Bonfá, Full Professor

  Hospital das Clínicas da Faculdade de Medicina da USP - HCFMUSP

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eloisa Bonfá, Full Professor

CONTACT

+55 11 30617492; eloisa.bonfa@hc.fm.usp.br

Luciana PC Seguro, PhD

CONTACT

+55 11 999916381; luciana.seguro@hc.fm.usp.br

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2025
• First Posted: December 10, 2025
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): December 30, 2029
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share