Antibiotic Prophylaxis After Simple Tooth Extraction in Immunosuppressed Patients With Autoimmune Rheumatic Diseases (PRO-EXOD)

University of Sao Paulo General Hospital

Status and phase: Not yet enrolling; Phase 4

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

Treatments: Other: Placebo; Drug: Amoxicillin

Study type: Interventional

Funder types: Other

Identifiers

NCT07275580

69108723.1.0000.0068

Details and patient eligibility

About

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.

Full 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, immunosuppressed 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.

Enrollment: 352 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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352 participants in 2 patient groups, including a placebo group

Arm 1 - Antibiotic Prophylaxis

Active Comparator group

Description:

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

Treatment:

Drug: Amoxicillin

Arm 2 - No Antibiotic Prophylaxis

Placebo Comparator group

Description:

Four matching placebo tablets administered 30-60 minutes before extraction

Treatment:

Other: Placebo