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NCT Number: NCT07275580

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

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.

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Key information

Conditions

Autoimmune Rheumatic Diseases Antibiotic Prophylaxis Infection Prevention Tooth Extraction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Amoxicillin

Drug

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

Placebo

Other

Matching placebo tablets administered as a single dose prior to extraction

Primary outcomes

  1. Frequency of postoperative infections

    Time frame: 7 days post-extraction

    Proportion of participants developing postoperative infection, defined as purulent/serous exudate, fever (>37.8°C), or clinical signs of local infection.

Secondary outcomes

  1. Severity and Duration of Infection

    Time frame: 7 days

    Presence and duration of purulent/serous exudate, fever (>37.8°C), or clinical signs of local infection and systemic symptoms

  2. Incidence of Postoperative Complications

    Time frame: 7 days

    Presence of alveolitis, fever, edema, erythema, trismus, exudate, and pain

  3. Influence of ARD Diagnosis and Immunosuppressive Regimen

    Time frame: 7 days

    Infection rate and severity related to ARD Diagnosis and Immunosuppressive Regimen

  4. Disease Activity Flares

    Time frame: Day 1 through Day 30

    Disease Activity Flares according to specific ARD definitions of exacerbation, as follows:

    Systemic Lupus Erythematosus(SLE): Increase >3 points in SLE Disease Activity Index 2000(SLEDAI-2K) Rheumatoid Arthritis(RA): Increase in Disease Activity Score-C-reactive protein(DAS28-CRP)>1.2, or >0.6 if baseline DAS28-CRP>3.2 Juvenile Idiopathic Arthritis(JIA): Increase in JIA Disease Activity Score(JADAS-27) >5 points, or worsening ≥2 active joints Ankylosing Spondylitis(AS): Increase in AS Disease Activity Score(ASDAS) >0.9. Psoriatic Arthritis(PsA): Worsening in Disease Activity Index for PsA(DAPSA) Systemic Vasculitis: Increase in Birmingham Vasculitis Activity Score(BVAS). Primary Sjögren's Syndrome: EULAR Sjögren's Syndrome Disease Activity Index(ESSDAI) Systemic Sclerosis (SSc): Increase in modified Rodnan skin score, new digital ulcers, worsening dyspnea, or increase in EULAR Systemic Sclerosis Impact of Disease Index (ScleroID) Inflammatory Myopathies (IIM): muscle weakness, CK

Study contacts

Contact information is provided by the study sponsor or research team.

Eloisa Bonfá, Full Professor

CONTACT

[email protected]

+55 11 30617492

Luciana PC Seguro, PhD

CONTACT

[email protected]

+55 11 999916381

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study title

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

Acronym: PRO-EXOD

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Dec 10, 2025
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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