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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 inpatients 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

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, 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
  • Use of prednisone and/or at least one synthetic immunosuppressant (methotrexate, azathioprine, mycophenolate mofetil, leflunomide, cyclophosphamide, cyclosporine, or tacrolimus), immunobiological agent or immunomodulator (chloroquine, sulfasalazine), with no plans to switch medications.
  • Indication for simple tooth extraction with chronic odontogenic focus
  • Provided informed consent

Exclusion criteria

  • Individuals who do not agree to participate in the study will be excluded.
  • Patients requiring extractions that are more complex from a technical standpoint, such as impacted third molars.
  • Patients with local or systemic conditions requiring more extensive antibiotic coverage, such as cases with clinical signs of acute infections, patients on anticoagulant therapy, patients with heart disease, patients who have undergone radiation therapy, or patients currently being treated for neoplasms;
  • Patients allergic to amoxicillin.
  • Patients currently receiving any antibiotic prophylaxis or treatment;
  • Patients who have undergone corticosteroid pulse therapy within the last month;
  • Patients taking drugs with antiresorptive effects on bone, such as oral or injectable bisphosphonates and denosumab.

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, or clinical signs of local infection.

Secondary outcomes

  1. Incidence of Postoperative Complications

    Time frame: 7 days post-extraction

    Presence of alveolitis, fever, edema, erythema, trismus, exudate, and pain between the two groups

  2. Severity and Duration of Infection

    Time frame: 7 days post-extraction

    To compare the duration and severity of the infection and any possible differences between the two groups

  3. impact of demographic data, different ARDs; disease activity, and treatment

    Time frame: 7 days post-extraction

    Compare the potential impact of demographic data, different ARDs; and treatment on the frequency and severity of infection in the two groups;

  4. Oral Health in the different ARDs

    Time frame: Day 1

    Characterize oral health in the different ARDs using the decayed, missing, or filled teeth index (DMF) and the simplified periodontal screening and recording (PSR).

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
Aug 6, 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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