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

August 3, 2026 updated by: University of Sao Paulo General Hospital

Effectiveness of Short-Course 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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, 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.

Study Type

Interventional

Enrollment (Estimated)

352

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm 1 - Antibiotic Prophylaxis
Four amoxicilin tablets (2g total) administered as single dose 30-60 minutes before tooth extraction
Drug: Amoxicillin
Amoxicillin 2 g a single prophylactic dose prior to simple extraction.
Placebo Comparator: Arm 2 - No Antibiotic Prophylaxis
Four matching placebo tablets administered 30-60 minutes before tooth extraction
Other: Placebo
Matching placebo tablets administered as a single dose prior to extraction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
7 days post-extraction

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Postoperative Complications
Time Frame: 7 days post-extraction
Presence of alveolitis, fever, edema, erythema, trismus, exudate, and pain between the two groups
7 days post-extraction
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
7 days post-extraction
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;
7 days post-extraction
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).
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Collaborators

Fundação de Amparo à Pesquisa do Estado de São Paulo

Investigators

  • Principal Investigator: Eloisa Bonfá, Full Professor, Hospital das Clínicas da Faculdade de Medicina da USP - HCFMUSP

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 20, 2026

Primary Completion (Estimated)

June 1, 2029

Study Completion (Estimated)

December 30, 2029

Study Registration Dates

First Submitted

November 27, 2025

First Submitted That Met QC Criteria

November 27, 2025

First Posted (Actual)

December 10, 2025

Study Record Updates

Last Update Posted (Actual)

August 6, 2026

Last Update Submitted That Met QC Criteria

August 3, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69108723.1.0000.0068

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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