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Could one antibiotic dose before tooth pulling prevent infections in Immune-Weakened patients?

NCT ID NCT07275580

Prevention Sponsor: University of Sao Paulo General Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 07, 2026 · Updated 2 times

Summary

This study tests whether a single dose of amoxicillin before a simple tooth extraction can prevent infections in people with autoimmune rheumatic diseases who are on immune-suppressing medications. Researchers will compare infection rates between those who get the antibiotic and those who get a placebo. The goal is to see if this common practice is actually effective and safe.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Amoxicillin
What this could lead to
If successful, this could show that a single antibiotic dose is enough to prevent infections after tooth extraction in immunosuppressed patients, reducing unnecessary antibiotic use.
What could go wrong
This is a Phase 4 trial, but it is not yet recruiting and has a moderate size (352 participants). The results may not apply to all autoimmune diseases or extraction types, and the placebo group could show similar infection rates.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 352 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

autoimmune disease rheumatic disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Antibiotic prophylaxis Autoimmune rheumatic diseases Infection prevention Tooth extraction

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

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More trials for these conditions

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