Autoimmune Rheumatic DiseasesPhase 4PRO-EXODNCT07275580
Antibiotic Prophylaxis After Simple Tooth Extraction in Immunosuppressed Patients With Autoimmune Rheumatic Diseases
A Phase 4 study testing Amoxicillin in people with Autoimmune Rheumatic Diseases and Tooth Extraction, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autoimmune Rheumatic Diseases, Tooth Extraction, Infection Prevention
- What is being tested?
- Amoxicillin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 352 participants
- Where
- 1 siteBrazil
- Study dates
- 7 Oct 2026to 30 Dec 2029
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Rheumatology Division, Faculdade de Medicina da USP, São Paulo, SP, São Paulo, Sao paulo 01246-903
São Paulo, São Paulo, 01246-903
Eloisa SDO Bonfa, Full Professor, +55 11 2661-8806, reumatologia.fmusp@hc.fm.usp.br
About this study
Official title: 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.
Read the 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.
- Conditions
- Autoimmune Rheumatic Diseases, Tooth Extraction, Infection Prevention, Antibiotic Prophylaxis
- Being tested
- Amoxicillin, Placebo
- Keywords
- Autoimmune Rheumatic Diseases, Tooth Extraction, Infection Prevention, Amoxicillin, Antibiotic Stewardship, hydroxychroloquine, immunosupressive therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmoxicillinDrug
Amoxicillin 2 g a single prophylactic dose prior to simple extraction.
PlaceboOther
Matching placebo tablets administered as a single dose prior to extraction
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 - Antibiotic Prophylaxis | Active comparator | Four amoxicilin tablets (2g total) administered as single dose 30-60 minutes before tooth extraction Receives: Drug: Amoxicillin |
| Arm 2 - No Antibiotic Prophylaxis | Placebo comparator | Four matching placebo tablets administered 30-60 minutes before tooth extraction Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of postoperative infections
Proportion of participants developing postoperative infection, defined as purulent/serous exudate, fever, or clinical signs of local infection.
Measured: 7 days post-extraction
Secondary outcomes (4)
Incidence of Postoperative Complications
Presence of alveolitis, fever, edema, erythema, trismus, exudate, and pain between the two groups
Measured: 7 days post-extraction
Severity and Duration of Infection
To compare the duration and severity of the infection and any possible differences between the two groups
Measured: 7 days post-extraction
impact of demographic data, different ARDs; disease activity, and treatment
Compare the potential impact of demographic data, different ARDs; and treatment on the frequency and severity of infection in the two groups;
Measured: 7 days post-extraction
Oral Health in the different ARDs
Characterize oral health in the different ARDs using the decayed, missing, or filled teeth index (DMF) and the simplified periodontal screening and recording (PSR).
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2025
- Study start7 Oct 2026
- Primary completion1 Jun 2029 (estimated)
- Study completion30 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Autoimmune Rheumatic DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 352 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Sponsor
- Investigators
- Eloisa Bonfá, Full Professor, Principal investigator, Hospital das Clínicas da Faculdade de Medicina da USP - HCFMUSP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07275580
- Sponsor's protocol ID
- 69108723.1.0000.0068
- Acronym
- PRO-EXOD
- Status last verified
- Oct 2026
- First submitted
- 27 Nov 2025
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Choi YY. Prescription of antibiotics after tooth extraction in adults: a nationwide study in Korea. J Korean Assoc Oral Maxillofac Surg. 2020 Feb;46(1):49-57. doi: 10.5125/jkaoms.2020.46.1.49. Epub 2020 Feb 26.
PubMed 32158681Campo-Trapero J, Cano-Sanchez J, del Romero-Guerrero J, Moreno-Lopez LA, Cerero-Lapiedra R, Bascones-Martinez A. Dental management of patients with human immunodeficiency virus. Quintessence Int. 2003 Jul-Aug;34(7):515-25.
PubMed 12946070Aletaha D, Neogi T, Silman AJ, Funovits J, Felson DT, Bingham CO 3rd, Birnbaum NS, Burmester GR, Bykerk VP, Cohen MD, Combe B, Costenbader KH, Dougados M, Emery P, Ferraccioli G, Hazes JM, Hobbs K, Huizinga TW, Kavanaugh A, Kay J, Kvien TK, Laing T, Mease P, Menard HA, Moreland LW, Naden RL, Pincus T, Smolen JS, Stanislawska-Biernat E, Symmons D, Tak PP, Upchurch KS, Vencovsky J, Wolfe F, Hawker G. 2010 Rheumatoid arthritis classification criteria: an American College of Rheumatology/European League Against Rheumatism collaborative initiative. Arthritis Rheum. 2010 Sep;62(9):2569-81. doi: 10.1002/art.27584.
PubMed 20872595Adeyemo WL, Ladeinde AL, Ogunlewe MO. Clinical evaluation of post-extraction site wound healing. J Contemp Dent Pract. 2006 Jul 1;7(3):40-9.
PubMed 16820806