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

NCT07275580 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: 69108723.1.0000.0068
• Study Type: interventional
• Target: 352
• Locations: 0 countries
• Sites: N/A

Brief 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). 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.

Conditions

Autoimmune Rheumatic Diseases; Tooth Extraction; Infection Prevention; Antibiotic Prophylaxis

Keywords

Autoimmune Rheumatic Diseases; Tooth Extraction; Infection Prevention; Amoxicillin; Antibiotic Stewardship; hydroxychroloquine; immunosupressive therapy

Outcome Measures

Primary Outcomes (1)

• Frequency of postoperative infections

  Proportion of participants developing postoperative infection, defined as purulent/serous exudate, fever, or clinical signs of local infection.

  7 days post-extraction

Secondary Outcomes (4)

• Incidence of Postoperative Complications

  7 days post-extraction

• Severity and Duration of Infection

  7 days post-extraction

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

  7 days post-extraction

• Oral Health in the different ARDs

  Day 1

Study Arms (2)

Arm 1 - Antibiotic Prophylaxis

ACTIVE COMPARATOR

Four amoxicilin tablets (2g total) administered as single dose 30-60 minutes before tooth extraction

Drug: Amoxicillin

Arm 2 - No Antibiotic Prophylaxis

PLACEBO COMPARATOR

Four matching placebo tablets administered 30-60 minutes before tooth extraction

Other: Placebo

Interventions

Amoxicillin DRUG

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

Arm 1 - Antibiotic Prophylaxis

Placebo OTHER

Matching placebo tablets administered as a single dose prior to extraction

Arm 2 - No Antibiotic Prophylaxis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Related Publications (4)

• 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.

  PMID: 32158681 BACKGROUND

• Campo-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.

  PMID: 12946070 BACKGROUND

• Aletaha 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.

  PMID: 20872595 BACKGROUND

• Adeyemo WL, Ladeinde AL, Ogunlewe MO. Clinical evaluation of post-extraction site wound healing. J Contemp Dent Pract. 2006 Jul 1;7(3):40-9.

  PMID: 16820806 BACKGROUND

MeSH Terms

Interventions

Amoxicillin

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Eloisa Bonfá, Full Professor

  Hospital das Clínicas da Faculdade de Medicina da USP - HCFMUSP

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eloisa Bonfá, Full Professor

CONTACT

+55 11 30617492; eloisa.bonfa@hc.fm.usp.br

Luciana PC Seguro, PhD

CONTACT

+55 11 999916381; luciana.seguro@hc.fm.usp.br

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2025
• First Posted: December 10, 2025
• Study Start: August 20, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): December 30, 2029
• Last Updated: August 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share