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

Официальное название

Effectiveness of Short-Course Antibiotic Prophylaxis After Simple Tooth Extraction in Immunosuppressed Patients With Autoimmune Rheumatic Diseases

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Amoxicillin
  Amoxicillin 2 g a single prophylactic dose prior to simple extraction.
• Другое Placebo
  Matching placebo tablets administered as a single dose prior to extraction

Первичные конечные точки

• Frequency of postoperative infections [Срок оценки: 7 days post-extraction]

Вторичные конечные точки (4)

• Incidence of Postoperative Complications [Срок оценки: 7 days post-extraction]
• Severity and Duration of Infection [Срок оценки: 7 days post-extraction]
• impact of demographic data, different ARDs; disease activity, and treatment [Срок оценки: 7 days post-extraction]
• Oral Health in the different ARDs [Срок оценки: Day 1]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• 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
• 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
• 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 PMID 20872595
• 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

Идентификаторы

NCT: NCT07275580 · 69108723.1.0000.0068

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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