Effectiveness of Short-Course Antibiotic Prophylaxis After Simple Tooth Extraction in Immunosuppressed Patients With Autoimmune Rheumatic Diseases
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 352
- 主要终点
- Frequency of postoperative infections
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Arm 1 - Antibiotic Prophylaxis
Four amoxicilin tablets (2g total) administered as single dose 30-60 minutes before tooth extraction
干预措施: Amoxicillin (Drug)
Arm 2 - No Antibiotic Prophylaxis
Four matching placebo tablets administered 30-60 minutes before tooth extraction
干预措施: Placebo (Other)
结局指标
主要结局
Frequency of postoperative infections
时间窗: 7 days post-extraction
Proportion of participants developing postoperative infection, defined as purulent/serous exudate, fever, or clinical signs of local infection.
次要结局
- 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)
- Severity and Duration of Infection(7 days)
- Incidence of Postoperative Complications(7 days)
- Influence of ARD Diagnosis and Immunosuppressive Regimen(7 days)
- Disease Activity Flares(Day 1 through Day 30)