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| Name | Class |
|---|---|
| Fundação de Amparo à Pesquisa do Estado de São Paulo | OTHER_GOV |
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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 in immunosuppressed patients 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.
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, immunosuppressed 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 - Antibiotic Prophylaxis | Active Comparator | Single 2 g oral dose administered 30-60 minutes before tooth extraction |
|
| Arm 2 - No Antibiotic Prophylaxis | Placebo Comparator | Four matching placebo tablets administered 30-60 minutes before extraction |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amoxicillin | Drug | Amoxicillin 2 g a single prophylactic dose prior to simple extraction. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of postoperative infections | Proportion of participants developing postoperative infection, defined as purulent/serous exudate, fever (>37.8°C), or clinical signs of local infection. | 7 days post-extraction |
| Measure | Description | Time Frame |
|---|---|---|
| Severity and Duration of Infection | Presence and duration of purulent/serous exudate, fever (>37.8°C), or clinical signs of local infection and systemic symptoms | 7 days |
| Incidence of Postoperative Complications |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| Eloisa Bonfá, Full Professor | Hospital das Clínicas da Faculdade de Medicina da USP - HCFMUSP | Principal Investigator |
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| Placebo | Other | Matching placebo tablets administered as a single dose prior to extraction |
|
Presence of alveolitis, fever, edema, erythema, trismus, exudate, and pain
| 7 days |
| Influence of ARD Diagnosis and Immunosuppressive Regimen | Infection rate and severity related to ARD Diagnosis and Immunosuppressive Regimen | 7 days |
| Disease Activity Flares | Disease Activity Flares according to specific ARD definitions of exacerbation, as follows: Systemic Lupus Erythematosus(SLE): Increase >3 points in SLE Disease Activity Index 2000(SLEDAI-2K) Rheumatoid Arthritis(RA): Increase in Disease Activity Score-C-reactive protein(DAS28-CRP)>1.2, or >0.6 if baseline DAS28-CRP>3.2 Juvenile Idiopathic Arthritis(JIA): Increase in JIA Disease Activity Score(JADAS-27) >5 points, or worsening ≥2 active joints Ankylosing Spondylitis(AS): Increase in AS Disease Activity Score(ASDAS) >0.9. Psoriatic Arthritis(PsA): Worsening in Disease Activity Index for PsA(DAPSA) Systemic Vasculitis: Increase in Birmingham Vasculitis Activity Score(BVAS). Primary Sjögren's Syndrome: EULAR Sjögren's Syndrome Disease Activity Index(ESSDAI) Systemic Sclerosis (SSc): Increase in modified Rodnan skin score, new digital ulcers, worsening dyspnea, or increase in EULAR Systemic Sclerosis Impact of Disease Index (ScleroID) Inflammatory Myopathies (IIM): muscle weakness, CK | Day 1 through Day 30 |
| ID | Term |
|---|---|
| D000658 | Amoxicillin |
| ID | Term |
|---|---|
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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