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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
352
Amoxicillin 2 g a single prophylactic dose prior to simple extraction.
Matching placebo tablets administered as a single dose prior to extraction
Frequency of postoperative infections
Proportion of participants developing postoperative infection, defined as purulent/serous exudate, fever, or clinical signs of local infection.
Time frame: 7 days post-extraction
Incidence of Postoperative Complications
Presence of alveolitis, fever, edema, erythema, trismus, exudate, and pain between the two groups
Time frame: 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
Time frame: 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;
Time frame: 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).
Time frame: Day 1
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.