Amoxicillin
DrugAmoxicillin 2 g a single prophylactic dose prior to simple extraction.
NCT Number: NCT07275580
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Phase 4
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Amoxicillin 2 g a single prophylactic dose prior to simple extraction.
Matching placebo tablets administered as a single dose prior to extraction
Time frame: 7 days post-extraction
Proportion of participants developing postoperative infection, defined as purulent/serous exudate, fever, or clinical signs of local infection.
Time frame: 7 days post-extraction
Presence of alveolitis, fever, edema, erythema, trismus, exudate, and pain between the two groups
Time frame: 7 days post-extraction
To compare the duration and severity of the infection and any possible differences between the two groups
Time frame: 7 days post-extraction
Compare the potential impact of demographic data, different ARDs; and treatment on the frequency and severity of infection in the two groups;
Time frame: Day 1
Characterize oral health in the different ARDs using the decayed, missing, or filled teeth index (DMF) and the simplified periodontal screening and recording (PSR).
Contact information is provided by the study sponsor or research team.
Eloisa Bonfá, Full Professor
CONTACT
Luciana PC Seguro, PhD
CONTACT
University of Sao Paulo General Hospital
Other
Effectiveness of Short-Course Antibiotic Prophylaxis After Simple Tooth Extraction in Immunosuppressed Patients With Autoimmune Rheumatic Diseases
Acronym: PRO-EXOD
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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