Abstract
Background: The problem of antibiotic resistance is becoming increasingly serious worldwide due to uncontrolled prescription of antibiotics. Studies show conflicting results on the use or not of antibiotic prophylaxis associated with dental implant placement; its benefits are unclear, and its use is increasingly questioned. The aim of this randomized controlled clinical trial (RCT) was to compare early implant failure and postoperative infectious complications between two groups of healthy, non-penicillin-allergic patients who received a single prophylactic dose of 2 g amoxicillin versus placebo 1 h before surgery for implants placed in a single operative field. Methods: A double-blind, parallel-group, single-center RCT was conducted. One hundred patients met the inclusion criteria and were randomly assigned to the amoxicillin (n = 50) or placebo (n = 50) group. The primary endpoints analyzed were early implant failure and the presence of postoperative infection at 7, 14, 30 and 90 days. The recommendations of the CONSORT 2025 statement for RCT reporting were followed. Results: A total of 151 implants were placed in 96 patients and 12 implants failed; 6 implants in the antibiotic group (7.7%) and 6 implants in the placebo group (8.2%), so no statistically significant differences were observed between groups in the rate of early implant failure. In contrast, 11 implants developed postoperative infection; 2 in the antibiotic group (2.6%) and 9 in the placebo group (12.3%), reaching statistically significant differences (p = 0.028). Conclusions: The use of antibiotic prophylaxis in healthy patients is not necessary to prevent early failure of implants placed in a single operative field; however, the higher rate of infectious complications in patients without antibiotic therapy still raises a question that requires further investigation.