Abstract

A randomized, double-blind, placebo-controlled clinical trial. To assess the impact of antibiotic prophylaxis on postoperative recovery and implant short-term survival in clinically healthy patients who underwent placement of 2-4 dental implants by inexperienced operators. The study adhered to the ethical guidelines of theHelsinki declaration, and followed the CONSORT protocol for randomized controlled trials (RCTs). Signed consent forms were provided by all patients. Included were healthy individuals aged over 18 years, with sufficient and fully healed alveolar ridge (undergone extraction at least 3 months prior), requiring placement of 2-4 dental implants, and were classified as ASA I or II. Exclusion criteria were: systemic diseases, hypersensitivity to penicillin, pregnancy or lactation, smoking, recent antibiotic usage, and history of periodontitis. Patients were randomly allocated into 2 groups: the antibiotic group received 1 g of amoxicillin one hour before surgery, while the placebo group was given starch-filled capsules that looked identical to the antibiotic. All implants were installed through 2-stage procedures by students of a specialization course in implant surgery, employing a standardized procedure and armamentarium. Each patient was evaluated preoperatively, and at 2 days and 7 days postoperatively, for the following parameters: mouth opening, experienced pain (using a visual analog scale), and signs of infection (fistula, wound ulceration, tissue necrosis, flap dehiscence, and purulent exudates). Implant survival was monitored for up to 90 days after implant surgery. A total of 90 patients (224 implants) were included: 43 patients (108 implants) in the antibiotic group, and 47 patients (116 implants) in the placebo group. Overall, there were 58 women and 32 men, aged from 23 to 70 years old. In terms of mouth opening, pain, and infection parameters, no statistically significant differences were observed between the groups at any of the time points evaluated. Similarly, there was no statistically significant difference regarding antibiotic usage and implant loss at the patient level (p = 0.06). However, at the implant level, significantly higher implant loss rate was noted in the placebo group (14.9%) compared to the antibiotic group (2.3%) [p < 0.05]. Prophylactic antibiotic administration effectively reduced the occurrence of implant loss after implant surgery performed by inexperienced practitioners.

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