Abstract
BACKGROUND: This study aims to enhance the current clinical understanding of prophylactic antibiotic treatment in China before implant surgeries, and improve the experience and adherence of patients who undergo implant procedures. METHODS : Patients eligible for inclusion in the past six years were divided into two groups of 500 patients each. Patients in the medication group received one 500 mg cefixime tablet and one 500 mg ornidazole tablet 0.5 hours before implantation. Patients in the non-medicated group did not receive any medicine. Patients were evaluated at two follow-ups: 7-14 days and 3-6 months after implant surgeries. The primary outcome was implant failure, which was characterized as implant detachment or complete loss during follow-ups, implant mobility (clinical mobility >1 mm) detected by surgeons when manually tightening abutments at the second follow-up (3-6 months after surgeries), or complications requiring clinical intervention occurred, including peri-implant bone resorption exceeding acceptable levels. Secondary outcomes were postoperative infection and adverse events. We statistically analyzed study outcomes using the Pearson Chi-square test, Fisher's exact test, and a multiple logistic regression model to evaluate differences between the two groups. P values less than 0.05 or 95% confidence intervals of relative risk or odds ratio values excluding one were considered statistically significant. RESULTS: We noted implant failures (medication group: four patients, 0.8% and non-medicated group: three patients, 0.6%) and postoperative infections (medication group: 23 patients, 4.6% and non-medicated group: 25 patients, 5.0%) were no statistically significant difference between the two groups. However, adverse events showed a statistically significant increase in the medication group (medication group: 111 patients, 22.2% and non-medicated group: 21 patients, 4.2%), including nausea, vomiting, hypersomnia, dizziness, and diarrhea. There was a statistically non-significant increase in fever in the non-medicated group. No statistically significant evidence existed in preventing postoperative infection between the two groups across smoking status, age, implant system, number of implants (1, 2-3, and ≥4), sinus elevation surgery, implant placement, and guided bone regeneration surgery. CONCLUSIONS: Antibiotic prophylaxis using ornidazole in conjunction with cefixime in implant surgery may not have clinical benefits but significantly increases adverse events. Therefore, the necessity of prophylactic antibiotic use in healthy patients before implant surgeries needs to be reconsidered.