Abstract
OBJECTIVES: To assess the effect of preoperative oral clindamycin in reducing early implant failure in healthy adults undergoing conventional implant placement. MATERIALS AND METHODS: We conducted a prospective, randomised, double-blind, placebo-controlled clinical trial in accordance with the ethical principles and Consolidated Standards of Reporting Trials statement. We included healthy adults who underwent a single oral implant without previous infection of the surgical bed or the need for bone grafting. They were randomly treated with a single dose of oral clindamycin (600 mg) 1 h before surgery or a placebo. All surgical procedures were performed by one surgeon. A single trained observer evaluated all patients on postoperative days 1, 7, 14, 28, and 56. Early dental implant failure was defined as the loss or removal of an implant for any reason. We recorded the clinical, radiological, and surgical variables, adverse events, and postoperative complications. The study outcomes were statistically analysed to evaluate differences between the groups. Furthermore, we calculated the number required to treat or harm (NNT/NNH). RESULTS: Both the control group and clindamycin group had 31 patients each. Two implant failures occurred in the clindamycin group (NNH = 15, p = 0.246). Three patients had postoperative infections, namely two placebo-treated and one clindamycin-treated, which failed (relative risk: 0.5, CI: 0.05-5.23, absolute risk reduction = 0.03, confidence interval: - 0.07-0.13, NNT = 31, CI: 7.2-∞, and p = 0.5). One clindamycin-treated patient experienced gastrointestinal disturbances and diarrhoea. CONCLUSIONS: Preoperative clindamycin administration during oral implant surgery in healthy adults may not reduce implant failure or post-surgical-complications. CLINICAL RELEVANCE: Oral clindamycin is not efficacy. TRIAL REGISTRATION: The present trial was registered (EudraCT number: 2017-002,168-42). It was approved by the Committee for the Ethics of Research with Medicines of Euskadi (CEIm-E) on 31 October 2018 (internal code number: 201862) and the Spanish Agency of Medicines and Medical Devices (AEMPS) on 18 December 2018.