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Publisher's version (útgefin grein), Objectives: The aim of the present superiority study was to determine the effect of systemic antibiotics primarily on patient-reported outcome measures (PROMs) and post-surgical complications in patients undergoing oral implant therapy with simultaneous guided bone regeneration (GBR). Materials and Methods: A total of 236 medically and periodontally healthy patients received oral implants with simultaneous GBR at seven centres. Pre-operative antibiotics of 2 g amoxicillin were prescribed to the test group 1 hr prior to surgery and 500 mg thrice daily on days 1–3 after surgery. The control group was given a placebo. Group allocation was performed randomly. Primary outcome variables were PROMs recorded as visual analogue scale scores assessed on days 1–7 and 14 on pain, swelling, haematoma and bleeding. Post-operative complications as secondary outcome variables were examined at 1, 2, 4 and 12 weeks from surgery. Chi-square tests and repeated measures of analysis of variance (ANOVA) were performed for statistical evaluation. Results: No statistically significant differences (p >.05) between the two groups were detected for the evaluated PROMs. The same was noted with respect to post-surgical complications. Four implants were lost—three in the test group and one in the control group. Conclusion: In this trial, systemic antibiotics did not provide additional benefits to PROMs, nor the prevention of post-surgical complications in medically and periodontally healthy patients undergoing oral implant therapy with simultaneous GBR. However, further studies with larger sample sizes are still required to support the clinical outcomes of this study., This study has been supported by a research grant of the ITI Foundation (ITI Grant‐No: No. 962_2013). Further, we want to thank the Geistlich AG, Wolhusen, Switzerland, for providing bone substitutes and collagen membranes (Bio‐Oss® and Bio‐Gide®); Medochemie Limassol, Cyprus, for providing the study medication; and the Straumann AG (Basel, Switzerland) for granting a 50% discount on all the implant materials used in the presented study. The co‐operation of the staff of the centres involved in the study is highly appreciated: (1) Peking University, School of Stomatology, Beijing PR China (2) Medical University Graz, University Clinic of Dental Medicine & Oral Health, Department of Oral Surgery and Orthodontics, Graz Austria (3) Griffith University, Gold Coast, School of Dentistry and Oral Health, Queensland, Australia (4) The University of Hong Kong, Faculty of Dentistry, Hong Kong SAR PR China (5) University of Iceland, Faculty of Odontology, Reykjavik, Iceland (6) Shanghai Jiao Tong University, Shanghai Ninth People's Hospital, Department of Implant Dentistry, Shanghai PR China (7) National Dental Centre Singapore, Singapore