| Methods |
Multicentre, placebo‐controlled, parallel RCT of 4 months' duration. 7 exclusions from each group for various explained reasons |
| Participants |
Partially‐ and fully‐edentulous participants. Adults treated in 11 private Italian dental practices. Participants excluded if they were: allergic to penicillins, needing prophylaxis for endocarditis, immunodeficient, diabetic, had implanted prostheses, required bone augmentation at implant placement with infections in the vicinity of the implant site(s), had been irradiated in the head and neck area, were already receiving antibiotic treatment, had been treated or receiving treatment with intravenous amino‐bisphosphonates, were pregnant or lactating. 165 participants included in each group and results given for 158 |
| Interventions |
2 g of amoxicillin given 1 h preoperatively versus identical placebo tablets. Operators were allowed to place and restore the implants according to their routine procedures. 1 week prior to implant placement, all participants underwent at least 1 session of oral hygiene instruction and professionally‐delivered debridement, if required. All participants rinsed with chlorhexidine digluconate 0.2% for 1 minute just prior to surgery and postoperatively twice a day for at least 1 week. Operators were allowed to place and restore the implants according to their routine procedures. Postoperative complications were assessed at 1 and 2 weeks, and implant success at 4 months. Various implant systems brands were used (Zimmer Dental, Dentsply Friadent, Nobel Biocare, Intra‐Lock, Camlog, Dyna, Biomet 3i, and Endopore) |
| Outcomes |
Prosthesis and implant failures, postoperative complications, adverse events. Postoperative complications assessed 1 and 2 weeks after placement, and implant stability at 4 months |
| Notes |
Antibiotics and placebo donated by a drug company manufacturing generic drug; the company was not involved in the design of the study, in the data evaluation, or in commenting on the manuscript. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Quoted from the article: "Twelve computer generated restricted randomization lists with equal groups of participants were made." |
| Allocation concealment (selection bias) |
Low risk |
Quoted from the article: "Only one of the investigators (Dr Marco Esposito), not involved in the selection and treatment of the patients, was aware of the randomization sequence and could have access to the randomization lists stored in his password protected portable computer. The randomized codes (1 or 2) were enclosed in sequentially numbered, identical, opaque, sealed envelopes. Envelopes were opened sequentially 1 hour prior to implant placement and patients assumed 2 tablets taken from identical white plastic containers labelled with the same code of the envelopes (1 or 2), containing the antibiotic or identical placebo tablets. Therefore treatment allocation was concealed to the investigators in charge of enrolling and treating the patients . . . " |
| Blinding (performance bias and detection bias)
All outcomes |
Low risk |
Quoted from the article: " . . . and both patients and operators/outcome assessors were blinded to the tested intervention. Also the statistician was kept blind and performed all analyses without knowing to which group the patients were allocated." |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
All exclusions and missing data reported and explained |
| Selective reporting (reporting bias) |
Low risk |
All outcome measures reported |
| Other bias |
Low risk |
No other bias identified |
