Felice 2013.
| Methods | Randomised trial of parallel group design, 1 year post‐loading follow‐up. 2 patients dropped out from the 1‐stage group just after augmentation: 1 never come back for unknown reasons and the other because of financial reasons | |
| Participants | Patients having 1 to 3 mm of alveolar bone height with a thickness of 5 mm or more below the sinus. Adults treated in dental hospitals/university clinics and private practices in Bologna, Roma and Chieti, Italy. Exclusion criteria were: general contraindications to implant surgery, subjected to irradiation in the head and neck area, immunosuppressed or immunocompromised, treated or under treatment with intravenous amino‐bisphosphonates, untreated periodontitis, poor oral hygiene and motivation, uncontrolled diabetes, pregnant or nursing, substance abusers, psychiatric problems or unrealistic expectations, lack of opposite occluding dentition/prosthesis in the area intended for implant placement, acute chronic infection/inflammation (sinusitis) in the area intended for implant placement, patients participating in other trials, if the present protocol could not be properly followed, referred only for implant placement or unable to attend a 5‐year follow‐up 30 patients were treated in each group, followed up to 1 year after loading |
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| Interventions | 1‐stage with simultaneous implant placement versus a 2‐stage lateral window sinus lift procedure with implant placement delayed by 4 months using a bone substitute (Bio‐Oss, Geistlich Pharmaceutical, Wolhusen, Switzerland). All patients were treated under local anaesthesia and the lateral sinus windows were sealed with resorbable collagen barriers (Bio‐Gide, Geistlich). 1 to 3, 11 to 15 mm long, tapered Way Milano implants (Geass, Pozzuolo del Friuli, UD, Italy) with microtextured surface treated with laser (Synthegra) and conical internal hexagonal connection were submerged for 4 months, loaded with reinforced provisional prostheses which were replaced, after 4 months, by definitive metal‐ceramic or zirconia restorations, rigidly joining the implants by being either provisionally cemented or screw‐retained | |
| Outcomes | Augmentation, prosthesis and implant failures, complications, and peri‐implant marginal bone level changes on periapical radiographs | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Article: "3 computer generated restricted randomisation lists were created. Only 1 of the investigators (Marco Esposito), not involved in the selection and treatment of the patients, was aware of the random sequence and could have access to the randomisation lists stored in his pass‐word protected portable computer" |
| Allocation concealment (selection bias) | Low risk | Article: "The random codes were enclosed in sequentially numbered, identical, opaque, sealed envelopes. Envelopes were opened sequentially after the sinus lining epithelium of was lifted, therefore, treatment allocation was concealed to the investigators in charge of enrolling and treating the patients" |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Article: "One dentist (Gerardo Pellegrino), not involved in the treatment of the patients, made all clinical assessments without knowing group allocation, therefore outcome assessor was blind" |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | All data presented, 2 drop‐outs |
| Selective reporting (reporting bias) | Low risk | All planned outcomes were reported |
| Other bias | Low risk | None apparent |