| Methods |
Randomised trial of split‐mouth design, 1 year post‐loading follow‐up. 1 patient, who had a complication, dropped out before prosthetic loading |
| Participants |
Patients having 1 to 4 mm of alveolar bone at the floor of the sinus. Adults treated in dental hospitals/university clinics in Bologna, Roma and Chieti, Italy. Exclusion criteria were: general contraindications to implant surgery, patients irradiated in the head and neck area, immunosuppressed or immunocompromised patients, patients who took or are taking bisphosphonates intravenously, patients with untreated periodontitis, poor oral hygiene and motivation, uncontrolled diabetes, pregnancy or lactation, addiction to alcohol or drugs, psychiatric problems, lack of opposite occluding dentition in the area intended for implant placement, patients with an acute or chronic infection inflammation in the area intended for implant placement. 10 patients were treated |
| Interventions |
2‐stage sinus lift with lateral window approach using either a synthetic resorbable barrier (Inion, GTR Biodegradable Membrane System, Tampere, Finland) to keep the sinus membrane or 100% granular Bio‐Oss. Inion barriers were used to seal the lateral windows. Inion barriers are made of a synthetic co‐polymer (trimethylene carbonate l‐lactide polyglycolide) that needs to be softened in a plasticising solution, allowing the membrane to be cut and mould to fit exactly the space. The barrier then harden in the new position maintaining the new shape and the space. This material should biodegrade in situ after 8‐12 weeks. All augmentation procedures were performed under local anaesthesia. After 6 months, 1 to 3 implants were placed per side and submerged for 4 months. Implants were Way (Geass, Pozzuolo del Friuli (UD), Italy) with a laser treated surface and internal connection. Provisional screw‐retained reinforced resin prostheses were replaced after 4 months by definitive screw‐retained metal‐ceramic prostheses. 1 patient was excluded after perforation |
| Outcomes |
Prosthesis and implant failures, complications, amount of vertically augmented bone (mm), peri‐implant marginal bone levels, patient and clinician preference. Time necessary to complete the augmentation procedure |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Article: "A computer generated restricted randomisation list was created" |
| Allocation concealment (selection bias) |
Low risk |
Article: "Only one of the investigators (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 list stored in his pass‐word protected portable computer. The randomized codes were enclosed in sequentially numbered, identical, opaque, sealed envelopes. Envelopes were opened sequentially after the sinus lining epithelium of site number 1 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 the clinical assessments without knowing group allocation, therefore outcome assessor was blinded, however Bio‐Oss augmented sites could be identified on radiographs because they appeared more radio‐opaque while Inion treated sites appeared rather radiolucent" |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
All data presented, 1 drop‐out after perforation |
| Selective reporting (reporting bias) |
Low risk |
All planned outcomes were reported |
| Other bias |
Low risk |
None apparent |
