| Methods |
Randomised trial of split‐mouth design, 1 year post‐loading follow‐up. 3 withdrawals between years 1 and 3 |
| Participants |
Patients having 5 to 7 mm of alveolar bone height with a thickness of 5 mm or more below the sinus. Adults treated in 2 private practices in Bologna, Italy. Exclusion criteria were: general contraindications to implant surgery, subjected to irradiation in the head and neck area, treated or under treatment with intravenous amino‐bisphosphonates, poor oral hygiene and motivation, untreated periodontal disease, uncontrolled diabetes, pregnant or lactating, substance abusers, psychiatric problems or unrealistic expectations, lack of opposite occluding dentition/prosthesis in the area intended for implant placement, acute or chronic infection/inflammation 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. 15 patients were treated and 12 patients were followed up to 3 years after loading |
| Interventions |
1‐stage crestal sinus lift according to the Summers' technique using dedicated osteotomes of increasing diameters and a mallet versus the Cosci's technique using dedicated rotatory instruments with increasing working lengths and finally a special drill with a non‐cutting head (atraumatic lifting drill). Particulate cancellous human allograft (Puros, Zimmer Dental, Carlsbad, Ca, USA) was used. Augmentation procedures were performed under local anaesthesia and 1 or 2 8 to 10 mm long TSV Screw‐Vent tapered implants with internal connection and MTX microtextured titanium surface (Zimmer Dental) were placed and submerged for 6 months. Provisional screw‐retained reinforced resin prostheses were replaced after 4 months by definitive provisionally cemented metal‐ceramic prostheses |
| Outcomes |
Prosthesis, implant and augmentation failures, complications, patient preference 1 and 5 months after augmentation, peri‐implant marginal bone level changes, operator preference, duration of the sinus lift procedures |
| 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.Only one of the investigators (Marco Esposito), not involved in the selection and treatment of the patients, was aware of the randomisation sequence and could have access to the randomisation list stored in his pass‐word protected portable computer" |
| Allocation concealment (selection bias) |
Low risk |
Article: "The randomised codes were enclosed in sequentially numbered, identical, opaque, sealed envelopes. Envelopes were opened sequentially after flap elevation, 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: "Follow‐ups were conducted by an independent blind outcome assessor (Gerardo Pellegrino)" |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
All data presented, no drop‐outs |
| Selective reporting (reporting bias) |
Low risk |
All planned outcomes were reported |
| Other bias |
High risk |
8 out of 15 patients were treated by Dr Cosci who was the inventor of the Cosci's technique |
