Felice 2012.
| Methods | Randomised trial of parallel group design, 1 year post‐loading follow‐up. 1 patient, from the maxillary augmented group, dropped out before the 1 year follow‐up because she did not want to continue the follow‐up at the dental practice | |
| Participants | Patients having 4 to 6 mm of alveolar bone height with a thickness of 6 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, 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. 20 patients were treated in each group | |
| Interventions |
Comparison 1: short implants without augmentation versus long implants with augmentation 1 to 3 5 mm long implants of 5 mm in diameter versus 1 to 3 10 mm or longer implants of 5 mm in diameter placed in 1‐stage laterally augmented sinuses using a 1 cc sterile syringe of a sticky paste of made of 600‐1000 micron pre‐hydrated collagenated cortico‐cancellous bone granules of porcine origin, mixed with OsteoBiol Gel 0 (mp3, OsteoBiol, Tecnoss Dental, Pianezza, TO, Italy) with their lateral windows sealed with a resorbable collagen membrane from equine pericardium (Evolution, Fine 30 x 30 mm, OsteoBiol) simultaneously to implant placement. Augmentation procedures were performed under local anaesthesia and implants were left to heal submerged for 4 months. ExFeel implants (MegaGen Implant Co. Lld., Gyeongbuk, South Korea), with external hexagon connection and a nanostructured calcium‐incorporated titanium surface (Xpeed), were used. Provisional screw‐retained reinforced resin prostheses were replaced after 4 months by definitive screw‐retained or provisionally cemented metal‐ceramic prostheses |
|
| Outcomes | Prosthesis and implant failures, complications, and peri‐implant marginal bone levels | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Article: "A computer generated restricted random 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 random sequence and could have access to the random list stored in his pass‐word protected portable computer. The information on how to treat each patient was enclosed in sequentially numbered, identical, opaque, sealed envelopes. Envelopes were opened sequentially after the patients signed the informed consent accepting to participate into the trial. 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: "Two dentists (Dr Laura Piana and Dr Daniele Panetta) not involved in the treatment of the patients performed all clinical measurements without knowing group allocation...." |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | All data presented, 1 drop‐out |
| Selective reporting (reporting bias) | Low risk | All planned outcomes were reported |
| Other bias | Low risk | None apparent |