Merli 2007.
Methods | 3‐year post‐loading follow‐up randomised, parallel group study. There were no withdrawals. | |
Participants | Patients subjected to vertical GBR procedures. Adults treated at a private practice in Rimini, Italy. Patients were excluded if they had any general contraindication to implant surgery, history of irradiation in the head and neck area, poor oral hygiene and motivation, uncontrolled diabetes, pregnant or lactating, substance abusers, smoking more than 20 cigarettes per day. 22 patients enrolled, 11 in each group. | |
Interventions | Autogenous particulate bone harvested from intraoral locations contained under non‐resorbable titanium‐reinforced ePTFE barrier (Gore‐Tex, WL Gore and Associates, Inc.) fixed with miniscrews (Gebrüder Martin GmbH & Co. KG, Tuttlingen, Germany) versus osteosynthesis plates (Gebrüder Martin GmbH & Co. KG, Tuttlingen, Germany), appropriately shaped and fixed with miniscrews, supporting resorbable collagen barriers (Bio‐Gide®, Geistlich Pharma AG, Wolhusen, Switzerland). All patients were treated with a 1‐stage approach, i.e. implants were inserted and the augmentation procedure was performed on the same occasion with or without intravenous sedation. Surgical templates were used to optimise implant insertion. XiVE®S CELLplus (Friadent GmbH, Mannheim, Germany) implants were used. All patients were rehabilitated with provisional resin fixed prostheses, replaced by metal ceramic definitive prostheses. | |
Outcomes | Prosthesis and implant failure, vertical bone gain, measured intrasurgically pre‐operatively and at abutment connection, complications and bone level changes after loading. | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Article: "Manually created randomisation list". |
Allocation concealment (selection bias) | Low risk | Article: "The outcome of the randomisation was kept in sequentially numbered, opaque, identical, sealed envelopes, which were opened at the time of surgery, after implant placement". |
Blinding (performance bias and detection bias) All outcomes | Low risk | Article: "Independent assessors were used but blinding was not always possible". "All (bone gain) measurements were then checked on clinical photographs by a second blind and independent assessor". "Blind outcome assessors were used after loading". It is judged as adequate. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Data of 4 patients were missing at the 1‐year evaluation but all data were present at the 3‐year follow‐up. |
Selective reporting (reporting bias) | Low risk | |
Other bias | Low risk |