Cannizzaro 2008b.
Methods | Trial design: randomised, parallel group trial Location: Pavia, Italy (private practice) Number of centres: one Recruitment period: November 2004 to November 2005 Funding source: "No commercial support of any form has been received by the investigators" |
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Participants | Inclusion criteria: patients with edentulous maxillae allowing the placement of 5 to 8 implants at least 10 mm long and with a diameter of 3.7 mm. For implants to be immediately loaded, a primary implant stability of 48 Ncm had to be achieved at insertion Exclusion criteria: irradiated head & neck less than 1 year previously, substance abusers, pregnancy or lactation, uncontrolled diabetes, and any systemic diseases likely to compromise implant surgery, need for augmentation procedures, lack of opposite occluding dentition/prosthesis, psychiatric problems Age at baseline: immediate 62 (45‐75); early 56 (42‐69) Gender: M15/F15 Number randomised: 30 Number evaluated: 30 |
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Interventions |
Comparison: Immediate versus early loading Gp A (n = 15) Immediate loading: 5‐8 implants, placed with a flapless procedure, immediately (same day) restored with metal reinforced acrylic provisional prostheses replaced 2 to 3 months after by full‐arch metal ceramic or metal resin prostheses with short cantilevers Gp B (n = 15) Early loading: 5‐8 implants, placed with a flapless procedure, restored after 2 months with metal reinforced acrylic provisional prostheses replaced 2 to 3 months after by full‐arch metal ceramic or metal resin prostheses with short cantilevers Zimmer SwissPlus (Zimmer, Carlsbad, Ca, USA) non‐submerged solid titanium screws were used Duration of follow‐up: 1‐year |
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Outcomes | Prosthesis/implant failures, Osstell, marginal bone level changes on intraoral radiographs, patient satisfaction, complications 1‐year data used |
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Notes | Sample size calculation: not reported, but authors note that the actual sample size was insufficient to detect a statistically significant difference in prosthesis/implant failures | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Reported in the article: "A computer generated restricted randomisation list was used to create two groups with equal numbers of patients by one of the authors who was not involved in patient recruitment or treatment and had access to the randomisation list stored in a password‐protected portable computer (Dr Marco Esposito)" |
Allocation concealment (selection bias) | Low risk | Reported in the article: "The randomised codes were enclosed in sequentially numbered, identical, opaque, sealed envelopes. Envelopes were opened sequentially only after all the implants were inserted, therefore treatment allocation was concealed to the investigator in charge of enrolling and treating the patients included in the trial" |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Reported in the article: "Complications were assessed by the treating dentist (Dr Gioacchino Cannizzaro), who was not blinded. Independent dentists who were not aware of patient allocation evaluated implant stability, including ISQ values (Dr Michele Leone) and marginal bone levels changes (Dr Cinzia Torchio)" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All data presented |
Selective reporting (reporting bias) | Low risk | All outcomes were presented |
Other bias | Unclear risk | More implants (n = 22) were placed in fresh extraction sockets in the early loaded group compared to the immediate loading group (n = 12 implants placed in fres extraction sockets) |