Cannizzaro 2008d.
Methods | Trial Design: randomised, split‐mouth group trial Location: Pavia, Italy (private practice) Number of centres: one Recruitment period: September to November 2007 Funding source: implants and prosthetic components were donated by Biomax and Biomet 3i |
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Participants | Inclusion criteria: partially edentulous patients needing 2 x 7 mm long single implants in bone at least 5.5 wide. For implants to be immediately loaded, a primary implant stability of 40 Ncm had to be achieved at insertion Exclusion criteria: irradiated in the head and/or neck less than 1 year previously, substance abusers, pregnancy or lactation, uncontrolled diabetes, severe bruxism or clenching, and any systemic diseases likely to compromise implant surgery, need for augmentation procedures with exception of Bio‐Oss in fresh extractions sockets, lack of opposite occluding dentition/prosthesis, psychiatric problems Age at baseline: 35 years (18‐57) 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: 2 single implants, planned to be placed with a flapless procedure, immediately (same day) loaded with acrylic crowns replaced by metal‐ceramic crowns after 9 weeks Gp B (n = 15) Early loading: 2 single implants, planned to be placed with a flapless procedure, early loaded after 6 weeks with acrylic crowns replaced by metal‐ceramic crowns after 3 weeks 7 mm* long Biomet 3i (Palm Beach, Florida, USA) Nanotite cylindrical titanium‐alloy implants non‐submerged were used Duration of follow‐up: 4 years |
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Outcomes | Prosthesis/implant failures, marginal bone level changes on intraoral radiographs, patient satisfaction, complications 9‐month data used |
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Notes | Sample size calculation: reported that 26 patients were required to show a change in failure rate from 39% to 4%, so the trial recruited 30 participants to allow for drop‐outs * In the first paper (Cannizzaro 2008d) with follow‐up data 9 months after loading, these implants were described as 6.5 mm because the implant height without the external hexagon is 6.5 mm. In the subsequent paper(Cannizzaro 2012) the same implants are described as 7 mm ‐ a measure which included the external hexagon |
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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 Dr Marco Esposito, who was not involved in patient recruitment or treatment and had access to the randomisation list stored in a password‐protected portable computer" |
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 the two implants were inserted, therefore treatment allocation was concealed to the investigator (GC) 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 (GC), who was not blinded, but implant stability and ISQ values were recorded by an independent dentist who was not aware of patient allocation (ML)" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All data presented |
Selective reporting (reporting bias) | Low risk | All outcomes were presented |
Other bias | Low risk | None detected |