Cannizzaro 2003.
Methods | Trial design: randomised, parallel group trial Location: Pavia, Italy (private practice) Number of centres: one Recruitment period: not stated Funding source: not stated |
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Participants | Inclusion criteria: partially edentulous patients (both mandibles and maxillae) allowing the placement of at least 13 mm long implants with a diameter of 3.7 mm. For implants to be immediately loaded, a primary implant stability of 45 Ncm had to be achieved at insertion Exclusion criteria: patients with type IV bone quality (very soft bone) according to the Lekholm and Zarb classification detected at implant insertion, less than 3 years irradiated jaws, severe bruxism, smoking habits (more than 10 cigarettes per day), substance abusers, pregnancy, uncontrolled diabetes, and any systemic diseases likely to compromise implant surgery Age at baseline: 18 to 72 years, Group 1 mean 37.1 years, Group 2 mean 38.6 years Gender: 14M/14F Number randomised: 28 Number evaluated: 28 (at 1 year) |
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Interventions |
Comparison: Immediate versus conventional loading Gp A (n = 14) Immediate loading: One or more adjacent implants restored first with acrylic restorations in full occlusion and then with cemented metal‐ceramic prostheses, loaded the same day Gp B (n = 14) Conventional loading: One or more adjacent implants restored first with acrylic restorations in full occlusion and then with cemented metal‐ceramic prostheses,loaded after 3.4 months (mandibles) or 4.5 months (maxillae) Zimmer (Zimmer, Carlsbad, Ca, USA) Spline Twist MTX titanium screws were used Duration of follow‐up: 2 years |
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Outcomes | Prosthesis/implant failures, Periotest, Osstell, marginal bone level changes on standardised intraoral radiographs, plaque accumulation, probing pocket depth 1‐year data used |
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Notes | Sample size calculation: not reported | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Nothing reported in the article Author replied that "random number tables were used" |
Allocation concealment (selection bias) | High risk | Nothing reported in the article Author replied that "just before the intervention the operator was informed of which therapy to deliver" |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Reported in the article: "A member of the treatment team recorded the following parameters 1 month after prosthesis seating (baseline) and every 6 months until conclusion of the study in June 2001" Author replied that: "3 blinded outcome assessors were used: Dr Fontana S. for radiographic evaluation, Dr Ignaccolo S. for Periotest evaluation, and Dr Leone M. for periodontal indexes evaluation" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All data presented |
Selective reporting (reporting bias) | Low risk | All outcomes appear to be presented |
Other bias | Low risk | None detected |