Chiapasco 2001.
| Methods | Trial design: randomised, parallel group trial Location: Milan, Italy Number of centres: one (University of Milan Dental clinic) Recruitment period: 1996 to 1997 Funding source: Z systems partially supported this trial |
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| Participants | Inclusion criteria: patients that have been edentulous in the mandible for at least 3 months. Mandibles allowing the placement of 4 implants at least 13 mm long Exclusion criteria: patients with type IV bone quality (very soft bone) according to the Lekholm and Zarb classification detected at implant insertion (none), previously irradiated jaws, severe bruxism, smoking habits (more than 10 cigarettes a day) and any systemic diseases likely to compromise implant surgery Age at baseline: mean age 58.4 years, (44 to 73) Gender: M5/F15 Number randomised: 20 Number evaluated: 20 |
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| Interventions |
Comparison: Immediate versus conventional loading Gp A (n = 10) Immediate loading: 4 implants immediately loaded (within 3 days of insertion) Gp B (n = 10) Conventional loading: 4 implants supporting a bar and an overdenture conventionally loaded 4 to 8 months later Brånemark (Nobel Biocare AB, Göteborg, Sweden) submerged turned titanium MKII screws were used Duration of follow‐up: 2 years |
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| Outcomes | Prosthesis/implant failures, Periotest, marginal bone level changes on panoramic radiographs, plaque accumulation, modified bleeding index, probing pocket depth 1‐year data used | |
| Notes | Sample size calculation: not reported | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | High risk | Reported in the article: "Patients were randomly assigned to 1 of 2 treatment groups: immediate loading (test group, n=10) or delayed loading (control group, n=10)" Author replied that "a drawing lot was used, however since there was a numeric imbalance between the 2 groups, once a group was completed the remaining patients were allocated to the other group" |
| Allocation concealment (selection bias) | High risk | Nothing reported in the article Reviewer comments: with the methods of randomisation used by the author it is not possible to ensure a proper allocation concealment |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Nothing reported in the article Author replied that "measurements were made by a blinded post‐graduate training specialist" |
| 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 |