Romeo 2002.
| Methods | Trial design: randomised, parallel group trial Location: Milan, Italy Number of centres: one (dental clinic of the University of Milan, Italy) Recruitment period: 1997‐1999 Funding source: not stated |
|
| Participants | Inclusion criteria: patients that have been edentulous in the mandible for at least 3 months. Mandibles allowing the placement of 4 implants of at least 10 mm length 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 20 cigarettes a day) and any systemic diseases likely to compromise implant surgery Age at baseline: mean 63.2 (range 42‐73 years) Gender: M8/F12 Number randomised: 20 Number evaluated: 20 (no withdrawals at 1 year) |
|
| Interventions |
Comparison: Immediate versus conventional loading Gp A (n = 10) Immediate loading: 4 implants immediately loaded (within 2 days from insertion) Gp B (n = 10) Conventional loading: 4 implants supporting a bar and an overdenture conventionally loaded (3 to 4 months) ITI (Institut Straumann AG, Waldenburg, Switzerland) SLA non‐submerged solid titanium screws were used Duration of follow‐up: 2 years |
|
| Outcomes | ||
| Notes | Sample size calculation: not reported but trial authors note that small sample size was a limitation of this study | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Reported in the article: "Patients were randomly attributed to the test (immediate loading) or control (delayed loading), each one made up of 10 patients" Author replied that "a drawing lot was used" Reviewer comments: with the methods of randomisation used by the author it is unlikely to have 2 numerically balanced groups |
| Allocation concealment (selection bias) | High risk | Nothing reported in the article Author replied that "the operator knew patient allocation the day of intervention" 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 calibrated blinded outcome assessor" |
| 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 |