Fischer 2004.
| Methods | Trial design: randomised, parallel group trial Location: Falun, Sweden Number of centres: one (County Hospital, Falun, Sweden) Recruitment period: April 1999 to September 2000 Funding source: Institut Straumann supported this study |
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| Participants | Inclusion criteria: patients with edentulous maxillae allowing the placement of 5 to 6 implants Exclusion criteria: smoking habits (more than 10 cigarettes a day), use of augmentation procedures at the implanted sites, and any systemic diseases likely to compromise implant surgery Age at baseline: mean 64 years Gender: immediate M6/F10; conventional M2/F6 Number randomised: 24 Number evaluated: 24 |
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| Interventions |
Comparison: Immediate versus conventional loading Gp A (n = 16) Immediate loading: 5‐6 implants per patient restored directly with definitive full‐arch titanium‐resin prosthesis with cantilevers (7‐11 mm long) at 9‐18 days. ITI SLA (Institut Straumann AG, Waldenburg, Switzerland) non‐submerged solid titanium screw type implants were used Gp B (n = 8) Conventional loading 5‐6 implants per patient restored directly with definitive full‐arch titanium‐resin prosthesis with cantilevers (7‐11 mm long) after 2.5‐5.1 months. Submerged ITI EstheticPlus implants in the conventionally loaded group (except for one patient) Duration of follow‐up: 5 years |
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| Outcomes | Prosthesis/implant failures, marginal bone level changes on standardised intraoral radiographs, plaque index, sulcus bleeding index, width of the keratinised mucosa 1‐year data used | |
| Notes | Sample size calculation: not reported | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Reported in the article: "Patients were randomized and consecutively enrolled in the study according to predefined inclusion and exclusion criteria" Reviewer comments: patients were randomised with a 2 to 1 ratio, i.e. 16 in the early loading group and 8 in the conventional loading group. There are no advantages by doing this and authors had further reduced their already small sample size |
| Allocation concealment (selection bias) | High risk | Nothing reported in the article Author replied that "When patient had signed the informed consent form a sealed treatment code envelope was opened through which patient was allocated to either the test or the control group" |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Nothing reported in the article Author replied that "outcome assessors were not blinded" |
| 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 |