Turkyilmaz 2007.
Methods | Trial Design: randomised, parallel group trial Location: Ankara, Turkey Number of centres: one (Faculty of Dentistry, Hecettepe University, Ankara, Turkey) Recruitment period: not stated Funding source: not stated |
|
Participants | Inclusion criteria: patients with edentulous mandibles allowing the placement of 2 x 15 mm long implants Exclusion criteria: patients with previously bone‐grafted or irradiated jaws, and any systemic diseases likely to compromise implant surgery Age at baseline: immediate 62.4 ± 8.6 years); delayed 62.3 ± 7.1 years Gender: M8/F12 Number randomised: 20 Number evaluated: 20 (no withdrawals at 1 year) |
|
Interventions |
Comparison: Early versus conventional loading Gp A (n = 5) Immediate loading: 2 unsplinted implants with ball attachments supporting an overdenture immediately loaded at 1 week Gp B (n = 5) Conventional loading: 2 unsplinted implants with ball attachments conventionally loaded at 3 months Brånemark® (Nobel Biocare AB, Göteborg, Sweden) non‐submerged TiUnite Mark III type titanium screws were used Duration of follow‐up: 2 years |
|
Outcomes | Prosthesis/implant failures, Osstell, marginal bone level changes on standardised intraoral radiographs, complications 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: "The patients randomly allocated into two groups pre‐operatively" Author replied that "We actually toss a coin (heads or tails) and created groups randomly" Reviewer comment: "it is possible but highly unlikely to create 2 groups with identical number of patients by tossing a coin" |
Allocation concealment (selection bias) | High risk | Nothing reported in the article Author replied that "The surgeon did not know the groups before implant placement" |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Nothing reported in the article Author replied that "the outcome assessor was 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 |