Enkling 2010.
| Methods | Trial design: randomised, parallel group trial Location: not reported Number of centres: not reported Recruitment period: not reported Funding source: not reported |
|
| Participants | Inclusion criteria: patients with edentulous mandibles allowing the placement of 2 interforaminal implants 9.5 mm long and wit 4 mm in diameter with an insertion torque of at least 35 Ncm. Patients were dissatisfied with the retention of their dentures after having wore them for at least 2 months Exclusion criteria: not reported Age at baseline: not reported Gender: not reported Number randomised: 32 Number evaluated: 30 (due to missing data) |
|
| Interventions |
Comparison: Immediate versus conventional loading Gp A (n = 16) Immediate loading: overdentures on 2 mandibular interforaminal implants using a prefabricated bar (SFI‐Bar®, C+M, Biel, Switzerland) Gp B (n = 16) Conventional loading: (3 months) loading of overdentures on 2 mandibular interforaminal implants using a prefabricated bar (SFI‐Bar®, C+M, Biel, Switzerland) SICace® (SIC invent AG, Basel, Switzerland) titanium screws were used Duration of follow‐up: 1 year |
|
| Outcomes | Prosthesis/implant failures, marginal bone levels, complications, oral‐health‐related‐quality‐of life (OHRQoL), plaque index, probing pocket depth, bleeding on probing, sounding 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) | Unclear risk | No information provided in the abstract Author replied that: "We recruited pairs of patients regarding the parameters age and gender. In each pair the allocation to the immediate or delayed loading group was randomized by a computer generated list" |
| Allocation concealment (selection bias) | Unclear risk | No information provided in the abstract No reply to this question |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | No information provided in the abstract Author replied that: "The clinical assessors as well as the assessors for the x‐rays (post‐graduate students) were blinded and were independent of the surgical and prosthetic team" |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No information provided in the abstract Author replied that: "After the first year, we had two drop‐outs as two paired female patients died due to age reasons" The problem is that the data at 1 year for one patient per group is missing |
| Selective reporting (reporting bias) | Low risk | All outcomes appear to be presented |
| Other bias | Low risk | None detected |