Donati 2008.
| Methods | Trial design: multicenter, randomised, parallel group trial with 3 arms Location: Italy Number of centres: eight (private practices in Italy) Recruitment period: not stated Funding source: "This study was supported by grants from Astra Tech Dental" |
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| Participants | Inclusion criteria: patients missing a single tooth in area 15‐25 and 35‐45 allowing the placement of 8 mm long and 4 mm large single implant Exclusion criteria: post‐extractive implants (at least 3 months healing was required), insertion torque < 20 Ncm, and any systemic diseases likely to compromise implant surgery Age at baseline: M mean age 46.7 (SD18.3); F Mean age 44.2 (SD 12.9) Gender: M70/F81 Number randomised: 139 (151 patients were randomised (57, 50, 54 tooth sites), however, 10 of these patients had 2 tooth sites treated according to a split mouth design and their data were excluded from this systematic review) Number evaluated: 137 patients (2 withdrawals from conventionally loaded group due to poor health) |
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| Interventions |
Comparison: Immediate versus conventional loading Gp A (n = 44) Immediate loading: Standard preparation procedure for implant placement and immediate functional loading Gp B (n = 42) Immediate loading: Modified preparation procedure with osteotomies, followed by immediate functional loading Gp C (n = 51) Conventional loading: Single implants restored after 3 months with occluding screw‐retained acrylic crowns, replaced after 6 months by cemented or screw‐retained metal‐ceramic crowns Astra OsseoSpeed® (Astra Tech Dental, Mölndal, Sweden) titanium grade 1 screws were used Duration of follow‐up: 1 year |
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| Outcomes | Prosthesis/implant failures, marginal bone level changes on standardised intraoral radiographs, plaque accumulation, mucositis, probing pocket depth, changes in papilla height and width of the keratinised mucosa 1‐year data used |
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| Notes | Sample size calculation: not reported 10 patients who were treated according to a split‐mouth design, and their data were excluded from this systematic review |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Reported in the article: "A randomization protocol was produced from a computer‐generated list for the distribution of subjects in the three treatment groups" |
| Allocation concealment (selection bias) | Unclear risk | Nothing reported in the article Author replied failed to clarify the matter |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Reported in the article: "The radiographs were analyzed by an experienced radiologist who was blinded with regard to treatment groups" Author replied that "the outcome assessor for the clinical outcomes was not blinded" |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | All data presented after clarification by the author |
| Selective reporting (reporting bias) | Low risk | All outcomes appear to be presented |
| Other bias | Low risk | None detected |