Schincaglia 2008.
| Methods | Trial Design: randomised, parallel group trial Location: Bologna, Italy Number of centres: one (School of Dentistry, University of Bologna, Italy) Recruitment period: 2002‐2004 Funding source: not stated |
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| Participants | Inclusion criteria: patients missing 1 mandibular first or second molar allowing the placement of a single implant at least 8.5 mm long and 5 mm wide with a minimal insertion torque of 20 Ncm Exclusion criteria: severe systemic conditions (ASA III), in need of bone augmentation, and if the tooth was extracted less than 4 months before Age at baseline: immediate 51.87 (range 31‐75 years); delayed 49.2 (range 35‐68 years) Gender: immediate M4/F11; delayed M5/F10 Number randomised: 30 Number evaluated: 30 (no withdrawals at 1 year) |
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| Interventions |
Comparison: Immediate versus conventional loading Gp A (n = 15) Immediate loading: Single implants restored the same day with occluding screw‐retained acrylic crowns, replaced after 3 to 4 months by cemented or screw‐retained metal‐ceramic crowns Gp B (n = 15) Conventional loading: Single implants were initially connected to a healing abutment and directly restored after 3‐4 months with cemented or screw‐retained metal‐ceramic crowns Brånemark® (Nobel Biocare AB, Göteborg, Sweden) non‐submerged TiUnite Mark III Wide‐Platform type titanium screws were used Duration of follow‐up: 1 year |
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| Outcomes | Prosthesis/implant failures, marginal bone level changes on intraoral radiographs, buccal peri‐implant marginal soft tissue levels 1‐year data used |
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| Notes | Sample size calculation: reported that 14 implants in each group were required to give 80% power detect a difference of 0.3 mm (SD 0.4 mm) | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Reported in the article: "Patients were allocated to either the immediate loading or in the delayed loading group using a randomization table" Author replied that: "The patients were consecutively assigned to test and control groups according to a predetermined randomization table" |
| Allocation concealment (selection bias) | High risk | Nothing reported in the article Author replied that: "the surgeon was not blinded in relation to the type of treatment before the implant placement" |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Reported in the article: "A blinded examiner made the bone height measurements" The author reply to our request of clarification implied that the other clinical outcome measures were not assessed by a 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 |