Hall 2006.
| Methods | Trial design: randomised, parallel group trial Location: Dunedin, New Zealand Number of centres: one (University of Otago Dental Clinic, Dunedin, New Zealand) Recruitment period: not stated Funding source: Southern Implants (Irene, south Africa) and Radiographic Supplies (Christchurch, New Zealand, supported this trial |
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| Participants | Inclusion criteria: patients missing a single tooth in anterior maxilla (premolar to premolar) with adjacent teeth present, allowing the placement of at least 10 mm long implant with a diameter of 2.5 mm Exclusion criteria: patients with type IV bone quality (very soft bone) according to the Lekholm and Zarb classification detected on radiographs, severe bruxism, smoking habits (more than 20 cigarettes per day), previous history of failed implants, and sites requiring augmentation surgery Age at baseline: mean 43.25 range 23 to 71 years Gender: not stated Number randomised: 28 Number evaluated: 25 (3 withdrawals at 1 year, 1 for the immediately loaded group and 2 from the conventionally loaded group for emigration) |
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| Interventions |
Comparison: Immediate versus conventional loading Gp A (n = 14) Immediate loading non‐occlusal ‐ single implants restored first with acrylic restorations (not in occlusion), then by screw‐connected metal‐ceramic crowns Gp B (n = 14) Conventional loading Single implants had screw‐retained provisional crowns placed after 6 months Definitive screw‐retained metal ceramic crowns were placed into occlusion for all participants 8 weeks after provisionalisation Southern (Southern Implants Ltd, Irene, South Africa) tapered sand‐blasted acid‐etched titanium screws were used Duration of follow‐up: 1 year |
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| Outcomes | Prosthesis/implant failures, Periotest, marginal bone level changes on standardised intraoral radiographs, plaque accumulation, sulcus bleeding index, unspecified peri‐implant soft tissues and prosthetic outcomes measures including the Papilla Index by Jemt 1997 1‐year data used |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Reported in the article: "Participants.....were randomly allocated using sealed envelopes to the conventional loading...." The reply of the author failed to clarified the issue |
| Allocation concealment (selection bias) | Unclear risk | Nothing reported in the article The reply of the author failed to clarified the issue |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Nothing reported in the article Author replied that "outcome assessors were blinded" |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | All data presented. 3 withdrawals at 1 year, 1 for the immediately loaded group (included in outcome based on email responses) and 2 from the conventionally loaded group for emigration |
| Selective reporting (reporting bias) | Low risk | All outcomes appear to be presented |
| Other bias | Low risk | None detected |