Payne 2002.
| 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: study was supported by ITI Research Foundation (Research Grant #203/2000 RCL), Institut Straumann AG (Waldenburg, Switzerland, Ivovclar Vivadent (Auckland New Zealand), Radiographic Supplies (Christchurch New Zealand) & Colgate Oral Care, New Zealand |
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| Participants | Inclusion criteria: elderly patients with edentulous mandibles having 13 to 15 mm of residual anterior bone height Exclusion criteria: patients with type IV bone quality (very soft bone) according to the Lekholm and Zarb classification detected at implant insertion (none), previously bone‐grafted or irradiated jaws, history of bruxism, any evidence of current or previous smoking and any systemic diseases likely to compromise implant surgery Age at baseline: range 55‐80 years Gender: M12/F12 Number randomised: 24 Number evaluated: 22 (2 withdrawals at 1 year from the conventionally loaded group for emigration) |
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| Interventions |
Comparison: Early versus conventional loading Gp A (n = 12) Early loading: 2 unsplinted implants with ball attachments early loaded at 6 weeks Gp B (n = 12) Conventional loading: 2 unsplinted implants with ball attachments supporting an overdenture conventionally loaded at 12 weeks ITI (Institut Straumann AG, Waldenburg, Switzerland) SLA non‐submerged solid titanium screws were used Duration of follow‐up: 2 years |
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| Outcomes | Prosthesis/implant failures, Periotest, Osstell, marginal bone level changes on standardised intraoral radiographs, plaque accumulation, modified sulcus bleeding index, probing pocket depth, width of the keratinised mucosa 1‐year data used |
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| Notes | Sample size calculation: not reported | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Reported in the article: "Using a table of random numbers participants were randomly allocated, with maximum allocation concealment (Esposito et al. 2001), to two treatment groups, each with 12 participants" |
| Allocation concealment (selection bias) | Unclear risk | Reported in the article: "Using a table of random numbers participants were randomly allocated, with maximum allocation concealment (Esposito et al. 2001), to two treatment groups, each with 12 participants" No clarifying reply to letter |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Nothing reported in the article Author replied that "measurements were made by calibrated blinded outcome assessors" |
| 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 |