De Rouck 2009.
Methods | Trial design: randomised, parallel group trial Location: Bruxelles, Belgium Number of centres: one (Dental Clinic of the Free University) Recruitment period: not stated Funding source: not stated |
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Participants | Inclusion criteria: patients requiring the immediate replacement of a single tooth in the anterior maxilla (15‐25) having both neighbouring teeth and at least 5 mm of bone height apical to the alveolus of the failing tooth to allow implant placement with a minimal insertion torque of 35 Ncm Exclusion criteria: systemic diseases, smoking more than 10 cigarettes a day, bruxism, lack of posterior occlusion, non‐treated periodontal diseases, presence of active infection (pus, fistula) around the hopeless tooth, loss of the labial crest after extraction of the failing tooth Age at baseline: immediate 55 years (SD 13); conventional 52 years (SD 12) Gender: immediate M11/F13; conventional M12/F13 Number randomised: 52 Number evaluated: 49 |
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Interventions |
Comparison: Immediate versus conventional loading Gp A (n = 26) Immediate loading: Single immediate post‐extractive implants restored the same day with non‐occluding screw‐retained acrylic crowns, replaced after 6 months by permanent metal‐ceramic crowns Gp B (n = 26) Conventional loading: Implants were conventionally loaded and restored after 3 months with screw‐retained acrylic crowns, replaced after 3 months by permanent metal‐ceramic crowns. A collagen membrane (Bio‐Gide, Geistlich Biomaterials) covered the implant prior to crown placement The implant‐bone gap was grafted with granules of anorganic bovine bone Nobelreplace Tapered Groovy (Nobel Biocare AB, Göteborg, Sweden) TiUnite 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, plaque, bleeding on probing, probing pocket depths, papilla levels, midfacial mucosal levels, patient's esthetic satisfaction 1‐year data used |
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Notes | Sample size calculation: paper states that 24 patients per group were required to show a difference in soft tissue dimensions of 0.5 mm | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Reported in the article: "This was performed by means of a computer‐generated randomization scheme" |
Allocation concealment (selection bias) | Unclear risk | Reported in the article: "After screening for recruitment, impressions were made to fabricate an acrylic stent for recording purposes. Thereupon, patients were randomly allocated to the ‘immediate restoration group’ (IRG) or the ‘delayed restoration group’ (DRG)". Allocation concealment not mentioned |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Nothing reported in the article No reply to letter |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Reported in the article: "From the 52 patients that had been recruited (actually randomised), 49 were included in the study [IRG: 24 patients, DRG: 25 patients]. In two patients the labial crest was partially lost following tooth removal. Another patient listed for immediate restoration was excluded as the insertion torque was only 20 Ncm" |
Selective reporting (reporting bias) | Low risk | All outcomes appear to be presented |
Other bias | High risk | The author used different baseline radiographic assessment making the 2 groups actually non‐comparable |