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. 2013 Mar 28;2013(3):CD003878. doi: 10.1002/14651858.CD003878.pub5

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
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
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
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
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