Fernandes 2011.
Study characteristics | ||
Methods | Trial design: randomised, split‐mouth trial Location: São Paulo, Brazil Number of centres: single centre, University of São Paulo, São Paulo, Brazil Recruitment period: February 2009 to March 2010 Funding source: BioHorizons, Birmingham, Alabama donated the grafting material used in this study |
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Participants | Inclusion criteria: systemic health; ≥ 20 teeth in both maxillary and mandibular arches; ≥ 2 hopeless, single‐rooted and non‐adjacent teeth in the maxilla Exclusion criteria: antibiotic therapy in the last 6 months; systemic involvement; smokers; pregnant or lactating patients Age at baseline: mean age 44.0 ± 8.10 years (33 to 58) Gender: M 5/F 13 Smokers: none Teeth extracted: maxillary anterior teeth Number randomised (participants/sites): 18/36 Number evaluated (participants/sites): 18/36 |
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Interventions |
Comparison: ARP (grafting material) versus ARP (grafting material) Test group: (n = 18 extraction sockets) acellular dermal matrix (ADM) (AlloDerm, LifeCell Corporation, The Woodlands, Texas, USA) + anorganic bovine bone matrix (ABM) with synthetic cell‐binding peptide P‐15 (PepGen P‐15, DENTSPLY Friadent CeraMed, Lakewood, Colorado, USA) Control group: (n = 18 extraction sockets) ADM only Surgical technique: flap, primary closure Type of socket: all alveolar sockets had buccal bone defects after extraction Duration of follow‐up: 6 months |
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Outcomes | Width and height of alveolar ridge Method of assessment: periodontal probe, template |
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Notes | Sample size calculation: reported The sample size was calculated with a power of 83%. A total of 18 participants per group was required to detect a difference in bucco‐palatal alveolar ridge of 1.5 mm |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "The sites for the test and control groups were randomly selected by a coin toss" |
Allocation concealment (selection bias) | High risk | The authors replied that no allocation concealment was attempted |
Blinding of outcome assessment (detection bias) All outcomes | High risk | The authors replied that examiners were not blinded |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All data presented |
Selective reporting (reporting bias) | Low risk | All outcomes appear to be reported |
Other bias | Low risk | None detected |