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. 2021 Apr 26;2021(4):CD010176. doi: 10.1002/14651858.CD010176.pub3

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
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
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
Outcomes Width and height of alveolar ridge
Method of assessment: periodontal probe, template
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
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