Iorio‐Siciliano 2020.
Study characteristics | ||
Methods | Trial design: randomised, parallel‐group trial Location: Naples, Italy Number of centres: single centre, University of Naples Federico II, Naples, Italy Recruitment period: not stated Funding source: self‐funded |
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Participants | Inclusion criteria: patients aged ≥ 18 years, required extraction of maxillary or mandibular posterior single‐ or multi‐rooted tooth and committed to replacement with dental implant after 6 months; full mouth plaque and bleeding scores of less than 25%; presence of at least 2 mm of keratinized tissue; sound socket walls, signed consent form Exclusion criteria: any medical condition that contraindicate surgery; pregnant or lactating women; smoking; periodontally compromised; acute abscess, third molars Age at baseline: 38.9 ± 10.1 (test group A); 43.6 ± 14.2 (test group B); 38.4 ± 13.2 (control group) years Gender: M 22/F 18 Smokers: 0 Teeth extracted: single‐ and multi‐rooted posterior teeth Number randomised (participants/sites): 45/45 Number evaluated (participants/sites): 40/40 |
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Interventions |
Comparison: ARP (grafting material) versus ARP (grafting material) versus extraction alone Test group A: (n = 12 extraction sockets) bovine‐derived xenograft with 10% collagen (Bio‐Oss Collagen, Geistlich Biomaterials, Wolhusen, Switzerland) + resorbable collagen membrane (Bio‐Gide, Geistlich, Biomaterials, Wolhusen, Switzerland) Test group B: (n = 13 extraction sockets) bovine‐derived xenograft (Bio‐Oss, Geistlich Biomaterials, Wolhusen, Switzerland) + resorbable collagen membrane (Bio‐Gide, Geistlich, Biomaterials, Wolhusen, Switzerland) Control group: (n = 15 extraction sockets) extraction alone Surgical technique: flap, no primary closure Type of socket: 4‐wall socket Duration of follow‐up: 6 months |
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Outcomes | Width and height of alveolar ridge, thickness of buccal wall Method of assessment: periodontal probe, caliper |
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Notes | Sample size calculation: reported The sample size was calculated with a power of 80% and an alpha level of 0.05. The calculations were based on previous literature and assumed mean horizontal bone difference of 17.3 ± 16.4% between test and control groups. A total of 15 participants per group was required based on possible dropouts |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Randomization procedure was performed by single examiner using a commercially available computer software package" |
Allocation concealment (selection bias) | Low risk | Quote: "Allocation was performed after tooth or root extraction by opening an opaque envelope" |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Quote: "The principal investigator and co‐investigators were not masked" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Number and reasons for withdrawals were reported. It does not seem that the lost data had affected the results. 5 dropouts were recorded; 2 participants had medical reasons, 1 was pregnant, 1 moved to another town, and 1 was not compliant with the research protocol |
Selective reporting (reporting bias) | Low risk | All outcomes appear to be reported |
Other bias | Low risk | None detected |