Scheyer 2016.
| Study characteristics | ||
| Methods | Trial design: randomised, parallel‐group trial Location: USA and Germany Number of centres: multicentre, private practices (Texas, Washington, Illinois, Massachusetts, California, Virginia, Michigan, USA), University of Washington (USA), University of Illinois (USA), Harvard School of Dental Medicine (USA), Virginia Commonwealth School of Dentistry (USA), University of Michigan (USA), University of Freiburg (Germany) Recruitment period: November 2013 to February 2015 Funding source: this study was partly supported by a grant from Geistlich Pharma AG |
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| Participants | Inclusion criteria: patients required extraction of premolar or molar tooth and committed to replacement with dental implant after 6 months; presence of neighbouring teeth; presence of buccal bone dehiscence of at least 1/3 of the socket height and width; signed an informed consent form Exclusion criteria: any systemic disease that may affect healing; use of immunosuppressive, systemic corticosteroids, intramuscular or intravenous bisphosphonates; radiotherapy or chemotherapy in the last 2 months; known allergy to materials used in this study; pregnant, lactating women or those intending to become pregnant; smoking in the last 6 months Age at baseline: range 18 to 70 years Gender: not mentioned Smokers: 0 Teeth extracted: premolar and molar teeth Number randomised (participants/sites): 40/40 Number evaluated (participants/sites): 40/40 |
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| Interventions |
Comparison: ARP (grafting material) versus ARP (grafting material) Test group A: (n = 21 extraction sockets) demineralised allograft (OraGraft DGC, LifeNet Health Inc, Virginia Beach, Virginia, USA) + cross‐linked bovine collagen membrane (BioMend Extend, Zimmer Dental Inc, Carlsbad, California, USA) Test group B: (n = 19 extraction sockets) deproteinised bovine bone mineral (DBBM) with 10% porcine collagen (Bio‐Oss Collagen, Geistlich Pharma AG, Wolhusen, Switzerland) + collagen barrier (Bio‐Gide, Geistlich Pharma AG, Wolhusen, Switzerland) Surgical technique: flap, no primary closure Type of socket: 3‐wall socket Duration of follow‐up: 6 months |
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| Outcomes | Width and height of alveolar ridge, soft tissue inflammation, histomorphometric analysis Method of assessment: periodontal probe, template |
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| Notes | Sample size calculation: reported The sample size was calculated using statistical software to assess non‐inferiority hypothesis. A total of 20 participants per group was required to account for possible dropouts |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "Subjects were randomly assigned to either the control or test therapy in a block 1:1 ratio" |
| Allocation concealment (selection bias) | Unclear risk | No information in the article |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information in the article |
| 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 |