Hoang 2012.
| Study characteristics | ||
| Methods | Trial design: randomised, parallel‐group trial Location: San Antonio, Texas, USA Number of centres: single centre, University of Texas Health Science Center at San Antonio (UTHSCSA) Recruitment period: November 2008 to May 2010 Funding source: no funding was received for this study |
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| Participants | Inclusion criteria: having 1 molar tooth requiring extraction, followed by replacement with a dental implant; adequate restorative space and height of alveolar bone; extracted teeth were removed as a result of non‐restorability, fracture, periodontal disease, or failed endodontic procedures; teeth with small apical lesions ≤ 3 mm were not excluded if it was determined that the lesion could be adequately debrided after extraction Exclusion criteria: pregnant or planning to become pregnant within the study period; had any medical contraindications to dental surgery or any medical conditions that may affect wound healing after dental surgery, such as autoimmune disorders and immunosuppressive therapy; molar sites, with a buccal bony dehiscence extending > 50% of the length of socket Age at baseline: mean age 56.1 years; range 29 to 76 Gender: M 15/F 15 Smokers: all non‐smokers Teeth extracted: molars Number randomised (participants/sites): 40/40 Number evaluated (participants/sites): 30/30 |
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| Interventions |
Comparison: ARP (grafting materials) versus ARP (grafting materials) Test group: (n = 15 extraction sockets) demineralised bone matrix, single particle size (SPS) between 125 μm and 710 μm in a carrier of bovine collagen and sodium alginate Control group: (n = 15 extraction sockets) demineralised bone matrix, multiple particle size (MPS) between 125 μm and 710 μm in a carrier of bovine collagen and sodium alginate + additional particles measuring approximately 2 to 4 mm in length Surgical technique: flaps were not reflected to obtain primary closure of the wound Type of socket: 4‐wall socket. 4 of the 16 subjects in the SPS group and 3 of the 14 subjects in the MPS group had a small dehiscence in the buccal wall (authors replied) Duration of follow‐up: 6 months (time of implant placement) |
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| Outcomes | Width and height of alveolar ridge Method of assessment: periodontal probe, caliper |
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| Notes | Sample size calculation: reported The sample size was calculated with a power of 88.5% and an alpha level of 0.05. The calculations were based on detecting a clinically significant mean difference of 1 standard deviation or more. A total of 20 participants per group was required based on a dropout rate of 30% |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "Immediately preceding the start of the surgical procedure, an envelope was drawn from a stack of sealed envelopes with the name of either graft material written inside" |
| Allocation concealment (selection bias) | Unclear risk | No information in the article |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Histologic examination was conducted by masked examiners but not clear whether clinical parameters were recorded by masked examiners |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | The study excluded 10 participants. Of which, 9 were non‐compliant with the trial protocol and 1 withdrew from the study at the time of surgery due to large buccal and palatal dehiscence after extracting the tooth Dropouts were equal in both groups |
| Selective reporting (reporting bias) | Low risk | All outcomes appear to be reported |
| Other bias | Low risk | None detected |