Madan 2014.
Study characteristics | ||
Methods | Trial design: randomised, split‐mouth trial Location: Uttar Pradesh, India Number of centres: single centre, Saraswati Dental College and Hospital, Lucknow, Uttar Pradesh, India Recruitment period: not stated Funding source: self‐funded |
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Participants | Inclusion criteria: patients required extraction of non‐molar tooth and committed to replacement with dental implant after 6 months; systemically healthy, compliant Exclusion criteria: systemic disease; radiographic bone height of < 7 mm at the site intended for surgery Age at baseline: range 20 to 45 years Gender: M 7/ F8 Smokers: 0 Teeth extracted: non‐molar teeth Number randomised (participants/sites): 15/60 Number evaluated (participants/sites): 15/60 |
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Interventions |
Comparison: ARP (grafting material) versus extraction alone Test group: (n = 30 extraction sockets) resorbable polylactide and polyglycolide (PLA‐PGA) sponge (Fisiograft, Ghimas SpA, Italy) Control group: (n = 30 extraction sockets) extraction alone Surgical technique: flapless, 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, histologic analyses Method of assessment: periodontal probe, computed tomography, template |
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Notes | Sample size calculation: not reported | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Extraction sockets were randomly allocated for test and control groups by the toss of a coin into equal numbers" |
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 |