Haraji 2010.
Study characteristics | ||
Methods | Study design: split‐mouth RCT Conducted in: Iran Number of centres: 1 Recruitment period: not stated |
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Participants | Inclusion criteria: patients with bilaterally impacted third molars with similar difficulty index Exclusion criteria: pre‐existing medical conditions, oral contraceptive use, systemic or neurological conditions, pregnancy, pericoronitis or pathological conditions associated with third molars Age: mean 19.94 ± 1.5 years Number randomised: 17 Number evaluated: unclear |
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Interventions | Buccal envelope versus modified triangular flap Group A (n = 17): buccal envelope flap Group B (n = 17): modified triangular flap All participants received local anaesthetic, oral cefalexin 500 mg 6 hourly for 5 days, and 500 mg acetaminophen codeine postoperatively. |
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Outcomes | Alveolar osteitis and "healing scores" | |
Notes | Sample size calculation: not reported E‐mail sent to Dr.a.Haraji@Dentaliau.ir on 12 March 2012 requesting further information. No reply received. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "allocated randomly" Comment: method of sequence generation not described |
Allocation concealment (selection bias) | Unclear risk | Not mentioned |
Blinding (performance bias and detection bias) patient | Low risk | Double‐blinded |
Blinding (performance bias and detection bias) assessor | Low risk | Double‐blinded. Paper does not state who conducted outcome assessment. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Outcomes reported as percentage only with no indication of how many participants were evaluated. |
Selective reporting (reporting bias) | High risk | Alveolar osteitis reported as percentage in each group and P value, no indication if paired data taken into account in analysis. Suggestion that a number of participants had bilateral osteitis. Pain and healing not reported. |
Other bias | Unclear risk | 41.7% control group rate of alveolar osteitis is very high, and it seems unlikely that a different flap design would have been solely responsible for the lower rate in the intervention group. Co‐intervention or aseptic conditions for surgery |