Sandhu 2010.
Study characteristics | ||
Methods | Study design: split‐mouth cross‐over RCT Conducted in: India Number of centres: 1 Recruitment period: not stated |
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Participants | Inclusion criteria: patients requiring extraction of bilateral impacted third molars, with no history of medical illness or medication use that could influence wound healing, healthy dental and periodontal status at the time of surgery. Attempt was made to include those with teeth of comparable position and expected difficulty during extraction. Exclusion criteria: not explicitly stated Age: mean 25 years Number randomised: 20 (40 teeth) Number evaluated: 20 |
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Interventions | Bayonet flap versus envelope flap Group A (n = 20): bayonet flap raised Group B (n = 20): envelope flap raised Minimum of 1 month between procedures All procedures performed under local anaesthetic. All participants given prophylactic intravenous amoxicillin/clavulanic acid, ibuprofen tablet, and CHX mouth rinse prior to surgery, and ibuprofen and CHX mouth rinses in the postoperative period. |
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Outcomes | Pain (0‐to‐10 VAS), facial swelling, trismus, wound dehiscence evaluated on days 1, 3, 7, 14, and 30 | |
Notes | Sample size calculation: not reported E‐mail sent 26 March 2012 requesting further information. Reply received 31 March 2012 with unpublished data. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quotes: "...randomized by systematic allocation"; "Both the type of flap used and the side operated were randomized by tossing a coin which was carried out by the surgeon, and communicated to the evaluator after the surgical procedure for recording" (e‐mail communication) |
Allocation concealment (selection bias) | High risk | Coin toss done by operating surgeon (e‐mail communication). |
Blinding (performance bias and detection bias) patient | Low risk | Quote: "...both patients and evaluator were blinded to the flap groups" |
Blinding (performance bias and detection bias) assessor | Low risk | Quote: "...both patients and evaluator were blinded to the flap groups" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All randomised participants included in the outcome evaluations. |
Selective reporting (reporting bias) | Low risk | All planned outcomes reported. |
Other bias | Low risk | No other sources of bias identified. |