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. 2020 Jul 26;2020(7):CD004345. doi: 10.1002/14651858.CD004345.pub3

Sandhu 2010.

Study characteristics
Methods Study design: split‐mouth cross‐over RCT
Conducted in: India
Number of centres: 1
Recruitment period: not stated
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
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.
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 Reply received 31 March 2012 with unpublished data.
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.