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

Kumar 2016.

Study characteristics
Methods Study design: split‐mouth RCT
Conducted in: India
Participants Inclusion criteria: systemically healthy people between 18 to 50 years with bilaterally completely impacted mandibular third molars indicated for surgical removal
Exclusion criteria: medical conditions that can complicate surgical extraction, obesity (body mass index ≥ 30 kg/m2), current smokers, pregnant or lactating females, those taking oral contraceptive drugs, and those under any antibiotic coverage
Age: 18 to 50 years
Participants: 30 participants/60 teeth
Interventions Tube drainage versus no tube
Control group (n = 30): primary closure was accomplished using 3‐0 silk suture
Experimental group (n = 30): tube drain was sutured by a circumferential suture tethered with the buccal flap through the releasing incision
Outcomes Pain scale: no pain‐slight pain‐mild‐severe‐very severe
Swelling: mean of horizontal and vertical measurements
Maximum interincisal opening in millimetres
Notes Sample size calculation: reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "left and right mandibular quadrants of each individual were randomly allocated by means of a tossing coin into two groups, test (with tube drain, n=30) and control (without tube drain, n=30)"
Comment: a coin‐tossing technique was used
Allocation concealment (selection bias) Unclear risk Comment: no concealment methods described
Blinding (performance bias and detection bias)
patient Unclear risk Quote: "The eligible individuals were informed of the nature, possible risks, and benefits of their participation in the study and a written informed consent was obtained from each participant."
Comment: it is unclear how much detail was given to participants, but it is likely that they would know which side a tube drain was placed as it was in situ for 3 days
Blinding (performance bias and detection bias)
assessor Unclear risk Comment: blinding of the assessor not mentioned
Incomplete outcome data (attrition bias)
All outcomes Low risk Comment: no dropouts mentioned
Selective reporting (reporting bias) Low risk Comment: planned outcomes reported
Other bias Unclear risk Quote: "Following the complete resolution of post‐operative sequelae the second surgical procedure of other side with tube drain was carried out in the same patient."
Comment: wash‐out period not specified. Any potential carry‐over effect was not analysed.