Kumar 2016.
Study characteristics | ||
Methods | Study design: split‐mouth RCT Conducted in: India |
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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 |
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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 |
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Outcomes | Pain scale: no pain‐slight pain‐mild‐severe‐very severe Swelling: mean of horizontal and vertical measurements Maximum interincisal opening in millimetres |
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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. |