Osunde 2012.
Study characteristics | ||
Methods | Study design: parallel‐group RCT Conducted in: Benin City, Nigeria Number of centres: 1 (Aminu Kano Teaching Hospital) Recruitment period: not stated |
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Participants | Inclusion criteria: patients aged 18 to 38 years with mesioangular, distoangular, horizontal, and vertical impactions with a difficulty index of 3‐8 according to Peterson's criteria. No symptoms of pain, facial swelling, or trismus in 10 days preceding surgery, non‐smokers, no concomitant medications or systemic diseases that could interfere with healing Exclusion criteria: pregnant or lactating females, patients with more than 1 third molar requiring treatment Number of participants randomised: 80 Number of participants evaluated: 80 |
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Interventions | No sutures versus multiple sutures for wound closure Group A (n = 40): no sutures Group B (n = 40): multiple sutures using 3/0 silk, placed at the interdental papilla immediately distil to the second molar, the buccal relieving incision, and the distil relieving incision Follow‐up: 7 days All procedures were carried out by the same surgeon and assistant under local anaesthetic. |
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Outcomes | Pain (0‐to‐10‐centimetre VAS), trismus, swelling, on days 1, 2, and 7 | |
Notes | Sample size calculation: not reported E‐mail sent to otdany@yahoo.co.uk on 12 March 2012 requesting additional information on randomisation and participants. No reply received. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "Consecutively randomised into two treatment groups" Comment: method of sequence generation not described |
Allocation concealment (selection bias) | Unclear risk | No mention of who conducted the random allocation and whether it was concealed from the surgeon |
Blinding (performance bias and detection bias) patient | Unclear risk | Not possible |
Blinding (performance bias and detection bias) assessor | Low risk | Quote: "...the patients were evaluated in a blinded manner by the same independent observer" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All randomised participants were included in the outcome assessment. |
Selective reporting (reporting bias) | Low risk | Planned outcomes reported in full. |
Other bias | Low risk | No other sources of bias identified. |