Pasqualini 2005.
Study characteristics | ||
Methods | Study design: parallel‐group RCT Conducted in: Italy Number of centres: 1 Recruitment period: not stated |
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Participants | Inclusion criteria: totally or partially bone‐impacted mandibular third molar with mesial inclination between 25 and 30°, no systemic disease, good general health, age less than 30 years, non‐smoker, no inflammation of the oral cavity, co‐operation with the study and with postoperative follow‐up, and no contraindication to anaesthetics or study drugs Number randomised: 200 Number evaluated: 200 |
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Interventions | Primary versus secondary wound closure Group A (n = 100): primary wound closure; "flap repositioned and sutured hermetically" Group B (n = 100): secondary wound closure; "a sedge of mucosa 5‐6 mm was removed from second molar and flap was repositioned and sutured" All procedures performed under local anaesthesia. All participants also received antibiotics (amoxicillin 2 g/day for 5 days and nimesulide 200 mg/day for 3 days) |
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Outcomes | Pain and swelling on 0‐to‐4 VAS daily for 7 days | |
Notes | Sample size calculation: not reported E‐mail sent to Dr Pasqualini (damianox@mac.com) who provided additional information on the methods of this trial 6 March 2012. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quotes: "...randomly divided"; "Randomization was performed using a computer generated random numbers sequence created by an independent research office" (e‐mail from author) |
Allocation concealment (selection bias) | Low risk | Quote: "Allocations were kept in sealed serially numbered opaque envelopes which were opened in sequence and showed to the surgeon at the moment of surgical closure, with at least one independent witness present (generally a nurse)" (e‐mail from author) |
Blinding (performance bias and detection bias) patient | Low risk | The participants were not aware of the type of closure (e‐mail from author). |
Blinding (performance bias and detection bias) assessor | Unclear risk | Quote: "The examiner who assessed the postoperative outcome at 7 and 30 days was not aware of the allocation. However they could have presumed it by looking at the residual wound" (e‐mail from author) |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All randomised participants included in the outcome evaluation. |
Selective reporting (reporting bias) | Low risk | Pain, swelling, and infection reported as planned. |
Other bias | Low risk | Author confirmed that no wound dressings were used in either group. |