Sweet 1976.
Study characteristics | ||
Methods | Study design: RCT (split‐mouth) Conducted in: United States Public Health Service Hospital, New York, USA |
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Participants | Inclusion criteria: male patients from 17 to 27 years of age, who were in good health, and who required bilateral, similarly impacted wisdom teeth extracted. Medical health was ascertained by a "complete physical examination by a physician, normal hospital screening tests, a resident's admission examination, and a complete medical history". In addition, "only patients with soft‐tissue or osseous‐tissue impactions which were asymptomatic were accepted for the study". Exclusion criteria: "patients with a preoperative infection or pericoronitis were eliminated from the study" Number of participants randomised: 103 men, 206 teeth Number of participants evaluated: 99; no withdrawals, but 4 patients with infection excluded from other outcome assessments |
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Interventions | Mechanical irrigation versus manual irrigation Group A (n = 103 teeth): postextraction mechanical lavage (350 mL sterile saline) Group B (n = 103 teeth): conventional manual syringe lavage (350 mL sterile saline) Procedures performed under general anaesthetic, both teeth extracted in same session by same surgeon. Follow‐up: days 3 and 5 |
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Outcomes | Alveolar osteitis, infection, pain (4‐point scale), swelling (4‐point scale) | |
Notes | Sample size calculation: not reported 4 participants who presented with alveolar osteitis or infection were excluded from other outcome assessments. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "The type of irrigation [...] was predetermined by random selection technique, with the use of random sampling numbers, before the study was begun" |
Allocation concealment (selection bias) | Unclear risk | Not mentioned |
Blinding (performance bias and detection bias) patient | Low risk | Blinding not mentioned, but it is likely that participants were unaware of lavage volume as they were sedated with pentobarbital. |
Blinding (performance bias and detection bias) assessor | Low risk | Quotes: "These examinations were made by a dental surgeon who was not involved with the operation"; "the surgical sites were observed by a dental surgeon who was not involved with the operation, and who was unaware of the irrigation methods used" Comment: assessor blinding successful |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No withdrawals, but 4 participants who had infections were excluded from wound healing outcome. However, in a split‐mouth study this is unlikely to have introduced bias. Quote: "once a patient was treated, he was then counted in the 'treated group', and was not evaluated for any healing results at the 3‐ or 5‐day levels" |
Selective reporting (reporting bias) | Low risk | All planned outcomes reported. |
Other bias | Low risk | No other sources of bias identified. |