Barone 2010.
Study characteristics | ||
Methods | Study design: RCT (parallel group) Conducted in: Versilia Hospital, Lido di Camaiore, Italy |
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Participants | Inclusion criteria: people referred for lower third molar extraction at Versilia Hospital who were systemically healthy Exclusion criteria: people with a history of systemic diseases that would contraindicate surgery, pregnant and lactating women, people in whom there was no need to raise the mucoperiosteal flap to remove the third molar, and people who smoked more than 10 cigarettes per day Age: mean 31.2 years Number randomised: 26 Number evaluated: 26 |
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Interventions | Ultrasound versus rotary instruments for bone removal Group A (n = 13): surgical removal of lower third molar using ultrasonic bone surgery under local anaesthesia Group B (n = 13): surgical removal of lower third molar using traditional rotary instruments under local anaesthesia (Rotary instruments were used for sectioning of teeth where necessary.) All procedures performed under local anaesthetic. Follow‐up: at days 1, 3, 5, and 7 |
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Outcomes | Surgical time (start of first incision to last suture) Pain (0‐to‐10 VAS) at days 1, 3, 5, and 7 Trismus (interincisal distance measured using callipers) at days 1, 3, 5, and 7 Cheek swelling (measured with a standard calliper from the lingual aspect of the midportion of the crown of the first mandibular molar to the tangent of the cheek's skin) at days 1, 3, 5, and 7 |
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Notes | Sample size calculation: not reported At baseline (parallel groups only) groups were comparable with regard to type of impaction. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "An independent evaluator allocated the patients into the test and control groups according to a computer‐generated randomisation list" |
Allocation concealment (selection bias) | Low risk | Allocation was performed by an independent evaluator. |
Blinding (performance bias and detection bias) patient | Unclear risk | All surgery performed on participants under local anaesthetic only, therefore blinding not possible |
Blinding (performance bias and detection bias) assessor | Unclear risk | Unclear who carried out the postoperative assessments |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All randomised participants evaluated. |
Selective reporting (reporting bias) | Low risk | Pain, swelling, trismus, analgesic consumption planned and recorded. |
Other bias | Low risk | Groups appeared to be similar at baseline. |