Piersanti 2014.
| Study characteristics | ||
| Methods | Study design: randomised clinical trial (split‐mouth, unblinded) Conducted in: Italy |
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| Participants | Inclusion criteria: had to be 18 to 25 years of age and require removal of the impacted lower third molars with a mucoperiosteal flap and osteoplasty; these 2 teeth in the same patient had to have the same difficulty extraction score, according to the Yuasa Scale Exclusion criteria: teeth affected by acute infections, such as pericoronitis, an acute alveolar abscess, or oral submucous fibrosis at the time of surgery Age: 22.4 ± 2.3 years Number randomised: 10 (6 female, 4 male) Number evaluated: 10 (20 teeth) |
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| Interventions | Compare the discomfort and surgical outcomes of a piezosurgery device versus rotatory instruments Group A (n = 10): piezosurgery device Group B (n = 10): rotatory instruments |
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| Outcomes | The primary outcome was a postoperative symptom severity scale known as PoSSe (0 to 100) 1 week after surgery. The scale consists of 7 subscales that investigate the patient’s ability to enjoy food; speak properly; perceive altered sensations, appearance, pain, and sickness; and interference with daily activities. Secondary outcomes included pain (VAS 0 to 10), trismus, and swelling. These variables were evaluated at baseline and 7 days postoperatively. |
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| Notes | Sample size calculation: not reported | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "Patients were randomly allocated to have the third molar removed with a conventional rotating handpiece or a piezosurgery unit" Comment: the method of randomisation is not described |
| Allocation concealment (selection bias) | Unclear risk | Comment: concealment approaches were not described |
| Blinding (performance bias and detection bias) patient | Unclear risk | Quote: "All patients were informed about the procedures, postoperative recovery times, and possible complications and signed a detailed consent form." Comment: it is unclear if the participant knew which side was the test side and which was the control |
| Blinding (performance bias and detection bias) assessor | High risk | Comment: it is unclear who the assessor was. It is mentioned that the trial was unblinded, but no further information is given. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: all participants completed the study |
| Selective reporting (reporting bias) | Low risk | Comment: all planned outcomes were reported |
| Other bias | Unclear risk | Comment: the carry‐over effect was not evaluated |