Rullo 2013.
Study characteristics | ||
Methods | Study design: RCT (split‐mouth), procedures 30 days apart Conducted in: Naples, Italy Number of centres: 1 Recruitment period: not stated |
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Participants | Inclusion criteria: (a) the presence in each person of bilateral and symmetrically oriented impacted lower third molars to be extracted for prophylactic reasons; (b) forceps extractions not requiring osteotomy were excluded; (c) no systemic diseases; (d) age > 18 years; (e) non‐smoker; (f) not pregnant; and (g) no allergy to penicillin or other drugs used in the standardised postoperative therapy Exclusion criteria: patients who were taking antibiotics for current infection or who had acute pericoronitis or severe periodontal disease at the time of operation Mean age: 26.2 years, range 18 to 54 years. Male 20, female 32 Number randomised: 52 Number evaluated: 52 |
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Interventions | Piezoelectric bone removal versus bur Group A (n = 52): piezoelectric hand‐piece operating with modulated ultrasound with a functional frequency of 25e29 kHz and a digital modulation of 30 kHz. The inserts moved with a linear vibration of between 60 and 210 mm. Group B (n = 52): osteotomies using a conventional rotating drill were carried out with a Stryker tungsten carbide bur mounted on a surgical high‐speed hand‐piece Procedures subgrouped into "simple extractions" and complex extractions. All procedures performed under local anaesthetic, and drain inserted. All participants received amoxicillin (500 mg 3 times daily for 7 days starting day before surgery), ibuprofen 600 mg 3 times daily for 4 days, and CHX mouthwash. Follow‐up: VAS (0 to 10) for pain completed daily for 6 days |
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Outcomes | Duration of procedure, pain (100‐point VAS), surgical difficulty (Parant scale), histological analysis of bone biopsy samples | |
Notes | Sample size calculation: not reported All procedures performed by the same surgeon. E‐mail sent to authors requesting additional information. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quotes: "...the instruments were randomly selected using a coin toss", "instrument sequence was random" |
Allocation concealment (selection bias) | Unclear risk | Unclear who performed the coin toss and exactly how the first extraction side was chosen |
Blinding (performance bias and detection bias) patient | Unclear risk | Participants and clinicians could not be blinded to allocated treatments. |
Blinding (performance bias and detection bias) assessor | High risk | No blinding of outcome assessment undertaken. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Unclear how many procedures were included in the simple and complex subgroups, for each procedure |
Selective reporting (reporting bias) | High risk | Pain measured and reported. It seems likely that attempts were made to measure swelling and trismus, but these outcomes were not reported because the measures were "not reproducible". |
Other bias | High risk | The outcomes in the graphs and in the tables are contradictory. |