Gargallo‐Albiol 2000.
Study characteristics | ||
Methods | Study design: RCT (parallel group) Conducted in: Department of Oral Surgery, Odontology, University of Barcelona, Spain |
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Participants | Inclusion criteria: 300 consecutive patients who needed 1 lower impacted wisdom tooth extracted Exclusion criteria: if the tooth did not need to be sectioned during the procedure, then it was excluded from the study Age: mean 27.4 years Number randomised: 300 Number evaluated: 300 |
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Interventions | Lingual nerve protection (subperiosteal retractor) versus none Group A (n = 142): lower third molar removed with subperiosteal insertion of retractor for lingual nerve protection Group B (n = 158): lower third molar removed without lingual nerve protection All molars removed under local anaesthetic. Follow‐up: days 7, 21, and 60 |
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Outcomes | Verbal self‐assessment and mechanosensory testing of lingual nerve function | |
Notes | Sample size calculation: not reported The author notes that the low incidence of sensory disturbance in this study may be related to the fact that the procedures were performed under local anaesthetic. Previous studies may indicate that procedures performed under general anaesthetic are associated with higher levels of sensory disturbances, but as the author rightly points out: "the choice of general anaesthesia [...] may also be related to the degree of difficulty when removing the third molar". Baseline comparability: information about the comparability of the groups at baseline not reported Letter sent to author who replied that no additional data were available. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "...patients were strictly randomised" Comment: method of sequence generation not stated |
Allocation concealment (selection bias) | Unclear risk | Not mentioned |
Blinding (performance bias and detection bias) patient | Unclear risk | Participant blinding is not mentioned, but it is likely that participants were aware of whether or not a retractor was used. |
Blinding (performance bias and detection bias) assessor | High risk | Quote: "...lingual nerve function was tested at one week [...] and was carried out by the same surgeon who performed the procedure" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No withdrawals mentioned, results reported as percentage and appear to include all randomised participants. This was confirmed by correspondence with author. |
Selective reporting (reporting bias) | Low risk | All prespecified outcomes reported on. |
Other bias | Low risk | No other sources of bias identified. |