Shad 2015.
| Study characteristics | ||
| Methods | Study design: RCT, parallel Conducted in: Lahore, Pakistan |
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| Participants | Inclusion criteria: patients who were clinically and radiographically diagnosed as having impacted mandibular third molar were included in the study Exclusion criteria: patients with medically compromised conditions that affect wound healing, e.g. diabetes mellitus, anaemia, patients on steroid therapy, and unco‐operative patients who were not willing to come for follow‐up Age: 18 to 38 years; mean 25.58 years (SD ± 5.11) Number randomised: 380 participants Number evaluated: 380 participants |
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| Interventions | Reflection and retraction of lingual flap (+ buccal flap) versus no lingual reflection and retraction (buccal flap only) Group A (n = 190): reflection and retraction of lingual flap in addition to buccal flap Group B (n = 190): no lingual flap procedure was performed (buccal flap only) Participants were operated under local anaesthesia through regional block of inferior alveolar, lingual, and buccal nerves. |
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| Outcomes | Sensory disturbance was evaluated on seventh postoperative day. Lingual nerve function was assessed by light touch, pin prick, 2 point discrimination, and taste. Lingual nerve was labelled injured if there was absence of any of the above mentioned sensations. Lingual nerve damage occurred in 8.94% in Group A in which lingual flap retraction was performed but damage was reversible. In Group B, 2.63% lingual nerve damage was observed, and nature of damage was permanent. The difference was statistically significant (P = 0.008). |
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| Notes | Comparison was made with Chi2. P ≤ 0.05 was considered significant. Sample size calculation: not reported |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Comment: blocked randomisation was used |
| Allocation concealment (selection bias) | Unclear risk | Comment: it remains unclear who recruited participants and who carried out the randomisation |
| Blinding (performance bias and detection bias) patient | Unclear risk | Comment: the procedure was explained to the participant, but the details of what was explained are unclear |
| Blinding (performance bias and detection bias) assessor | Unclear risk | Comment: it is unclear whether the person measuring the outcomes was different to the surgeons |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: all outcome data for all participants were reported |
| Selective reporting (reporting bias) | Low risk | Comment: all intended outcomes were reported |
| Other bias | Low risk | Comment: no other sources of bias were identified |