Briguglio 2011.
Study characteristics | ||
Methods | Study design: parallel‐group RCT Conducted in: Brazil (but researchers based in Italy) |
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Participants | Inclusion criteria: patients between the ages of 18 and 41 requiring extraction of mandibular third molars. Those with moderate impaction mesio‐angularly with a tilt degree more than 25° in relation to the second molar. Only impacted third molars with distil periodontal defects at the second molar with PPD ≥ 7 mm and CAL ≥ 6 mm were selected. Exclusion criteria: systemic disease, pregnancy, smoking, and medication (unspecified) Age: 18 to 45 years Number randomised: 45 Number evaluated: 45 |
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Interventions | Laskin triangular flap versus Thibault and Parant modified envelope flap versus Laskin envelope flap Group A (n = 15): Laskin triangular flap Group B (n = 15): Thibault and Parant modified envelope flap Group C (n = 15): Laskin envelope flap All participants had a preoperative dental hygiene check, and procedures were performed under local anaesthetic. All participants given 1 g amoxicillin + sulbactam preoperation, and all used CHX mouthwash pre‐ and postoperation. |
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Outcomes | Short‐term complications (pain swelling and infection) and PPD and CAL at 3, 6, 12, and 24 months | |
Notes | Sample size calculation: not reported Gaetano Isola provided additional data on short‐term complications by e‐mail 7 March 2012. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Comment: whilst the technique used in each case was randomly selected, the authors do not specify any further details on this allocation process |
Allocation concealment (selection bias) | Unclear risk | Comment: no details of the allocation concealment provided |
Blinding (performance bias and detection bias) patient | Unclear risk | Quote: "A clot of PRF, which was produced in a 10 ml tube, was enough to fill the socket of each patient." Comment: it is unclear if all participants had blood samples taken, or whether samples were only taken from participants in the PRF group. This could be a source of bias. |
Blinding (performance bias and detection bias) assessor | Low risk | Quote: "all measurements were assessed by the same person (not the operating surgeon)" Comment: the assessor was blind to the allocations |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: all randomised participants were included until the end of the study |
Selective reporting (reporting bias) | Low risk | All planned outcomes were reported on. |
Other bias | High risk | Comment: some participants had unilateral extractions, whilst others had bilateral extractions. This could have influenced outcomes such as pain perception and trismus. |