Gulsen 2017.
Study characteristics | ||
Methods | Study design: split‐mouth RCT Conducted in: Turkey |
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Participants | Inclusion criteria: fit study requirements including follow‐ups and informed consent; healthy without significant medical diseases or a history of bleeding problems; symmetrical impacted third molars with same level of surgical difficulty, requiring the same surgical technique to be performed; third molars in Class I, Level B position (according to Pell and Gregory) and in vertical positions according to Winter. Exclusion criteria: pregnant and lactating women; signs of pericoronitis; chronic use of medications such as antihistamines, non‐steroidal anti‐inflammatory drugs, steroids, and antidepressants, which would complicate the evaluation of their postoperative response. Age: between 17 to 27 years Number randomised: 30 participants/60 teeth |
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Interventions | PRF versus none Intervention group (n = 30): on the intervention side, the socket was filled with 3 pieces of PRF membrane, and the flap was primarily closed with 3–0 silk sutures Control group (n = 30): none |
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Outcomes | Facial swelling was determined by measuring distances from gonion ‐ commissura labiorum, tragus – commissura labiorum and tragus – lateral canthus. Pain evaluated with a VAS, with endpoints of 0 (no pain) to 100 (worst pain). |
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Notes | Infection was noted in 3 participants who did not have PRF. Sample size calculation: not reported Infection was not stated as an intended outcome, but was reported (infection not defined in the paper). |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "study sides and control sides randomly selected" Comment: method of randomisation not described |
Allocation concealment (selection bias) | Unclear risk | Comment: concealment methods not described. It is not mentioned how the side of the intervention was selected and whether it was concealed or not. |
Blinding (performance bias and detection bias) patient | Unclear risk | Comment: participants were informed of the nature of the surgical and experimental procedures. The side in which the PRF was inserted into may have been known to the participant, but this is unclear. |
Blinding (performance bias and detection bias) assessor | Unclear risk | Quote: "For standardization all measurements were performed by the same surgeon (UG)." Comment: measurements were all done by the same surgeon (UG), but it is not described if "UG" was also the operating surgeon |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No dropouts reported. |
Selective reporting (reporting bias) | Low risk | All planned outcomes were reported, and infection incidence was also reported, although not as a primary outcome variable. |
Other bias | High risk | Quote: "Bilateral removal of the third molar was performed in a single appointment. For the study side, the sockets were filled with PRF, whereas for the control side, the sockets were left empty." Comment: in this split‐mouth study, both procedures were carried out at the same time. This may have affected the participant perception of pain. |