Gogulanathan 2015.
Study characteristics | ||
Methods | Study design: RCT split‐mouth method Conducted in: India |
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Participants | Inclusion criteria: over 18 years of age; ASA 1 (American Society of Anesthesiology) patient with no systemic diseases or conditions; patient requiring surgical removal of bilaterally impacted mandibular third molars; bilateral impactions with a relatively similar classification and degree of difficulty, based on the Pell and Gregory system; patient agreement to the surgical procedure and clinical trial, providing informed consent Exclusion criteria: presence of systemic diseases; presence of bleeding disorders; patients on antiplatelet or anticoagulant therapy; pregnant or nursing mothers; patients with a known history of allergy to lidocaine; patient not consenting to the procedure or study Number randomised: 30 participants/60 teeth Number evaluated: 30 participants |
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Interventions | Fibrin sealant versus conventional suturing using 3–0 black silk Group A (n = 30): fibrin sealant Group B (n = 30): primary closure by suturing Using a split‐mouth study design, wound closure following extraction was done using fibrin sealant on the study side and primary closure suturing on the control side. Procedure was carried out under local anaesthetic. |
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Outcomes | Primary outcome measures were (1) the time taken to achieve wound closure and haemostasis and (2) postoperative mouth opening, pain, and swelling. | |
Notes | As this was a split‐mouth study, the paired t‐test was used to compare the mean values between the control and experimental groups. The paired t‐test was also applied for comparisons between time points. The level of significance was fixed as a = 0.05 (2‐ tailed). IBM SPSS Statistics for Windows, version 20.0 (IBM Corp, Armonk, NY, USA) was used for the data analysis. 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 | Quote: "The patient pool was sequentially numbered 1–30. Lots were drawn, one for each patient, from sealed envelopes that contained combinations of the agent (fibrin sealant/suturing) and the side to be operated (right/left)" Comment: sequentially numbered, sealed envelopes were used |
Allocation concealment (selection bias) | Low risk | Comment: sealed envelopes were used |
Blinding (performance bias and detection bias) patient | Unclear risk | Comment: it is unclear if participants were blinded to the procedure. This is not stated specifically; it is possible the participant would be aware of the presence (or absence) of sutures in mouth. |
Blinding (performance bias and detection bias) assessor | Unclear risk | Comment: unclear if the assessor was different to the operating surgeon |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "no patients discontinued the trial or were lost to follow‐up" Comment: all participants were analysed |
Selective reporting (reporting bias) | Low risk | All planned outcomes were reported. |
Other bias | Unclear risk | This was a cross‐over trial. The order of the receiving of treatments was randomised. There is potential bias from a carry‐over effect; carry‐over effect was not evaluated. |