Koyuncu 2013.
Study characteristics | ||
Methods | Study design: a randomised single‐blind clinical trial, parallel Conducted in: Turkey |
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Participants | Inclusion criteria: patients with no history of medical illness or medication that could influence the course of postoperative wound healing or alter their wound healing after surgery were selected Exclusion criteria: patients were excluded from randomisation if they had a pre‐existing abscess or cellulitis, acute pericoronitis, or pre‐existing conditions associated with their third molars. Those who required antibiotics for some other reason (such as prophylaxis for endocarditis) were also excluded, as were those who had been given radiotherapy. Immunocompromised patients, pregnant women, those already taking antimicrobials, and those with systemic diseases, such as diabetes, cancer, or renal failure, were excluded. Age: 18 to 29 Number randomised: 80 Number evaluated: 80 |
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Interventions | Envelope flap type versus modified triangular flap type Group A (40 participants): envelope flap type Group B (40 participants): modified triangular flap type All operations were done under local anaesthesia (inferior alveolar block, 2 mL 2% lidocaine with 1:80,000 epinephrine). A primary wound closure was carried out in all cases. All participants were given amoxicillin (500 mg/8 h) for 7 days and diclofenac potassium (50 mg/12 h) for pain after surgery. Postoperative instructions for the participants included soft diet and oral hygiene with 0.2% chlorhexidine mouth rinse. Sutures were removed 7 days after surgery. | |
Outcomes | Primary outcome: any postoperative complication; alveolar osteitis classified as present or absent Secondary outcomes: postoperative side effects (including pain, swelling, and trismus assessed during the postoperative time periods)
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Notes | This study was mentioned in the previous review update, but was not published at that time. Sample size calculation: not reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "investigators designed and implemented a randomized single‐blind clinical trial. The flap design was randomly assigned for each patient" Comment: unclear how the participants were recruited and randomised |
Allocation concealment (selection bias) | Unclear risk | Comment: concealment approaches were not described |
Blinding (performance bias and detection bias) patient | Low risk | Comment: unclear as it was not described. However, it is unlikely that the participant would have known which flap they had unless they were explicitly told. |
Blinding (performance bias and detection bias) assessor | Low risk | Quote: "The surgeon that had operated on the patients was never involved in the preoperative or postoperative assessment" Comment: assessor blinding was appropriate |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: outcomes were reported for all participants (n = 80). 100 participants were initially recruited; the reason for the final number (80) was explained appropriately (they did not meet the inclusion criteria). |
Selective reporting (reporting bias) | Low risk | All intended outcomes were reported. |
Other bias | Low risk | No other sources of bias identified. |