Skip to main content
. 2020 Jul 26;2020(7):CD004345. doi: 10.1002/14651858.CD004345.pub3

Koyuncu 2013.

Study characteristics
Methods Study design: a randomised single‐blind clinical trial, parallel
Conducted in: Turkey
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
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)
  • pain (0‐to‐10 VAS), daily for 7 days

  • swelling (subjective and objective measurements). Subjective assessment was made of swelling on the second and seventh days after extraction, based on a 4‐point scale: 1 no swelling; 2 mild swelling; 3 moderate swelling; and 4 severe swelling. Objective measurement: 2 distances were measured by a modification of a tape‐measuring method on the second and seventh days after extraction. These 2 measurements were made between 3 reference points: tragus, pogonion, and the corner of the mouth. The preoperative sum of the 2 measurements was considered to be the baseline.

  • trismus: maximum mouth opening was measured before surgery and again on the second and seventh days after extraction

Notes This study was mentioned in the previous review update, but was not published at that time.
Sample size calculation: not reported
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.