Şimşek Kaya 2019.
Study characteristics | ||
Methods | Study design: split‐mouth RCT Conducted in: Turkey |
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Participants | Inclusion criteria: patients for surgical removal of bilaterally impacted mandibular third molars (with the ability to understand verbal and written instructions) were included in study. Additional inclusion criteria were American Society of Anesthesiologists (ASA) physical status class I (indicating a normally healthy patient), no medication use, asymptomatic bilateral symmetrically impacted mandibular third molars with mesioangular (Winter classification) 18 class II B impaction (Pell and Gregory classification) 19 and healthy dental and periodontal status with no local inflammation or pathology at the time of surgery. Exclusion criteria: patients with allergies or contraindications to the anaesthetics employed, with local inflammation or pathology in the oral cavity, with poor oral hygiene, ASA > 1, pregnant or lactating women, or women regularly using oral contraceptives were excluded Age: 18 to 40 years Number randomised: 30 Number evaluated: 30 |
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Interventions | Envelope flap versus modified triangular flap techniques Group A: modified triangular flap techniques Group B: envelope flap A minimum of 1 month was allowed to elapse between the 2 procedures. In the postoperative period, amoxicillin (1000 mg, 2 x 1/day), ibuprofen (400 mg, 3 × 1/day), and 0.2% chlorhexidine gluconate (30 mL, 2 × 1/day) were prescribed to all participants for 5, 7, and 5 days, respectively. |
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Outcomes | Pain (0‐to‐10‐centimetre scale), swelling, trismus, alveolar osteitis (Blum's criteria), wound dehiscence | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Treatment modalities for each patient were determined by a nurse not involved in the study using the lottery method" |
Allocation concealment (selection bias) | Low risk | Quote: "The treatment allocation sequence was concealed using sequentially numbered, opaque, sealed envelopes. Allocation concealment was intended to prevent selection bias and to protect the assignment sequence until the first procedure." "The treatment allocation sequence was concealed using sequentially numbered, opaque, sealed envelopes. Allocation concealment was intended to prevent selection bias" |
Blinding (performance bias and detection bias) patient | Unclear risk | Comment: it is not explicitly stated that the participants were blinded as to which intervention they received, but it seems unlikely that they would have been aware of the type of intervention |
Blinding (performance bias and detection bias) assessor | Low risk | Quote: "One author, responsible for calculation and calibration and not involved in the selection and intervention of participants (GYY), performed all the measurements." Comment: of note, the authors state that the operator and dental assistant who performed the surgical intervention could not be blinded due to the nature of the interventions |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: no withdrawal |
Selective reporting (reporting bias) | Low risk | Comment: all prespecified outcomes were reported on |
Other bias | Low risk | Comment: no other sources of bias identified |
CAL: clinical attachment level; CHX: chlorhexidine; IDN: inferior dental nerve; IID: interincisal distance; IND: inferior dental nerve; IOPA: intra‐oral periapical; MMO: maximum mouth opening; OPG: orthopantomogram; PPD: probing pocket depth; PRF: platelet rich fibrin; RCT: randomised controlled trial; SD: standard deviation; TMD: temporomandibular disorder; rmp: revolutions per minute; VAS: visual analogue scale