Mobilio 2017.
| Study characteristics | ||
| Methods | Study design: a randomised prospective study; parallel groups Conducted in: Italy |
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| Participants | Inclusion criteria: 25 medication‐free, otherwise healthy consecutive patients (18 women and 7 men; mean age: 27.88 ± 9.75 years, age range: 18 to 61 years) scheduled for lower third molar extraction on an ambulatory basis were included in the study Exclusion criteria: age < 18, diagnosed psychiatric disorders, diagnosed neurological diseases, diagnosed impaired communicative or cognitive abilities, contraindications to non‐steroidal anti‐inflammatory drugs or amoxicillin Age: 18 to 61 Number randomised: 25 participants/25 teeth |
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| Interventions | Comparison: envelope flap versus triangular flap Group A (n = 13): envelope flap Group B (n = 12): triangular flap Mepivacaine (2%) containing 1:100,000 adrenaline was administered as the inferior alveolar, buccal and lingual nerve block. Standard analgesics were prescribed (ketoprofen 80 mg: first dose after 2 hours, second after 8 hours, then 3 times a day for days 2 and 3); 0.12% chlorhexidine mouth rinse was prescribed from day 2 until day 7. A postoperative meeting was scheduled on days 2 and 7 to check swelling and trismus. The sutures were removed during the second appointment. | |
| Outcomes | Pain: 0‐to‐100‐millimetre VAS at day 7 Swelling: 5 distances (in millimetres) through 6 facial points (angle of the mandible to tragus, to eye outer canthus, to labial commissure, to nasal border, and to soft pogonion) were measured, and then the average percentage value was obtained. Trismus (millimetres): to assess trismus (represented by maximum intercisal opening (MIO) reduction), the distance between the incisal edges of the upper and lower central incisors was measured in millimetres 3 times each day. The differences between initial MIO and 2‐day MIO and initial MIO and 7‐day MIO were assumed as trismus on days 2 and 7, respectively. |
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| Notes | P < 0.05 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: "The patients were randomly assigned to two groups in terms of flap design: group A (envelope flap) and group B (triangular flap)" Comment: the method of randomisation is not described. |
| Allocation concealment (selection bias) | Unclear risk | Comment: methods of concealment were not described |
| Blinding (performance bias and detection bias) patient | Unclear risk | Quote: "Each patient provided a written informed consent for participation." Comment: participants were consented for the procedure, but it is unclear if the details of the study were revealed to them |
| Blinding (performance bias and detection bias) assessor | Low risk | Quote: "Swelling and trismus were assessed by the third examiner before and after surgery, on days 0, 2 and 7." Comment: the role of the third examiner is not well described here, but it is indicated that the third examiner was not involved in the randomisation or surgical procedure |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: no dropouts were mentioned |
| Selective reporting (reporting bias) | Low risk | Comment: all outcomes are reported |
| Other bias | Unclear risk | Selective reporting (reporting bias) |