Gharaibeh 2008.
| Methods |
Trial design: quasi‐randomised, 2‐arm parallel groups, superiority. Setting: Jordan University of Science and Technology, Jordan. Number of centres: 1. Study duration: not reported. |
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| Participants |
Inclusion criteria: patients with unilateral palatally impacted maxillary canines. Exclusion criteria: not reported. Other prognostic factors: bone removal required for some patients (open: 10; closed: 11). Age: open: mean age 17.3 (SD 4.5) years; closed: mean age 17.6 (SD 2.4) years. Gender: open: 14 females, 2 males; closed: 14 females, 2 males. Number randomised: 32 (open: 16; closed: 16). Number evaluated: 32 (open: 16; closed: 16). |
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| Interventions |
Comparison: open surgical exposure technique versus closed surgical exposure technique All exposures carried out under local anaesthetic and by the same surgeon. In both groups, a standard mucoperiosteal flap was raised and if the crown of the canine was covered by bone, bone was removed with a rotary instrument. This was followed by:
All patients given co‐amoxiclav 625 mg and ibuprofen 400 mg every 8 hours for 5 days starting 1 hour after end of surgery and chlorhexidine 0.2% mouthwash 3 times daily for 7 days starting 24 hours after surgery. |
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| Outcomes |
Patient response – pain: worst pain experienced each day for 1 week postoperatively measured on a 1 to 10 scale; reported as daily incidence of mild (1 to 3), moderate (4 to 7) and severe (8 to 10). Length of treatment – duration of surgery: measured from initial incision until final suture, reported in minutes. |
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| Notes |
Sample size calculation: not reported. Adverse effects: not reported. Funding: not reported. Declarations/conflicts of interest: not reported. |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | High risk | Quote: "The exposure type was randomly selected". Comment: no details given on how random sequence was generated. Additional information from correspondence: quasi‐randomisation using alternate allocation. |
| Allocation concealment (selection bias) | High risk | Quote: "Half of the participants had closed‐eruption surgical exposure of the maxillary canine. The other half had open‐eruption exposure". Comment: not possible to conceal allocation when using alternate allocation. |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Comment: it was not possible to blind the participants or personnel. One surgeon operated, however it is not clear if they were equally proficient in both surgical techniques. |
| Blinding of outcome assessment (subjective outcomes) | Unclear risk | Comment: it was not possible to blind the participants, but as they only received one of the procedures it is unlikely that they were biased. |
| Blinding of outcome assessment (objective outcomes) | Unclear risk | Blinding was not mentioned for timing of surgical duration. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | All randomised participants were included in the analyses. |
| Selective reporting (reporting bias) | Unclear risk | Through correspondence with the author, we found out that data on periodontal health was recorded, but there is no mention of this in the paper and we are unsure if this was in the original protocol. The data are not yet available |
| Other bias | Low risk | None apparent. |