Miles 2012.
| Study characteristics | ||
| Methods | Setting: Caloundra and University of Queensland Department of Orthodontics, Australia Design: parallel (2 arms) No. of centres: 1 Study duration: 10 weeks |
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| Participants | Inclusion criteria: "children aged between 11 to 15 years, a non‐extraction treatment plan in the lower arch, no impactions/unerupted teeth, fixed appliances bonded from first molar to first molar in both arches, and living locally to allow for additional appointments for impressions" Exclusion criteria: not reported Participant sampling: N = 66 selected Group 1 (n = 33 for irregularity, 31 for discomfort): 19 female, 14 male (mean age of 13.1 ± 0.18 years) Group 2 (n = 33 for irregularity, 29 for discomfort): 21 female, 12 male (mean age of 13.0 ± 0.18 years) Sex: 40 female, 26 male Dropouts: Group 1 = irregularity 0 (0%); discomfort 1 (4%) Group 2 = irregularity 2 (6%); discomfort 1 (3%) |
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| Interventions | Orthodontic intervention: fixed appliances and auxiliaries Vibrational appliance versus no vibrational appliance (control) |
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| Outcomes | Crowding, harms (discomfort) | |
| Notes | Funding source not cited | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Unclear method of randomisation |
| Allocation concealment (selection bias) | Unclear risk | Unclear if allocation sequence concealed from those assigning patients to participant groups |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Clinicians blinded, however not possible to blind participants due to the different interventions used |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Assessor blinded, however not possible to blind participants, who assessed their own pain levels, due to the different interventions used. Quote: "A staff member who was blinded to the study groups and trained in the use of a micrometer measured the VAS data." |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Low dropout rate Quote: “Sixty‐six patients were enrolled in the study, of whom 64 patients reported for all 4 impression appointments. Pain scores were recorded by 60 patients, with 58 completing all 5 time points” |
| Selective reporting (reporting bias) | Low risk | All outcomes reported |
| Other bias | Low risk | None identified |