Miles 2010.
| Study characteristics | ||
| Methods |
Setting: Caloundra, Queensland, Australia Design: parallel (2 arms) No. of centres: 1 Study duration: 10 weeks |
|
| Participants | Inclusion criteria: "consecutive subjects scheduled for non‐extraction treatment in the upper arch" Exclusion criteria: not reported Participant sampling: N = 68 selected Group 1 (n = 34): sex and mean age of group at start not reported Group 2 (n = 34): sex and mean age of group at start not reported Overall age reported across both groups at the end of the study: 13.5 ± 1.5 years Sex at the end of the study: Group 1 = 19 female, 11 male Group 2 = 19 female, 11 male Dropouts: Group 1 = 4 (11.7%) Group 2 = 4 (11.7%) |
|
| Interventions | Orthodontic intervention: fixed appliances and auxiliaries Self‐ligating brackets versus conventional brackets |
|
| Outcomes | Crowding, ligation time, 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 | Not possible to blind participants and personnel due to the different interventions used |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Adequate blinding of assessor |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Unclear impact of missing data Quote: "Of the 68 patients enrolled in the study, follow‐up impressions were missed for two subjects in Group 1 and four subjects in Group 2"; "...42 (70%) returned the discomfort questionnaires." |
| Selective reporting (reporting bias) | Low risk | All outcomes reported |
| Other bias | Unclear risk | Unclear impact of missing data Quote: “Two subjects, matched for age, gender and incisor irregularity, with two subjects in Group 2, were dropped from Group 1 to keep the same number of subjects in each group." |