Pandis 2010a.
Study characteristics | ||
Methods | Setting: Corfu, Greece, private practice of study author Design: parallel (2 arms) No. of centres: 1 Study duration: 175 days |
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Participants | Inclusion criteria: "non‐extraction treatment in both arches, eruption of all maxillary teeth, no spaces in the maxillary arch, no high canines, maxillary irregularity index greater than 4 mm, and no therapeutic intervention planned involving intermaxillary or other intraoral or extraoral appliances including elastics, maxillary expansion appliances, or headgear". Exclusion criteria: not reported Participant sampling: N = 70 selected Group 1 (n = 35): 60% female, 40% male (mean age of 13.8 ± 1.8 years) Group 2 (n = 35): 57% female, 43% male (mean age of 13.8 ± 1.7 years) Sex: 58.6% female, 41.4% male Dropouts: 4 (2 per group) |
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Interventions | Orthodontic intervention: fixed appliances and auxiliaries Active versus passive self‐ligating brackets |
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Outcomes | Crowding, time to alignment | |
Notes | Funding source: not reported | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Adequate method of randomisation "Randomization was accomplished by generating random permuted blocks of variable size; this ensured equal patient distribution between the 2 trial arms." |
Allocation concealment (selection bias) | Low risk | Adequate method of allocation concealment "Numbered, opaque, sealed envelopes were prepared before the trial containing the treatment allocation card. After patient selection, the secretary of the practice was responsible for opening the next envelope in sequence." |
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 | Unclear risk | Unclear if assessor was blinded "Measurements were made twice on the initial casts by the first author with a digital caliper (Digimatic NTD12‐6’’C, Mitutoyo, Tokyo, Japan)." |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 4 dropouts (2 per group) = 6% |
Selective reporting (reporting bias) | Low risk | All outcomes reported |
Other bias | Unclear risk | Single centre, private practice; per‐protocol analysis |