Pandis 2011.
Study characteristics | ||
Methods | Setting: Corfu, Greece, private practice of study author Design: parallel (2 arms) No. of centres: 1 Study duration: 16 months |
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Participants | Inclusion criteria: "non‐extraction treatment on both arches, eruption of all mandibular teeth, no spaces in the mandibular arch, mandibular irregularity index greater than 2 mm (canine to canine), and no therapeutic intervention planned involving intermaxillary or other intraoral or extraoral appliances including elastics, maxillary expansion appliances, or headgears before the end of the observation period". Exclusion criteria: not reported Participant sampling: N = 50 selected Group 1 (n = 25): 64% female, 36% male (mean age of 13.4 ± 1.6 years) Group 2 (n = 25): 68% female, 32% male (mean age of 13.2 ± 1.6 years) Sex: 66% female, 34% male Dropouts: none |
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Interventions | Orthodontic intervention: fixed appliances and auxiliaries Self‐ligating brackets versus conventional brackets |
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Outcomes | 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 “Fifty patients were randomized to either a conventional or a self‐ligating appliance. The statistical software package was used by the first author, and the user‐written ralloc command was implemented to generate the random allocation sequence. Randomization was accomplished by generating random permuted blocks of variable size (2 and 4), which assured equal patient distribution between the 2 trial arms.” |
Allocation concealment (selection bias) | Low risk | Adequate method of allocation concealment “Sequentially numbered, opaque, sealed envelopes were prepared before the trial containing the treatment allocation cards. After patient selection and recording of baseline information, the secretary in the practice was responsible for opening the next envelope in sequence and allocation.” |
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 “Impressions were taken, plaster models were prepared, and the brackets from second premolar to second premolar were scraped off with a curving knife by the laboratory technician to facilitate blind measurements. Each model had an identification number so that the measurements could be correctly entered into the spreadsheet” |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No dropouts |
Selective reporting (reporting bias) | Low risk | All outcomes reported |
Other bias | Unclear risk | Single centre, private practice |