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. 2021 Dec 31;2021(12):CD003453. doi: 10.1002/14651858.CD003453.pub2

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
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
Interventions Orthodontic intervention: fixed appliances and auxiliaries
Self‐ligating brackets versus conventional brackets
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