Gill 2007.
Methods | 2‐arm parallel randomised controlled trial | |
Participants |
Numbers recruited: 60 (authors reported gender of participants who completed the study: 32 females and 25 males) Mean (± SD) age: Group 1: 13.72 ± 2.5 years, Group 2: 13.37 ± 1.42 years Inclusion criteria:
Exclusion criteria:
Setting: hospital department in the UK, participants treated free of charge |
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Interventions |
Comparison: part‐time wear of upper and lower thermoplastic (vacuum‐formed) retainer vs. upper and lower full‐time wear of thermoplastic (vacuum‐formed) retainer Group 1: part‐time wear of vacuum‐formed retainers (sleeping hours with minimum of 8 hours of wear) Group 2: full‐time wear of vacuum‐formed retainers The vacuum‐formed retainers were full‐arch coverage and made from 1 mm thick polycarbonate sheets |
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Outcomes |
Outcome relevant to review: stability Stability assessed using Little's Irregularity Index, intercanine width and intermolar width in both arches, and overjet and overbite. PAR index reported in a graph, but data not sufficiently clear for further analysis Outcomes were measured after 6 months |
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Notes | Authors reported the type of initial malocclusion, whether the participants were treated by extraction or non‐extraction and the time in treatment. Despite randomisation, there were more Class II participants in the part‐time group | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | The authors confirmed the randomisation was generated by rolling a die and allocating the group according to odd or even numbers |
Allocation concealment (selection bias) | Low risk | "Identical opaque sealed envelopes containing a slip for group allocations were used for the purpose of random allocation" |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Outcome assessor was blind to the treatment group |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Loss of follow‐up data were reported in Consort diagram. Effect was not analysed, but as drop‐out was low, it is unlikely to have a significant effect |
Selective reporting (reporting bias) | Low risk | Authors confirmed they did not collect any other outcomes and there was no selective reporting |
Other bias | Low risk | No areas of risk of bias were identified |