Millett 2007.
Methods | 2‐arm parallel randomised controlled trial | |
Participants |
Numbers recruited: 85 (46 females and 39 males) Mean age: not reported Inclusion criteria: all participants had undergone fixed appliance treatment in at least the lower arch with satisfactory alignment and:
Exclusion criteria:
Setting: hospital department in Cork, Republic of Ireland |
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Interventions | Comparison: lower bonded retainer vs. lower vacuum‐formed retainer Group 1: bonded retainer was 0.018" stainless steel multistrand wire bonded to lingual of all lower incisors and canines Group 2: vacuum‐formed retainer was full‐occlusal coverage worn on a nights only basis from the day it was fitted In the upper arch, the clinician chose the upper retainer (Hawley or vacuum‐formed) |
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Outcomes |
Outcomes relevant to review: stability, survival of retainers, adverse effects on health and participant satisfaction Stability assessed by Little's Irregularity Index. The initial protocol discussed the use of PAR index, but these data were not collected Survival of retainers ‐ vacuum‐formed retainers were assessed as failed if they fractured or were lost (but not worn); bonded retainers were assessed as failed if debonded (clarified this with the authors) Adverse effects on health ‐ caries (evidence of decalcification) and periodontal health (gingival bleeding and periodontal probing > 3 mm) was assessed for lower anterior teeth Participant satisfaction ‐ participant questionnaire assessing retainer wear and acceptability recorded. Data for both retainers available for the following questions:
Outcomes collected 1 year after debond |
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Notes | Additional outcome was operator perception of each retainer type ‐ this will not be reported here, as this is not part of this review. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Authors confirmed computer‐generated random sequence |
Allocation concealment (selection bias) | Low risk | Sealed consecutive opaque envelopes in a separate co‐ordinating centre |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Contact with the author confirmed the assessor was blinded for the intervention type |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Drop‐outs were reported. Authors confirmed the data was analysed on an intention‐to‐treat basis |
Selective reporting (reporting bias) | High risk | Not all outcomes were reported in the abstracts that had been described in the protocol (PAR index for occlusal change was not collected). Further data will be reported after 2 years of wear |
Other bias | Unclear risk | As this study was only available as research abstracts, it is unclear as to whether other bias exists |