Bolla 2012.
Methods | 2‐arm parallel randomised controlled trial | |
Participants |
Numbers recruited: 85 (56 females and 29 males) Mean age: 21.9 years Inclusion criteria: people who had been treated with fixed appliances, with:
Exclusion criteria:
Setting: university clinic in Italy and participants had to pay for treatment (information provided by authors) |
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Interventions |
Comparison: polyethylene ribbon retainer vs. multistrand retainer Group 1: polyethylene ribbon retainer were silanised, 14 µm, unidirectional, glass fibre devices embedded in a resin matrix Group 2: multistrand retainer were 0.0175" dead‐soft passive multistrand wire Both types were bonded lateral incisor to lateral incisor in upper, and canine to canine in the lower All were placed under rubber dam using a standardised bonding process |
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Outcomes |
Outcome relevant to review: survival of retainers Number of detachments or bond failures recorded after 6 years |
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Notes | No measures of patient satisfaction, effect on health or stability were recorded | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Contacted authors who confirmed, "the operator tossed a coin for every patient" after agreeing to be in the study |
Allocation concealment (selection bias) | Low risk | Contacted authors who confirmed, "the operator tossed a coin for every patient" after agreeing to be in the study |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Not feasible as the outcome assessor could not be blinded to the presence or absence of the wire |
Incomplete outcome data (attrition bias) All outcomes | High risk | Paper recorded no drop‐outs, but on contacting the authors reported that, "we described only the patients that completed the trial, we estimate, now, we had a drop out of 15‐20 per group" |
Selective reporting (reporting bias) | High risk | Contacted authors who reported, "we started to check the periodontium, but it was making the visit too long for the administration therefore we had to terminate that evaluation" They also started "evaluating the bacterial flora taking a sample every 3 months, unfortunately we ran out of funds" |
Other bias | Low risk | No other areas of risk of bias identified |