Pandis 2013.
Study characteristics | ||
Methods | 2‐arm parallel RCT | |
Participants |
Number recruited: 220 participants (110 in each group) Median age (IQR)(years): 16.0 (2) Sex (M:F): 60:160 Inclusion criteria: no active caries, restorations, fractures on the mandibular anterior teeth or periodontal disease; adequate oral hygiene Exclusion criteria: unwilling to be assigned to any of the approaches or had any abnormal oral or medical condition contraindicating fixed retention Setting: private practice at Bern, Switzerland |
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Interventions |
2 types of adhesives and composites
All participants received a soft‐bonded lingual retainer of 0.022 inch (Tru‐Chrome multi‐stranded wire; Rocky Mountain Orthodontics, Denver, Colo) that was fabricated intraorally. |
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Outcomes | Survival: failure of the lingual retainer, failure risk (hazard ratio), adhesive remnant index (ARI) scores Time points: 3, 6, 12, 18, 24 months |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Well‐reported randomisation process, using a computer random number generator (Stata software, Corp, College Station, Tex) in random permuted blocks of 20 participants, ensuring equal distribution in the 2 groups |
Allocation concealment (selection bias) | Low risk | Central allocation by the practice manager responsible for opening the next envelope in sequence |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | The outcome assessment was blinded. "Blinding was applicable for outcome assessment only." |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Trial authors imputed missing data using appropiate methods. Trial authors carried out imputations under the missing at random assumption. |
Selective reporting (reporting bias) | Unclear risk | The study protocol is not available. Insufficient information to permit judgement of ‘low risk’ or ‘high risk’ |
Other bias | Low risk | The study appears to be free of other sources of bias. |