Shim 2022.
Study characteristics | ||
Methods | 3‐arm parallel RCT | |
Participants |
Number recruited: 75 (group 1 30; group 2 20; group 3 25); 46 attended 3‐month visit (group 1 16; group 2 16; group 3 14) and those participants were analysed Sex (M:F): 18:29 (group 1: 9M, 7F; group 2: 4M, 12F; group 3: 5M, 9F) Median age (IQR): group 1: 16.5 (15.3); group 2: 15.8 (13.6); group 3: 15.2 (13.6) Inclusion criteria: completion of comprehensive orthodontic treatment; Class I molar and canine relationship based on Andrew’s criteria for finishing; need for a fixed retainer on the mandibular anterior teeth assessed before debonding Exclusion criteria: refusal to participate in the study and conditions contraindicating fixed retainers, including poor oral hygiene and pathology Setting: orthodontic clinic of Saint Louis University, Saint Louis, Missouri, USA |
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Interventions |
3 types of lower fixed retainers:
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Outcomes | Stability: LII and intercanine width changes Failure rate: complete or partial detachment were considered failures Time points: 3 and 6 months |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Well‐informed randomisation process generation. A simple software‐generated randomisation was performed by a statistician not involved in the study. |
Allocation concealment (selection bias) | Low risk | The sequence generator was contacted by phone for group assignment after determining patient eligibility for enrolment. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | "The principal investigator and the clinicians bonding the fixed retainers could not be blinded regarding the assignment of patients to groups in the clinical setting. Upon data analysis, patients’ records were encrypted to minimize observer and measurement bias." It is likely to be influenced by lack of blinding. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Missing outcome data balanced in numbers across intervention groups, with similar reasons for missing data across groups |
Selective reporting (reporting bias) | Unclear risk | The present study was not registered. Insufficient information to permit judgement. The published report includes the main primary outcomes. |
Other bias | Low risk | The study appears to be free of other sources of bias. |