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. 2023 May 22;2023(5):CD002283. doi: 10.1002/14651858.CD002283.pub5

Scribante 2011.

Study characteristics
Methods 2‐arm parallel RCT
Participants Number recruited: 34
Sex (M:F): 9:25
Mean age (years): 14.3 (SD not provided)
Inclusion criteria: correct dental alignment, need for permanent orthodontic retention in the lower anterior segments, free of occlusal interferences in order to eliminate the influence of trauma
Exclusion criteria: not mentioned
Setting: Unit of Orthodontics and Paediatric Dentistry, University of Pavia, Italy
Interventions Two types of lower lingual fixed retainers:
  • Group 1: ⌀ 0.0175 mm multistranded wire 

  • Group 2: fibre‐reinforced composite retainer preimpregnated with Transbond XT Primer (3M Unitek, Monrovia, California, USA) 

Outcomes Survival: numbers (percentage) of total detachment at the end of follow‐up, Kaplan‐Meier survival plots and hazard ratio
Patient satisfaction: opinion about the aesthetic result while talking and smiling by means of VAS
Time points: every month for 12 months
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Just mentioned "randomly assigned"
Allocation concealment (selection bias) Unclear risk Not mentioned
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Not mentioned
Incomplete outcome data (attrition bias)
All outcomes Unclear risk The number of participants is not clear: "34 patients were enroled: 17 with a multistrand wire retainer, while 15 with a polyethylene fiber‐reinforced resin composite"
Selective reporting (reporting bias) Low risk No dropouts in the 12‐month follow‐up
Other bias Unclear risk Not reported using CONSORT standards