title: A multi-center randomized controlled trial to compare a self-ligating bracket with a conventional bracket in a UK population: Part 1: Treatment efficiency.
abstract: OBJECTIVE
  To use a two-arm parallel trial to compare treatment efficiency between a self-ligating and a conventional preadjusted edgewise appliance system.
  
  
  METHODS
  A prospective multi-center randomized controlled clinical trial was conducted in three hospital orthodontic departments. Subjects were randomly allocated to receive treatment with either a self-ligating (3M SmartClip) or conventional (3M Victory) preadjusted edgewise appliance bracket system using a computer-generated random sequence concealed in opaque envelopes, with stratification for operator and center. Two operators followed a standardized protocol regarding bracket bonding procedure and archwire sequence. Efficiency of each ligation system was assessed by comparing the duration of treatment (months), total number of appointments (scheduled and emergency visits), and number of bracket bond failures.
  
  
  RESULTS
  One hundred thirty-eight subjects (mean age 14 years 11 months) were enrolled in the study, of which 135 subjects (97.8%) completed treatment. The mean treatment time and number of visits were 25.12 months and 19.97 visits in the SmartClip group and 25.80 months and 20.37 visits in the Victory group. The overall bond failure rate was 6.6% for the SmartClip and 7.2% for Victory, with a similar debond distribution between the two appliances. No significant differences were found between the bracket systems in any of the outcome measures. No serious harm was observed from either bracket system.
  
  
  CONCLUSIONS
  There was no clinically significant difference in treatment efficiency between treatment with a self-ligating bracket system and a conventional ligation system.
authors: a  Specialist Orthodontist, Dublin Dental University Hospital, Dublin, Ireland.
authors: Lian
authors: L
authors: O'Dywer
authors: b  Consultant in Orthodontics, St Luke's Hospital, Bradford, UK.
authors: Simon J
authors: SJ
authors: Littlewood
authors: c  Specialist Orthodontist, Private Practice, Howard Marshall Dentistry, London, UK.
authors: Shahla
authors: S
authors: Rahman
authors: d  Consultant in Orthodontics, Pinderfields Hospital, Wakefield, UK.
authors: R James
authors: RJ
authors: Spencer
authors: e  Specialty trainee in Orthodontics, Leeds Dental Institute, Leeds, UK.
authors: Sophy K
authors: SK
authors: Barber
authors: f  Consultant in Orthodontics, The James Cook University Hospital, Middlesbrough, UK.
authors: Joanne S
authors: JS
authors: Russell
mesh_terms: D000293:Adolescent; D001071:Appointments and Schedules; D006801:Humans; D016382:Orthodontic Appliance Design; D016910:Orthodontic Brackets; D009971:Orthodontics, Corrective; D011446:Prospective Studies
keywords: Bond failure; Self-ligating; SmartClip; Treatment efficiency; Treatment time