Shahla Rahman1, R James Spencer2, Simon J Littlewood3, Lian O'Dywer4, Sophy K Barber5, Joanne S Russell6. 1. a Specialist Orthodontist, Private Practice, Howard Marshall Dentistry, London, UK. 2. b Consultant Orthodontist, Pinderfields Hospital, Wakefield, UK. 3. c Consultant Orthodontist, St Luke's Hospital, Bradford, UK. 4. d Specialist Orthodontist, Dublin Dental University Hospital, Dublin, Ireland. 5. e Post-CCST Trainee in Orthodontics, Leeds Dental Institute, Leeds, UK. 6. f Consultant Orthodontist, James Cook University Hospital, Middlesbrough, UK.
Abstract
OBJECTIVE: To compare pain experience between self-ligating and conventional preadjusted edgewise appliance systems with a two-arm parallel trial. MATERIALS AND METHODS: A prospective multicenter 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™) bracket system with stratification for operator and center. Standardized protocol was followed for bracket bonding procedure and archwire sequence. Subject pain was recorded using a Verbal Rating Scale to assess discomfort felt on the teeth and soft tissues at the time of the appointment and 1, 3, and 5 days after each archwire change up to the working archwire. Multilevel modeling was used to analyze the data by blinded assessors. RESULTS:One hundred thirty-eight subjects (mean age 14 years 11 months) were enrolled in the study, of which 135 subjects (97.8%) completed the study and 113 (82%) returned the required data regarding pain/discomfort. Perceived pain was statistically higher with the SmartClip™ system compared to the Victory™ system, but this difference was not deemed to be clinically significant. Discomfort was greatest after placement of the initial 0.014-inch nickel-titanium archwire, compared with subsequent wires, and was greatest on day 1, less on day 3, and much less on day 5 after each archwire change. Age and gender did not affect the level of discomfort experienced by subjects undergoing fixed appliance treatment. CONCLUSION: No clinically significant difference in pain experience was found between patients treated with a self-ligating bracket system compared to those treated with a conventional ligation system.
RCT Entities:
OBJECTIVE: To compare pain experience between self-ligating and conventional preadjusted edgewise appliance systems with a two-arm parallel trial. MATERIALS AND METHODS: A prospective multicenter 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™) bracket system with stratification for operator and center. Standardized protocol was followed for bracket bonding procedure and archwire sequence. Subject pain was recorded using a Verbal Rating Scale to assess discomfort felt on the teeth and soft tissues at the time of the appointment and 1, 3, and 5 days after each archwire change up to the working archwire. Multilevel modeling was used to analyze the data by blinded assessors. RESULTS: One hundred thirty-eight subjects (mean age 14 years 11 months) were enrolled in the study, of which 135 subjects (97.8%) completed the study and 113 (82%) returned the required data regarding pain/discomfort. Perceived pain was statistically higher with the SmartClip™ system compared to the Victory™ system, but this difference was not deemed to be clinically significant. Discomfort was greatest after placement of the initial 0.014-inch nickel-titanium archwire, compared with subsequent wires, and was greatest on day 1, less on day 3, and much less on day 5 after each archwire change. Age and gender did not affect the level of discomfort experienced by subjects undergoing fixed appliance treatment. CONCLUSION: No clinically significant difference in pain experience was found between patients treated with a self-ligating bracket system compared to those treated with a conventional ligation system.
Entities:
Keywords:
Pain; Randomized control trial; Self-ligating; SmartClip
Authors: Matheus Melo Pithon; Antônio Carlos de Oliveira Ruellas; David Normando; Carlos Flores-Mir; Dauro Douglas Oliveira Journal: Dental Press J Orthod Date: 2015 May-Jun
Authors: Abdullah A Al Nazeh; Ibrahim Alshahrani; Serene A Badran; Salem Almoammar; Abdulaziz Alshahrani; Bashar A Almomani; Mahmoud K Al-Omiri Journal: Sci Rep Date: 2020-11-24 Impact factor: 4.379
Authors: Neil R Woodhouse; Andrew T DiBiase; Spyridon N Papageorgiou; Nicola Johnson; Carmel Slipper; James Grant; Maryam Alsaleh; Martyn T Cobourne Journal: Sci Rep Date: 2015-11-27 Impact factor: 4.379