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Angle Orthod. 2016 Jan;86(1):149-56. doi: 10.2319/112414-838.1. Epub 2015 Mar 26.

A multicenter randomized controlled trial to compare a self-ligating bracket with a conventional bracket in a UK population: Part 2: Pain perception.

Author information

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.

KEYWORDS:

Pain; Randomized control trial; Self-ligating; SmartClip

PMID:
25811246
DOI:
10.2319/112414-838.1
[Indexed for MEDLINE]

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