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A multicenter randomized controlled trial to compare a self-ligating bracket with a conventional bracket in a UK
Shahla Rahman1, R James Spencer2, Simon J Littlewood3
1a Specialist Orthodontist, Private Practice, Howard Marshall Dentistry, London, UK.
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.
