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

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 TM ) or conventional (3M Victory TM ) 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 TM system compared to the Victory TM 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. (Angle Orthod. 2016;86:149-156.)

Comparison of pain levels in patients treated with 3 different orthodontic appliances - a randomized trial

“…Discomfort and pain experienced during orthodontic treatment reduces compliance and is a reason to discontinue therapy [4]. The level of pain experienced during orthodontic treatment shows substantial individual variation due to psychological, environmental, psychosocial and emotional factors [5]. Several studies [6][7][8][9][10][11][12] have demonstrated that pain intensity rises between 4 to 24 hours after commencement of orthodontic treatment, lasts for 2 to 3 days with high intensity and gradually drops to baseline level by the 7 th day.…”

“…Conventional and self ligating fixed appliances cause greater initial discomfort due to an increased inflammatory response and sensitized nociceptors. Some studies [5][6][7] have mentioned that there were no significant differences in pain experience with self ligating and conventional bracket systems, but in contrast, others reported [15][16][17] that patients treated with conventional appliances experienced higher levels of discomfort than self ligating appliances during initial alignment. Clear aligners were introduced into orthodontic practice in 1997 and since then, with improvements in technology and additional innovations, have become one of the most preferred orthodontic appliances by patients and orthodontists alike [18,19].…”

Pain perception among patients treated with passive self-ligating fixed appliances and Invisalign®aligners during the first week of orthodontic treatment

“…However, they observed more discomfort during the insertion and removal of archwires with self-ligating brackets. A recent study by Rahman et al16 showed that patients treated with self-ligating (3M SmartClip; 3M Unitek, Monrovia, CA, USA) brackets experienced statistically higher pain than did patients treated with a conventional (3M Victory; 3M Unitek) bracket system. These authors concluded there was no clinical difference in pain perception among patients treated with both appliance systems 16…”

Pain experience in adults undergoing treatment: A longitudinal evaluation

“…3,4 It is therefore surprising, particularly as treatment continues to become more accepted in adult populations and better informed patients demonstrate a more positive attitude toward treatment. 3,[5][6][7][8] Moreover, the literature concerning the initial pain experience has typically focused on the first week following appliance placement, [9][10][11][12] with relatively few studies evaluating more prolonged effects. 3,13 Orthodontic pain has been related to a range of factors, such as the degree of malalignment, analgesic use, and the type of appliance used.…”