American journal of orthodontics and dentofacial orthopedics : official publication of the American Association of Orthodontists, its constituent societies, and the American Board of Orthodontics · 2010
Treatment of pain after initial archwire placement: a noninferiority randomized clinical trial comparing over-the-counter analgesics and bite-wafer use.
СтатьяРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Murdock Sean, Phillips Ceib, Khondker Zakaria, Hershey H Garland
Аннотация
INTRODUCTION: Pain is a major concern of patients before orthodontic treatment. Currently, the most frequently recommended treatments for pain after archwire placement or appliance adjustment are over-the-counter (OTC) analgesics. Although the overuse of OTC medications and their potential side effects are concerns, particularly for children, no study to date has investigated a nonpharmacologic option for pain management as an alternative for these analgesics.
METHODS: A parallel 2-group stratified block randomized clinical trial was designed to assess the pain response of adolescents during the first week after initial archwire placement. The subjects were randomly assigned to 1 of 2 pain management groups: bite wafer (BW) or OTC analgesics. Pain levels were reported on a numerical rating scale. The intensity and unpleasantness of the pain were also assessed. Data were collected at 8 times over a 7-day period. A general linear mixed model with heterogeneous compound symmetry covariance matrix was fitted separately for each outcome. Estimates from the mixed model were used to test a noninferiority hypothesis that the BW group, on average, was not inferior with respect to pain management to the OTC group.
RESULTS: The patterns of pain level, intensity, and unpleasantness over time were similar for the 2 groups (P >0.33). Pain management for the BW group as indicated by pain level, intensity, and unpleasantness was not inferior to that of the OTC group (P >0.39).
CONCLUSIONS: In adolescents, the BW is a nonpharmacologic option for pain management after orthodontic procedures that is at least as effective as OTC analgesics.
METHODS: A parallel 2-group stratified block randomized clinical trial was designed to assess the pain response of adolescents during the first week after initial archwire placement. The subjects were randomly assigned to 1 of 2 pain management groups: bite wafer (BW) or OTC analgesics. Pain levels were reported on a numerical rating scale. The intensity and unpleasantness of the pain were also assessed. Data were collected at 8 times over a 7-day period. A general linear mixed model with heterogeneous compound symmetry covariance matrix was fitted separately for each outcome. Estimates from the mixed model were used to test a noninferiority hypothesis that the BW group, on average, was not inferior with respect to pain management to the OTC group.
RESULTS: The patterns of pain level, intensity, and unpleasantness over time were similar for the 2 groups (P >0.33). Pain management for the BW group as indicated by pain level, intensity, and unpleasantness was not inferior to that of the OTC group (P >0.39).
CONCLUSIONS: In adolescents, the BW is a nonpharmacologic option for pain management after orthodontic procedures that is at least as effective as OTC analgesics.