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. 2010 American Association of Orthodontists. Published by Mosby, Inc. All rights reserved.
RCT Entities:
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. 2010 American Association of Orthodontists. Published by Mosby, Inc. All rights reserved.