A double-blinded randomized clinical trial of pain perception during orthodontic treatment

Abstract

Abstract Introduction Orthodontic movement can cause painful symptoms, especially in the early stages of treatment. Objective This study aimed to compare the performance of chewing gum and ibuprofen in pain control during the initial period of orthodontic treatment. Material and method A randomized blind clinical trial, with an allocation ratio of 1:1, was developed with patients aged ≥18 years old. The sample size was established considering a significance level of 5% and test power of 80%, resulting in a minimum of 30 volunteers per group (n=90). Participants were paired regarding sex, age, the severity of malocclusion, defined by the Dental Health Component (DHC) of the Index of Orthodontic Treatment Need (IOTN), and crowding, determined by Little’s irregularity index. The sample was randomly allocated to three groups: Group I (control) placebo; Group II chewing gum; and Group III Ibuprofen. Pain perception was evaluated by the Visual Analog Scale (VAS) in the first 24, 36, and 48 hours after activation of the orthodontic appliance. The data were analyzed by generalized linear models for repeated measures in time. Result No statistically significant difference (p>0.05) was observed among the groups for the methods of pain therapy evaluated in 24, 36, and 48 hours post-activation. Conclusion There was no difference among the method used for pain control during the orthodontic treatment.