A double-blind, randomized clinical trial assessing the effects of a single dose of preemptive anti-inflammatory treatment in orthodontic pain

Abstract Objective Strategies about how to mitigate or prevent the appearance of pain associated with orthodontic treatment are poorly defined. Herein we conduct a prospective, double-blind, randomized controlled clinical trial assessing the effects of a single dose of anti-inflammatory medication to preemptively treat pain following the placement of orthodontic separating elastics. Materials and methods Fifty one participants were randomly selected and divided into three groups: (a) 17 patients took placebo one hour prior to the elastic separator placement; (b) 17 patients took 400 mg lumiracoxib one hour prior to the elastic separator placement; and (c) 17 patients didn’t take anything prior to the procedure. Discomfort and pain intensity levels were measured by an analog 10-points visual scale at 2 hours, 6 hours, 24 hours, 2 days and 4 days after the procedure. Results When comparing the three groups (no treatment, placebo and active) no significant differences were found. Nonetheless, pain severity was always lower in individuals receiving the drug. Similar pattern was seen for the other time points. Conclusions Our study does not support the use of a single dose of medication with anti-inflammatory properties in the preemptive treatment of pain following an orthodontic procedure. Further investigation is required in order to ascertain whether recurrent doses (vs a single dose) can impact outcomes.