ABSTRACT
BACKGROUND: The pain involved in orthodontic treatments may involve inflammatory processes. This study evaluated the effect of using a naproxen patch for pain reduction in the separating stage of fixed orthodontic treatment. METHODS: In this double-blind, randomized, controlled clinical trial of 35 orthodontic patients (age: 14–19 years) who had pain during separator placement, each patient randomly placed naproxen and placebo patches in the first permanent molar region, in opposite quadrants of the same jaw. Patches were replaced every 8 hours until 3 days after separator placement. Patients recorded their pain perception at 2, 6, and 24 hours, and on days 2 (6 PM), 3 (10 AM and 6 PM), and 7 (10 AM and 6 PM), using a visual analog scale. Mean pain scores were compared for the two patches, and effects of sex and age thereon determined. RESULTS: Data from 29 patients (21 girls, eight boys) were analyzed. Mean pain values decreased over time for both patches (P < 0.001). Recorded pain did not differ significantly between the sexes (P = 0.059) or between those aged <16 and those ≥16 years (P = 0.106). Mean pain recorded with naproxen patches was statistically significantly less than that with placebo patches at all time points (P = 0.004). CONCLUSION: The naproxen patch was more efficient than the placebo patch for reducing pain at all time points. The highest pain score was recorded at 6 hours, and the least pain was recorded at the 7th day after separator placement.