The Analgesic Efficacy of 5% Naproxen Gel for Pain Associated with Orthodontic Separator Placement: A Randomized Double-Blind Controlled Trial

BACKGROUND AND OBJECTIVES Several methods have been proposed to relieve orthodontic pain, each with its advantages and disadvantages. This study aimed at assessing the efficacy of 5% naproxen gel to relieve pain associated with orthodontic separator placement. METHODS This double-blind randomized controlled trial was conducted on 41 patients between 14 and 20 years old complaining of pain due to placement of orthodontic elastic separators. Five-percent naproxen and placebo gels were applied randomly in a spilt mouth design to the permanent first molars area. The gels were applied every 8 hours for 3 days after placement of separators. Patients recorded their level of pain at determined time points using a 0 to 100 visual analog scale. Normal distribution was assessed by the Kolmogorov-Smirnov test. Paired samples t test was used to compare the mean pain score between the two gels. Multi-factorial repeated measures analysis of variance (ANOVA) compared the severity of pain based on gender and age. RESULTS Out of 41 patients, 34 completed this trial (23 females and 11 males). The mean pain score significantly decreased over time in both sides and for both genders (P < 0.001). Pain score was not significantly different between males and females or between patients < 16 and ≥ 16 years of age. The mean pain score was significantly lower in the naproxen group at all-time points (P < 0.001). Naproxen gel showed significantly higher analgesic efficacy when compared to the placebo at all-time points. The highest and lowest pain score was noted at 2 hours and at 7 days after separator placement, respectively. CONCLUSIONS Using 5% naproxen gel is an effective method for reducing orthodontic pain following elastic separator placement.