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.