Methods: In this prospective, randomized, double blind clinical trial, 115 patients aged 14 to 29 years who had pain in previous appointments, were randomly assigned to 1 of 3 experimental groups: ketoprofen chewing gum, ketoprofen gel and placebo chewing gum. All subjects were instructed to use the gum and gel at three times a day until three days after activation of fixed orthodontic appliances. Patients recorded their pain perception at times of 2, 6 and 24 hours; and 2, 3 and 7 days after treatment appointment using 5 scores visual analogue scale. Two-way analysis of variance (ANOVA) and repeated measures were used to compare differences in pain scores between three groups.
Results: Eighty seven patients (54 female, 33 male) completed their questionnaire and data were statistically analyzed. Mean value was lower in ketoprofen chewing gum group compared to ketoprofen gel and placebo chewing gum groups but no statistically significant differences were observed between three groups (Mean VAS scores were 0.82, 1.15 and 1.15 according to ANOVA; P-value: Non significant and mean scores were 0.87, 1.17 and 1.15 according to repeated measures; P-value: Non significant).
Conclusions: Although ketoprofen chewing gum showed more effectiveness in pain relief than ketoprofen gel and placebo chewing gum, this was not supported statistically. Also, the greater scores of pain observed after 6 hours which reduced afterwards and reached the least values in 7 days after activation of fixed orthodontic appliances.