RESUMEN
This study compared the efficacy of pharmaceutical (ibuprofen) and non-pharmaceutical (photobiomodulation and chewing gum) interventions for pain reduction after elastomeric separator placement in orthodontic patients. This 3-arm, parallel-group randomized clinical trial was conducted on 90 orthodontic patients. The level of anxiety and pain threshold of patients were measured at baseline using the Pain Catastrophizing Scale (PCS) and an algometer, respectively. The patients were randomly assigned to three groups (n = 30; equal number of males and females). In the laser group, 940 nm diode laser (Epic X, Biolase, USA, 12.35 J/cm2 energy density and 300 mW power in continuous-wave mode., The cross-sectional area of the laser handpiece tip was 1.7 cm2.) was irradiated to the buccal and lingual surfaces for 35 s each, prior to placement of separators. In the gum group, the patients were asked to chew a piece of sugar-free gum immediately after the placement of separators and repeat every 8 h for 5 min for one week in case of pain. In the ibuprofen group, patients received 400 mg ibuprofen (Hakim Pharmaceuticals, Tehran, Iran) after the placement of separators and were asked to take one tablet every 8 h for one week in case of pain. The pain score was recorded using the Modified McGill Pain Questionnaire (MPQ). The normality of data distribution was analyzed by the Kolmogorov-Smirnov test. ANOVA was applied to compare age, and the Chi-square and Monte Carlo Chi-square tests were used to compare gender and patient responses to the questions among the groups. Repeated measures ANOVA was used to compare the pain score at different time points and among the three groups. All statistical analyses were conducted using SPSS version 19 (SPSS Inc., Chicago, IL, USA) at 0.05 level of significance. Data analysis in this study had an intention to treat approach. Although the pain score was slightly lower in ibuprofen and gum groups, the difference among the three groups was not statistically significant (P > 0.05). 'Repeated measures ANOVA showed no significant effect of method of pain reduction on pain score (F = 1.520, P = 0.225). Time had a significant effect on pain score (F = 20.310, P < 0.001). The interaction effect of time and pain reduction method on pain score was not significant (F = 0.737, P = 0.651). patients experienced a lower level of pain in the ibuprofen and chewing gum groups, the difference in pain score was not significant among the three groups (P = 0.225). patients experienced a higher level of pain at 12 and 24 hours after the placement of separators in all groups. Considering the comparably equal analgesic efficacy of this modalities, non-pharmaceutical interventions can be used for pain reduction of elastomeric separator. The study protocol was registered in the Iranian Registry of Clinical Trials (IRCT20210927052611N1). Date of registration 2022/03/14.