Efficacy of Chewing Gum to Reduce Orthodontic Pain Compared to Placebo: A Blinded, Parallel-Group, Preliminary Clinical Trial

Aims: To quantify the pain experienced by orthodontic patients during the first 10 days of appliance placement, to determine whether chewing gum reduces orthodontic pain compared to placebo, and to examine patients' overall perceptions of the impact of orthodontic pain. Methods: Patients bonded with fixed appliances were randomly assigned to one of two groups (gum group [GG] or placebo group [PG]) and then followed for 10 days. The main outcome was a visual analog scale (VAS) pain score, and the secondary outcomes included patients' subjective assessments of overall pain level, the impact of pain on hygiene habits and treatment decision, and the frequency of analgesics consumption. Eighty kits (40 for GG and 40 for PG) were pre-randomized and concealed before patient enrollment using a computer-generated random sequence. Operators and patients were blinded. Data were analyzed using generalized linear models and Mann-Whitney U, chi-square, and Fisher exact tests. Results: A total of 75 patients were allocated to intervention groups; 37 participated and completed diaries (20 in GG and 17 in PG). No statistically significant differences were detected between the GG and PG groups in any tested variable. Pain negatively affected some patients' oral hygiene practices. A mismatch existed between patient expectations and actual pain experiences. Female patients used analgesics more frequently than male patients (P = .046). Conclusion: Chewing gum three times per day does not seem to significantly reduce orthodontic pain compared to placebo. Orthodontists should manage their patients' pain expectations. Palabras clave: chewing gum, fixed appliance, orthodontic pain, placebo, randomized controlled trial, visual analog scale