RESUMO
INTRODUCTION: The efficacy of trypsin-chymotrypsin in postoperative pain management following single-visit root canal treatment of teeth with symptomatic irreversible pulpitis was evaluated. Additionally, synergistic effects with nonsteroidal anti-inflammatory drugs and reported side effects were also investigated. METHODS: This prospective, parallel, triple-blinded phase IV randomized controlled trial included 60 patients with mandibular first molars exhibiting symptomatic irreversible pulpitis. The patients were randomly allocated using computer software to one of four treatment groups (n = 15 each), and either ibuprofen (600 mg), ambezim-G (trypsin 5mg-chymotrypsin 5 mg), a combination of both, or a placebo drug were administered postoperatively. The participants scored pain intensity at different time-intervals using a numerical scale, and passive surveillance of harm was used to detect clinical safety. Age was compared between groups using a one-way analysis of variance test. Pain scores were analyzed using the Kruskal-Wallis and Friedman's tests and, if significant, Dunn's test was used for pairwise comparisons. The chi-square test was used to compare qualitative data, and the significance level was set at P value ≤ .05. RESULTS: All interventions were found to be effective in reducing postoperative pain, and no statistically significant differences were observed between the ibuprofen, trypsin-chymotrypsin, and combination groups. However, all 3 groups differed significantly from the placebo group. The safety profile of the interventions did not differ significantly. CONCLUSIONS: Trypsin-chymotrypsin exhibits comparable efficacy to nonsteroidal anti-inflammatory drugs. No synergistic effects occur when the 2 are used in combination. This is the first randomized controlled trial to assess the effects of proteolytic enzymes on postendodontic pain. TRIAL REGISTRATION: clinicaltrials.gov, Identifier: NCT05479747.