A ASSOCIAÇÃO ANALGÉSICA PARACETAMOL / CODEÍNA NÃO REDUZ A SENSIBILIDADE INDUZIDA PELO CLAREAMENTO DENTAL: ENSAIO CLÍNICO RANDOMIZADO, PARALELO, TRIPLO-CEGO

Abstract

Background: Bleaching-induced TS is highly prevalent. The combination of Opioids and non opioids analgesics may provide a better analgesic effect. Objective: To evaluate the effect of the combination of paracetamol / codeine administered before and postoperatively on the risk and intensity of TS induced by dental whitening. Methods: A triple-blind, parallel, randomized clinical trial was conducted with 105 health patients who received either a placebo or an association of codeine/acetaminophen. The first dose of Tylex® 30 mg (acetaminophen 500 mg/codeine 30 mg) or placebo was administered 1 h before the in-office bleaching (35% hydrogen peroxide), and extra doses were administered every 6 h for 48 h. The TS was recorded using two scales: 0-10 visual analog scale and a 0-4 numeric rating scale in different periods: during bleaching, 1 h up to 24 h, 24 h up to 48 h postbleaching. The color was measured before and one month after dental bleaching with a visual shade guide Vita Classical, Vita Bleachedguide 3D-Master and spectrophotometer Vita Easyshade (Vita Zahnfabrik). The absolute risk of TS was evaluated by Fisher’s exact test. Data of TS intensity with NRS scale of the two groups were compared with Mann-Whitney and Friedman tests, while data from the VAS scale were evaluated by two-way repeated measures ANOVA. The color changes between groups were compared using a Student t-test (α = 0.05). Results: No significant differences between the groups were observed in the risk and intensity of TS. The overall absolute risk of TS was approximate 96%. A color change of nearly 5 shade guide units of the Vita Classical was detected in both groups, which were statistically similar (p > 0.05). Conclusion: The use of acetaminophen/codeine association pre and post in-office bleaching does not reduce the risk and intensity of bleaching-induced TS. Practical Implications: The use of an opioid analgesic drug was not capable to prevent TS arising from in-office dental bleaching.