Avaliação da efetividade de um agente dessensibilizante à base de glutaraldeído na sensibilidade pós-operatória e desempenho clínico de restaurações posteriores: ensaio clínico randomizado duplo-cego

Abstract

Objectives: To evaluate the effectiveness of a glutaraldehyde-based desensitizer in reducing

postoperative sensitivity (POS) in posterior restorations with universal adhesive applied in self- etch (SE) and etch-and-rinse (ER) strategies after 7, 14 and 30 days; and evaluate the clinical

performance of restorations up to 24 months of clinical service. Methodologies: for this work, a multicenter, double-blind, split mouth randomized clinical trial (RCT) was carried out comparing the SE and ER strategies., in which 228 class I and II composite resin restorations at least 3mm deep were inserted in 57 patients. The universal adhesive was used with or without the previous application of a desensitizing agent based on glutaraldehyde (Gluma Desensitizer - GL). Cavities were restored with bulk-fill resin (Tetric N-Ceram Bulk Fill). POS was assessed 7 days after the restorative procedure using the Visual Analog Scale (VAS) and the Numerical Rating Scale (NRS). After 7, 14 and 30 days, participants were re-evaluated for evaluation of POS induced by stimuli (air blast, cold, horizontal and vertical percussion). In addition, marginal discoloration, marginal adaptation, fracture, and caries recurrence were assessed using FDI (World Dental Federation) criteria for up to 24 months. The risk of spontaneous and stimuli-induced POS was compared using Fisher's exact test. The intensity of spontaneous POS after 7 days was assessed using the Mann-Whitney test for the VAS and ANOVA scores and Tukey's tests for the NRS scores. The POS risks according to the characteristics of the cavities were compared using the Chi-square test (α = 0.05). Results: No significant spontaneous or stimulus-induced POS was observed when comparing the restorations with or without GL application (p>0.05). A higher risk of spontaneous POS was observed at 7 days (35.09%; 95% CI 24.00 to 48.06), with no statistically differences between groups. After 24 months, 5 restorations were considered clinically unsatisfactory and 73 restorations showed small discrepancies in fit, with no significant difference between groups (p>0.05). There was no recurrence of caries in this period. Conclusions: Previous application of GL did not significantly reduce spontaneous or stimuli-induced POS in posterior composite resin restorations with the bulkfill technique at any time, regardless of the adhesive strategy used, as well as it did not result in difference in the clinical performance of the restorations over 24 months.