Objective: This study aimed to explore the effect of lavage with sterile saline (SS), sodium hypochlorite (NaOCl), and Ethylenediaminetetraacetic acid (EDTA) on success rate and postoperative pain in direct pulp capping of mature permanent teeth.
Methods: In this double-blind trial (NCT05878249), 140 patients with reversible pulpitis in permanent molars due to caries were enrolled. Following complete caries removal, hemostasis was achieved, and the cavities were randomly assigned to four groups for lavage: (European Society of Endodontology (ESE) developed by:, Duncan HF et al. Int Endod J 52(7):923-34, 2019); SS ( Asgary S et al. J Endod 44(4):529-35, 2018); 2.5% NaOCl ( Cushley S et al. Int Endod J 54(4):556-71, 2021); 12% EDTA, and ( Ricucci D et al. J Endod 49(1):45-54, 2023), 2.5% NaOCl followed by 12% EDTA (NaOCl/EDTA). Biodentine was applied to the exposed pulp, followed by a resin-modified glass-ionomer liner and composite restoration. Clinical and radiographic success was evaluated at 6 and 12 months. Visual Analog Scale was used to record pain for 7 days. Statistical analysis included Mann-Whitney U, Kruskal-Wallis, Chi-square tests, and Kaplan-Meier analysis. Multivariate Cox regression analysis was used to identify risk factors associated with tooth survival.
Results: The overall clinical and radiographic success rate at 12 months was 86.9%. Individual success rates among groups were 71.9% (SS), 90.6% (NaOCl), 87.9% (EDTA), and 97.0% (NaOCl/EDTA). NaOCl/EDTA group showed significantly higher success rates than SS group (p < 0.05). NaOCl and NaOCl/EDTA groups showed a significant reduction in pain compared to SS group on days 5-7 (p < 0.05). Pulp survival analysis revealed an overall success rate of 87.9%. Survival rates among the groups were: SS group - 74.3%, NaOCl group - 91.4%, EDTA group - 88.6%, and NaOCl/EDTA group - 97.1%. Log-rank test revealed a significant difference in the survival between the groups (p = 0.020). NaOCl, EDTA, and NaOCl/EDTA provided higher survival probability (meaning fewer failures) compared to the use of SS alone (P > 0.05). The failure risk was 14.3 times higher with SS than with NaOCl/EDTA (HR: 14.3, 95% CI: 1.7-118.6, p = 0.013).
Conclusions: The combined use of NaOCl/EDTA increased the success rates at 12 months. NaOCl and NaOCl/EDTA elicited significantly less postoperative pain than other groups.
Clinical relevance: Lavage with NaOCl/EDTA increased the success rates of direct pulp capping.
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