Comparison of Post Endodontic Pain After Endomethasone N vs SP

Objectives: Post Endodontic Pain (PEP) after endodontic treatment (ET) might be reduced by adding cortisone to the composition of the Root Canal Sealer (RCS) although no grade A evidence supports this statement.
Methods: A multicenter prospective randomized controlled clinical trial was performed in general practice (ClinicalTrials.gov # NCT04885686) between June 2021 and May 2022. Its main objective was to demonstrate the superiority of Endomethasone N RCS (EndoN), compared to its hydrocortisone-free equivalent Endomethasone SP RCS (EndoSP), with regard to reduction of the maximum spontaneous PEP pain during the 7 days following the ET, self-estimated on a 0-100mm Visual Analogic Scale (VAS). The secondary objectives were to assess 1) spontaneous PEP; 2) provoked (masticatory) PEP; 3) intake of analgesics; 4) quality of life and anxiety after ET; 5) safety of ET. Adult patients with indication of ET in a molar or premolar in one session were included between 2021 and 2022 in 15 centers.
Results: The final sample consisted of 286 patients. The mean age of the sample was 47.7 y.o. including 49% men and 51% women. Before ET, 49.7% of the teeth were asymptomatic; provoked pain occurred in 29.4% and spontaneous pain in 21.0%. The maximum PEP intensity was mild. The study evidenced a lower maximum spontaneous PEP intensity during the 7 days following ET in the EndoN compared to the EndoSP group (13.5±17.9 vs 23.9±26.6, IC 95% [5.2-15.8], p<0.0001 Wilcoxon test). Maximal masticatory PEP was also lower in the EndoN group (12.3±19.1 vs 24±27.8, p<0.0001). At every evaluation time, the masticatory PEP in the EndoSP group was higher than in the EndoN group. In addition, no serious adverse events occurred during the study.
Conclusions: This RCT demonstrated the superiority of EndoN compared to Endo SP in reducing both spontaneous and masticatory PEP during the 7 days following ET.