Spontaneous and Masticatory Post-endodontic Pain After Using Endomethasone N vs SP Root Canal Sealers: A Randomised Controlled Clinical Trial

Abstract

Objective: Post-endodontic pain (PEP) after endodontic treatment (ET) might be reduced by adding cortisone to the composition of root canal sealer (RCS). This study aimed to test this hypothesis using grade A methodology.

Methods: A multicentric prospective randomised controlled clinical trial was performed in general practice. Adult patients with an indication of ET in a molar or premolar performed in one session were included be-tween 2021 and 2022 in 15 centres. The main objective was to demonstrate the superiority of Endomethasone N RCS (EndoN), compared to its hydrocortisone-free equivalent Endomethasone SP RCS (EndoSP), regarding the reduction of the maximum spontaneous PEP pain during the 7 days following the ET, self-estimated on a 0���100 mm Visual Analogic Scale (VAS). The secondary objectives were to assess 1) spontaneous PEP, 2) pro-voked (masticatory) PEP, 3) intake of analgesics, 4) quality of life and anxiety before and after ET, and 5) safety.

Results: The final sample consisted of 286 patients with a mean age of 47.7 years, including 51% men and 49% women. Before ET, 49.7% of the teeth were asymptomatic; provoked pain occurred in 29.4% and sponta-neous pain in 21.0%. The study evidenced a lower maximum spontaneous PEP intensity during the 7 days fol-lowing ET in EndoN compared to the EndoSP group (13.5+-17.9 vs 23.9+-26.6, IC 95% 10.5 [5.2���15.8], p=0.0001 Wilcoxon test). Maximal masticatory PEP was also lower in the EndoN group (12.3+-19.1 vs 24.0+-27.8, IC 95% 11.7 [5.8���17.6], p<0.0001 Wilcoxon test). 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.

Conclusion: This RCT demonstrated EndoN's superiority over EndoSP in reducing spontaneous and mastica-tory PEP during the 7 days following ET. This study was funded by the Septodont company (Saint Maur des Foss��s, France) and registered at ClinicalTrials.gov # NCT04885686.

Figure 1

CONSORT flow diagram. 300 patients were assessed for eligibility and signed an informed consent. Among them, 2 were not included, resulting in a sample of 298 patients with a similar distribution between groups (EndoN=148, EndoSP=150), with no allocation error during the study. At the end of the study, 286 patients were analysed: 141 in the EndoN group and 145 in the EndoSP group EndoN: Endomethasone N root canal sealer, EndoSP: Endomethasone SP root canal sealer

Figure 2

Boxplots of maximum spontaneous pain level following the 7 days after endodontic treatment (VAS 100mm). (a) In the whole sample, a 10.5 VAS significant difference was found between the EndoN and EndoSP groups (p=0.0001). (b) In the subset of patients with post-endodontic pain, an 8.8 significant VAS difference was found between the EndoN and EndoSP groups (p=0.0232). In red; Min: Minimum (lowest value excluding outliers), Q1: Lower Quartile (25^th percentile), Med: Median value (50^th percentile), Q3: Upper Quartile (75^th percentile), Max: Maximum (highest value excluding outliers), mean by group (green lines), global mean (grey line) and observed values (black dots) of maximum spontaneous pain level following the 7 days after endodontic treatment (VAS 100mm) EndoN: Endomethasone N root canal sealer, EndoSP: Endomethasone SP root canal sealer, VAS: Visual Analogic Scale

Figure 3

Mean and CI95% of VAS score (0-100) for spontaneous pain according to group in FAS population after endodontic treatment. At every evaluation time, the pain intensity reported by the patients was higher in the EndoSP group than in the EndoSP group. This difference in pain intensity was not significant at T0h (p=0.3442), at T3h (p=0.1111) and at T6h (p=0.1582) but became significant at T12h (p=0.0034) and stayed significant until the end of the 7 days follow-up period; at 24h (p=0.0009), 48h (p=0.0020), day 3 (p=0.0002), day 4 (p=0.0022), day 5 (p=0.0219), day 6 (p=0.0037) and day 7 (p=0.0033) CI: Confidence interval, VAS: Visual Analogic Scale, FAS: Full analysis set, EndoSP: Endomethasone SP root canal sealer

Figure 4

Maximum masticatory pain level in the 7 days after endodontic treatment self-estimated on a 0-100mmm visual analogic scale (VAS) in the FAS population. (a) Boxplot of maximum masticatory pain intensity. A significant difference was found between EndoN and EndoSP pain scores (p<0.0001). In red; Min: Minimum (lowest value excluding outliers), Q1: Lower Quartile (25^th percentile), Med: Median value (50^th percentile), Q3: Upper Quartile (75^th percentile), Max: Maximum (highest value excluding outliers), mean by group (green lines), global mean (grey line) and observed values (black dots) of maximum spontaneous pain level following the 7 days after endodontic treatment (VAS 100mm). (b) Mean and CI95% of VAS score during the 7 days of the follow-up EndoN: Endomethasone N root canal sealer, EndoSP: Endomethasone SP root canal sealer, FAS: Full analysis set, CI: Confidence interval