RESUMO
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.
RESUMO
STATEMENT OF PROBLEM: Gingival displacement is used in prosthodontics to obtain an accurate impression. However, randomized clinical trials to analyze the performance of different gingival displacement products are lacking. PURPOSE: The purpose of this prospective, comparative randomized clinical trial was to evaluate the clinical effectiveness of 3 gingival displacement techniques: Racegel cordless, Racegel with a cord, and Racestyptine with a cord. MATERIAL AND METHODS: A prospective, multicenter randomized, open label, 3-arm parallel group study was carried out in private dental practices. Patients with prepared teeth with healthy gingiva were recruited to make impressions before and after gingival displacement, which were digitized. Lateral and vertical gingival displacements were measured with computer-aided 3-dimensional analysis performed by a single operator who was blinded to the technique and the patient. For mean lateral gingival displacement, each gingival displacement method was compared with a required clinical value of 200 µm with the Student t test. The comparison of means among the 3 groups was performed using an ANOVA. Periodontal indices were recorded immediately and 7 to 14 days after gingival displacement. The percentages were compared with the chi-squared test or the Fisher exact test (α=.05 for all tests). RESULTS: Eighty-eight participants were enrolled. The mean lateral gingival displacement obtained by Racestyptine with a cord (253 ±59 µm, P<.001) and by Racegel with a cord (247 ±61 µm, P<.001) were significantly higher than 200 µm. Lateral displacement observed with Racegel cordless was 207 ±57 µm (P=.53). For vertical gingival displacement, no difference among the 3 techniques was found. The astringent effect of these products was confirmed by the absence of crevicular fluid or bleeding. No periodontal damage was observed immediately or 7-14 days after displacement. CONCLUSIONS: The study showed that cord impregnated with Racestyptine and Racegel with or without a cord provided a sufficient sulcus opening before impression making in prosthodontics, consistent with the clinical requirements for lateral displacement.
