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.
ABSTRACT
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.
ABSTRACT
Patients with Ehlers-Danlos Syndrome (EDS) frequently suffer from severe chronic pain. We carried out an observational cohort study to assess the effectiveness of compression garments (CGs) for reducing this pain. Patients with non-vascular EDS were given custom-made Cerecare® CGs during a visit to a specialist clinic (visit V0). They were followed up over 2 years with visits every 6 months (V1-V4). At each visit, pain was assessed for the joints treated with CGs using a visual analogue scale (VAS; 0-100 mm). Additional measures were obtained to assess neuropathic pain (painDETECT questionnaire), proprioception/balance (Berg Balance Scale), and functional independence, amongst others. Data were analyzed for 67 patients with EDS (hypermobile: 91%; classical: 6%; kyphoscoliotic: 3%). For the most painful joint, the mean VAS rating was 71.5 ± 22.8 mm at V0; this decreased to 53.5 ± 25.5 mm at V1 and 45.7 ± 29 mm at V4 (t-tests: p < 0.0001). From V0 to V4, improvements were also seen for pain at the other joints, neuropathic pain, functional independence, proprioception/balance, and the incidence of sprains and dislocations/subluxations, although not all comparisons were statistically significant (p < 0.05 level). These results indicate that CGs may effectively reduce the pain and joint instability in non-vascular EDS patients.
ABSTRACT
BACKGROUND: HIV pre-exposure prophylaxis (PrEP) data in men who have sex with men (MSM) in west Africa are essential to guide its large-scale implementation. We assessed the uptake of event-driven and daily PrEP, HIV incidence, and changes over time in sexual behaviours and prevalence of bacterial sexually transmitted infections (STIs) in MSM in Burkina Faso, Côte d'Ivoire, Mali, and Togo. METHODS: We did a prospective cohort study from Nov 20, 2017, to April 14, 2020, in four community-based clinics in Abidjan (Côte d'Ivoire), Bamako (Mali), Lomé (Togo), and Ouagadougou (Burkina Faso). Participants were MSM aged 18 years or older at substantial risk of HIV infection. Participants could choose between event-driven (2+1+1 dosing) and daily oral PrEP (tenofovir disoproxil fumarate 300 mg plus emtricitabine 200 mg), switch regimen, and discontinue or restart PrEP. We compared HIV incidence in this study with that of the same cohort before the availability of PrEP (CohMSM). Statistical analysis included the Kaplan-Meier method and mixed-effects regression models. This study is registered with ClinicalTrials.gov, NCT03459157. FINDINGS: We followed up 598 participants for a total of 743·6 person-years. At enrolment, 445 (74%) of 598 participants chose event-driven PrEP and 153 (26%) of 598 chose daily PrEP. 60 (13%) of 445 and 65 (42%) of 153 participants switched PrEP regimen at least once (p<0·0001). 159 participants (27%) were lost to follow-up. Overall HIV incidence was 2·3 per 100 person-years (95% CI 1·3-3·7; adjusted incidence rate ratio 0·21, 95% CI 0·12-0·36 compared with CohMSM). Adherence was optimal in 802 (41%) of 1946 measures with event-driven PrEP and in 394 (71%) of 554 measures with daily PrEP (p<0·0001). Coverage of sex acts with PrEP only and PrEP and condom decreased during follow-up (p=0·039 if PrEP only; p=0·0025 if PrEP and condom). The frequency of condomless anal sex remained stable (p=0·96). The number of male sexual partners (p<0·0001) and number of sex acts with casual male partners (p=0·0014 for 1-4 sex acts in previous 4 weeks; p=0·030 for ≥5 sex acts) decreased. The prevalence of gonorrhoea, chlamydia, and syphilis remained stable. INTERPRETATION: PrEP availability helped prevent HIV infection and did not lead to an increase in risky sexual behaviours or other STIs. PrEP should be urgently implemented in west Africa. Retention in care and PrEP adherence require special attention to ensure PrEP reaches its full prevention potential. FUNDING: ANRS and Expertise France. TRANSLATION: For the French translation of the abstract see Supplementary Materials section.
