Éxito y fracaso de restauraciones postendodónticas individuales

Objetivo: El presente estudio tuvo como objetivo determinar el éxito o fracaso de restauraciones postendodónticas individuales (RPI), con sistema poste-corona, realizadas en la Facultad de Odontología de la Universidad de Cuenca en el periodo 2012 - 2017. Metodología: Fue un estudio descriptivo de corte transversal en el cual se examinó una muestra de 121 RPI con poste-corona. Se realizó un análisis clínico para verificar fallas en las restauraciones seleccionadas. En casos de sospecha de fractura del sistema poste-corona, se realizó un análisis radiográfico para establecer el estado de éxito o fracaso de dichas restauraciones. Resultados: Se evidenció un 87,6% de RPI exitosas. La causa de fracaso clínico más frecuente fue la descementación de la corona. Las restauraciones coronales de cerámica presentaron un éxito de 96,8%; mientras que las RPI que tuvieron como material de restauración coronal al acrílico, presentaron un 100% de fracaso. Conclusiones: Con el presente estudio fue posible evidenciar un alto porcentaje de éxito en las RPI realizadas en la Facultad de Odontología de la Universidad de Cuenca. El éxito fue superior en: restauraciones ubicadas en piezas posteriores y también en las piezas que utilizaron postes intraconducto de metal colado; no hay diferencia en el porcentaje de éxito y fracaso entre los diferentes materiales de restauración coronal, salvo en RPI con coronas de acrílico que mostraron fracaso total. La causa de fracaso más frecuente fue la descementación coronalObjective: The aim of this study was to determine the success or failure of postendodontic individual restorations (IPR), with a post-crown system, carried out in the Faculty of Dentistry of the University of Cuenca in the period 2012 - 2017. Methods: It was a descriptive cross-sectional study in which a sample of 121 IPR with post-crown was examined. A clinical analysis was performed to verify faults in the selected restorations. In cases of suspected post-crown system fracture, a radiographic analysis was made in order to corroborate the clinical evidence. Results: 87.6% of successful IPRs were evidenced. The most frequent cause of clinical failure was the de-coronation. The coronal ceramic restorations presented a success of 96.8%; while the IPR that had as a coronal restoration material to the acrylic, presented a 100% failure. Conclusions: With the present study it was possible to demonstrate a high percentage of success in the IPR performed in the Faculty of Dentistry of the University of Cuenca. The success was superior in: restorations located in posterior pieces and also in the pieces that used intra root cast metal posts; there is no difference in the percentage of success and failure between the different coronal restoration materials, except in IPR with acrylic crowns that showed total failure. The most frequent cause of failure was crown descementationOdontólogoCuenc

Efficacy and safety of the CVnCoV SARS-CoV-2 mRNA vaccine candidate in ten countries in Europe and Latin America (HERALD): a randomised, observer-blinded, placebo-controlled, phase 2b/3 trial

Background: Additional safe and efficacious vaccines are needed to control the COVID-19 pandemic. We aimed to analyse the efficacy and safety of the CVnCoV SARS-CoV-2 mRNA vaccine candidate. Methods: HERALD is a randomised, observer-blinded, placebo-controlled, phase 2b/3 clinical trial conducted in 47 centres in ten countries in Europe and Latin America. By use of an interactive web response system and stratification by country and age group (18–60 years and ≥61 years), adults with no history of virologically confirmed COVID-19 were randomly assigned (1:1) to receive intramuscularly either two 0·6 mL doses of CVnCoV containing 12 μg of mRNA or two 0·6 mL doses of 0·9% NaCl (placebo) on days 1 and 29. The primary efficacy endpoint was the occurrence of a first episode of virologically confirmed symptomatic COVID-19 of any severity and caused by any strain from 15 days after the second dose. For the primary endpoint, the trial was considered successful if the lower limit of the CI was greater than 30%. Key secondary endpoints were the occurrence of a first episode of virologically confirmed moderate-to-severe COVID-19, severe COVID-19, and COVID-19 of any severity by age group. Primary safety outcomes were solicited local and systemic adverse events within 7 days after each dose and unsolicited adverse events within 28 days after each dose in phase 2b participants, and serious adverse events and adverse events of special interest up to 1 year after the second dose in phase 2b and phase 3 participants. Here, we report data up to June 18, 2021. The study is registered at ClinicalTrials.gov, NCT04652102, and EudraCT, 2020–003998–22, and is ongoing. Findings: Between Dec 11, 2020, and April 12, 2021, 39 680 participants were enrolled and randomly assigned to receive either CVnCoV (n=19 846) or placebo (n=19 834), of whom 19 783 received at least one dose of CVnCoV and 19 746 received at least one dose of placebo. After a mean observation period of 48·2 days (SE 0·2), 83 cases of COVID-19 occurred in the CVnCoV group (n=12 851) in 1735·29 person-years and 145 cases occurred in the placebo group (n=12 211) in 1569·87 person-years, resulting in an overall vaccine efficacy against symptomatic COVID-19 of 48·2% (95·826% CI 31·0–61·4; p=0·016). Vaccine efficacy against moderate-to-severe COVID-19 was 70·7% (95% CI 42·5–86·1; CVnCoV 12 cases in 1735·29 person-years, placebo 37 cases in 1569·87 person-years). In participants aged 18–60 years, vaccine efficacy against symptomatic disease was 52·5% (95% CI 36·2–64·8; CVnCoV 71 cases in 1591·47 person-years, placebo, 136 cases in 1449·23 person-years). Too few cases occurred in participants aged 61 years or older (CVnCoV 12, placebo nine) to allow meaningful assessment of vaccine efficacy. Solicited adverse events, which were mostly systemic, were more common in CVnCoV recipients (1933 [96·5%] of 2003) than in placebo recipients (1344 [67·9%] of 1978), with 542 (27·1%) CVnCoV recipients and 61 (3·1%) placebo recipients reporting grade 3 solicited adverse events. The most frequently reported local reaction after any dose in the CVnCoV group was injection-site pain (1678 [83·6%] of 2007), with 22 grade 3 reactions, and the most frequently reported systematic reactions were fatigue (1603 [80·0%] of 2003) and headache (1541 [76·9%] of 2003). 82 (0·4%) of 19 783 CVnCoV recipients reported 100 serious adverse events and 66 (0·3%) of 19 746 placebo recipients reported 76 serious adverse events. Eight serious adverse events in five CVnCoV recipients and two serious adverse events in two placebo recipients were considered vaccination-related. None of the fatal serious adverse events reported (eight in the CVnCoV group and six in the placebo group) were considered to be related to study vaccination. Adverse events of special interest were reported for 38 (0·2%) participants in the CVnCoV group and 31 (0·2%) participants in the placebo group. These events were considered to be related to the trial vaccine for 14 (<0·1%) participants in the CVnCoV group and for five (<0·1%) participants in the placebo group. Interpretation: CVnCoV was efficacious in the prevention of COVID-19 of any severity and had an acceptable safety profile. Taking into account the changing environment, including the emergence of SARS-CoV-2 variants, and timelines for further development, the decision has been made to cease activities on the CVnCoV candidate and to focus efforts on the development of next-generation vaccine candidates. Funding: German Federal Ministry of Education and Research and CureVac