Efficacy and Safety of Subcutaneous Esketamine in the Treatment of Suicidality in Major Depressive Disorder and Bipolar Depression.

BACKGROUND AND OBJECTIVE: Affective disorders account for most cases of suicide. The pharmacological arsenal to treat suicidality is limited and available agents take too long to take effect. A large body of evidence shows optimal results of ketamine for treating depression, but the evidence concerning suicidality has not been fully described. We report the first real-world study of severely depressed patients presenting with suicide ideation who were treated with repeated administration of subcutaneous esketamine. METHODS: We analyzed data from 70 acutely depressed subjects diagnosed with resistant major depressive disorder or bipolar depression. Subjects were administered subcutaneous esketamine once a week for 6 weeks. The primary efficacy endpoint, the change from baseline to 24-h post-administration 6 in the item 10 Montgomery-Åsberg Depression Rating Scale score, was analyzed using a mixed-effects repeated-measures model. RESULTS: There were significant effects for time on item 10 Montgomery-Åsberg Depression Rating Scale scores (p < 0.0001) but not for a time × diagnosis interaction (p = 0.164) from baseline to the end of the study. Efficacy of esketamine did not differ between groups (major depressive disorder vs bipolar depression) at any timepoint. Statistical significance on suicidality scores was observed from 24 h after the first administration (p < 0.001), and a further reduction was observed with repeated administrations. Esketamine was safe and well tolerated. Mean heart rate remained stable during the administrations and the blood pressure increase was self-limited. CONCLUSIONS: Repeated subcutaneous esketamine administration had significant anti-suicidality effects in both major depressive disorder and bipolar groups, with a rapid onset of action and a good tolerability profile. Large randomized controlled trials are warranted to confirm these preliminary findings.

Medidas de control epidemiológico en el sector empresarial e impacto de la pandemia sobre la creación de empresas en el departamento del Magdalena Colombia / Epidemiological control measurements at the business sector and impact of pandemic on business creation in the department of Magdalena Colombia

Este trabajo se propone analizar el impacto de la pandemia por COVID-19 en los registros de creación de nuevas empresas en el departamento del Magdalena (Colombia) principalmente entre el 2019 y 2020, de la misma manera se desarrolla un análisis de las medidas de control epidemiológico a nivel nacional y a nivel departamental para comprender de mejor manera las iniciativas de contención de la COVID-19. Para el desarrollo de este trabajo, se tomaron como referencia los datos de creación de empresas de los últimos cinco años (2016 ­ 2020) en el Magdalena; así como se analizaron medidas para el control epidemiológico a nivel nacional (prevenir, mitigar, y suprimir), así como las adoptadas específicamente para el Magdalena. Entre los principales hallazgos, se encontró que, al contrastar los años 2019 y 2020, hubo una disminución del 2,6% en la creación de nuevas empresas en el departamento del Magdalena, porcentaje que representa 202 unidades productivas menos que en 2019; esta tendencia decreciente en materia de creación de empresas, venía desde 2019, año en el que hubo una caída del 0,8% en los nacimientos de nuevas empresas con respecto al 2018 -62 empresas menos-; la contundente caída en el año 2020 es un reflejo del nefasto efecto de la aparición de la COVID-19 en las dinámicas empresariales en el Magdalena; de otra parte, resaltan medidas de gestión intergremial al igual que las estrategias de apoyo financiero para dinamizar la economía en el Magdalena, así como una cronología prudente en materia de controles epidemiológicos en el Territorio(AU)

This study aims to analyze the impact of the COVID-19 pandemic on the records of the creation of new companies in the department of Magdalena (Colombia), mainly between 2019 and 2020. In the same way, an analysis of epidemiology control measures is developed at the national and departmental levels to better understand COVID-19 containment initiatives. For the development of this study, the data on business creation of the last five years (2016 - 2020) in Magdalena was taken as a reference; as well as measures for epidemiological control at the national level (prevent, mitigate, and suppress), along with those adopted specifically for Magdalena were analyzed. Among the main findings, it was found that, when comparing the years 2019 and 2020, there was a 2.6% decrease in the creation of new companies in Magdalena, a percentage that represents 202 production units less than in 2019; This downward trend in the creation of companies came from 2019, the year in which there was a 0.8% drop in the establishment of new companies compared to 2018 -62 fewer companies-; the overwhelming drop in 2020 is a reflection of the disastrous effect of the appearance of COVID-19 on business dynamics in Magdalena; On the other hand, the business associations management measures were a key important factor. Additionally, the financial support to boost the economy in Magdalena, as well as a prudent chronology - in terms of epidemiological controls in the Territory(AU)

Impact of Repeated Doses of Subcutaneous Esketamine on Acute Dissociative Symptoms in Treatment-Resistant Depression.

BACKGROUND: Esketamine has been approved by the US Food and Drug Administration (FDA) as an adjunctive treatment for use in conjunction with an oral antidepressant for patients with treatment-resistant depression (TRD), but dissociative symptoms are common adverse effects. METHODS: A retrospective analysis of 394 subcutaneous esketamine injections given to 70 patients with TRD that were administered once a week during a six-week trial in conjunction with oral antidepressant therapy. Doses between 0.5 to 1.0 mg/kg were administered according to the patient's response. Dissociative symptoms were assessed using the Clinician-Administered Dissociative States Scale (CADSS) 30 and 60 min after every weekly treatment (day 1, 8, 15, 22, 29 and 36). RESULTS: Seventy patients received a total of 394 subcutaneous esketamine injections over six weeks. Over time, the evolution of CADSS scores demonstrated a significant mean difference of CADSS at 60 min post-injection (p = 0.010) throughout the six infusions. The mean CADSS scores at 60 min on day 22, 29 and 36 were similar. There were no differences between mean CADSS scores 30 min after the injections, no clinical correlation between response and dissociative symptoms, no correlation between time and demographic and clinical characteristics and no interactions between time and combined medication. CONCLUSIONS: Our results suggest that repeated subcutaneous esketamine doses are safe and well-tolerated regarding their acute dissociative and psychotomimetic symptoms. Symptoms usually peak at 30 min and decrease at 60 min post-injection, returning to their pretreatment levels at 120 min. Dissociative symptoms do not correlate with antidepressant response.

The probability of response after each subcutaneous injection of esketamine in treatment-resistant depression.

INTRODUCTION: The administration of multiple esketamine doses has shown efficacy for unipolar and bipolar treatment-resistant depression (TRD). Nevertheless, the probability of responding or not after each dose in the real-world remains unknown. This study aimed to estimate it throughout four doses of esketamine, administrated via subcutaneous (SC). MATERIAL AND METHODS: We conducted a retrospective analysis of a case series of 70 patients with TRD who received treatment from the esketamine assistance program at Federal University of Sao Paulo, between April 2017 and December 2018. The SC injections were administrated weekly at a dose of 0.5-1.0mg/kg, in conjunction with patients' psychotropic drugs. Response was defined as a decrease of at least 50% in the Montgomery-Åsberg Depression Rating Scale between baseline and 24h after dose. We used hidden Markov modeling in order to estimate de probability of response after each esketamine injection. RESULTS: The probability of a patient that was a "non-responder" to become a "responder" following a SC injection of esketamine was 17.30% and the probability that this patient remains a "non-responder" was 82.70%. The probability of a patient that was a "responder" to remain as a "responder" was 95%. CONCLUSIONS: Patients with TRD who had not responded after the first dose of esketamine, still had a chance of responding after the subsequent dose administrated via SC.

A global field study of the international classification of diseases (ICD-11) mood disorders clinical descriptions and diagnostic guidelines.

BACKGROUND: We report results of an internet-based field study evaluating the diagnostic guidelines for ICD-11 mood disorders. Accuracy of clinicians' diagnostic judgments applying draft ICD-11 as compared to the ICD-10 guidelines to standardized case vignettes was assessed as well as perceived clinical utility. METHODS: 1357 clinician members of the World Health Organization's Global Clinical Practice Network completed the study in English, Spanish, Japanese or Russian. Participants were randomly assigned to apply ICD-11 or ICD-10 guidelines to one of eleven pairs of case vignettes. RESULTS: Clinicians using the ICD-11 and ICD-10 guidelines achieved similar levels of accuracy in diagnosing mood disorders depicted in vignettes. Those using the ICD-11 were more accurate in identifying depressive episode in recurrent depressive disorder. There were no statistically significant differences detected across classifications in the accuracy of identifying dysthymic or cyclothymic disorder. Circumscribed problems with the proposed ICD-11 guidelines were identified including difficulties differentiating bipolar type I from bipolar type II disorder and applying revised severity ratings to depressive episodes. Clinical utility of ICD-11 bipolar disorders was found to be significantly lower than for ICD-10 equivalent categories. LIMITATIONS: Standardized case vignettes were manipulated to evaluate specific changes. The degree of accuracy of clinicians' diagnostic judgments may not reflect clinical decision-making with patients. CONCLUSIONS: Alignment of the ICD-11 with current research appears to have been achieved without sacrificing diagnostic accuracy or clinical utility though specific training may be necessary as ICD-11 is implemented worldwide. Areas in which the ICD-11 guidelines did not perform as intended resulted in further revisions.

A Clinical Rationale for Assessing the Impact of Childhood Sexual Abuse on Adjunctive Subcutaneous Esketamine for Treatment-Resistant Depression.

Background: A history of child sexual abuse (CSA) is related to higher suicide rates and poor treatment outcomes in depressed adult patients. Twenty years after the first study investigating the effects of ketamine/esketamine on depression and suicide, there is a lack of data on the CSA effects on this emerging treatment. Here, we assess the impact of CSA on adjunctive subcutaneous (SC) esketamine for treatment-resistant depression (TRD). Methods: A directed acyclic graphic (DAG) was designed to identify clinical confounders between CSA and esketamine predictors of response. The confounders were applied in a statistical model to predict depression symptom trajectory in a sample of 67 TRD outpatients. Results: The patient sample had a relatively high prevalence rate of CSA (35.82%). Positive family history of first-degree relatives with alcohol use disorder and sex were clinical mediators of the effects of esketamine in a CSA adult population. Overall, the presence of at least one CSA event was unrelated to esketamine symptom reduction. Conclusions: Unlike responses to conventional antidepressants and psychotherapy, CSA does not appear to predict poor response to esketamine.

Repeated subcutaneous esketamine for treatment-resistant depression: Impact of the degree of treatment resistance and anxiety comorbidity.

BACKGROUND: A large number of studies indicate that subanesthetic doses of ketamine induce a fast antidepressant effect. Limited studies have investigated the subcutaneous (SC) route, and it remains unclear for whom this treatment is most suitable. AIMS: The aim of this study was to examine the effect on depressive symptoms of repeated subanesthetic doses of SC esketamine in unipolar and bipolar treatment-resistant depression (TRD) and clinical predictors of response. METHODS: A retrospective analysis of 70 patients who received six SC esketamine doses weekly as an adjunctive treatment was carried out. Doses started at 0.5 mg/kg and it could be titrated up to 1 mg/kg, according to response. The primary outcome was reduction in depressive symptoms. Statistical analysis to investigate clinical predictors of effectiveness included logistic regression analysis using a dependent variable of a 50% reduction in rating scale scores at the end of treatment. Comparisons between groups were made through analysis of variance and treatment effects. RESULTS: At baseline, our sample presented with severe treatment resistance in 65.7%, as assessed by the Maudsley Staging Method (MSM), and 47.1% had anxiety disorder comorbidity. The response rate was 50%. A better outcome was predicted by mild and moderate MSM scores (OR = 3.162, p = 0.041) and anxiety disorder comorbidity (OR = 3.149, p = 0.028). CONCLUSIONS: Our results suggest that higher levels of treatment resistance may be associated with a poor response to SC esketamine. Unlike traditional pharmacotherapies, it might benefit those with poor prognosis such as patients with depression and comorbid anxiety. Therefore, future research could investigate whether esketamine should receive a more prominent place in the treatment algorithm for TRD.

Comparative effectiveness of esketamine in the treatment of anhedonia in bipolar and unipolar depression.

BACKGROUND: Anhedonia is a symptom associated with poorer outcomes in depression treatment, including resistance to treatment, higher functional impact and suicidality. Few drugs are known to adequately treat anhedonia in both unipolar and bipolar depression. The NMDA antagonist ketamine has been demonstrated to be effective in rapidly ameliorating anhedonia in depressive episodes. The main aim of present study is to evaluate the anti-anhedonic effect of esketamine, the S-enantiomer of ketamine recently approved for treatment-resistant depression, in unipolar and bipolar depression. METHODS: 70 patients with unipolar or bipolar depression were treated with 6 weekly subcutaneous esketamine infusions (0.5-1mg/kg). Anhedonia was measured through MADRS item 8 before and 24h after each infusion. RESULTS: A significant reduction in anhedonia severity was observed (p<0.0001) after 6 infusions. The effect was statistically significant 24h after the first infusion (p<0.001) in both unipolar and bipolar groups and increased with repeated infusions. Anti-anhedonic effect of esketamine did not differ between groups. LIMITATIONS: This is an open-label, real-world study. Lack of blinding and of a placebo arm may limit the interpretation of findings. CONCLUSION: Although preliminary, present findings suggest that repeated subcutaneous esketamine infusions are effective for the treatment of anhedonia in both unipolar and bipolar depressed patients. These results need to be confirmed through replication in larger double-blinded controlled trials.

The probability of response after each subcutaneous injection of esketamine in treatment-resistant depression.

INTRODUCTION: The administration of multiple esketamine doses has shown efficacy for unipolar and bipolar treatment-resistant depression (TRD). Nevertheless, the probability of responding or not after each dose in the real-world remains unknown. This study aimed to estimate it throughout four doses of esketamine, administrated via subcutaneous (SC). MATERIAL AND METHODS: We conducted a retrospective analysis of a case series of 70 patients with TRD who received treatment from the esketamine assistance program at Federal University of Sao Paulo, between April 2017 and December 2018. The SC injections were administrated weekly at a dose of 0.5-1.0mg/kg, in conjunction with patients' psychotropic drugs. Response was defined as a decrease of at least 50% in the Montgomery-Åsberg Depression Rating Scale between baseline and 24h after dose. We used hidden Markov modeling in order to estimate de probability of response after each esketamine injection. RESULTS: The probability of a patient that was a "non-responder" to become a "responder" following a SC injection of esketamine was 17.30% and the probability that this patient remains a "non-responder" was 82.70%. The probability of a patient that was a "responder" to remain as a "responder" was 95%. CONCLUSIONS: Patients with TRD who had not responded after the first dose of esketamine, still had a chance of responding after the subsequent dose administrated via SC.

Effects of subcutaneous esketamine on blood pressure and heart rate in treatment-resistant depression.

INTRODUCTION AND OBJECTIVES: The impact of multiple subcutaneous (s.c.) esketamine injections on the blood pressure (BP) and heart rate (HR) of patients with unipolar and bipolar treatment-resistant depression (TRD) is poorly understood. This study aimed to assess the cardiovascular safety of multiple s.c. doses of esketamine in patients with TRD. METHODS: Seventy TRD patients received 394 weekly s.c. esketamine injections in conjunction with oral antidepressant therapy for up to six weeks. Weekly esketamine doses were 0.5, 0.75 or 1.0 mg/kg according to each patient's response to treatment. Participants were monitored before each treatment and every 15 minutes thereafter for 120 minutes. We assessed systolic blood pressure (SBP), diastolic blood pressure (DBP), and HR measurements for the entire treatment course. RESULTS: BP increased after the first s.c. esketamine injection, reaching maximum mean SBP/DBP levels of 4.87/5.54 mmHg within 30-45 minutes. At the end of monitoring, 120 minutes post dose, vital signs returned to pretreatment levels. We did not detect significant differences in BP between doses of 0.5, 0.75, and 1 mg/kg esketamine. Mean HR did not differ significantly between doses or before and after s.c. esketamine injection. CONCLUSIONS: The BP changes observed with repeated s.c. esketamine injections were mild and well tolerated for doses up to 1 mg/kg. The s.c. route is a simple and safe method of esketamine administration, even for patients with clinical comorbidities, including obesity, hypertension, diabetes, and dyslipidemia. However, 14/70 patients experienced treatment-emergent transient hypertension (SBP >180 mmHg and/or a DBP >110 mmHg). Therefore, we strongly recommend monitoring BP for 90 minutes after esketamine dosing. Since s.c. esketamine is cheap, requires less frequent dosing (once a week), and is a simpler procedure compared to intravenous infusions, it might have an impact on public health.

Which materials would account for a better mechanical behavior for direct endocrown restorations?

PURPOSE: To investigate the mechanical performance and fracture behavior of endocrown restorations prepared using different composite materials and following a direct technique. METHODS: Sound molars were cut at 2 mm above the cementoenamel junction, endodontically treated, and allocated according to the type of restoration (n = 7): without post (endocrowns) or with post (post-retained restorations). Endocrowns were fabricated with conventional composite (Filtek Z350); bulk fill composite (Filtek Bulk Fill); conventional composite modeled using resin adhesives (SBMP: Scotchbond Multipurpose Adhesive; or SBU: Scotchbond Universal Adhesive); and lithium disilicate ceramic (E.max; Positive control). The post-retained restorations were fabricated with glass-fiber post combined with conventional or bulk fill composites. All restorations were bonded following an etch-and-rise adhesive approach or self-adhesive resin cement. The teeth were submitted to fatigue (Byocycle) and compression (EMIC DL500) testing at a crosshead speed of 1 mm/min. Data were analyzed with ANOVA and Tukey (p < 0.05) and Weibull analysis was carried out in order to evaluate the reliability of restorations. RESULTS: The bulk-fill-based endocrown showed a stronger performance than the control. The presence of SBMP or the use of bulk-fill composite resulted in the occurrence of less aggressive fractures than the other restorative systems. Endocrowns bonded directly to the tooth seemed to produce similar fracture strength properties as compared to endocrowns bonded using self-adhesive resin cementation. The bulk-fill-based endocrown showed the greatest reliability of study. CONCLUSION: Resin-based restorative materials seem to be interesting alternative options to fabricate large dental restorations in lieu of the more traditionally used glass ceramics or root canal post systems.

Efficacy and safety of adjunctive therapy using esketamine or racemic ketamine for adult treatment-resistant depression: A randomized, double-blind, non-inferiority study.

BACKGROUND: Ketamine and its enantiomers have recently been highlighted as one of the most effective therapeutic options in refractory depression. However, racemic ketamine and esketamine have not been directly compared. The aim of this study is to assess the efficacy and safety of esketamine compared to ketamine in patients with treatment-resistant depression (TRD). METHODS: This is a randomized, double-blind, active-controlled, bicentre, non-inferiority clinical trial, with two parallel groups. Participants were randomly assigned to a 40-min single intravenous infusion of ketamine 0.5 mg/kg or esketamine 0.25 mg/kg. The primary outcome was the difference in remission rates for depression 24 h following intervention using the Montgomery-Åsberg Depression Rating Scale (MADRS), with a non-inferiority margin of 20%. RESULTS: 63 subjects were included and randomly assigned (29 to receive ketamine and 34 to receive esketamine). At 24 h, 24.1% of participants in the ketamine group and 29.4% of participants in the esketamine group showed remission, with a difference of 5.3% (95% CILB -13.6%), confirming non-inferiority. MADRS scores improved from 33 (SD 9.3) to 16.2 (SD 10.7) in the ketamine group and from 33 (SD 5.3) to 17.5 (SD 12.2) in the esketamine one, with a difference of -5.27% (95% CILB, -13.6). Both groups presented similar mild side effects. CONCLUSIONS: Esketamine was non-inferior to ketamine for TRD 24 h following infusion. Both treatments were effective, safe, and well tolerated. TRIAL REGISTRATION: Registered in Japan Primary Registries Network: UMIN000032355.

New material perspective for endocrown restorations: effects on mechanical performance and fracture behavior.

The aim of this study was to investigate the mechanical performance and the fracture behavior of endocrown restorations prepared using distinct restorative materials. A total of 42 sound molars with similar crown size and shape were cut at 2 mm above the cementoenamel junction and endodontically treated. They were categorized according to the restorative material used to fabricate endocrown restorations (n=7), namely, conventional composite (Filtek™ Z350 XT), bulk fill composite (Filtek™ Bulk Fill), conventional composite modeled using resin adhesives (SBMP: Scotchbond™ Multipurpose Adhesive; or SBU: Scotchbond™ Universal Adhesive), and IPS e.max lithium disilicate (Ivoclar Vivadent; positive control). Unprepared sound teeth were used as negative control. All endocrowns were bonded using a self-adhesive cement (Rely-X™ U200). The teeth were submitted to fatigue (Byocycle) and fracture (EMIC DL500) testing. Load-to-fracture (in N) and work-of-fracture (Wf, in J/m2) values were analyzed by ANOVA (p < 0.05). The endocrowns did not fracture or de-bond upon fatigue, showing similar load-to-fracture and work-of-fracture values, regardless of the restorative material (p > 0.05). The endocrowns fabricated by combining Z350 and SBMP had the least harsh fractures, in contrast to endocrowns prepared using Z350 only, which exhibited an equilibrium between repairable and irrepairable fractures. The e.max endocrowns exhibited more aggressive failures (root fracture) than other groups, resulting in higher rates of irrepairable fractures. In conclusion, dental practitioners may satisfactorily restore severely damaged nonvital teeth using the endocrown technique. Composite endocrowns prepared using resin adhesive as modeler liquid or using bulk fill material may result in less aggressive failures, thus providing a new material perspective for endocrown restorations.

New material perspective for endocrown restorations: effects on mechanical performance and fracture behavior

Abstract The aim of this study was to investigate the mechanical performance and the fracture behavior of endocrown restorations prepared using distinct restorative materials. A total of 42 sound molars with similar crown size and shape were cut at 2 mm above the cementoenamel junction and endodontically treated. They were categorized according to the restorative material used to fabricate endocrown restorations (n=7), namely, conventional composite (Filtek™ Z350 XT), bulk fill composite (Filtek™ Bulk Fill), conventional composite modeled using resin adhesives (SBMP: Scotchbond™ Multipurpose Adhesive; or SBU: Scotchbond™ Universal Adhesive), and IPS e.max lithium disilicate (Ivoclar Vivadent; positive control). Unprepared sound teeth were used as negative control. All endocrowns were bonded using a self-adhesive cement (Rely-X™ U200). The teeth were submitted to fatigue (Byocycle) and fracture (EMIC DL500) testing. Load-to-fracture (in N) and work-of-fracture (Wf, in J/m2) values were analyzed by ANOVA (p < 0.05). The endocrowns did not fracture or de-bond upon fatigue, showing similar load-to-fracture and work-of-fracture values, regardless of the restorative material (p > 0.05). The endocrowns fabricated by combining Z350 and SBMP had the least harsh fractures, in contrast to endocrowns prepared using Z350 only, which exhibited an equilibrium between repairable and irrepairable fractures. The e.max endocrowns exhibited more aggressive failures (root fracture) than other groups, resulting in higher rates of irrepairable fractures. In conclusion, dental practitioners may satisfactorily restore severely damaged nonvital teeth using the endocrown technique. Composite endocrowns prepared using resin adhesive as modeler liquid or using bulk fill material may result in less aggressive failures, thus providing a new material perspective for endocrown restorations.

Comparative study of esketamine and racemic ketamine in treatment-resistant depression: Protocol for a non-inferiority clinical trial.

INTRODUCTION: The use of ketamine as an option in the treatment of depressive disorder is growing rapidly, supported by numerous clinical trials attesting its efficacy and safety. Esketamine, the S (+) enantiomer of ketamine, is the most widely used form in the anesthetic environment in some countries, and new studies have shown that it may also be effective in depression and with better tolerability. However, no study so far has directly compared esketamine with racemic ketamine. Here we propose a protocol of a clinical trial to evaluate esketamine as a noninferior medication when compared to ketamine in the treatment of patients with treatment-resistant depression. METHODS/DESIGN: This study protocol is for a randomized, controlled, double-blind noninferiority clinical trial. Subjects will be 18 years or older, with major depression characterized as treatment-resistant. Participants will receive a single infusion of either esketamine (0.25 mg/kg) or ketamine (0.5 mg/kg) over 40 minutes. The primary outcome will be the difference in remission rates between the 2 treatment arms at 24 and 72 hours after drug infusion. Secondary outcomes will include other timepoints, measurements of cognition, dissociation, and blood biomarkers. DISCUSSION: A head-to-head study is the best way to evaluate whether the esketamine is in fact comparable to the racemic ketamine in terms of both efficacy and safety, and, if positive, it would be an initial step to increase the access to that type of treatment worldwide. ETHICS AND DISSEMINATION: The study was approved by the local Institutional Review Board (University Hospital Professor Edgard Santos-Federal University of Bahia-Number: 46657415.0.0000.0049). Subjects will only participate after voluntarily agreeing and signing the Informed Consent Form. The study findings will be published in peer-reviewed journals and presented at national and international conferences. TRIAL REGISTRATION: This trial has been registered in the Japan Primary Registries Network (JPRN): UMIN000032355, which is affiliated with the World Health Organization.

Translucency and color stability of resin composite and dental adhesives as modeling liquids - A one-year evaluation.

The aim of this study is to evaluate the influence of modeling liquids on the translucency and color shade of resin composites (RCs) after one year of storage. RC specimens were prepared using either a conventional insertion technique (control; without modeling liquid) or a restorative dental modeling insertion technique (RDMIT) with dental adhesives as modeling liquids (Scotchbond™ Multi-Purpose [SBMP; 3M ESPE] or Adper™ Single Bond 2 [SB; 3M ESPE]). The initial colors of the specimens were obtained with a digital spectrophotometer and the CIEL*a*b* color system, after which specimens were stored (37°C) in distilled water or red wine for 12 months. Color measurements were reassessed after 6 and 12 months of storage, and scanning electron microscopy was performed after 12 months. Translucency and color change (ΔE*) were calculated and analyzed using ANOVA and Tukey's test (α = 5%). RC samples prepared via RDMIT showed a translucency similar to that of control samples. ΔE* was also less intense for RCs containing SBMP than for RCs containing SB. Specimens stored in wine showed a clear pattern of degradation, especially in the control group, and surface degradation seemed to be less intense for specimens prepared with SBMP and SB than for specimens without. Specimens stored in water did not show clear evidence of surface degradation. RDMIT appears to be an interesting approach to reduce ΔE* in RCs over time without negative effects on the translucency of the material. However, the modeling liquid should feature a hydrophobic composition, similar to that used in the SBMP group, the achieve the best results.

Knowledge and attitudes of students and dentists about the use and cementation of intra-radicular posts / Conhecimentos e atitudes de estudantes e dentistas sobre o uso e cimentação de pinos intrarradiculares

Objectives: The aim of the study was assess the knowledge and attitudes of students and dentists about the use and cementation of intra-radicular posts. Material and Methods: This cross-sectional study interviewed 150 students and 150 dentists in the city of Pelotas (Brazil). A questionnaire containing questions regarding restorative choice in teeth with large coronal destruction, level of confidence for the use of post and resin cement, function of intra-radicular posts and social-demographic characteristics was applied. Data were analysed using descriptive analysis and associations were tested through logistic regression using 95% confidence intervals. Results: The analysis showed that students presented an odd to choose prefabricated posts 127% greater than the dentists for anterior teeth, 105% greater to choose self-adhesive resin cement and 46% greater to choose conventional resin cement. Considering posterior teeth, students presented an odd to choose prefabricated posts 40% smaller than the dentists and an odd 51% greater to choose conventional resin cement. Conclusion: The formation level (students or dentists) was directly related to clinical choices of the interviewed. The use of prefabricated posts seems to be related to the location of the tooth in the arch, with pre-fabricated posts being more indicated for anterior teeth. Use of pre-fabricated posts in teeth with large coronal destruction is accepted in the literature. However, dentists are still not confident to use of pre-fabricated fiber posts especially in posterior teeth with large coronal destruction. (AU)

Objetivo: o objetivo do estudo foi avaliar o conhecimento e as atitudes dos alunos e dentistas sobre o uso e cimentação de pinos intra-radiculares. Material e Métodos: este estudo transversal entrevistou 150 estudantes e 150 dentistas na cidade de Pelotas (Brasil). Foi aplicado um questionário contendo perguntas sobre a escolha restauração em dentes com grande destruição coronária, nível de confiança para o uso de pinos e cimento resinoso, função dos pinos intra-radiculares e características sociodemográficas. Os dados foram analisados utilizando análise descritiva e as associações foram testadas através de regressão logística usando intervalos de confiança de 95%. Resultados: A análise mostrou que os alunos apresentaram uma chance para escolher pinos pré-fabricados 127% maior que os dentistas para dentes anteriores, 105% maior para escolher cimento resinoso autoadesivo e 46% maior para escolher o cimento resinoso convencional. Considerando os dentes posteriores, os estudantes apresentaram uma chance para escolher os pinos pré-fabricados 40% menor do que os dentistas e uma chance 51% maior para escolher o cimento resinoso convencional. Conclusão: O nível de formação (estudantes ou dentistas) está diretamente relacionado às escolhas clínicas dos entrevistados. O uso de pinos pré- fabricados parece estar relacionado à localização do dente no arco, com pinos pré-fabricados sendo mais indicados para os dentes anteriores. O uso de pinos pré-fabricados em dentes com grande destruição coronária é aceito na literatura. No entanto, os dentistas ainda não estão confiantes para o uso de pinos pré-fabricados de fibra, especialmente em dentes posteriores com grande destruição coronária. (AU)

Translucency and color stability of resin composite and dental adhesives as modeling liquids - A one-year evaluation

Abstract The aim of this study is to evaluate the influence of modeling liquids on the translucency and color shade of resin composites (RCs) after one year of storage. RC specimens were prepared using either a conventional insertion technique (control; without modeling liquid) or a restorative dental modeling insertion technique (RDMIT) with dental adhesives as modeling liquids (Scotchbond™ Multi-Purpose [SBMP; 3M ESPE] or Adper™ Single Bond 2 [SB; 3M ESPE]). The initial colors of the specimens were obtained with a digital spectrophotometer and the CIEL*a*b* color system, after which specimens were stored (37°C) in distilled water or red wine for 12 months. Color measurements were reassessed after 6 and 12 months of storage, and scanning electron microscopy was performed after 12 months. Translucency and color change (ΔE*) were calculated and analyzed using ANOVA and Tukey's test (α = 5%). RC samples prepared via RDMIT showed a translucency similar to that of control samples. ΔE* was also less intense for RCs containing SBMP than for RCs containing SB. Specimens stored in wine showed a clear pattern of degradation, especially in the control group, and surface degradation seemed to be less intense for specimens prepared with SBMP and SB than for specimens without. Specimens stored in water did not show clear evidence of surface degradation. RDMIT appears to be an interesting approach to reduce ΔE* in RCs over time without negative effects on the translucency of the material. However, the modeling liquid should feature a hydrophobic composition, similar to that used in the SBMP group, the achieve the best results.

Activity/rest rhythm of depressed adolescents undergoing therapy: case studies / Ritmo de atividade e repouso em adolescentes deprimidos durante terapia: estudos de caso

Abstract Introduction: Disorders of circadian rhythms have been reported in studies of both depressed children and of depressed adolescents. The aim of this study was to evaluate whether there is a relationship between the 24-hour spectral power (24h SP) of the activity/rest rhythm and the clinical course of depression in adolescents. Methods: Six 14 to 17-year-old adolescents were recruited for the study. They were all suffering from major depressive disorder, according to the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria, as identified by the Schedule for Affective Disorders and Schizophrenia for School Aged Children: Present and Lifetime Version (K-SADS-PL). Depressive symptoms were assessed using the Children's Depression Rating Scale - Revised (CDRS-R) and clinical evaluations. Locomotor activity was monitored over a period of 13 consecutive weeks. Activity was measured for 10-minute periods using wrist-worn activity monitors. All patients were prescribed sertraline from after the first week up until the end of the study. Results: We found a relationship between high CDRS values and low 24-hour spectral power. Conclusions: The 24h SP of the activity/rest rhythm correlated significantly (negatively) with the clinical ratings of depression.

Resumo Introdução: Distúrbios do ritmo circadiano têm sido relatados em estudos com crianças e adolescentes deprimidos. O objetivo deste estudo foi avaliar se existe relação entre a potência espectral de 24 horas do ritmo de atividade e repouso e sintomas clínicos de depressão em adolescentes. Métodos: Seis adolescentes com idade entre 14 e 17 anos foram recrutados para o estudo. Eles foram diagnosticados com depressão maior de acordo com os critérios do Manual Diagnóstico e Estatístico de Transtornos Mentais, 4ª edição (DSM-IV), identificados utilizando-se o instrumento Schedule for Affective Disorders and Schizophrenia for School Aged Children: Present and Lifetime Version (K-SADS-PL). Os sintomas depressivos foram avaliados pelo questionário Children's Depression Rating Scale - Revised (CDRS-R) e por avaliações clínicas. A atividade motora foi monitorada por um período de 13 semanas consecutivas e registrada a cada 10 minutos utilizando-se monitores de atividades usados no pulso. Todos os pacientes utilizaram o antidepressivo sertralina começando após a primeira semana até o final do estudo. Resultados: Foi observada uma relação entre escores altos no CDRS-R e valores baixos de potência espectral de 24 horas no ritmo de atividade e repouso. Conclusão: A potência espectral de 24 horas do ritmo de atividade e repouso apresentou uma correlação significativa (negativa) com os sintomas clínicos de depressão.