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OBJECTIVES: To evaluate structural damage and loosening of abutments placed on narrow diameter implants after cyclic fatigue. METHODS: Sixty Morse taper narrow diameter implants (Neodent, Brazil) received two types of abutments (1PA- one-piece abutment or 2PA- two-piece abutment), which were randomly divided into 3 fatigue experiments (n = 10). The implants were placed into a customized supporting holder and a software-assisted digital torque wrench secured the manufacturer recommended torque for each abutment. Cone beam computed tomography (CBCT) scans were acquired, before and after fatigue, and post-processed (software e-Vol DX) to assess damage and abutment displacement. The boundary fatigue method was adapted to use 2 × 106 cycles, 2 Hz of frequency and constant peak load of 80 N (first experiment) that varied according to the failure rate of previous specimens (second and third experiments). Failure was evaluated using CBCT scans and removal torque values. Data were used to estimate long-term torque degradation, probability of failure and Weibull modulus (software ALTA PRO9). RESULTS: All 2PA specimens became loosen independently of the applied fatigue load, and structural bending was observed in 14 abutments. Eight 1PA got loosen during the fatigue experiment. The Weibull analysis showed a lower modulus (m = 1.0; 0.7, 1.4) for 1PA than for 2PA (m = 2.6; 2, 3.4) resulting in longer predicted lifetimes and slower torque degradation for 1PA than for 2PA specimens. SIGNIFICANCE: 1PA showed greater long-term survival probability than 2PA. Predicting the lifetime and mechanical behavior of implant-abutment systems are useful information to clinicians during the decision-making process of oral rehabilitations.

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Soft robots claim the architecture of actuators, sensors, and computation demands with their soft bodies by obtaining fast responses and adapting to the environment. Sensory-motor coordination is one of the main design principles utilized for soft robots because it allows the capability to sense and actuate mutually in the environment, thereby achieving rapid response performance. This work intends to study the response for a system that presents coupled actuation and sensing functions simultaneously and is integrated in an arbitrary elastic structure with ionic conduction elements, called as soft sensory-motor system based on ionic solution (SSMS-IS). This study provides a comparative analysis of the performance of SSMS-IS prototypes with three diverse designs: toroidal, semi-toroidal, and rectangular geometries, based on a series of performance experiments, such as sensitivity, drift, and durability. The design with the best performance was the rectangular SSMS-IS using silicon rubber RPRO20 for both internal and external pressures applied in the system. Moreover, this work explores the performance of a bioinspired soft robot using rectangular SSMS-IS elements integrated in its body. Further, it investigated the feasibility of the robot to adapt its morphology online for environment variability, responding to external stimuli from the environment with different levels of stiffness and damping.

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Experiments are useful scientific tools for testing hypotheses by manipulating variables of interest while controlling for other factors that can bias or confuse the results and their interpretation. To ensures accuracy and reproducibility, experiments must have transparent and repeatable methodologies. Due to the importance of shredder invertebrates in organic matter processing, carbon cycling, and nutrient cycling, we tested experimentally the effect of different methodological approaches in microcosm experiments on the consumption and survival of shredders. We found that the shredder species, the presence or absence of the case, and the use or non-use of air-pumps in the microcosms did not affect shredder performance (i.e., consumption and survival). Furthermore, the type of water (stream or bottled) did not affect shredder performance. On the other hand, the amount of light had a negative effect on shredder performance, with constant light (i.e., 24 h) reducing shredder consumption and survival. Our results demonstrate that the use of different methodologies does not always result in changes in outcomes, thus ensuring comparability. However, luminosity is a critical factor that deserves attention when conducting microcosm experiments. Our findings provide valuable insights that can assist researchers in designing experiments with shredders from neotropical streams and conducting systematic reviews and meta-analyses.

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INTRODUCTION: Promptly providing new drugs to fulfill unmet medical needs requires changes in drug development and registration processes. Health Authorities (HAs) considered as reference due to their experience and acknowledgement (Food and Drug Administration [FDA] among others) already consider innovative clinical trial (CT) designs and flexible approval procedures, but Latin America (LATAM) regulations are still far. A comparison was performed to identify gaps. MATERIALS AND METHODS: CT requirements for drug Marketing Authorization Application (MAA) and CT approval regulations were compared between LATAM and reference HAs (FDA/European Medicines Agency [EMA]/Health-Canada/Swissmedic/Therapeutic Goods Administration [TGA]/Pharmaceuticals and Medical Devices Agency [PMDA]), as of August 2022. Procedure included reference HAs regulations review, item selection, identification in LATAM regulations, and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines (ICH-E6[R2]/ICH-E8[R1]) implementation revision. RESULTS: For MAA, specific application requirements or ICH guideline M4(R4) on common technical document (CTD) adoption are generally stated, and phase-I/III performance is mandatory (explicitly/implicitly). Faster patient access procedures are infrequent: Priority-drug programs, conditional authorizations, or expedited procedures are scarce or non-existent. Regulatory reliance procedures are adopted through different pathways. Regarding CT approval, innovative/complex CT designs are not prohibited but usually omitted. Some countries implemented adapted CT conducting during the COVID-19 pandemic. Early scientific advice meetings (HA-sponsor) are occasionally considered. Most countries are not formally ICH-joined. CONCLUSIONS: LATAM regulations must adapt to new regulatory standards (FDA/EMA/ICH) through implementation of frequent updates, reliance/expedited procedures, early HA-sponsor interactions, innovative/complex CTs, mandatory phase-III reaching elimination, and decentralized elements for CT conducting.

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Crop improvement efforts have exploited new methods for modeling spatial trends using the arrangement of the experimental units in the field. These methods have shown improvement in predicting the genetic potential of evaluated genotypes. However, the use of these tools may be limited by the exposure and accessibility to these products. In addition, these new methodologies often require plant scientists to be familiar with the programming environment used to implement them; constraints that limit data analysis efficiency for decision-making. These challenges have led to the development of Mr.Bean, an accessible and user-friendly tool with a comprehensive graphical visualization interface. The application integrates descriptive analysis, measures of dispersion and centralization, linear mixed model fitting, multi-environment trial analysis, factor analytic models, and genomic analysis. All these capabilities are designed to help plant breeders and scientist working with agricultural field trials make informed decisions more quickly. Mr.Bean is available for download at https://github.com/AparicioJohan/MrBeanApp.

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Buriti (Mauritia flexuosa L.) is a significant source of carotenoids, but these compounds have been extracted using laborious and low-effective methods. The present work evaluated the high-intensity ultrasound combined with a chemometric approach to developing an optimal extraction method of carotenoids from buriti pulp. The multivariate optimization was carried out through two steps. First, a simplex-lattice mixture design was used to optimize the extractor solution finding higher extraction yield (903 ± 21 µg g-1) with the acetone:ethanol (75/25) mixture. After, sample mass (80 mg) and sonication time (30 min) were optimized applying central composite design (CCD) which provided a 14% improvement in the extraction method yield. So, the total carotenoid content (TCC) with optimal extraction conditions was 1026 ± 13 µg g-1which is almost twice the yield of methods known in the literature for buriti. The RP-HPLC-DAD analysis revealed that the carotenoids are gently extracted and ß-carotene is the major compound in the extracts. To confirm the accuracy, buriti samples spiked with ß-carotene standard and the developed method showed recovery >84% and precision <6.5%. Furthermore, the optimized ultrasound-assisted extraction (UAE) method was applied to other samples (tomato, guava, carrot, mango, acerola, papaya, and pumpkin) and presented a yield to 5.5-fold higher when compared to the reported methods indicating high robustness. Based on results, the UAE method developed has demonstrated feasibility and reliability for the study of carotenoids in buriti pulp as well as in other plant matrices with high biological relevance.

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The Readiness for Interprofessional Learning Scale (RIPLS) has been widely used to measure students' and professionals' attitudes toward interprofessional learning. However, inconsistencies have been reported concerning its validity and reliability. This study aimed to translate, adapt, and validate the RIPLS questionnaire to be applied to Spanish-speaking health sciences students in Chile. Content and construct validity evidence of the newly created Spanish version of the RIPLS scale were analyzed. An exploratory (EFA) and confirmatory (CFA) analysis were conducted, determining goodness-of-fit indexes. Reliability was evaluated through Cronbach's Alpha Coefficient. We assessed sensitivity to change of the RIPLS scale by comparing pre- and post-interprofessional education workshop scores. The EFA showed that there were three factors. In the CFA, most of the standardized factor loadings were higher than 0.3. Regarding internal consistency, Cronbach's Alpha was 0.86. The differences between the total RIPLS scores before and after the workshops were statistically significant. The Spanish version of RIPLS showed evidence of validity and reliability for use amongst health sciences students. The construct was adequately measured and was shown that it could be used to assess the impact of interprofessional education workshops.

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Objective: Evaluate the effect of Implant prosthetic designs and restorative material on the stress concentration of 3-unit implant-supported restoration with two restorative materials. Material and Methods: Six different screw-retained prostheses models were virtually designed and divided according to design: fixed bridge (FB), cantilever bridge (CB), and separate crowns (SC). Then, each model was also divided into two subgroups according to the material: Ultra-translucent multi-layered zirconia (Kuraray Noritake Dental Inc., Japan); or a combination of PEEK (Polyetheretherketone) framework (BioHPP, Bredent, GmbH & Co., KG, Germany) and zirconia (ZR) crowns (ultra-translucent multi-layered zirconia, Kuraray Noritake Dental Inc., Japan). A vertical load of 100 N was applied statically perpendicular to the central fossa of each crown. The von-Mises stress was computed using Solidworks software (SolidWorks Corp, Massachusetts, USA), based on the physical parameters of the materials. Results: FB showed the lowest von Mises stress values out of all 3 design models. Moreover, the combination of PEEK and zirconia showed strain values smaller than full zirconia. The highest von Mises stress value was recorded in CB with the zirconia subgroup at (1098 MPa) while the lowest von Mises stress value was recorded in FB with combined PEEK and zirconia subgroup at (190 MPa). Conclusion: For three-unit implant supported restorations, the use of PEEK framework and zirconia crowns was found to be more favorable biomechanically regarding the prosthetic components, implant and bone stresses. (AU)

Objetivo: Avaliar o efeito do desenho da prótese sobre implantes e do material restaurador na concentração de tensão de próteses fixas de 3 elementos implantossuportada, com dois materiais restauradores. Material e Métodos: Seis diferentes modelos de próteses aparafusadas foram virtualmente projetados e divididos de acordo com o desenho: ponte fixa (PF), ponte cantilever (PC) e coroas individuais (CI). Em seguida, cada modelo também foi dividido em dois subgrupos de acordo com o material: Zircônia multicamada ultra translúcida (Kuraray Noritake Dental Inc., Japão); ou associada a uma estrutura de PEEK (Polyetheretherketone) (BioHPP, Bredent, GmbH & Co., KG, Alemanha) e coroas de zircônia (CZ) (zircônia multicamada ultra translúcida, Kuraray Noritake Dental Inc., Japão). Uma carga vertical estática de 100 N foi aplicada perpendicular à fossa central de cada coroa. A tensão de von-Mises foi calculada usando o software Solidworks (SolidWorks Corp, Massachusetts, EUA), com base nos parâmetros físicos dos materiais. Resultados:PF apresentou os menores valores de tensão de von Mises de todos os 3 modelos propostos. Além disso, a combinação de PEEK e zircônia apresentou valores de deformação menores do que a zircônia pura. O maior valor de tensão de von Mises foi registrado em PC com o subgrupo de zircônia em (1098 MPa), enquanto o menor valor de tensão de von Mises foi registrado em PF com PEEK combinado e subgrupo de zircônia em (190 MPa). Conclusão: Para ponte fixa de 3 elementos implantossuportadas, o uso de estrutura PEEK e coroas de zircônia mostrou-se mais favorável biomecanicamente em relação aos componentes protéticos, implante e tensão sobre o osso. (AU)

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Phase 1 dose-escalation trials are crucial to drug development by providing a framework to assess the toxicity of novel agents in a stepwise and monitored fashion. Despite widely adopted, rule-based dose-escalation methods (such as 3 + 3) are limited in finding the maximum tolerated dose (MTD) and tend to treat a significant number of patients at subtherapeutic doses. Newer methods of dose escalation, such as model-based and model-assisted designs, have emerged and are more accurate in finding MTD. However, these designs have not yet been broadly embraced by investigators. In this review, we summarise the advantages and disadvantages of contemporary dose-escalation methods, with emphasis on model-assisted designs, including time-to-event designs and hybrid methods involving optimal biological dose (OBD). The methods reviewed include mTPI, keyboard, BOIN, and their variations. In addition, the challenges of drug development (and dose-escalation) in the era of immunotherapeutics are discussed, where many of these agents typically have a wide therapeutic window. Fictional examples of how the dose-escalation method chosen can alter the outcomes of a phase 1 study are described, including the number of patients enrolled, the trial's timeframe, and the dose level chosen as MTD. Finally, the recent trends in dose-escalation methods applied in phase 1 trials in the immunotherapeutics era are reviewed. Among 856 phase I trials from 2014 to 2019, a trend towards the increased use of model-based and model-assisted designs over time (OR = 1.24) was detected. However, only 8% of the studies used non-rule-based dose-escalation methods. Increasing familiarity with such dose-escalation methods will likely facilitate their uptake in clinical trials.

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Design of Experiments (DoE) is a statistical tool used to plan and optimize experiments and is seen as a quality technology to achieve products excellence. Among the experimental designs (EDs), the mixture designs (MDs) stand out, being widely applied to improve conditions for processing, developing, or formulating novel products. This review aims to provide useful updated information on the capacity and diversity of MDs applications for the industry and scientific community in the areas of food, beverage, and pharmaceutical health. Recent works were selected following the Preferred Reporting Items for Systematic Review and Meta-Analyses statement (PRISMA) flow diagram. Data analysis was performed by self-organizing map (SOM) to check and understand which fields of application/countries/continents are using MDs. Overall, the SOM indicated that Brazil presented the largest number of works using MDs. Among the continents, America and Asia showed a predominance in applications with the same amount of work. Comparing the MDs application areas, the analysis indicated that works are prevalent in food and beverage science in the American continent, while in Asia, health science prevails. MDs were more used to develop functional/nutraceutical products and the formulation of drugs for several diseases. However, we briefly describe some promising research fields in that MDs can still be employed.

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BACKGROUND: Nonribosomal peptide synthases (NRPS) can synthesize functionally diverse bioactive peptides by incorporating nonproteinogenic amino acids, offering a rich source of new drug leads. The bacterium Escherichia coli is a well-characterized production host and a promising candidate for the synthesis of nonribosomal peptides, but only limited bioprocess engineering has been reported for such molecules. We therefore developed a medium and optimized process parameters using the design of experiments (DoE) approach. RESULTS: We found that glycerol is not suitable as a carbon source for rhabdopeptide production, at least for the NRPS used for this study. Alternative carbon sources from the tricarboxylic acid cycle achieved much higher yields. DoE was used to optimize the pH and temperature in a stirred-tank reactor, revealing that optimal growth and optimal production required substantially different conditions. CONCLUSIONS: We developed a chemically defined adapted M9 medium matching the performance of complex medium (lysogeny broth) in terms of product concentration. The maximum yield in the reactor under optimized conditions was 126 mg L-1, representing a 31-fold increase compared to the first shaking-flask experiments with M9 medium and glycerol as the carbon source. Conditions that promoted cell growth tended to inhibit NRPS productivity. The challenge was therefore to find a compromise between these factors as the basis for further process development.

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Ensaios clínicos randomizados (ECR) são o padrão ouro para desenho experimental de estudo ou ensaio clínico. Apenas por meio de uma investigação do tipo ECR é possível avaliar e demonstrar a relação de causa-e-efeito entre um conjunto de variáveis independentes e dependentes. O ECR adicionou vantagens em relação aos outros modelos experimentais, principalmente devido à presença de um grupo controle. Existem várias críticas à validade interna das pesquisas em saúde, incluindo preconceitos e desvantagens que são apontadas para seu descrédito. OBJETIVO: O objetivo do presente estudo é informar características, vantagens, desvantagens e desvios deste método científico. MATERIAL E MÉTODOS: Análise crítica de método científico com base em revisão narrativa da literatura. Foi consultada a base de dados Medline por meio dos portais PubMed e Scopus, sem data de início e até julho de 2020, para extração das informações relativas aos ECR. Apenas artigos de língua inglesa foram incluídos, usando as palavras-chave "estudo randomizado controlado", "ensaio clínico randomizado", "projeto experimental" e "estudo experimental", intercaladas pelos operadores booleanos "AND ," "OR" e "NOT". Anais de conferências e resumos não foram considerados para a análise dos dados. RESULTADOS: Dos ECR selecionados, foram extraídas características, vantagens, desvantagens, importância e vantagens dos controles em pesquisa, o princípio de equilíbrio, ensaios clínicos randomizados na população pediátrica, ECR na população geriátrica, ameaças à validade interna e medidas para minimização de viéses e preconceitos em ECR. CONCLUSÃO: Tópicos relevantes dos ECR foram explicados nesta revisão que devem guiar pesquisadores clínicos.

Randomized controlled trial (RCT) is the gold standard of experimental design or clinical trial design. Only by RCT in research, the cause-and-effect relationship between a set of independent and dependent variables could be demonstrated. RCT has added advantages over other experimental designs due to the presence of the control group. The importance of control in health research trials and its advantages to be elaborated. Though various threats to internal validity in health research trials could be minimized by RCT, various biases in RCT and disadvantages add to its discredit. OBJECTIVE: The aim of the present narrative review is to brief the characteristics, advantages, disadvantages, and various biases in RCT. METHODS: This review does not follow the PRISMA statement, as it was a narrative review. Two databases, namely, Medline through PubMed and Scopus, were searched from inception to July 2020 for the information pertaining to RCTs and included in this narrative review. Only English language articles were searched with the keywords, "Randomized controlled trial," "Randomized clinical trial," "experimental design," and "experimental study." These keywords are linked together by the Boolean words, "AND," "OR" and "NOT." Conference proceedings and only abstracts were not considered for the review. RESULTS: RCTs were explained under characteristics, advantages, disadvantages, importance, and advantages of controls in research, the principle of equipoise, RCTs in the pediatric population, RCTs in the geriatric population, threats to internal validity and steps to minimize them and various biases in RCTs. CONCLUSION: The narrative presentation of RCTs under various important topics have been explained in this review.

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Aromatization of extra-virgin olive oil (EVOO) with aromatic plants is commonly used to enrich the oil with aromatic and antioxidant compounds. Ultrasound can be an alternative to accelerate this process. The objective of this work was to determine if ultrasound is able to accelerate EVOO aromatization with rosemary and basil and how it affects the migration of volatile and other compounds, the oxidative stability and the antioxidant capacity of the aromatized products. Ultrasound parameters (amplitude, time, and temperature of extraction) were optimized for each herb with central composite designs. Free fatty acid, peroxide value, K232, K270, ΔK, fatty acid profile, total phenolics, antioxidant capacity, polar compounds, oxidative stability and volatile compounds profile were evaluated in all samples. Physical effects of ultrasound on the herbs were observed by scanning electron microscopy. In the optimization, variables related to the oxidative processes were minimized and compounds migration and oxidative stability were maximized. Results were 70.09% amplitude, 36.6 min and 35 °C for rosemary and 95.98% amplitude, 9.9 min and 30 °C for basil. These conditions were compared to 7 and 15 days of conventional maceration (CM). Aromatization of EVOO with rosemary, both by ultrasound assisted maceration (UAM) or CM, improved total phenolics, terpenes, esters, ketones, stability and induction times, as well as decreased the values for the quality parameters. The use of UAM accelerated the process to 37 min. However, aromatization with basil by CM increased the values for the quality parameters and reduced the total phenolics, the antioxidant capacity and the induction and stability times. UAM with basil reached better results than those observed for CM, in only 10 min. In conclusion, rosemary is more appropriate than basil for EVOO aromatization, and UAM was the best choice to accelerate the processes when compared to CM.

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Objective: The purpose of the study was to evaluate the effect of different preparation designs and different surface treatments on the fracture resistance of monolithic zirconia inlay-retained fixed dental prosthesis [IRFDP]. Material and methods: Forty-five translucent zirconia IRFDPs were divided into three groups according to preparation designs (n = 15); group I: proximal box, group II: inlay-box and group III: butterfly wing (modified inlay). Each group was further subdivided into three subgroups according to the surface treatments utilized (n = 5); sandblasting, tribochemical silica coating (Cojet system) and erbium, chromium: Yttrium, scandium, gallium, garnet (Er, Cr: YSGG) laser irradiation. All zirconia IRFDPs were cemented to their respective resin models using selfadhesive resin cement. All cemented IRFDPs were subjected to fracture resistance test using universal testing machine. The initial fracture site was determined by using a stereomicroscope (x6.7magnification). Two-way analysis of variance (ANOVA) was used to evaluate the effect of different designs, different surface treatments and their interaction on the mean fracture resistance. Bonferroni's post-hoc test was used when ANOVA is significant (P ≤ 0.05). Results: Butterfly wings design showed the highest fracture resistance values followed by inlay and box designs respectively (P ≤ 0.05). Sandblasting and Cojet showed significantly the highest mean fracture resistance values than Laser with no significance difference between them. Conclusion: The butterfly wing design increased the fracture resistance of the zirconia IRFDPs. Sandblasting and tribochemical silica coating of zirconia surfaces had a greater effect than Er, Cr: YSGG laser to gain higher fracture resistance of zirconia IRRDPs (AU)

Objetivo: O objetivo do estudo foi avaliar o efeito de diferentes modelos de preparações e diferentes tratamentos de superfície na resistência à fratura de inlays de zircônia monolítica. Material e métodos: Quarenta e cinco inlays translúcidos de zircônia foram divididos em três grupos de acordo com os desenhos de preparação (n = 15); grupo I: caixa proximal, grupo II: inlay convencional e grupo III: asa de borboleta (inlay modificado). Cada grupo foi subdividido em três subgrupos de acordo com os tratamentos de superfície utilizados (n = 5); jateamento de areia, revestimento triboquímico de sílica (sistema Cojet) e érbio, cromo: ítrio, escândio, gálio, granada (Er, Cr: YSGG) irradiação a laser. Todos os inlays de zircônia foram cimentados em seus respectivos modelos de resina usando cimento de resina auto-adesivo. Todos os inlays cimentados foram submetidos a teste de resistência à fratura usando máquina de teste universal. O local inicial da fratura foi determinado usando um estereomicroscópio (ampliação de 6,7x). A análise de variância (ANOVA) de dois fatores foi usada para avaliar o efeito de diferentes desenhos, diferentes tratamentos de superfície e sua interação na resistência média à fratura. O teste post-hoc de Bonferroni foi usado quando a ANOVA foi significativa (P ≤ 0,05). Resultados: O design das asas de borboleta apresentou os maiores valores de resistência à fratura, seguidos pelos designs de inlay convencional e caixa, respectivamente (P ≤ 0,05). O jateamento de areia e o Cojet apresentaram significativamente os maiores valores médios de resistência à fratura do que o Laser, sem diferença de significânc=ia entre eles. Conclusão: O design da asa de borboleta aumentou a resistência à fratura dos inlays de zircônia. O revestimento por jato de areia e triboquímica de sílica das superfícies de zircônia teve um efeito maior que o laser Er, Cr: YSGG para obter maior resistência à fratura dos inlays de zircônia. (AU)

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ABSTRACT Objective: This study aimed at comparing the dentoskeletal changes in patients with Class II division 1 malocclusion, treated with three types of fixed functional appliances. Methods: A sample comprising 95 patients with the same malocclusion, retrospectively selected, and divided into four groups, was used: G1 consisted of 25 patients (mean age 12.77 ± 1.24 years) treated with Jasper Jumper appliance; G2, with 25 patients (mean age 12.58 ± 1.65 years) treated with the Herbst appliance; G3, with 23 patients (mean age 12.37 ± 1.72 years) treated with the Mandibular Protraction Appliance (MPA); and a Control Group (CG) comprised of 22 untreated subjects (mean age 12.66 ± 1.12 years). Intergroup comparison was performed with ANOVA, followed by Tukey test. Results: The Jasper Jumper and the Herbst group showed significantly greater maxillary anterior displacement restriction. The Jasper Jumper demonstrated significantly greater increase in the mandibular plane angle, as compared to the control group. The MPA group demonstrated significantly greater palatal inclination of the maxillary incisors. Vertical development of the maxillary molars was significantly greater in the Herbst group. Conclusions: Despite some intergroup differences in the amount of dentoskeletal changes, the appliances were effective in correcting the main features of Class II malocclusions.

RESUMO Objetivo: o objetivo do presente estudo foi comparar as alterações dentoesqueléticas em pacientes com má oclusão de Classe II, divisão 1, tratados com três tipos de aparelhos funcionais fixos. Métodos: a amostra compreendeu 95 pacientes, selecionados retrospectivamente e divididos em quatro grupos: G1, composto por 25 pacientes (idade média de 12,77 ± 1,24 anos), tratados com aparelho Jasper Jumper; G2, com 25 pacientes (idade média de 12,58 ± 1,65 anos), tratados com aparelho Herbst; G3, com 23 pacientes (idade média de 12,37 ± 1,72 anos), tratados com o Aparelho de Protração Mandibular (APM); e um Grupo Controle (GC), composto por 22 sujeitos não tratados (idade média de 12,66 ± 1,12 anos) que apresentavam a mesma má oclusão. A comparação intergrupos foi realizada com ANOVA, seguida do teste Tukey. Resultados: os grupos Jasper Jumper e Herbst apresentaram significativamente maior restrição de deslocamento anterior da maxila. O Jasper Jumper demonstrou aumento significativamente maior no ângulo do plano mandibular, em comparação ao grupo controle. O grupo APM demonstrou inclinação palatina significativamente maior dos incisivos superiores. O desenvolvimento vertical dos molares superiores foi significativamente maior no grupo Herbst. Conclusões: apesar de algumas diferenças intergrupos na quantidade de alterações dentoesqueléticas, os aparelhos foram eficazes na correção das principais características das más oclusões de Classe II.

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El avance de la ciencia y tecnología en los últimos años dio lugar a la necesidad de dar respuesta a una mayor cantidad de preguntas en investigación de forma más eficiente. Esto ha provocado la generación de nuevos diseños en investigación, dando origen a los "protocolos maestros". A diferencia de los diseños tradicionales en los que en cada ensayo clínico se prueba habitualmente un solo fármaco, en una única población, con una patología determinada, los protocolos maestros utilizan una estructura con un diseño de ensayo clínico y un protocolo para evaluar simultáneamente múltiples fármacos y/o enfermedades, en múltiples sub-estudios. Entre estos novedosos diseños se pueden mencionar tres tipos: canasta (basket), paraguas (umbrella) y plataforma (platform) los cuales serán analizados en este artículo. Debido a su complejidad, el abordaje de estos nuevos modelos de ensayo clínico requiere la revisión y actualización permanente de los estándares vigentes y una constante discusión por parte de las diferentes agencias regulatorias a nivel mundial. Estos diseños no deben considerarse a priori como medios para reducir la rigurosidad de la planificación de los ensayos clínicos ni disminuir los estándares regulatorios, sino como herramientas para gestionar situaciones experimentales complejas. Desde el punto de vista regulatorio, para poder analizar y dar respuesta a estos desafíos, ANMAT cuenta, actualmente, con espacios de intercambio que permiten crear el ámbito apropiado de discusión científica-regulatoria que aliente el desarrollo de nuevos medicamentos, pero manteniendo estrictos estándares de calidad éticos y científicos. En esta revisión se plantea la necesidad de conocer en detalle estos nuevos diseños analizando sus potenciales beneficios y limitaciones

The need to answer a greater number of questions more efficiently has led to the generation of new designs in research, giving rise to the "master protocols". This term refers to a clinical trial design created to evaluate multiple hypotheses through substudies that are developed simultaneously and that may contain an adaptive design. Among these novel designs, three types can be mentioned: basket, umbrella and platform which will be analyzed in this article. Due to their complexity, the approach of these new clinical trial designs requires the continuing revision and updating of the current standards and a constant discussion by the different regulatory agencies worldwide. From the regulatory point of view, in order to analyze and satisfy these challenges, ANMAT currently has exchange spaces that allow the creation of the appropriate field of scientific-regulatory discussions that encourage the development of new medicines, while maintaining strict standards of ethical and scientific quality. This revision raises the need to know in detail these new designs analyzing their potential benefits and limitations.

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Research designs refer to the way information is obtained and are limited by ethical, economic and temporal viability. Research designs are standardized strategies to reduce biases, which in the architectural model of research are identified in the baseline state, the maneuver and the outcome; hence, there are no specific designs for each question. The design with the lowest probability of bias is the clinical trial, followed by cohort and case-control studies and, finally, by cross-sectional surveys. Among the main characteristics that give merit to research designs are the following: population inquiry, which refers to the situation of the population in relation to the clinical course/natural history of the disease; the maneuver, or action that is expected to modify the baseline state, which can be observational or experimental; follow-up, or documented monitoring that is given to each subject, which can be longitudinal or cross-sectional; and directionality, which can prolective or retrolective and refers to the timing of data collection for research purposes. It will always be better having a valuable question, even when answered with a design with higher risk of bias, than a question that is irrelevant or has no applicability.

Los diseños de investigación se refieren a la forma como se obtiene la información y están limitados por viabilidad ética, económica y temporal. Son estrategias estandarizadas para disminuir los sesgos que en el modelo arquitectónico de la investigación se identifican en el estado basal, maniobra y desenlace; de ahí que no hay diseños específicos para cada pregunta. El diseño con menor probabilidad de sesgos es el ensayo clínico, seguido de la cohorte, el estudio de casos y controles y, finalmente, la encuesta transversal. Entre las principales características que dan mérito a los diseños están las siguientes: la pesquisa de la población, que se refiere a la ubicación de la población en relación con el curso clínico o historia natural de la enfermedad; la maniobra, o acción que se espera modifique la condición basal, que puede ser observacional o experimental; el seguimiento, o monitoreo documentado que se le da a cada sujeto, que puede ser longitudinal o transversal; y la direccionalidad, prolectiva o retrolectiva, que alude al tiempo de recopilación de la información con fines de investigación. Siempre será mejor tener una pregunta valiosa, incluso cuando se responda con un diseño con mayor riesgo de sesgos, que una pregunta irrelevante o sin aplicabilidad.

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RESUMO

An extraction method based on a multivariate analytical approach was developed for enhancement of the phenolic compounds in cashew nut extracts. The different extractor solvents (acetone, water, ethanol, and methanol) and their binary, ternary, and quaternary combinations were evaluated using a simplex-centroid design and surface response methodology. The special cubic model exhibits no lack of fit and explains 89.2% of the variance. The total phenolic measurements by the Folin-Ciocalteu method revealed the highest values for ethanol (5.93 mg GAE g-1) and acetone-methanol-ethanol ternary mixture (5.92 mg GAE g-1) extracts. ESI (-)-Q/TOFMS analyses combined with PCA and HCA revealed the presence of fatty acids, phospholipids, and sugars in the ternary mixture cashew extract, while for the ethanol extract only phenolic compounds, such as anacardic acids and derivatives, were found. The proposed approach was adequate to reach the optimal extractor which ethanol, a low-toxicity solvent, enabled the selective extraction of a high content of phenolic compounds from cashew nuts.

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RESUMEN Fundamento: Los estudios de causalidad deben aportar resultados certeros, lo cual depende de la adecuación de los mismos, de ahí la necesidad de conocer los métodos que aseguren la validez de estas investigaciones. Objetivo: Sistematizar los métodos actuales para el estudio de causalidad en Medicina que incluye el diseño, los requerimientos que aseguran su validez y los métodos para el cumplimiento de estos requerimientos. Desarrollo: Se realizó una revisión bibliográfica en bases de datos biomédicas, se seleccionó la literatura de mayor actualidad, integralidad y cientificidad con la cual se organizó una síntesis crítica, a la que se le agregó la experiencia de las autoras. Se presentan técnicas para la detección y tratamiento de la confusión y la interacción y para garantizar la comparabilidad entre grupos. Entre las técnicas se destacan la aleatorización mendeliana, el puntaje de susceptibilidad, los G-métodos, los modelos estructurales marginales y anidados, la lógica difusa y el análisis estadístico implicativo. Conclusiones: A pesar del avance en los métodos estadísticos es el investigador el encargado de garantizar la no confusión residual y discernir entre lo estadísticamente significativo y lo clínicamente aceptable.

ABSTRACT Background: Causality studies must provide accurate results, which depends on their adequacy, therefore the need of knowing the methods that ensure the validity of these investigations. Objective: To systematize the current methods for the study of causality in Medicine that includes the design, the requirements that ensure its validity and the methods for complying with these requirements. Development: It was carried out a bibliographic review in biomedical databases and selected the most current, comprehensive, scientific literature, with this, a critical synthesis was organized, with the experience of the authors. Techniques for the detection and treatment of confusion and interaction were presented, also to ensure comparability between groups. Among the techniques, Mendelian randomization, susceptibility score, G-methods, marginal and nested structural models, fuzzy logic and implicative statistical analysis stand out. Conclusions: Despite the progress in statistical methods, the researcher is responsible for guaranteeing residual non-confusion and distinguishing between statistically significant and clinically acceptable.

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