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O objetivo deste estudo foi aprofundar o conhecimento sobre o efeito da adi??o de nanopart?culas nas propriedades mec?nicas das resinas. No primeiro artigo foi avaliado in vitro o efeito da incorpora??o de nanopart?culas de s?lica silanizada e n?o silanizada (~ 160 nm) nas propriedades mec?nicas (resist?ncia flexural, microdureza e rugosidade superficial) das resinas acr?licas autopolimeriz?veis. Foram produzidos cinco grupos de amostras (n=6), seguindo as especifica??es ISO 20795-1: 2013. No grupo controle (Ctrl), nenhuma part?cula foi adicionada ? composi??o da resina. Nanopart?culas de s?lica n?o silanizada foram adicionadas ao pol?mero (0,7 wt%, G1) ou ao mon?mero; (0,27 wt%, G2). Dois grupos equivalentes foram formados para resinas compostas com nanopart?culas silanizadas (grupos G3 com 0,7 wt% incorporado ao pol?mero e G4 com 0,27 wt% adicionado ao mon?mero). Os dados foram submetidos a Shapiro-Wilk (? = 0,05) e ANOVA / Tukey (? = 0,05). N?o foram registradas diferen?as significativas para a microdureza Vickers entre os diferentes grupos. As resinas nas quais foram adicionadas nanopart?culas, entretanto, mostraram uma redu??o de 20-30% na resist?ncia flexural, dependendo do grupo. A silaniza??o da superf?cie n?o causou efeito significativo no comportamento mec?nico das nanoresinas, mas parece melhorar a dispersibilidade, conforme indicado por uma menor rugosidade da superf?cie. No segundo artigo, um estudo in vitro, investigou-se a resina autopolimeriz?vel e a resina para impress?o 3D com tecnologia DLP (processamento digital de luz) com adi??o de nanopart?culas de s?lica (~ 63 nm) e comparou-as com os blocos de PMMA e a resina termopolimeriz?vel quanto a resist?ncia flexural e a rugosidade. Foram criados oito grupos (n = 12) de acordo com a composi??o: resinas autopolimeriz?veis, resina para impress?o, bloco de PMMA para fresagem e resina termopolimeriz?veis. Eles diferem no conte?do de nanopart?culas e t?cnica de confec??o. Os grupos G1, G2, G3 e G4 foram confeccionados com resina autopolimeriz?vel. O grupo G1 era o controle (resina sem adi??o de nanopart?culas). Nos grupos G2 0,5 wt%, G3 1,0 wt%, G4 1,5 wt% foram adicionadas s-SiO2-NPs ao mon?mero (l?quido). O grupo G5 e G6 foram compostos de resina de impress?o 3D. O grupo G5 foi o (controle) e no grupo G6 adicionado 1,0 wt% de s-SiO2-NP na resina para impress?o 3D. O grupo G7 foi composto de amostras produzidas de bloco de PMMA para fresagem. O grupo G8 foi composto com amostras de resina termopolimeriz?vel. Para cada grupo, foram realizadas medidas de resist?ncia ? flex?o e rugosidade superficial. Os dados foram submetidos ao teste de normalidade de Kolmogorov-Smirnov e posteriormente avaliados por An?lise de Vari?ncia (ANOVA de uma via), seguida do teste post-hoc de Tukey, quando foram encontradas diferen?as significativas entre os grupos. O n?vel de signific?ncia foi considerado p 60 MPa). The aim of this study was to increase the knowledge about the effect of the addition of nanoparticles on the mechanical properties of resins. In the first article, was to evaluate in vitro the effect of the incorporation of silanized and non-silanized silica nanoparticles (~160 nm) in mechanical properties and surface roughness of self-cured acrylic resins. Five groups of samples were produced (n=6), following the ISO 20795-1:2013 specifications. In the control group (Ctrl), no particles were added in the resin composition. Non-silanized silica nanoparticles were added either into the polymer (0.7 wt%, group G1) or into the monomer; (0.27 wt%, G2). Two similar groups were formed for composite resins with silanized nanoparticles (groups G3 with 0.7 wt% incorporated into the polymer, and G4 with 0.27 wt% added into the monomer). Data were submitted to Shapiro-Wilk (?=0.05) and ANOVA/Tukey (?=0.05). No significant differences were recorded for the Vickers microhardness among the different groups. Nanoparticle loaded resins, however, showed a 20-30% reduction in flexural strength, depending on the group. Surface silanization, caused no significant effect on improvement in the mechanical behavior of the nanoresins, but appears to improve dispersibility, as indicated by a smaller surface roughness. In the second article, an in vitro study, the self-curing resin and printing resin with DLP technology (digital light processing) with the addition of silica nanoparticles (~ 63 nm) was investigated and compared with PMMA blocks and thermopolymerizable resin for flexural strength and roughness. Eight groups were created (n = 12): self-curing resins, printing resin, PMMA block for milling and thermopolymerizable resin. They differ in nanofiller content and manufacturing techniques. The groups G1, G2, G3 and G4 were made with self-cured resin. The group G1 is control (resin without the addition of nanoparticles). In the group G2 0.5 wt%, G3 1.0 wt%, G4 1.5 wt% of s-SiO2-NP were added to the liquid monomer. The group G5 is print resin whithout nanoparticles. In the group G6 was added 1.0 wt% of s-SiO2-NP into printing resin with DLP technology (digital light processing). The G7 group is a circular PMMA block for milling. The group G8 is thermopolymerizable resin. For each group, measurements of the flexural strength and surface roughness, were performed, as described below. Data were firstly submitted to Kolmogorov-Smirnov normality test, and then evaluated by oneway ANOVA, followed by post-hoc Tukey test, when significant differences between groups were found. The significance level was considered p 60 MPa). Coordena??o de Aperfei?oamento de Pessoal de N?vel Superior - CAPES

Submitted by Jean Medeiros (jeanletras@uepb.edu.br) on 2022-03-29T11:42:18Z No. of bitstreams: 1 PDF - Diogo Pontes Costa.pdf: 24682946 bytes, checksum: 17dc53d8a2bc567309d6072d91d823bd (MD5) Approved for entry into archive by Secta BC (secta.csu.bc@uepb.edu.br) on 2022-03-30T08:39:24Z (GMT) No. of bitstreams: 1 PDF - Diogo Pontes Costa.pdf: 24682946 bytes, checksum: 17dc53d8a2bc567309d6072d91d823bd (MD5) Made available in DSpace on 2022-03-30T08:46:08Z (GMT). No. of bitstreams: 1 PDF - Diogo Pontes Costa.pdf: 24682946 bytes, checksum: 17dc53d8a2bc567309d6072d91d823bd (MD5) Previous issue date: 2019-10-18 This study was conducted at the Núcleo de Tecnologias Estratégicas em Saúde da Universidade Estadual da Paraíba - Paraíba, where a research related to issues related to the CAD/CAM system was conducted, observing its main characteristics and applications in health. In addition, the main objective is the development of a protocol for the materialization of glasses frame for children with microcephaly, being developed through open virtual code creation software (OnShape) and used by three-dimensional printing by filament processing. Deposition - FDM, using the Polyurethane (TPU) filament as material. Initially, the main themes of the project proposal are presented, such as information on assistive technologies and development of additive manufacturing technologies applied to health. Also, note the presence of a procedure adopted in the project and the indication of the need for a Systematic Review and anthropometric survey of children's head. Subsequently, review or develop the Review, or which was aided by the Start® tool, including review objectives and questions, search methods and selection procedures, inclusion and exclusion constraints, extraction and summarization of results, search languages , in addition to descriptions of rounds such as strings. In addition, data were collected with the anthropometric facial measurements of the children and subject them to analysis in order to extract as media and this creates a 3D humanoid that was used as support in the development of tests, since thus, It was possible to develop some interaction tests with the device, even before being printed three-dimensionally. Then, after this creation, it was possible to start the development of the device and create the protocol, where we rely on the use of free virtual modeling software, using 3D printers, as well as the post-finishing process. Subsequently, perform a weapon design protocol validation test with some designers to improve it and mitigate potential failures. Finally, the CAD file of the eyeglass frame was made available, free of charge, on digital platforms, in order to be used in laboratories of the SUS network. Este estudo foi realizado no Núcleo de Tecnologias Estratégicas em Saúde da Universidade Estadual da Paraíba - Paraíba, onde se propõe a realizar uma pesquisa relativa aos temas concernentes ao sistema CAD/CAM, observando suas principais características e aplicações à saúde. Além disso, tem-se como objetivo principal o desenvolvimento de um protocolo para materialização de armação de óculos para crianças com Microcefalia, sendo desenvolvido por meio de um software de criação virtual de código aberto (OnShape) e obtido por Impressão tridimensional pelo processamento de Filament Deposition Modeling – FDM, utilizando o filamento de Poliuretano (TPU) como material. Inicialmente, apresenta-se os principais temas para a fundamentação da proposta de projeto, as informações acerca das Tecnologias Assistivas e do desenvolvimento das tecnologias de manufatura aditiva aplicadas à saúde. Além disso, observa-se a presença do procedimento a ser adotada no projeto e da indicação da necessidade uma Revisão Sistemática e do levantamento de dados antropométricos da cabeça das crianças. Posteriormente, realizou-se o desenvolvimento da Revisão, o qual teve como auxílio a ferramenta Start®, contendo os objetivos e questões da revisão, métodos de buscas e procedimentos de seleção, critérios de inclusão e exclusão, extração e sumarização dos resultados, idiomas de busca, além das descrições das rodadas com as strings. Ademais, foi realizada uma coleta de dados com as medidas faciais antropométricas das crianças e submete-las à análise com intuído de extrair as médias e com isso criar um humanoide 3D que foi utilizado como suporte no desenvolvimento da propostas, visto que assim, foi possível desenvolver alguns testes de interação com o dispositivo, antes mesmo de ser impresso tridimensionalmente. Então, após essa criação, foi possível partir para o desenvolvimento do dispositivo e criação do protocolo, onde contou com o uso dos softwares livres de modelagem virtual, com a utilização das impressoras 3D, bem com o processo de pós-acabamento. Posteriormente, realizou-se um teste para validação do protocolo da criação da armação com alguns projetistas, afim de melhorá-lo e mitigar as possíveis falhas. Por fim, o arquivo CAD da armação de óculo foi disponibilizado, gratuitamente, em plataformas digitais, afim de serem utilizados em laboratórios da rede SUS.

RésuméL’impression 3D est de plus en plus utilisée dans les établissements de santé notamment dans le but de fabriquer des dispositifs médicaux (DM). Cependant, la fabrication et la mise sur le marché des DM sont réglementées. Le but de notre travail était de faire le point sur la réglementation française actuellement applicable concernant la fabrication de DM sur mesure par impression 3D dans un établissement de santé. Les DM sont tous les dispositifs qui ont pour but de diagnostiquer, de prévenir ou de traiter une pathologie chez un patient. Les prototypes et les modèles anatomiques ne sont pas considérés comme des DM et aucune loi spécifique ne s’applique à eux. Les guides de coupe, les attelles, les plaques d’ostéosynthèse ou les prothèses sont des DM. Pour devenir fabricant de DM en France, un établissement de santé doit respecter les exigences de la directive 93/42/CEE. Les DM sur mesure réalisés par impression 3D doivent de plus respecter l’annexe VIII de cette directive. Ceci nécessite la rédaction d’une déclaration de conformité, le respect des exigences essentielles (règles permettant de prouver qu’un dispositif est conforme à ce que l’on attend et qu’il n’est pas dangereux pour le patient), une analyse de risques, la qualification des procédés et le contrôle de la biocompatibilité des matériaux. Les documents attestant du respect de cette réglementation doivent pouvoir être produits. Devenir fabricant réglementaire de DM en France est possible pour un établissement de santé à condition de respecter un cahier des charges précis.SummaryHealth care facilities more and more use 3D printing, including making their own medical devices (MDs). However, production and marketing of MDs are regulated. The goal of our work was to clarify what is the current French regulation that should be applied concerning the production of custom-made MDs produced by 3D printing in a health care facility. MDs consist of all devices used for diagnosis, prevention, or treatment of diseases in patients. Prototypes and anatomic models are not considered as MDs and no specific laws apply to them. Cutting guides, splints, osteosynthesis plates or prosthesis are MDs. In order to become a MD manufacturer in France, a health care facility has to follow the requirements of the 93/42/CEE directive. In addition, custom-made 3D-printed MDs must follow the annex VIII of the directive. This needs the writing of a declaration of conformity and the respect of the essential requirements (proving that a MD is secure and conform to what is expected), the procedure has to be qualified, a risk analysis and a control of the biocompatibility of the material have to be fulfilled. The documents proving that these rules have been respected have to be available. Becoming a regulatory manufacturer of MD in France is possible for a health care facility but the specifications have to be respected.