A three-dimensional printed photopolymer resin implant for orbital rehabilitation for evisceration / Implante de resina fotocurável para evisceração produzido por impressora tridimensional

ABSTRACT Purpose: To evaluate the biocompatibility of three-dimensional (3D) printed orbital spheres for evisceration. Materials: A total of 10 consecutive patients (eight females and two males; mean age, 46.8 ± 14.2 years) underwent evisceration of blind painful eyes. 3D spherical implants produced by a rapid prototype machine were used to restore orbital volume. The implants were produced from a commercially available photocurable resin (Fullcure®). Systemic toxicity was evaluated by comparing serum biochemical measurements (creatine phosphokinase, aspartate aminotransferase, alanine aminotransferase, albumin, creatinine, urea, alkaline phosphatase, and C-reactive protein) before and at 12 months after surgery. Local toxicity was assessed by the evaluation of signs of socket inflammation at the first postoperative month. Changes in implant size were determined by computed tomography scans at 2 and 12 months after surgery. Results: The postoperative evaluations were uneventful. The biochemical evaluation showed no significant changes after surgery. None of the patients presented signs of orbital implant inflammation, infection, exposure, or extrusion. Computed tomography scan evaluations revealed no changes in implant size. Conclusion: To the best of our knowledge, this is the first phase-1 clinical study to certify the biocompatibility of the Fullcure resin for orbital implants in humans. The 3D printing technology permits fast and accurate production of implants for this purpose.

RESUMO Objetivos: Avaliar a biocompatibilidade das esferas produzidas por impressora tridimensional em evisceração. Pacientes e métodos: Evisceração por olho cego doloroso foi realizada em 10 pacientes consecutivos (8 mulheres, idade média: 46.8 ± 14.2 anos). Os implantes esféricos foram produzidos pelo sistema de prototipagem rápida utilizando dados tridimensionais computadorizados. O material utilizado para produção dos implantes foi a resina fotocurável Fullcure®. A avaliação da toxicidade sistêmica do material foi realizada por meio da dosagem de marcadores bioquímicos (creatina fosfoquinase, aspartato aminotransferase, alanina aminotransferase, albumina, creatinina, ureia, fosfatase alcalina, e proteína C-reactiva) antes da cirurgia e aos 12 meses de pós-operatorio. A avaliação da toxicidade local foi realizada por meio do registro qualitativo dos sinais inflamatórios no lado operado durante o primeiro mês de pós-operatório. O tamanho dos implantes foi medido em tomografias computadorizadas (CT) aos 2 e 12 meses de pós-operatório. Resultados: A avaliação bioquímica mostrou que os marcadores estudados não sofreram alterações significativas após a cirurgia. Nenhum paciente apresentou sinais de inflamação atípica, infecção, exposição ou extrusão. A avaliação tomográfica não demonstrou mudanças nos tamanhos dos implantes. Conclusão: O presente trabalho é o primeiro estudo clínico realizado para atestar a biocompatibilidade dos implantes orbitais de resina fotocurável Fullcure. A produção dos implantes pela técnica de impressão tridimensional, utilizando essa resina, permite a disponibilização rápida e acurada do produto final

A three-dimensional printed photopolymer resin implant for orbital rehabilitation for evisceration.

PURPOSE: To evaluate the biocompatibility of three-dimensional (3D) printed orbital spheres for evisceration. MATERIALS: A total of 10 consecutive patients (eight females and two males; mean age, 46.8 ± 14.2 years) underwent evisceration of blind painful eyes. 3D spherical implants produced by a rapid prototype machine were used to restore orbital volume. The implants were produced from a commercially available photocurable resin (Fullcure®). Systemic toxicity was evaluated by comparing serum biochemical measurements (creatine phosphokinase, aspartate aminotransferase, alanine aminotransferase, albumin, creatinine, urea, alkaline phosphatase, and C-reactive protein) before and at 12 months after surgery. Local toxicity was assessed by the evaluation of signs of socket inflammation at the first postoperative month. Changes in implant size were determined by computed tomography scans at 2 and 12 months after surgery. RESULTS: The postoperative evaluations were uneventful. The biochemical evaluation showed no significant changes after surgery. None of the patients presented signs of orbital implant inflammation, infection, exposure, or extrusion. Computed tomography scan evaluations revealed no changes in implant size. CONCLUSION: To the best of our knowledge, this is the first phase-1 clinical study to certify the biocompatibility of the Fullcure resin for orbital implants in humans. The 3D printing technology permits fast and accurate production of implants for this purpose.

Recomendação nº 036, de 9 de agosto de 2018: recomenda aos Deputados Federais e Senadores da República que toda e qualquer legislação alusiva a pesquisa envolvendo seres humanos respeite os princípios e pressupostos normativos do marco regulatório brasileiro, que tratam da proteção dos direitos e da segurança dos participantes de pesquisa, referendados pelo Conselho Nacional de Saúde, por meio da Comissão Nacional de Ética em Pesquisa ­ CONEP/CNS / Recommendation No. 036, of August 9, 2018: recommends to Federal Deputies and Senators of the Republic that any and all legislation referring to research involving human beings respects the normative principles and presuppositions of the Brazilian regulatory framework, which deal with the protection of rights and security of research participants, endorsed by the National Health Council

Recomenda aos Deputados Federais e Senadores da República que toda e qualquer legislação alusiva a pesquisa envolvendo seres humanos respeite os princípios e pressupostos normativos do marco regulatório brasileiro, que tratam da proteção dos direitos e da segurança dos participantes de pesquisa, referendados pelo Conselho Nacional de Saúde, por meio da Comissão Nacional de Ética em Pesquisa ­ CONEP/CNS; e que garanta a referida proteção dos direitos e a segurança dos participantes de pesquisas, no Projeto de Lei nº 7.082/2017, a partir das seguintes ressalvas: que a instância nacional de ética em pesquisa clínica a que se refere o inciso XXV preserve o caráter de regulação social que desempenha na função de relevância pública, por meio da Comissão Nacional de Ética em Pesquisa do Conselho Nacional de Saúde (CONEP/CNS). Nas condições propostas da atual versão do Projeto de Lei, a CONEP/CNS terá sua independência institucional ameaçada ao se vincular operacionalmente a um órgão executivo do governo. Além do mais, como o PL não define o mandato dos membros da comissão, a CONEP/CNS ficará vulnerável às mudanças de cargos no Ministério. Que a representação dos usuários se dê, preferencialmente, pelos conselhos de saúde de forma a ex

Current Methods Applied to Biomaterials - Characterization Approaches, Safety Assessment and Biological International Standards.

Safety and biocompatibility assessment of biomaterials are themes of constant concern as advanced materials enter the market as well as products manufactured by new techniques emerge. Within this context, this review provides an up-to-date approach on current methods for the characterization and safety assessment of biomaterials and biomedical devices from a physical-chemical to a biological perspective, including a description of the alternative methods in accordance with current and established international standards.

Impact of Different Implant Surfaces Topographies on Peri-Implant Tissues: An Update of Current Available Data on Dental Implants Retrieved from Human Jaws.

The high success range obtained with the implant-supported restorations has improved its applicability on routine of the daily clinical practice. This elevated percentage of success is related to the previous pre-clinical data obtained from animal and in vitro studies that evaluated the impact of implant surface topographies on bone tissue. However, the histological evaluation of human bone tissue is scarce. Therefore, the aim of this review is to depict an actual panorama of the data available on boneto- implant contact (BIC) of retrieved implants from human jaws. Some aspects of implant surface topography as well as systemic conditions as osteoporosis and smoking habit were demonstrated to have a strong impact, suggesting that the data obtained from human bone tissue is still valuable for the better understanding of the osseointegration process. This article also highlighted that most data in humans are difficult to interpret, due to the lack of detailed information about the surfaces found in retrieved implants. Without the definition of the surface characteristics, it is difficult to link exactly the surface patterns to specific clinical observations, and all observations remain de facto incomplete. As a conclusion, data from implants retrieved from human jaws are very important for our understanding, however the studies remain scarce and data is fragmented. This important approach should be improved, completed and developed in the future.

Desenvolvimento e análise de bandagem de bioestimulação dentino/pulpar (BBio) / Development and analysis of dental/pulpar bio-stimulation bandage ("BBIO")

O desenvolvimento de biomateriais com aplicações na área da saúde mostram-se cada vez mais importantes e a procura por novos polímeros com propriedades bioativas, biodegradabilidade, atoxicidade são o foco das principais pesquisas em diferentes aplicações médicas e odontológicas. Os materiais capeadores pulpares evoluíram rapidamente na ultima década, sendo que são disponibilizadas atualmente diversas alternativas para uso clínico odontológico. Este trabalho teve como objetivo o desenvolvimento de um novo produto bioestimulador e capeador dentino/pulpar que poderá ser base para o desenvolvimento e recobrimento de scaffolds para reparo das diferentes estruturas dentárias. O desenvolvimento das bandagens BBio e os resultados obtidos nos testes das propriedades físico-químicas (absorção de água, perda de massa e pH), bem como as análises biológicas da morfologia celular e viabilidade celular com MTT a BBio apresentaram dados favoráveis e desejáveis para sua aplicação clínica. A propriedade de liberação de cálcio foi bastante promissora, sendo esta uma condição que dará a diferenciação positiva da BBio como um produto bioestimulador pulpar. Com esses dados pode-se concluir que a mesma se encontra dentro dos parâmetros desejados para o produto final e com propriedades semelhantes aos produtos existentes no mercado, de qualidade e aprovados pelas agências reguladoras.(AU)

The development of biomaterials with applications in the health area are increasingly important and the search for new polymers with bioactive properties, biodegradability and toxicity are the focus of the main researches in different medical and dental applications. The pulp capping materials evolved rapidly in the last decade, and several alternatives are now available for clinical dental use. This project aimed to develop a new biostimulating and dentin / pulp capping product that could be the basis for the development and recoating of "scaffolds" for repair of different dental structures. The development of the BBio bandages and the results obtained in the physical-chemical properties tests (water absorption, loss of mass and pH), as well as the biological analyzes of the cellular morphology and cell viability with MTT to BBio presented favorable and desirable data for its clinical application. The calcium release property was quite promising, and this is a condition that will give BBio a positive differentiation as a pulp biostimulator product. With this data it can be concluded that it is within the parameters desired for the final product and with properties similar to the products on the market, of quality and approved by the regulatory agencies.(AU)

Ata da ducentésima vigésima reunião ordinária do Conselho Nacional de saúde ­ CNS / Minutes of the 220th ordinary meeting of the National Health Council - CNS

Aos seis e sete dias do mês de abril de dois mil e onze, no Plenário do Conselho Nacional de Saúde Omilton Visconde, Ministério da Saúde, Bloco G, Edifício Anexo, 1º andar, ala "B", Brasília, Distrito Federal, realizou-se a Ducentésima Vigésima Reunião Ordinária do CNS.

Resumo executivo da ducentésima vigésima reunião ordinária do Conselho Nacional de Saúde / Executive summary of the 220th ordinary meeting of the National Health Council - CNS

Aprovação da ata da 219ª reunião ordinária do CNS.

Reparo periapical com retro-obturações de MTA e Super EBA em cães / Periapical repair with root end filling of MTA and Super EBA in dogs

O objetivo deste estudo foi avaliar a resposta biológica de MTA e Super EBA (SEBA) em retro-obturações em cães. Lesões periapicais induzidas foram tratadas por cirurgia parendodôntica com retro-obturação utilizando MTA (n = 12) ou SEBA (n = 12). Após 180 dias, necrópsias foram coletadas, submetidas ao processamento histológico e análise estatística. MTA gerou menor presença de células inflamatórias e maior presença de cápsula fibrosa e de novo cemento em relação ao SEBA. Conclui-se que MTA e SEBA são biocompatíveis, mas apenas o MTA é bioativo com maior capacidade cementogênica.

The aim of this study was evaluate the biological response of MTA and Super EBA (SEBA) in root end filling in dogs. Parendodontic surgery and root end filling were used to treat induced periapical lesions using MTA (n = 12) or SEBA (n = 12). After 180 days, necropsies were collected, submitted to histological processing and statisticalanalysis. MTA induced smaller presence of inflammatory cells and higher presence of fibrous capsule and new cementum than SEBA. It was concluded that MTA and SEBA are biocompatible but only MTA is bioactive with the highest cementogenic capacity.

Avaliação da dureza de diferentes metais utilizados na confecção de pinos pré-fabricados / Assessment of different metal hardness used in the manufacture of pre-fabricated posts

Diversos tipos de materiais metálicos vêm sendo pesquisados nos últimos anos, indicados para a confecção de pinos pré-fabricados, com o objetivo de serem utilizados como retentores intrarradiculares visando à restauração estética e funcional. Pode-se afirmar que, apesar de algum ganho na utilização de materiais não metálicos para a confecção de pinos intrarradiculares, o metal ainda representa uma alternativa altamente confiável, especialmente porque o desempenho clínico dos retentores metálicos tem se mostrado excelente. O presente estudo teve como finalidade avaliar a dureza Vickers de três diferentes metais (Titânio C. P., Liga de Titânio/Vanádio/Alumínio e Liga de Aço Inoxidável), que podem ser utilizados para este fim. Os resultados obtidos demonstraram significativas diferenças entre os três materiais testados.

In vivo qualitative analysis of the biocompatibility of different cyanoacrylate-based adhesives.

Cyanocrylates have been widely used in the medical and dental fields for several years. In Dentistry, cyanoacrylates have been used for suturing, pulp capping, as retrofilling material in endodontic surgeries, and as cervical plug for pulpless teeth bleaching. The biocompatibility of these adhesives has been the topic of many researches and subcutaneous implantation is an effective methodology for these studies. The present study evaluated the biocompatibility of three different cyanoacrylate-based adhesives. Thirty-six Wistar rats were used, divided into four groups of 9 animals each: A (control)--distilled water, B--cyanoacrylate ester (Super Bonder), C - n-butyl-cyanoacrylate (Histoacryl) and D--alpha-cyanoacrylate (Three Bond). The materials were dispensed in sponges of polyvinyl chloride, the animals were incised and the sponges were inserted in the subcutaneous tissue and sutured. Each group was sub-divided according to the time of sacrifice of the animals: 7, 21 and 45 days. Subjective analysis of the histologic material showed that all groups presented some degree of irritability, but the inflammatory reaction decreased with the experimental time in all groups. Group D showed an inflammatory reaction which was closer to that of the control group and was considered to have good biocompatibility. Groups B and C were similar and presented more aggressive inflammatory reactions when compared to the control group. Based on the results, it was concluded that alpha-cyanoacrylate (Three Bond) was the most biocompatible adhesive because it caused the lowest levels of inflammation.

In vivo qualitative analysis of the biocompatibility of different cyanoacrylate-based adhesives

Cyanocrylates have been widely used in the medical and dental fields for several years. In Dentistry, cyanoacrylates have been used for suturing, pulp capping, as retrofilling material in endodontic surgeries, and as cervical plug for pulpless teeth bleaching. The biocompatibility of these adhesives has been the topic of many researches and subcutaneous implantation is an effective methodology for these studies. The present study evaluated the biocompatibility of three different cyanoacrylate-based adhesives. Thirty-six Wistar rats were used, divided into four groups of 9 animals each: A (control) - distilled water, B - cyanoacrylate ester (Super Bonder), C - n-butyl-cyanoacrylate (Histoacryl) and D - alpha-cyanoacrylate (Three Bond). The materials were dispensed in sponges of polyvinyl chloride, the animals were incised and the sponges were inserted in the subcutaneous tissue and sutured. Each group was sub-divided according to the time of sacrifice of the animals: 7, 21 and 45 days. Subjective analysis of the histologic material showed that all groups presented some degree of irritability, but the inflammatory reaction decreased with the experimental time in all groups. Group D showed an inflammatory reaction which was closer to that of the control group and was considered to have good biocompatibility. Groups B and C were similar and presented more aggressive inflammatory reactions when compared to the control group. Based on the results, it was concluded that alpha-cyanoacrylate (Three Bond) was the most biocompatible adhesive because it caused the lowest levels of inflammation.

[Bioethics and biosafety: the use of biomaterials in dental practice]. / Bioética e biossegurança: uso de biomateriais na prática odontológica.

OBJECTIVE: To analyze the use of biomaterials in surgical procedures carried out by specialist dental surgeons, in light of the Principalist Bioethics Theory and the Individual and Collective Ethics of Responsibility. METHODS: Dental surgeons (n=95), who were registered as specialists at the Regional Dentistry Council of Brasilia as of 2002, completed questionnaires regarding the use of biomaterials in their work. Data relating to sanitary control were collated, based on these dental surgeons' responses and research at relevant organizations. RESULTS: All of the professionals in the survey used biomaterials on a regular basis; 45% believed their use to be risk-free for patients, and 48% did not classify biomaterials as drugs. About 70% of professionals trust the source of the biomaterials even though membranes and bones are the items most commonly bought from individual suppliers. Nonetheless, 96% of interviewees believed that government sanitation agencies should regulate more. More than half of the professionals (51%) pointed to little or no participation by the patient in the process of therapeutic choice. A copy of the informed consent form was provided by 12% of the dental surgeons interviewed produced. CONCLUSIONS: The results showed that the professionals use biomaterials without knowing about related risks and adverse side effects, contrary to the principle of beneficence. Government agencies and professional bodies alike do not show evidence of observing public responsibility ethics. Informed consent is not yet integrated fully into professional practice and the doctor-patient relationship in dentistry remains markedly vertical.

Biological response of pulps submitted to different capping materials.

Pulp capping is a procedure that comprises adequate protection of the pulp tissue exposed to the oral environment, aiming at the preservation of its vitality and functions. This study evaluated the response of the dental pulps of dog teeth to capping with mineral trioxide aggregate (MTA) or calcium hydroxide P.A. For that purpose, 37 teeth were divided into two groups, according to the capping material employed. Two dogs were anesthetized and, after placement of a rubber dam, their pulps were exposed in a standardized manner and protected with the experimental capping materials. The cavities were then sealed with resin-modified glass ionomer cement and restored with composite resin. After sixty days, the animals were killed and the specimens were processed in order to be analyzed with optic microscopy. It was observed that MTA presented a higher success rate compared to calcium hydroxide, presenting a lower occurrence of infection and pulp necrosis.

The role of bovine preserved peritoneum in rats ventral hernia: a histological evaluation / Aspectos histológicos do uso do peritônio bovino conservado na correção de hérnia ventral em ratos

PURPOSE: To assess the role of preserved bovine parietal peritoneum as a material for hernia repair in a rat ventral hernia model. METHODS: An abdominal wall defect (15mm x 25mm) was created in Wistar male rats (n=40). Control animals (n=20) had the polypropylene (PP) mesh sutured into the defect, whereas bovine preserved peritoneum (BPP) was used in experimental group (n=20). After 7 and 28 days, the abdominal wall was taken off and histological studies of the amount of collagen by Sirius Red stain and morphometric evaluation consisted in quantitative analysis of the collagen by using specific software (Imagelab®). The Mann-Whitney, Kruskal-Wallis and ANOVA tests were applied for statistical analysis (pd"0.05). RESULTS: Histological examination revealed no difference between the BPP and PP groups (p = 0.55 NS). CONCLUSION: BPP is suitable for the closure of ventral hernias in rat model as shown by its morphological properties.

OBJETIVO: Estudar os aspectos histológicos do uso de uma prótese de peritônio bovino na correção de hérnia ventral em um modelo animal de doença. MÉTODOS: Utilizando 40 ratos machos Wistar, comparou-se o implante do peritônio bovino com a tela de polipropileno na correção de um defeito provocado na parede abdominal do animal. Após 7 (sub-grupo A) e 28 (sub-grupo B) dias de observação, as peças foram retiradas e procedeu-se o estudo histológico através da quantificação de colágeno pelo método de captação e processamento digital de imagens, sob a coloração do Sirius Red. Os testes de Mann-Whitney, de Kruskal-Wallis e ANOVA foram utilizados e estabeleceu-se em 0,05 o nível para rejeição da hipótese de nulidade (pd"0.05). RESULTADOS: A quantificação do colágeno na interface do implante mostrou equivalência entre os grupos Peritônio e Polipropileno (p=0,55 NS). CONCLUSÃO: O peritônio parietal bovino apresentou infiltração de tecido fibrocolágeno semelhante a da tela de polipropileno na correção de hérnia ventral em ratos.

The role of bovine preserved peritoneum in rats ventral hernia: a histological evaluation.

PURPOSE: To assess the role of preserved bovine parietal peritoneum as a material for hernia repair in a rat ventral hernia model. METHODS: An abdominal wall defect (15mm x 25mm) was created in Wistar male rats (n=40). Control animals (n=20) had the polypropylene (PP) mesh sutured into the defect, whereas bovine preserved peritoneum (BPP) was used in experimental group (n=20). After 7 and 28 days, the abdominal wall was taken off and histological studies of the amount of collagen by Sirius Red stain and morphometric evaluation consisted in quantitative analysis of the collagen by using specific software (Imagelab). The Mann-Whitney, Kruskal-Wallis and ANOVA tests were applied for statistical analysis (pd"0.05). RESULTS: Histological examination revealed no difference between the BPP and PP groups (p = 0.55 NS). CONCLUSION: BPP is suitable for the closure of ventral hernias in rat model as shown by its morphological properties.

Biological response of pulps submitted to different capping materials / Resposta biológica de polpas submetidas a diferentes materiais capeadores

Pulp capping is a procedure that comprises adequate protection of the pulp tissue exposed to the oral environment, aiming at the preservation of its vitality and functions. This study evaluated the response of the dental pulps of dog teeth to capping with mineral trioxide aggregate (MTA) or calcium hydroxide P.A. For that purpose, 37 teeth were divided into two groups, according to the capping material employed. Two dogs were anesthetized and, after placement of a rubber dam, their pulps were exposed in a standardized manner and protected with the experimental capping materials. The cavities were then sealed with resin-modified glass ionomer cement and restored with composite resin. After sixty days, the animals were killed and the specimens were processed in order to be analyzed with optic microscopy. It was observed that MTA presented a higher success rate compared to calcium hydroxide, presenting a lower occurrence of infection and pulp necrosis.

O capeamento pulpar é um procedimento que consiste na adequada proteção do tecido pulpar exposto ao meio oral, objetivando a preservação de sua vitalidade e suas funções. O objetivo deste trabalho foi observar a resposta da polpa dental de cães ao capeamento com o agregado de trióxido mineral (MTA) ou hidróxido de cálcio P.A. Para tanto, 37 dentes foram divididos em dois grupos, de acordo com o material capeador utilizado. Dois cães foram anestesiados e após o isolamento absoluto do campo operatório, realizou-se exposição padronizada da polpa, proteção com os materiais capeadores testados e selamento das cavidades com cimento modificado de ionômero de vidro. Os dentes foram então restaurados com resina composta. Após sessenta dias, os animais foram sacrificados e as peças foram processadas para a análise microscópica dos dentes. Observou-se que o MTA apresentou maior índice de sucesso em relação ao hidróxido de cálcio, evidenciando menor ocorrência de infecção e necrose pulpar.

[Retrieval and failure analysis of surgical implants in Brazil: the need for proper regulation]. / Análise de falhas de implantes cirúrgicos no Brasil: a necessidade de uma regulamentação adequada.

This paper summarizes several cases of metallurgical failure analysis of surgical implants conducted at the Laboratory of Failure Analysis, Instituto de Pesquisas Tecnológicas (IPT), in Brazil. Failures with two stainless steel femoral compression plates, one stainless steel femoral nail plate, one Ti-6Al-4V alloy maxillary reconstruction plate, and five Nitinol wires were investigated. The results showed that the implants were not in accordance with ISO standards and presented evidence of corrosion-assisted fracture. Furthermore, some of the implants presented manufacturing/processing defects which also contributed to their premature failure. Implantation of materials that are not biocompatible may cause several types of adverse effects in the human body and lead to premature implant failure. A review of prevailing health legislation is needed in Brazil, along with the adoption of regulatory mechanisms to assure the quality of surgical implants on the market, providing for compulsory procedures in the reporting and investigation of surgical implants which have failed in service.