Dental stem cells in intraoral regenerative therapy: a systematic review / Células-tronco dentárias na terapia regenerativa intraoral: uma revisão sistemática

Objective: 1) To critically review the published literature on applications of dental stem cells in the regeneration of intraoral tissues. 2) To provide an evidence-based level on research regarding application of dental stem cells in intraoral tissues regeneration. Methodology: This systematic review is conducted as per the JBI guidelines and reported as per the PRISMA. An initial literature search of papers published between 2004 and 2018 yielded 421 manuscripts. Nineteen studies satisfied the inclusion / exclusion criteria and were included for qualitative synthesis. Studies were categorized as animal (11) and human (8) trials. Five independent reviewers critically assessed the included studies. Risk of bias was assessed using SYstematic Review Centre for Laboratory animal Experimentation (SYRCLE) bias risk tool, robins-I tool for non-randomised clinical trial and Cochrane Collaboration's Tool for randomised clinical trial. Evidence levels were assessed based on JBI Criteria. Results: Animal trials mainly focused on periodontal regeneration. A high or unclear Risk of bias was more commonly found amongst animal studies. Laboratory, clinical and radiographic evaluation were used to assess the outcome. A total of Eight Human studies were conducted on a total samples size of 153 upon a wide age ranging from seven years to 60 years. Nearly 70% of the human studies used DPSC for regenerating alveolar bone defects. Conclusion: Appropriate well designed double-blind randomized clinical trials of longer duration are yet to be performed. Evidence for the included studies were 1C and 1D as per the JBI Criteria. Stem cell therapy demonstrated promising results in Periodontal tissue and alveolar bone regeneration. However, the number of studies to claim such a benefit are very limited (AU)

Objetivo: 1) Revisar criticamente a literatura publicada sobre aplicações de células-tronco dentárias na regeneração de tecidos intraorais. 2) Fornecer um nível baseado em evidências sobre pesquisas relacionadas à aplicação de células-tronco dentárias na regeneração de tecidos intraorais. Metodologia: Esta revisão sistemática é conduzida de acordo com as diretrizes do JBI e relatada de acordo com o PRISMA. Uma pesquisa bibliográfica inicial de artigos publicados entre 2004 e 2018 resultou em 421 manuscritos. Dezenove estudos satisfizeram os critérios de inclusão / exclusão e foram incluídos para síntese qualitativa. Os estudos foram categorizados como ensaios em animais (11) e humanos (8). Cinco revisores independentes avaliaram criticamente os estudos incluídos. O risco de viés foi avaliado usando a ferramenta de risco de viés do Centro de Revisão Sistemática para Experimentação com Animais de Laboratório (SYRCLE), a ferramenta robins-I para ensaios clínicos não randomizados e a Ferramenta da Colaboração Cochrane para ensaios clínicos randomizados. Os níveis de evidência foram avaliados com base nos critérios JBI. Resultados: Os ensaios em animais focaram principalmente na regeneração periodontal. Um risco alto ou pouco claro de viés foi mais comumente encontrado entre os estudos com animais. Avaliações laboratorial, clínica e radiográfica foram utilizadas para avaliar o resultado. Um total de oito estudos em humanos foram conduzidos em um tamanho total de amostras de 153 com ampla faixa etária, variando de sete a 60 anos. Quase 70% dos estudos em humanos usaram DPSC para regeneração de defeitos ósseos alveolares. Conclusão: Ensaios clínicos randomizados duplo-cegos apropriados e bem elaborados de maior duração ainda precisam ser realizados. As evidências para os estudos incluídos foram 1C e 1D de acordo com os critérios JBI. A terapia com células-tronco demonstrou resultados promissores na regeneração do tecido periodontal e do osso alveolar. No entanto, o número de estudos para reivindicar tal benefício é muito limitado (AU)

Bone mineral density assessment for research purpose using dual energy X-ray absorptiometry

Dual energy X-ray absorptiometry (DXA) has become the most common method for measuring bone mineral density (BMD) of small animals in metabolic bone disease research, and errors should be minimized in all procedures involved in research studies in order to increase the accuracy of the study results. DXA is simpler and rapid compared to Micro-computed tomography for quantitative analysis of change in trabecular bone of test subject. In human research, measuring BMD is widely used; post-operative evaluation on orthopedic surgery, evaluation of osteoporosis medication in menopause and many other areas of study. For the study, the inspector should be trained by the equipment manufacturer regarding the utilization and analysis of the equipment and regular phantom testing should be conducted to ensure the stability of the equipment, and precision tests should be conducted to analyze the positioning and data analysis. They should also be familiar with the clinical trials and conduct studies based on the approval of the Institutional Review Board. In the absolute BMD measurement of the human body, it is necessary to apply and compare the position and condition, rotation degree, region of interest, and area of the scan in the follow-up test. In the case of small animals, animal selection, measurement and equipment should be modeled to match the research. Therefore, we would like to provide information for researchers to minimize the errors, effective data management and accurate data presentation. This article reviews the process of DXA measurement for research purpose including plan for DXA examination, BMD measurement in a human body study and small animal studies.

Human Studies on Functional Foods: How They Are Regulated

Along with the steady growth of health functional food (HFF) markets, research evaluating the human effects of HFF has been expanding. In this study, we investigated the regulatory and management system of human study on HFF in the USA, Japan and UK, and the Korean domestic regulations on HHF, medicines, medical devices, cosmetics and biotechnology in order to improve the domestic management system. In these four countries, institutional review board (IRB) or research ethics committee (REC) approvals are required for on human study of HHF, but regulatory and management systems differ from country to country. In the USA, human studies on HFF for structure/function claims do not require the FDA's prior approval but clinical trials of the disease treatment effects of HHF require prior approval from the FDA. In the USA, IRBs are managed by the Department of Health and Human Services (DHHS) rather than the FDA, and IRBs in those institutions which would execute the clinical trials requiring prior approval from the FDA or human studies funded by the USA federal government are required to be registered on the DHHS. In the UK, although the government does not require prior approval of human study, authorized RECs managed by the National Research Ethics Service (NRES) and other independent RECs review the human study. In Japan, human study for HFF must conform with "Ethical guidelines for epidemiological research" and IRB registration has not been required. In Korean domestic regulations, the responsibilities, compositions, functions and operations of IRBs on medicines, medical devices and biotechnology are legally specified, but not those of IRB on HHF. These foreign statuses for the management of human study on HFF and comparisons with Korean regulations are expected to be used as basic data to improve the domestic legal system.