• 대한의용생체공학회:의공학회지
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• 제44권3호
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• pp.204-210
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• 2023

This study focuses on analyzing medical device standards and regulatory requirements in the medical device industry, based on the Medical Device Act in Korea. The objective of this analysis is to determine whether the domestic standards for medical devices in Korea align with international and regional standards. Furthermore, it aims to identify the current application of domestic standards in ensuring the safety and essential performance of medical devices. The analysis revealed that out of a total of 281 domestic standards, 127 standards reference international standards. In terms of the application of domestic standards to specific items, there were 473 types of instruments/machines, 30 types of medical supplies, and 45 types of dental materials. However, the level of compliance with international standards among the domestic medical device standards was only 21%. Upon detailed analysis, general and collateral standards accounted for 24%, while particular standards accounted for 19%. This indicates a significant deviation from the latest international standards. On the other hand, the level of compliance with international standards was analyzed to be 60% for particular standards and 72% for general and collateral standards in Korean industrial standards (KS). Considering these results, the disparities between domestic standards and international standards underscore the need for discussions on domestic medical device regulation and standardization. In conclusion, this study emphasizes the significance of maintaining up-to-date medical device standards and ensuring their alignment with international standards to ensure the safety and quality of medical devices. The findings highlight the necessity for further efforts to strengthen the domestic standardization system in order to promote the development of safe and high-quality medical devices.

• Journal of Periodontal and Implant Science
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• 제52권6호
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• pp.479-495
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• 2022

Purpose: Rodent models have emerged as an alternative to established larger animal models for peri-implantitis research. However, the construct validity of rodent models is controversial due to a lack of consensus regarding their histological, morphological, and biochemical characteristics. This systematic review sought to validate rodent models by characterizing their morphological changes, particularly marginal bone loss (MBL), a hallmark of peri-implantitis. Methods: This review was conducted following the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines. A literature search was performed electronically using MEDLINE (PubMed), and Embase, identifying pre-clinical studies reporting MBL after experimental peri-implantitis induction in rodents. Each study's risk of bias was assessed using the Systematic Review Center for Laboratory animal Experimentation (SYRCLE) risk of bias tool. A meta-analysis was performed for the difference in MBL, comparing healthy implants to those with experimental peri-implantitis. Results: Of the 1,014 unique records retrieved, 23 studies that met the eligibility criteria were included. Peri-implantitis was induced using 4 methods: ligatures, lipopolysaccharide, microbial infection, and titanium particles. Studies presented high to unclear risks of bias. During the osseointegration phase, 11.6% and 6.4%-11.3% of implants inserted in mice and rats, respectively, had failed to osseointegrate. Twelve studies were included in the meta-analysis of the linear MBL measured using micro-computed tomography. Following experimental peri-implantitis, the MBL was estimated to be 0.25 mm (95% confidence interval [CI], 0.14-0.36 mm) in mice and 0.26 mm (95% CI, 0.19-0.34 mm) in rats. The resulting peri-implant MBL was circumferential, consisting of supra- and infrabony components. Conclusions: Experimental peri-implantitis in rodent models results in circumferential MBL, with morphology consistent with the clinical presentation of peri-implantitis. While rodent models are promising, there is still a need to further characterize their healing potentials, standardize experiment protocols, and improve the reporting of results and methodology.

• Journal of Oral Medicine and Pain
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• 제47권1호
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• pp.10-26
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• 2022

Purpose: The purpose of this study was to investigate whether various saliva collection methods affect the observed salivary microbiome and whether microbiomes of stimulated and unstimulated saliva and plaque differ in richness and diversity. Methods: Seven sampling methods for unstimulated saliva, stimulated saliva, and plaque samples were applied to six orally and systemically healthy participants. Bacterial 16S ribosomal RNA genes of 10 major oral bacterial species, namely, Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Tannerella forsythia, Treponema denticola, Fusobacterium nucleatum, Prevotella intermedia, Prevotella nigrescens, Streptococcus mitis, Streptococcus sobrinus, and Lactobacillus casei, were analyzed by real-time polymerase chain reaction. We comprehensively examined the dependence of the amount of bacterial ribosomal DNA (rDNA), bacterial-community composition, and relative abundance of each species on sample collection methods. Results: There were significant differences in the bacterial rDNA copy number depending on the collection method in three species: F. nucleatum, P. nigrescens, and S. mitis. The species with the highest richness was S. mitis, with the range from 89.31% to 100.00%, followed by F. nucleatum, P. nigrescens, T. denticola, T. forsythia, and P. intermedia, and the sum of the proportions of the remaining five species was less than 1%. The species with the lowest observed richness was P. gingivalis (<0.1%). The Shannon diversity index was the highest in unstimulated saliva collected with a funnel (4.449). The Shannon diversity index was higher in plaque samples (3.623) than in unstimulated (3.171) and stimulated (3.129) saliva and in mouthwash saliva samples (2.061). Conclusions: The oral microbial profile of saliva samples can be affected by sample collection methods, and saliva differs from plaque in the microbiome. An easy and rapid technique for saliva collection is desirable; however, observed microbial-community composition may more accurately reflect the actual microbiome when unstimulated saliva is assayed.

• 대한치과교정학회지
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• 제52권2호
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• pp.85-101
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• 2022

Objective: To classify facial asymmetry (FA) phenotypes in adult patients with skeletal Class III (C-III) malocclusion. Methods: A total of 120 C-III patients who underwent orthognathic surgery (OGS) and whose three-dimensional computed tomography images were taken one month prior to OGS were evaluated. Thirty hard tissue landmarks were identified. After measurement of 22 variables, including cant (°, mm), shift (mm), and yaw (°) of the maxilla, maxillary dentition (Max-dent), mandibular dentition, mandible, and mandibular border (Man-border) and differences in the frontal ramus angle (FRA, °) and ramus height (RH, mm), K-means cluster analysis was conducted using three variables (cant in the Max-dent [mm] and shift [mm] and yaw [°] in the Manborder). Statistical analyses were conducted to characterize the differences in the FA variables among the clusters. Results: The FA phenotypes were classified into five types: 1) non-asymmetry type (35.8%); 2) maxillary-cant type (14.2%; severe cant of the Max-dent, mild shift of the Man-border); 3) mandibular-shift and yaw type (16.7%; moderate shift and yaw of the Man-border, mild RH-difference); 4) complex type (9.2%; severe cant of the Max-dent, moderate cant, severe shift, and severe yaw of the Man-border, moderate differences in FRA and RH); and 5) maxillary reverse-cant type (24.2%; reverse-cant of the Max-dent). Strategic decompensation by pre-surgical orthodontic treatment and considerations for OGS planning were proposed according to the FA phenotypes. Conclusions: This FA phenotype classification may be an effective tool for differential diagnosis and surgical planning for Class III patients with FA.

• Restorative Dentistry and Endodontics
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• 제46권1호
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• pp.13.1-13.9
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• 2021

Objectives: This study aimed to evaluate and compare the efficacy of the S1 reciprocating system and the D-Race retreatment rotary system for filling material removal and the apical extrusion of debris. Materials and Methods: Sixty-four freshly extracted maxillary canines were shaped with size 10 and size 15 K-files, instrumented using ProTaper Gold under irrigation with 2.5% sodium hypochlorite (NaOCl), obturated according to the principle of thermo-mechanical condensation with gutta-percha and zinc oxide eugenol sealer, and allowed to set for 3 weeks at 37℃. Subsequently, the teeth were divided into a control group (n = 4), the D-Race rotary instrument group (n = 30), and the S1 reciprocating instrument group (n = 30). After classical retreatment, the canals were subjected to a complementary approach with the XP-Endo Shaper. Desocclusol was used as a solvent, and irrigation with 2.5% NaOCl was performed. Each group was divided into subgroups according to the timing of radiographic readings. The images were imported into a software program to measure the remaining filling material, the apical extrusion, and the root canal space. The data were statistically analyzed using the Z-test and JASP graphics software. Results: No significant differences were found between the D-Race and S1 groups for primary retreatment; however, using a complementary cleaning method increased the removal of remnant filling (p < 0.05). Conclusions: Classical removal of canal filling material may not be sufficient for root canal disinfection, although a complementary finishing approach improved the results. Nevertheless, all systems left some debris and caused apical extrusion.

• Smart Structures and Systems
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• 제30권5호
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• pp.545-556
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• 2022

Through the examination of literatures, electronic commerce is a subject which is accepted in enterprises to define e-commerce adoption, trends, and issues that are assisting and obstructing its efficacy. E-commerce offers numerous advantages to consumer satisfaction in any place and helps the company to get a competitive benefit over its competitors. The Internet has expanded the scope of business. Many business information is available by the global network that supports information gathering between organizations, businesses and their clients, while various divisions of a business is increasing at an exponential rate. Meanwhile, there are a few barriers to proper e-commerce usage and adoption, such as reliable internet connections, poor e-commerce supporting infrastructures, logistics systems presenting socio-regulatory and poor transportation barriers and demonstrating the significant improvement of e-commerce reliable and affordable Internet provisions, i.e., Internet cost, intensity, and reasonable level of e-readiness. The operational and strategic significance of information-based virtual value chains for all organizations cannot be emphasized. As a consequence, this study confirms worldwide market elements of e-commerce, such as its issues, benefits, relevance, scope, facilitators and projects prospective obstacles in a developing economy.

• Restorative Dentistry and Endodontics
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• 제47권2호
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• pp.15.1-15.18
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• 2022

This review aimed to characterize the effect of direct restorative material types and adhesive protocols on marginal adaptation and the bond strength of the interface between the material and the proximal dentin/cementum. An electronic search of 3 databases (the National Library of Medicine [MEDLINE/PubMed], Scopus, and ScienceDirect) was conducted. Studies were included if they evaluated marginal adaptation or bond strength tests for proximal restorations under the cementoenamel junction. Only 16 studies met the inclusion criteria and were included in this review. These studies presented a high degree of heterogeneity in terms of the materials used and the methodologies and evaluation criteria of each test; therefore, only a descriptive analysis could be conducted. The included studies were individually evaluated for the risk of bias following predetermined criteria. To summarize the results of the included studies, the type of restorative material affected the test results, whereas the use of different adhesive protocols had an insignificant effect on the results. It could be concluded that various categories of resin-based composites could be a suitable choice for clinicians to elevate proximal dentin/cementum margins, rather than the open sandwich technique with resin-modified glass ionomers. Despite challenges in bonding to proximal dentin/cementum margins, different adhesive protocols provided comparable outcomes.

• Restorative Dentistry and Endodontics
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• 제48권3호
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• pp.26.1-26.12
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• 2023

Objective: This in vitro study aimed to evaluate the effects of different whitening toothpastes on a composite resin during at-home bleaching with 10% carbamide peroxide. Materials and Methods: Sixty samples (7 mm × 2 mm) were used for color and roughness analyses, while another 60 samples (3 mm × 2 mm) were utilized to assess microhardness. The factors analyzed included toothpaste, for which 5 options with varying active agents were tested (distilled water; conventional toothpaste; whitening toothpaste with abrasive agents; whitening toothpaste with abrasive and chemical agents; and whitening toothpaste with abrasive, chemical, and bleaching agents). Brushing and application of whitening gel were performed for 14 days. Surface microhardness (SMH), surface roughness (Ra), and color (ΔL^*, Δa^*, Δb, ΔE^*_ab, and ΔE₀₀) were analyzed. The Ra and SMH data were analyzed using mixed generalized linear models for repeated measures, while the color results were assessed using the Kruskal-Wallis and Dunn tests. Results: Between the initial and final time points, all groups demonstrated significant increases in Ra and reductions in SMH. No significant differences were found between groups for SMH at the final time point, at which all groups differed from the distilled water group. Conventional toothpaste exhibited the lowest Ra, while whitening toothpaste with abrasive agent had the highest value. No significant differences were observed in ΔL^*, Δa^*, and Δb. Conclusions: While toothpaste composition did not affect the color stability and microhardness of resin composite, combining toothbrushing with whitening toothpaste and at-home bleaching enhanced the change in Ra.

• IMMUNE NETWORK
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• 제23권6호
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• pp.44.1-44.16
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• 2023

Mesenchymal stem cells (MSCs) are effective in treating autoimmune diseases and managing various conditions, such as engraftment of allogeneic islets. Additionally, autologous and HLA-matched allogeneic MSCs can aid in the engraftment of human allogeneic kidneys with or without low doses of tacrolimus, respectively. However, HLA alloantigens are problematic because cell therapy uses more HLA-mismatched allogeneic cells than autologous for convenience and standardization. In particular, HLA-mismatched MSCs showed increased Ag-specific T/B cells and reduced viability faster than HLA-matched MSCs. In CRISPR/Cas9-based cell therapy, Cas9 induce T cell activation in the recipient's immune system. Interestingly, despite their immunogenicity being limited to the cells with foreign Ags, the accumulation of HLA alloantigen-sensitized T/B cells may lead to allograft rejection, suggesting that alloantigens may have a greater scope of adverse effects than foreign Ags. To avoid alloantigen recognition, the β2-microglobulin knockout (B2MKO) system, eliminating class-I MHC, was able to avoid rejection by alloreactive CD8 T cells compared to controls. Moreover, universal donor cells in which both B2M and Class II MHC transactivator (CIITA) were knocked out was more effective in avoiding immune rejection than single KO. However, B2MKO and CIITA KO system remain to be controlled and validated for adverse effects such as the development of tumorigenicity due to deficient Ag recognition by CD8 T and CD4 T cells, respectively. Overall, better HLA-matching or depletion of HLA alloantigens prior to cell therapy can reduce repetitive transplantation through the long-term survival of allogeneic cell therapy, which may be especially important for patients seeking allogeneic transplantation.

• Restorative Dentistry and Endodontics
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• 제49권2호
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• pp.15.1-15.11
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• 2024

Objectives: This study aimed to establish a single-session associative protocol for nonrestorative management of dentin hypersensitivity (DH). Materials and Methods: Twenty-four individuals with DH and a minimum sensitivity level of 4 on the visual analog scale (VAS) were selected. The study was conducted in a split-mouth design, with each participant (n = 20) having at least 1 affected tooth in all quadrants. The management protocols consisted of control group: universal adhesive, Neural Desensitizing Protocol group: 5% potassium nitrate, Mixed Desensitizing Protocol (PAM) group: 5% sodium fluoride and 5% potassium nitrate, Remineralizing Desensitizing Protocol (PDR) group: surface-partially reacted glass technology photopolymerizable varnish. Evaluations were performed immediately after application, at 1 week, 1 month, 2 months, and 12 months using the VAS sensitivity test. Results: The scores were subjected to statistical analysis using the Friedman test (p < 0.05), Durbin-Conover test (p < 0.05), and Wilcoxon test (p < 0.05). At the 12-month evaluation, all groups showed statistically significant differences compared to the initial assessment. For the evaluation after 12 months, there was a statistically significant difference between the PAM group, the control group, and the PDR group. Conclusions: It can be concluded that all groups were effective in controlling DH, but there were significant results in the control group and PDR group. The clinical relevance of this study is to demonstrate that the application of single-session desensitizing protocols can be effective in controlling DH for up to 12 months.