Effect of Dentin Contamination with Hemostatic Agents and Cleaning Techniques on Bonding with Self-Adhesive Resin Cement.

BACKGROUND Dentin contamination with hemostatic agents before bonding indirect restorations negatively affects the bond strength. However, the consensus on which materials could be used to clean contamination of hemostatic agents has not been explored. The aim of this study was to assess the effect of Katana Cleaner applied on the surface of dentin contaminated with hemostatic agents on the shear bond strength (SBS) of self-adhesive resin cement by comparing it with three other surface cleaners. MATERIAL AND METHODS Ninety dentin specimens were divided into a no contamination group (control) (n=10), 4 groups contaminated with 25% aluminum chloride (Viscostat Clear) (n=40), and 4 groups contaminated with 20% ferric sulfate (Viscostat) (n=40). Subsequently, 4 different cleaners were used for each contamination group (water rinse, phosphoric acid, chlorhexidine, and Katana Cleaner). Then, self-adhesive resin cement was directly bonded to the treated surfaces. All specimens were subjected to 5000 thermal cycles of artificial aging. The shear bond strength was measured using a universal testing machine. RESULTS Two-way analysis of variance showed that the contaminant type as the main factor was statistically non-significant (p=0.655), cleaner type as the main factor was highly significant (p<0.001), and interaction between the contaminant and cleaner was non-significant (p=0.51). The cleaner type was the main factor influencing the bond strength. Phosphoric acid and chlorhexidine showed better performance than Katana Cleaner. CONCLUSIONS Cleaning dentin surface contamination with phosphoric acid and chlorhexidine had better performance than with Katana Cleaner.

The Impact of Repeated Steam Sterilization Cycles on the Efficacy of Chairside Adjustment Kits for Polishing Monolithic Multi-Layered Zirconia Dental Restoration Material.

BACKGROUND Before insertion, chairside adjustment kits are heat sterilized for positioning and polishing dental restorations. This study aimed to evaluate the effects of 2 steam sterilization cycles on the efficacy of polishing highly translucent monolithic zirconia (HTMLZ) dental restoration material. MATERIAL AND METHODS 100 HTMLZ disc-shaped specimens were adjusted (grinding, finishing, polishing) with EVE Diacera kit. Two steam sterilization techniques [standard (Gp S), immediate/flash (Gp (F)] of CAK were further subgrouped based on number of sterilization cycles [cycle 1 (control), cycle 5, 10, 15, and 20 (experimental)] (n=10 each). Each subgroup accordingly was evaluated for average surface roughness (Ra) and root mean square roughness (Rq) using a profilometer. Mean and standard deviation of 5 subgroups were statistically analyzed using one-way ANOVA/post hoc Tukey's test. Scanning electron microscopy complemented Ra, Rq measurements. Statistical differences of P≤0.05 were considered significant. RESULTS HTMLZ specimens in both groups showed increased (Ra/Rq) values after repeated sterilization of EVE Diacera kit, with Gp F showing lesser increase than Gp S (20 cycles). Gp F at 10 cycles and Gp S at 15 cycles showed clinically unacceptable roughness threshold (0.25 µm). Differences between subgroups for Ra and Rq values were significant (P≤0.05) with less differences within groups observed in early cycles (1, 10). Results validate the manufacturer's recommendations of using flash sterilization/10 cycles for EVE Diacera kit. CONCLUSIONS Repeated sterilization reduces efficacy of chairside adjustment kit to produce smooth surfaces on HTMLZ. This study recommends flash sterilization to a maximum of 10 times to get the clinically acceptable results of Ra and Rq.

Interface stress transfer model and modulus parameter equivalence method for composite materials embedded with tensile pre-strain shape memory alloy fibers.

The constitutive model and modulus parameter equivalence of shape memory alloy composites (SMAC) serve as the foundation for the structural dynamic modeling of composite materials, which has a direct impact on the dynamic characteristics and modeling accuracy of SMAC. This article proposes a homogenization method for SMA composites considering interfacial phases, models the interface stress transfer of three-phase cylinders physically, and derives the axial and shear stresses of SMA fiber phase, interfacial phase, and matrix phase mathematically. The homogenization method and stress expression were then used to determine the macroscopic effective modulus of SMAC as well as the stress characteristics of the fiber phase and interface phase of SMA. The findings demonstrate the significance of volume fraction and tensile pre-strain in stress transfer between the fiber phase and interface phase at high temperatures. The maximum axial stress in the fiber phase is 705.05 MPa when the SMA is fully austenitic and the pre-strain increases to 5%. At 10% volume fraction of SMA, the fiber phase's maximum axial stress can reach 1000 MPa. Ultimately, an experimental verification of the theoretical calculation method's accuracy for the effective modulus of SMAC lays the groundwork for the dynamic modeling of SMAC structures.

Biotribological properties of 3D printed high-oriented short carbon fiber reinforced polymer composites for artificial joints.

Short carbon fiber (SCF) reinforced polymer composites are expected to possess outstanding biotribological and mechanical properties in certain direction, while the non-oriented SCF weakens its reinforcing effect in the matrix. In this work, high-oriented SCF was achieved during nozzle extrusion, and then SCF reinforced polyether-ether-ketone (PEEK) composites were fabricated by fused deposition modeling (FDM). The concrete orientation process of SCF was theoretically simulated, and significant shear stress difference was generated at both ends of SCF. As a result, the SCF was distributed in the matrix in a hierarchical structure, containing surface layer I, II and core layer. Moreover, the SCF was oriented highly along the printing direction and demonstrated a more competitive orientation distribution compared to other studies. The SCF/PEEK composites showed a considerable improvement in wear resistance by 44 % due to self-lubricating and load-bearing capability of SCF. Besides, it demonstrated enhancements in Brinell hardness, compressive and impact strength by 48.52 %, 16.42 % and 53.64 %, respectively. In addition, SCF/PEEK composites also showed good cytocompatibility. The findings gained herein are useful for developing the high-oriented SCF reinforced polymer composites with superior biotribological and mechanical properties for artificial joints.

In vivo study of a novel 3D-printed motion-preservation artificial cervical corpectomy construct: short-term imaging and biocompatibility evaluations in a goat model.

BACKGROUND: Nonfusion technologies, such as motion-preservation devices, have begun a new era of treatment options in spine surgery. Motion-preservation approaches mainly include total disc replacement for anterior cervical discectomy and fusion. However, for multisegment fusion, such as anterior cervical corpectomy and fusion, the options are more limited. Therefore, we designed a novel 3D-printed motion-preservation artificial cervical corpectomy construct (ACCC) for multisegment fusion. The aim of this study was to explore the feasibility of ACCC in a goat model. METHODS: Goats were treated with anterior C3 corpectomy and ACCC implantation and randomly divided into two groups evaluated at 3 or 6 months. Radiography, 3D CT reconstruction and MRI evaluations were performed. Biocompatibility was evaluated using micro-CT and histology. RESULTS: Postoperatively, all goats were in good condition, with free neck movement. Implant positioning was optimal. The relationship between facet joints was stable. The range of motion of the C2-C4 segments during flexion-extension at 3 and 6 months postoperatively was 7.8° and 7.3°, respectively. The implants were wrapped by new bone tissue, which had grown into the porous structure. Cartilage tissue, ossification centres, new blood vessels, and bone mineralization were observed at the porous metal vertebrae-bone interface and in the metal pores. CONCLUSIONS: The ACCC provided stabilization while preserving the motion of the functional spinal unit and promoting bone regeneration and vascularization. In this study, the ACCC was used for anterior cervical corpectomy and fusion (ACCF) in a goat model. We hope that this study will propel further research of motion-preservation devices.

Effects of hexagonal boron nitride on mechanical properties of bone cement (Polymethylmethacrylate).

OBJECTIVES: The aim of this study was to investigate the effects of adding hexagonal boron nitride at four different concentrations to polymethylmethacrylate (PMMA) bone cement, which is commonly used in orthopedic surgeries, on the mechanical properties and microarchitecture of the bone cement. MATERIALS AND METHODS: The study included an unaltered control group and groups containing four different concentrations (40 g of bone cement with 0.5 g, 1 g, 1.5 g, 2 g) of hexagonal boron nitride. The samples used for mechanical tests were prepared at 20±2ºC in operating room conditions, using molds in accordance with the test standards. As a result of the tests, the pressure values at which the samples deformed were determined from the load-deformation graphs, and the megapascal (MPa) values at which the samples exhibited strength were calculated. RESULTS: The samples with 0.5 g boron added to the bone cement had significantly increased mechanical strength, particularly in the compression test. In the group where 2 g boron was added, it was noted that, compared to the other groups, the strength pressure decreased and the porosity increased. The porosity did not change particularly in the group where 0.5 g boron was added. CONCLUSION: Our study results demonstrate that adding hexagonal boron nitride (HBN) to bone cement at a low concentration (0.5 g / 40 g PPMA) significantly increases the mechanical strength in terms of MPa (compression forces) without adversely affecting porosity. However, the incorporation of HBN at higher concentrations increases porosity, thereby compromising the biomechanical properties of the bone cement, as evidenced by the negative impact on compression and four-point bending tests. Boron-based products have gained increased utilization in the medical field, and HBN is emerging as a promising chemical compound, steadily growing in significance.

Design and Biocompatibility of a Novel, Flexible Artificial Cornea.

Purpose: We sought to introduce the materials, design, and biocompatibility of a flexible and suturable artificial corneal device. Methods: Single-piece, fully synthetic, optic-skirt design devices were made from compact perfluoroalkoxy alkane. The skirt and the optic wall surfaces were lined with a porous tissue ingrowth material using expanded polytetrafluoroethylene. Full-thickness macroapertures around the skirt perimeter were placed to facilitate nutrition of the recipient cornea. Material properties including the skirt's modulus of elasticity and bending stiffness, optic light transmission, wetting behavior, topical drug penetrance, and degradation profile were evaluated. Results: The final prototype suitable for human use has a transparent optic with a diameter of 4.60 mm anteriorly, 4.28 mm posteriorly, and a skirt outer diameter of 6.8 mm. The biomechanical and optical properties of the device closely align with the native human cornea with an average normalized device skirt-bending stiffness of 4.7 kPa·mm4 and light transmission in the visible spectrum ranging between 92% and 96%. No optical damage was seen in the 36 devices tested in fouling experiments. No significant difference was observed in topical drug penetrance into the anterior chamber of the device implanted eye compared with the naïve rabbit eye. Conclusions: The flexibility and biocompatibility of our artificial cornea device may offer enhanced tissue integration and decreased inflammation, leading to improved retention compared with rigid keratoprosthesis designs. Translational Relevance: We have developed a fully synthetic, flexible, suturable, optic-skirt design prototype artificial cornea that is ready to be tested in early human feasibility studies.

A Novel growth guidance system for early onset scoliosis: a preliminary in vitro study.

PURPOSE: The purpose of the study was to describe a novel growth guidance system, which can avoid metal debris and reduce the sliding friction forces, and test the durability and glidability of the system by in vitro test. METHOD: Two major modifications were made to the traditional Shilla system, including the use of ultra-high molecular weight polyethylene (UHMWPE) gaskets to avoid direct contact between the screw and rod, and polishing the surface of the sliding part of the rod. We tested the durability of the system by a fatigue test, which the samples were test on the MTS system for a 10 million cycle of a constant displacement. Pre and post-testing involved weighing the UHMWPE gaskets and observing the wear conditions. The sliding ability were measured by a sliding displacement test. The maximum sliding displacement of the system was measured after a 300 cycles of dynamic compressive loads in a sinusoidal waveform. RESULTS: After the fatigue test, all the UHMWPE gaskets samples showed some of the fretting on the edge of the inner sides, but its still isolated and avoided the friction between the screws and rods. There was no production of metallic fretting around the sliding screws and rods. The average wear mass of the UHMWPE gaskets was 0.002 ± 0.001 g, less than 1.7% of the original mass. In the sliding test, the novel growth guidance system demonstrated the best sliding ability, with an average maximum sliding distance(AMSD) of 35.75 ± 5.73 mm, significantly better than the group of the traditional Shilla technique(AMSD 3.65 ± 0.46 mm, P < 0.0001). CONCLUSION: In conclusion, we modified the Shilla technique and designed a novel growth guidance system by changing the friction interface of sliding screw and rod, which may significantly reduce the metallic debris and promote spine growth. The fatigue test and sliding dislocation test demonstrated the better durability and glidability of the system. An in vivo animal experiment should be performed to further verify the system.

Effects of washing agents on the mechanical and biocompatibility properties of water-washable 3D printing crown and bridge resin.

Three-dimensional (3D) printing, otherwise known as additive manufacturing in a non-technical context, is becoming increasingly popular in the field of dentistry. As an essential step in the 3D printing process, postwashing with organic solvents can damage the printed resin polymer and possibly pose a risk to human health. The development of water-washable dental resins means that water can be used as a washing agent. However, the effects of washing agents and washing times on the mechanical and biocompatibility properties of water-washable resins remain unclear. This study investigated the impact of different washing agents (water, detergent, and alcohol) and washing time points (5, 10, 20, and 30 min) on the flexural strength, Vickers hardness, surface characterization, degree of conversion, biocompatibility, and monomer elution of 3D printed samples. Using water for long-term washing better preserved the mechanical properties, caused a smooth surface, and improved the degree of conversion, with 20 min of washing with water achieving the same biological performance as organic solvents. Water is an applicable agent option for washing the 3D printing water-washable temporary crown and bridge resin in the postwashing process. This advancement facilitates the development of other water-washable intraoral resins and the optimization of clinical standard washing guidelines.

Evaluation of Retentive Strength of 50 Endodontically-Treated Single-Rooted Mandibular Second Premolars Restored with Cast Post Cores Using 5 Common Luting (Cement) Agents.

BACKGROUND A luting agent is a dental cement used to secure a dental restoration. This study aimed to evaluate retentive strength of 50 endodontically-treated single-rooted mandibular second premolars (extracted) restored using 5 common luting (cement) agents. MATERIAL AND METHODS Fifty single-rooted mandibular second premolars with adequate root length and uniform size/shape were decoronated. After completing endodontic biomechanical preparation and obturation, root canals of all specimens were prepared to receive a cast post core. Depending upon cementation type, CPC specimens were divided in 5 groups (10 each) (Gp): Zinc phosphate (Gp ZP), polycarboxylate (Gp PC), glass ionomer (Gp GI), resin-modified glass ionomer (Gp RGI), and resin cement (Gp RC). Retentive strength was determined using the adhesive failure pull-out test. Mean/standard deviations were calculated for tensile forces (in kilograms) and differences were determined using analysis of variance (ANOVA). Multiple comparison was performed using the t test. A P value of ≤0.05 indicated a statistically significant difference. RESULTS The order of mean tensile strength from higher to lower was Gp RC (21.46) >Gp RGI (18.17) >Gp GI (16.07) >Gp ZP (15.33) >Gp PC (13.63). Differences in retentive strengths between the cements were significant (P≤0.05). Multiple-group comparisons showed that except for Gp ZP and Gp GI, all groups differed significantly from each other. CONCLUSIONS All investigated cements provided optimal retentive strengths, with wide differences between them. Resin cements should be used when CPC removal is not anticipated, while polycarboxylate or zinc phosphate should be used if CPC removal is anticipated.

Implications of variability on medical device chemical equivalence assessment.

Chemical equivalence testing can be used to assess the biocompatibility implications of a materials or manufacturing change for a medical device. This testing can provide a relatively facile means to evaluate whether the change may result in additional or different toxicological concerns. However, one of the major challenges in the interpretation of chemical equivalence data is the lack established criteria for determining if two sets of extractables data are effectively equivalent. To address this gap, we propose a two-part approach based upon a relatively simple statistical model. First, the probability of a false positive conclusion, wherein there is an incorrectly perceived increase for a given analyte in the comparator relative to the baseline device, can be reduced to a prescribed level by establishing an appropriate acceptance criterion for the ratio of the observed means. Second, the probability of a false negative conclusion, where an actual increase in a given analyte cannot be discerned from the test results, can be minimized by specifying a limiting value of applicability based on the margin of safety (MoS) of the analyte. This approach provides a quantitative, statistically motivated method to interpret chemical equivalence data, despite the relatively high intrinsic variability and small number of replicates typically associated with a chemical characterization evaluation.

A comparative in vitro analysis of various temporization materials with respect to pulp chamber temperature changes during polymerization.

AIM: (1) To compare the temperature rise in the pulp chamber with different resin materials used for making provisional fixed partial dentures in anterior and posterior region while using Polyvinylsiloxane impression materials as matrix. (2) To identify a superior provisionalization material based on the amount of heat dissipated suitable for anterior and posterior provisional fixed partial denture fabrication. SETTINGS AND DESIGN: Temporary crowns and bridges are integral to Fixed Prosthodontics. It has been observed that conventional fixed prosthesis temporisation materials release heat due to the exothermic polymerisation reaction. When such a provisional material is directly let to set on a vital tooth, the heat transfer causes irreversible changes in the pulp tissue depending of the degree of change. Hence, this study observes amount of heat generation in various materials during temporisation procedure, by simulating similar conditions. MATERIALS AND METHODS: Two Models were fabricated, one simulating missing lateral incisor (Model A) and another simulating missing first molar (Model B). Intact maxillary central incisors and canine for Model A and intact mandibular Second Premolar and Second Molar were selected to act as abutments. These abutment teeth were fitted with the tip of a K-type Thermocouple inside their pulp chambers and these were connected to a digital thermometer. Five temporisation materials were chosen for fabrication of temporary crowns through Direct technique. (1) polymethy methacrylate (Self Cure acrylic), (2) bisacryl composite (Protemp 4), (3) visible light cure urethane dimethacrylate (Revotec LC), (4) barium glass and fumed silica infused methacrylate (Dentsply Integrity) and (5)nano-hybrid composite (VOCO Structur 3). Ten observations were made for each provisional material on each model. During each observation, temperature rise was recorded at 30s interval from the time of application, through the peak and till a decrease in temperature is observed. Polyvinyl siloxane was used as matrix for all except light cure resin, where polypropylene sheet was used. STATISTICAL ANALYSIS USED: Anova test used for statistical. RESULTS: ANOVA test revealed that there was a significant difference in the temperature changes associated with the provisional restorative materials used. Among the five, polymethy methacrylate (self cure resin) showed the maximum rise in temperature, followed by bisacryl composite (Protemp 4), visible light cure urethane dimethacrylate (Revotec LC), barium glass and fumed silica infused methacrylate (Dentsply Integrity) and nano-hybrid composite (VOCO Structur 3). There was no comparable difference between Model A and B but an overall reduction of temperature rise was observed in model B. CONCLUSION: VOCO Structur 3 showed the least temperature rise in the pulp chamber, and overall temperature rise was less for model B which can be attributed to the residual dentin thickness.

A comparative evaluation of the variations on the shades of pressable ceramic system with the layering technique after different number of firing cycles: An in vitro study.

AIM: The main aim of the present study was to compare and evaluate the effect of repetitive firings on different shades of a pressable all ceramic system layered with veneering porcelain. SETTING AND DESIGN: In-vitro comparative study. MATERIALS AND METHODS: An in vitro comparative study was conducted, and a total of 60 disc shaped specimens (15 mm in diameter and 0.8 mm in thickness) were made of heat pressed ceramic of shades A2, A3, and B2 (20 discs of each shade) grouped as Group I, II, and III, respectively, using the lost wax technique. The discs were subsequently layered with veneering porcelain followed by glazing and overglazing and underwent a firing cycle at each step until six times combined. CIE L*a*b* measurements were noted on each sample after the third, fourth, fifth, and sixth firing using VITA Easyshade Advance 4.0 spectrophotometer. STATISTICAL ANALYSIS USED: Statistical Analysis was done by SPSS 17.0 software. One way analysis of variance, multiple comparisons using the Tukey test, and descriptive statistical analysis were done for all the groups in the study. P <0.05 was statistically significant. RESULTS: The mean color differences for the repeated firings were imperceptible (ΔE <1.67) to the human eye for all ceramic samples tested except between the fourth and fifth firing of Group II (shade A3). CONCLUSION: The analysis revealed that although repeated firings lead to changes in L*, a*, and b* values, the mean color difference was below the clinically acceptable color change (ΔE <3.7).

Comparative evaluation on wear resistance of metal sleeve, sleeve-free resin, and reinforced sleeve-free resin implant guide: An in vitro study.

BACKGROUND: In-office three-dimensional (3D) printers and metal sleeveless surgical guides are becoming a major trend recently. However, metal sleeve-free designs are reported to be more prone to distortion which might lead to variation in the inner diameter of the drill hole and cause deviation and inaccuracy in the placement of the implant. Carbon fiber nanoparticles are reported to improve the properties of 3D printing resin material in industrial application. AIM: The purpose of the study is to evaluate and compare the wear resistance of 3D-printed implant guides with metal sleeve, sleeve-free, and reinforced sleeve-free resin to the guide drill. MATERIALS AND METHODS: A total of 66 samples with 22 samples in each group. Three groups including 3D-printed surgical guide with metal sleeve (Group A), without metal sleeve (Group B), an carbon fiber reinforced without metal sleeve (Group C) were included in the study. All samples were evaluated before sequential drilling and after sequential drilling using Vision Measuring Machine. The data were tabulated and statistically evaluated. RESULTS: The data obtained were statistically analyzed with one-way analysis of variance and posthoc test. The data obtained for wear observed in the samples showed that the wear was highest in Group B with a mean of 0.5036 ± 0.1118 and the least was observed in Group A with a mean of 0.0228 ± 0.0154 and Group C was almost similar to Group A with mean of 0.0710 ± 0.0381. The results showed there was a significant difference between Group B with Group A and C, respectively (P < 0.05). The results showed that there was no significant difference regarding the wear observed between Groups A and C (P > 0.05). CONCLUSION: The wear observed in the guide with a metal sleeve and carbon fiber reinforced without a metal sleeve was almost similar. The carbon fiber-reinforced guide showed better tolerance to guide drill equivalent to metal sleeve. Thus, carbon fiber nanoparticles reinforced in 3D printing resin have shown improved strength and can be used as a good replacement for a metal sleeve for an accurate placement of the implant.

Hemocompatibility studies in nanotoxicology: Hemolysis or eryptosis? (A review).

Hemocompatibility evaluation is an important step in nanotoxicological studies. It is generally accepted that nanomaterials promote lysis of erythrocytes, blood clotting, alter phagocytosis, and upregulate pro-inflammatory cytokines. However, there are no standardized guidelines for testing nanomaterials hemocompatibility despite the fact that nanomaterials enter the bloodstream and interact with blood cells. In this review, the current knowledge on the ability of nanomaterials to induce distinct cell death modalities of erythrocytes is highlighted primarily focusing on hemolysis and eryptosis. This review aims to summarize the molecular mechanisms underlying erythrotoxicity of nanomaterials and critically compare the sensitivity and efficiency of hemolysis or eryptosis assays for nanomaterials blood compatibility testing. The list of eryptosis-inducing nanomaterials is growing, but it is still difficult to generalize how physico-chemical properties of nanoparticles affect eryptosis degree and molecular mechanisms involved. Thus, another aim of this review is to raise the awareness of eryptosis as a nanotoxicological tool to encourage the corresponding studies. It is worthwhile to consider adding eryptosis to in vitro nanomaterials hemocompatibility testing protocols and guidelines.

Challenging applicability of ISO 10993-5 for calcium phosphate biomaterials evaluation: Towards more accurate in vitro cytotoxicity assessment.

Research on biomaterials typically starts with cytocompatibility evaluation, using the ISO 10993-5 standard as a reference that relies on extract tests to determine whether the material is safe (cell metabolic activity should exceed 70 %). However, the generalized approach within the standard may not accurately reflect the material's behavior in direct contact with cells, raising concerns about its effectiveness. Calcium phosphates (CaPs) are a group of materials that, despite being highly biocompatible and promoting bone formation, still exhibit inconsistencies in basic cytotoxicity evaluations. Hence, in order to test the cytocompatibility dependence on different experimental setups and material-cell interactions, we used amorphous calcium phosphate, α-tricalcium phosphate, hydroxyapatite, and octacalcium phosphate (0.1 mg/mL to 5 mg/mL) with core cell lines of bone microenvironment: mesenchymal stem cells, osteoblast-like and endothelial cells. All materials have been characterized for their physicochemical properties before and after cellular contact and once in vitro assays were finalized, groups identified as 'cytotoxic' were further analyzed using a modified Annexin V apoptosis assay to accurately determine cell death. The obtained results showed that indirect contact following ISO standards had no sensitivity of tested cells to the materials, but direct contact tests at physiological concentrations revealed decreased metabolic activity and viability. In summary, our findings offer valuable guidelines for handling biomaterials, especially in powder form, to better evaluate their biological properties and avoid false negatives commonly associated with the traditional standard approach.

Study on design optimization of GFRP tubular column composite structure based on machine learning method.

Circular reinforced concrete wound glass fiber reinforced polymer (GFRP) columns and reinforced concrete filled GFRP columns are extensively utilized in civil engineering practice. Various factors influence the performance of these two types of GFRP columns, thereby impacting the whole project. Therefore, it is highly significant to establish the prediction models for ultimate displacement and ultimate bearing capacity to optimize the design of the two types of GFRP columns. In this study, based on the experiments conducted under different conditions on the two kinds of GFRP columns, automatic machine learning along with four other commonly used machine learning methods were employed for modeling to analyze how the column parameters (cross section shape, concrete strength, height of GFRP column, wound GFRP wall thickness, inner diameter of wound GFRP column) affect their performance. The differences in performance among these five machine learning methods were analyzed after modeling. Subsequently, we obtained the variation patterns in ultimate displacement and ultimate bearing capacity of the columns influenced by each parameter by testing the data using the optimal model. Based on these findings, the optimal design schemes for the two types of GFRP columns are proposed. The contribution of this paper is three-fold. First, AutoML sheds light on the automatic prediction of ultimate displacement and ultimate bearing capacity of GFRP column. Second, in this paper, two optimal design schemes of GFRP columns are proposed. Third, for AEC industrial practitioners, the whole process is automatic, accurate and less reliant on data expertise and the optimization design scheme proposed in the article is relatively scientific.

Taring the scales: Weight-of-evidence framework for biocompatibility evaluations.

ISO 10993-1:2018 describes evaluating the biocompatibility profile of a medical device from a risk-based approach. This standard details the battery of information that should be considered within the assessment of a device, including raw material composition data, manufacturing processes, and endpoint testing. The ISO 10993/18562 series requires worst-case assumptions and exposure scenarios to be used in the evaluation, which may result in an over-estimation of patient safety risk. Currently, biocompatibility assessments evaluate each data set independently, and the consequence of this individualized assessment of exaggerated inputs is potential false alarms regarding patient safety. To evaluate these safety concerns, the ISO standards indicate that professional judgement should be used to estimate patient risk but does not provide guidance on incorporating a holistic review of the data into the risk assessment. Recalibrating these worst-case data to evaluate them in a weight-of-evidence (WoE) approach may provide a more realistic data set to determine actual patient risk. This proposed WoE framework combines understanding data applicability with a method for gauging the strength of data that can provide additional support for the final safety conclusion. Using a WoE framework will allow risk assessors to contextualize the data and utilize it to comprehensively estimate patient safety.

A High-Density Hydrogen Bond Locking Strategy for Constructing Anisotropic High-Strength Hydrogel-Based Meniscus Substitute.

Mimicking anisotropic features is crucial for developing artificial load-bearing soft tissues such as menisci). Here, a high-density hydrogen bond locking (HDHBL) strategy, involving preloading a poly(N-acryloylsemicarbazide) (PNASC) hydrogel with an aqueous solution containing a hydrogen bond breaking agent, followed by water exchange, to fabricate anisotropic high-strength hydrogels are proposed. During this process, multiple high-density hydrogen bonds of the PNASC network are re-established, firmly freezing oriented molecular chains, and creating a network with an anisotropic microstructure. The resulting anisotropic hydrogels exhibit superior mechanical properties: tensile strength over 9 MPa, Young's modulus exceeding 120 MPa along the orientation direction, and fatigue thresholds exceeding 1900 J m-2. These properties meet the mechanical demands for load-bearing tissue substitutes compared to other reported anti-fatigue hydrogels. This strategy enables the construction of an anisotropic meniscal scaffold composed of circumferentially oriented microfibers by preloading a digital light processing-3D printed PNASC hydrogel-based wedge-shaped construct with a resilient poly(N-acryloyl glycinamide) hydrogel. The 12-week implantation of a meniscus scaffold in rabbit knee joints after meniscectomy demonstrates a chondroprotective effect on the femoral condyle and tibial plateau, substantially ameliorating the progression of osteoarthritis. The HDHBL strategy enables the fabrication of various anisotropic polymer hydrogels, broadening their scope of application.

Establishing finite element model credibility of a pedicle screw system under compression-bending: An end-to-end example of the ASME V&V 40 standard.

Computational modeling and simulation (CM&S) is a key tool in medical device design, development, and regulatory approval. For example, finite element analysis (FEA) is widely used to understand the mechanical integrity and durability of orthopaedic implants. The ASME V&V 40 standard and supporting FDA guidance provide a framework for establishing model credibility, enabling deeper reliance on CM&S throughout the total product lifecycle. Examples of how to apply the principles outlined in the ASME V&V 40 standard are important to facilitating greater adoption by the medical device community, but few published examples are available that demonstrate best practices. Therefore, this paper outlines an end-to-end (E2E) example of the ASME V&V 40 standard applied to an orthopaedic implant. The objective of this study was to illustrate how to establish the credibility of a computational model intended for use as part of regulatory evaluation. In particular, this study focused on whether a design change to a spinal pedicle screw construct (specifically, the addition of a cannulation to an existing non-cannulated pedicle screw) would compromise the rod-screw construct mechanical performance. This question of interest (?OI) was addressed by establishing model credibility requirements according to the ASME V&V 40 standard. Experimental testing to support model validation was performed using spinal rods and non-cannulated pedicle screw constructs made with medical grade titanium (Ti-6Al-4V ELI). FEA replicating the experimental tests was performed by three independent modelers and validated through comparisons of common mechanical properties such as stiffness and yield force. The validated model was then used to simulate F1717 compression-bending testing on the new cannulated pedicle screw design to answer the ?OI, without performing any additional experimental testing. This E2E example provides a realistic scenario for the application of the ASME V&V 40 standard to orthopedic medical device applications.