The influence of hygroscopic expansion of resin supporting dies on the fracture resistance of ceramic restorations during thermal cycling.

OBJECTIVES: To evaluate the hygroscopic expansion characterization of resin composite dies during thermal cycling, and their influence on the fracture resistance of dental ceramic materials as well as the effect of pre-immersion on these measurements. METHODS: Disc-shaped specimens (φ = 15.0 mm, h = 1.2 mm) and anatomical crown dies of four resin composites (epoxy, Z350, P60, G10) were fabricated. Disc-shaped samples were continuously soaked in distilled water and the volume expansion was measured at different time point by Archimedes method. Disc-shaped samples were pre-immersed for 0, 7, or 30 days, elastic modulus and hardness were measured using Nanoindentation test; thermal cycling (TC) test was performed (5 °C-55 °C, 104 cycles), and volume expansion during TC was measured. Four kinds of resin die with pre-immersion for 0, 7, or 30 days were cemented to 5Y-Z crown, or epoxy dies without pre-immersion were cemented to 5Y-Z, 3Y-Z and lithium disilicate glass (LDG) crowns, and load-to-failure testing was performed before and after TC. Finite element analysis (FEA) and fractography analysis were also conducted. RESULTS: The hygroscopic expansion was in the order: epoxy > Z350 > P60 > G10. Except for G10, the other three resin composites exhibited different degrees of hygroscopic expansion during TC. Only the elastic modulus and hardness of epoxy decreased after water storage. However, only the fracture loads of 5Y-Z and LDG crowns supported by epoxy dies were significantly decreased after TC. FEA showed a stress concentration at the cervical region of the crown after volume expansion of the die, leading to the increase of the peak stress at the crown during loading. SIGNIFICANCE: Only the hygroscopic expansion of epoxy dies caused by TC led to the decrease in the fracture resistance of the 5Y-Z and LDG crown, which may be related to the decrease in the elastic modulus of the epoxy die and the tensile stress caused by it.

Effects of Cu/SnAgCu Powder Fraction and Sintering Time on Microstructure and Mechanical Properties of Transient Liquid Phase Sintered Joints.

The effects of the sintering duration and powder fraction (Ag-coated Cu/SnAgCu) on the microstructure and reliability of transient liquid phase sintered (TLPS) joints are investigated. The results show that two main intermetallic compounds (IMCs, Cu6Sn5 and Cu3Sn) formed in the joints. The Cu6Sn5 ratio generally decreased with increasing sintering time, Cu powder fraction, and thermal treatment. The void ratio of the high-Cu-fraction joints decreased and increased with increasing sintering and thermal stressing durations, respectively, whereas the low-Cu-fraction counterparts were stable. We also found that the shear strength increased with increasing thermal treatment time, which resulted from the transformation of Cu6Sn5 and Cu3Sn. Such findings could provide valuable information for optimizing the TLPS process and assuring the high reliability of electronic devices.

Soldering Pressure Effect on Lifetime of Thermoelectric Modules under Thermal Cycling.

For practical industrial applications, enhancing the longevity and the reliability of thermoelectric modules (TEMs) is equally as crucial as improving their conversion efficiency. This study proposes a strategy for extending the lifespan and introduces the quality evaluation criteria for the most extensively used commercial bismuth telluride TEM. By varying the soldering pressure during module assembly, its impact on the quality of the module's internal interfacial connections was investigated, via analyzing its contact resistivity, shear modulus, and antifatigue ability through thermal cycling tests. The findings reveal that increasing the soldering pressure leads to a slight reduction in interfacial contact resistivity and has no significant effect on the shear modulus but notably enhances the module's antifatigue ability during thermal cycling tests. According to the SEM results, it can be evidently deduced that the aforementioned phenomena are directly correlated with the size and quantity of voids distributed in the solder layer, which is regarded as the origin of antifatigue ability. Thus, it can be inferred that augmenting the soldering pressure represents an effective approach to prolonging the lifespan of TEMs assembled by using the soldering method. Furthermore, the existence of voids within the solder layer can serve as a criterion for an initial assessment of module longevity. This study provides a reference for both the industrial assembly and lifespan evaluation of commercial bismuth telluride TEMs.

Effect of curing mode of resin composite cements on water sorption, color stability, and biaxial flexural strength.

OBJECTIVES: To determine whether water sorption and solubility of a recently introduced self-adhesive cement is comparable to two clinically tested resin composite cements after thermal aging, and if this is affected by the curing mode. Whether water sorption is correlated with color difference and biaxial flexural strength was also investigated. METHODS: Water sorption and solubility of three resin composite cements {RelyX Universal (RUV), (Panavia V5 (PV5), Panavia SA plus (PSA)} were measured after thermal aging. Disk-shaped specimens were either light-cured or autopolymerized (n = 15 per group). Color difference ΔE00 and biaxial flexural strength were also obtained. RESULTS: Sorption was highest for RUV (auto: 54.9 ± 9.0 µg/mm3, light: 49.7 ± 4.9 µg/mm3), followed by PSA (auto: 37.7 ± 1.4 µg/mm3, light: 34.5 ± 1.1 µg/mm3) and PV5 (auto: 21.7 ± 0.7 µg/mm3, light: 22.1 ± 0.4 µg/mm3). Light-curing reduced solubility values, particularly for RUV (from 60.7 ± 20.8 µg/mm3 to 6.4 ± 0.8 µg/mm3). Color differences of ΔE00 > 1.8 (considered clinically not acceptable) were noted after aging for RUV and PSA. Sorption and ΔE00 values after aging were correlated linearly (R2 = 0.970). Biaxial flexural strength values were highest for PV5 (light: 153.4 ± 15.9 MPa; auto: 133.2 ± 18.0 MPa) and lowest for RUV (light: 99.3 ± 12.8 MPa; auto: 35.1 ± 8.3 MPa). SIGNIFICANCE: Light-curing has beneficial effects on sorption, color stability, and biaxial flexural strength of resin composite cements. Cements containing 2-hydroxymethacrylate such as RUV and PSA are more prone to water sorption and color changes.

Real-time imaging and quantitative analysis of internal gap formation in bulk-fill and conventional resin composites: An OCT evaluation.

BACKGROUND: This study used optical coherence tomography (OCT) to observe real-time internal gap formation in both bulk-fill and conventional resin composites. It aimed to provide a quantitative analysis of variations, addressing the inconclusive nature of microleakage assessment caused by differences in testing methods. METHODS: Fifty extracted third molars prepared with Class I cavities, were divided into five groups (n = 10). Conventional resin Filtek Z350 XT (FZX) was applied with a double-layer filling of 2 mm per layer. Bulk-fill resins X-tra fil (XTF), Filtek Bulk Fill Posterior Restorative (FBP), Surefil SDR Flow + (SDR), and Filtek Flowable Restorative (FFR) were applied with a single-layer filling of 4 mm. Real-time OCT imaging was conducted during light curing. Post-curing, the entire sample was OCT-scanned. Following this, ImageJ software was used to measure the gap (G1 %). Subsequently, thermal cycling (TC) (5000 times, 5 °C-55 °C) was applied, followed by OCT scanning to calculate the gap (G2 %) and ΔG%. Data were analyzed using two-way repeated measures ANOVA, Kruskal-Wallis test, and Duncan's test (α=0.05). RESULTS: There was no significant difference in G1 % among the groups (p > 0.05). Following TC, FZX exhibited the highest G2 %, succeeded by FFR, FBP, XTF, and SDR, with SDR demonstrating the lowest G2 % (p < 0.05). FZX showed the highest ΔG% (p < 0.05), while SDR exhibited the lowest ΔG% (p < 0.05). CONCLUSION: OCT proves to be a promising tool for detecting microleakage. TC exerted a more significant negative impact on conventional resin. Surefil SDR Flow + displayed the least microleakage, both before and after TC.

Study on pulse current auxiliary heating process of submerged arc welding.

During the welding process, temperature filed distribution of weldment is one of the key factors which influence welding quality. In order to improve the mechanical properties of welding joint, a technology for heating process of weldment using auxiliary pulse current was proposed in this article. Firstly, through metallographic experiment, strength experiment and hardness experiment, it was proved that the auxiliary pulse current not only can refine grain size but also improves the mechanical property of the welding joint. Then the paper used ANSYS and its ANSYS Parametric Design Language parametric design language to simulate the welding process with assistant pulse current, and the temperature field, the pulse current density distribution and the time of effective pulse current in the welded joint were obtained. Quantitative analyses were undertaken on the influence laws of auxiliary pulse current parameters on weld temperature field, auxiliary pulse current density distribution and the time of effective pulse current. A new parameter was defined as time-current density (the time integral of current density) to demonstrate the change rule of auxiliary pulse current density distribution with time. Finally, analyzing the reasons for raising the welding quality. There were two reasons for such phenomenon: one was auxiliary pulse current change the state of heat distribution in the weld seam area, the other was that the impulse oscillation of the auxiliary pulse influences the nucleation process of melting region.

Influence of screw channel angulation on reverse torque value and fracture resistance in monolithic zirconia restorations after thermomechanical cycling: an in-vitro study.

BACKGROUND: While the concept of angled screw channels has gained popularity, there remains a scarcity of research concerning the torque loss and fracture strength of monolithic zirconia restorations with various screw channel angulations when exposed to thermomechanical cycling. This in-vitro study aimed to evaluate the reverse torque value and fracture resistance of one-piece screw-retained hybrid monolithic zirconia restorations with angulated screw channels after thermomechanical cycling. METHODS: One-piece monolithic zirconia restorations, with angulated screw channels set at 0°, 15°, and 25° (n = 6 per angulation) were fabricated and bonded to titanium inserts using a dual-cure adhesive resin cement. These assemblies were then screwed to implant fixtures embedded in acrylic resin using an omnigrip screwdriver, and reverse torque values were recorded before and after thermomechanical cycles. Additionally, fracture modes were assessed subsequent to the application of compressive load. One-way ANOVA and Bonferroni post hoc test were used to compare the groups (α = 0.05). RESULTS: The study groups were significantly different regarding the fracture resistance (P = 0.0015), but only insignificantly different in the mean percentage torque loss (P = 0.4400). Specifically, the fracture resistance of the 15° group was insignificantly higher compared to the 0° group (P = 0.9037), but significantly higher compared to the 25° group (P = 0.0051). Furthermore, the fracture resistance of the 0° group was significantly higher than that of the 25° group (P = 0.0114). CONCLUSIONS: One-piece hybrid monolithic zirconia restorations with angulated screw channels can be considered an acceptable choice for angulated implants in esthetic areas, providing satisfactory fracture strength and torque loss.

Processing-Microstructure-Properties of Columns in Thermal Barrier Coatings: A Study of Thermo-Chemico-Mechanical Durability.

Contemporary gas turbine engines rely on thermal barrier coatings (TBCs), which protect the structural components of the engine against degradation at extremely high operating temperatures (1300-1500 °C). The operational efficiencies of aircraft engines have seen significant improvement in recent years, primarily through the increase in operating temperatures; however, the longevity of TBCs can be potentially impacted by several types of degradation mechanisms. In this comprehensive study, a wide range of novel columnar suspension plasma sprayed (SPS) coatings were developed for their erosion, calcium-magnesium-aluminum-silicate (CMAS), and furnace cycling test (FCT) performance. Through a comprehensive investigation, the first of its kind, we achieved a range of SPS microstructures by modifying the spray parameters and measuring their microhardness, fracture toughness, column densities, and residual stresses using Raman spectroscopy. We were able to produce dendritic, lateral, branched, and columnar microstructures with a unique set of processing parameters. Coatings enhanced with a refined columnar microstructure, achieved by modulating the distance from the plasma torch, exhibited superior thermal cycling resilience. Conversely, the development of a columnar microstructure with dendritic branches, obtained by decreasing the robot's traversal speed during deposition, bolstered resistance to erosion and minimized damage from molten CMAS infiltration, thereby notably augmenting the coating's lifespan and robustness. The pursuit of the optimal columnar microstructure led to the conclusion that for each SPS coating, a general framework of optimization needs to be conducted to achieve their desired thermo-chemico-mechanical resistance as the properties required for TBCs are intertwined.

Evaluation of surface microhardness and gingival marginal adaptation of three different bulk-fill flowable resin composites: A comparative study.

OBJECTIVES: To evaluate surface microhardness and gingival marginal adaptation of three different bulk-fill flowable resin composites (FB-RBCs) in Class V cavities with enamel or dentin margins before and after thermocycling (TMC). MATERIALS AND METHODS: Three available FB-RBCs were used; Palfique Bulk Flow (PaBF) (Tokuyama Dental), SDR Flow+ Bulk Fill Flowable (Dentsply Sirona), and I-Flow Bulk Fill (I-Dental). Thirty discs were prepared from each type of FB-RBCs. The discs were subjected to Vickers microhardness tester machine. Class V cavities were prepared on 180 molars. Gingival margins of half the specimens were prepared above CEJ and the other half below CEJ. Cavities were restored with FB-RBCs for gingival marginal adaptation test. Two-way ANOVA was used in microhardness, while three-way ANOVA was used for marginal adaptation. RESULTS: The used materials showed statistically significant differences in microhardness and marginal adaptation. CONCLUSIONS: Regarding microhardness, PaBF showed the highest value before TMC and SDR was the highest after TMC. Regarding marginal adaptation, SDR revealed the best marginal adaptation than PaBF and I-flow, either subjected to TMC or not. CLINICAL SIGNIFICANCE: The longevity of cervical restorations depend on both the location of the cavity margin and the material used. The microfractures in resin composite surface due to low surface microhardness as well as marginal gaps seen in laboratory studies could be considered as an indicative parameter for clinical problem associated with marginal differences.

Amplifying PCR productivity and environmental sustainability through shortened cycling protocols.

Since its inception in the 1980s, advancements in PCR technology using improved thermal cyclers, engineered DNA polymerases and commercial master mixes, have led to increased PCR productivity. Despite these advancements, PCR cycling protocols have largely remained unchanged over the same period. This study aimed to systemically evaluate the effect of reduced PCR cycling parameters on amplicon production. The 1466bp fragment from the 16S rRNA gene present in low-, medium- and high-CG bacteria was amplified using three commercially available PCR master mixes. The shortest cycling parameters required to successfully amplify the 16S fragment from all bacteria and master mixes comprised 30-cycles of 5 s denaturation, 25 s annealing, and 25 s extension. While all produced an amplicon with sufficient yield to enable downstream sequence analysis, the PCRBIO Ultra Mix in conjunction with the shortened parameters was found to achieve the highest amplicon yield across low-, medium- and high CG bacteria. Comparing the run times to that of a typical 16S PCR protocol, the shortened cycling parameters reduced the program duration by 46 % and consumed 50 % less electricity, translating into increased productivity and helping to improve laboratory environmental sustainability.

Effect of Ceramic Thickness on the Bond Strength to Resin-Luting Agents before and after Thermal Cycling

Abstract This study investigated microshear bond strength (µSBS) of two (2) dual-cured resin-luting agents (RelyX™ Ultimate and RelyX™ U200) when photoactivated through varying thicknesses of lithium disilicate, with or without thermal cycling. Discs of IPS e.max Press of 0.5, 1.5, and 2 mm in thickness were obtained. Elastomer molds (3.0 mm in thickness) with four cylinder-shaped orifices 1.0 mm in diameter, were placed onto the ceramic surfaces and filled with resin-luting agents. A Mylar strip, glass plate, and load of 250 grams were placed over the filled mold. The load was removed and the resin-luting agents were photoactivated through the ceramics using a single-peak LED (Radii Plus.) All samples were stored in distilled water at 37oC for 24 h. Half of the samples were subjected to thermal cycling (3,000 cycles; 5ºC and 55ºC). All samples were then submitted to µSBS test using a universal testing machine (Instron 4411) at a crosshead speed of 0.5 mm/min. Data were submitted to three-way ANOVA and Tukey post-hoc test (α=0.05). The mean µSBS at 24 h was significantly higher than after thermal cycling (p<0.05). No statistical difference was found between resin-luting agents (p > 0.05). The mean µSBS for groups photoactivated through 0.5 mm ceramic were significantly higher than 1.5 mm and 2.0 mm (p < 0.05). In conclusion, increased ceramic thicknesses reduced the bond strength of tested resin-luting agents to lithium disilicate. No differences were found between resin-luting agents. Thermal cycling reduced the bond strength of both resin-luting agents.

Resumo: Este estudo investigou a resistência de união ao microcisalhamento (RUµC) de dois (2) agentes de cimentação de resina dual (RelyX™ Ultimate e RelyX™ U200) quando fotoativados através de diferentes espessuras de dissilicato de lítio, com ou sem ciclagem térmica. Discos do IPS e.max Press de 0,5, 1,5 e 2 mm de espessura foram obtidos. Moldes de elastômero (3,0 mm de espessura) com quatro orifícios cilíndricos de 1,0 mm de diâmetro foram colocados sobre as superfícies cerâmicas e preenchidos com agentes de cimentação de resina. Uma tira Mylar, placa de vidro e carga de 250 gramas foram colocadas sobre o molde preenchido. A carga foi removida e os agentes de cimentação resinosos foram fotoativados através da cerâmica usando um LED de pico-único (Radii Plus). Todas as amostras foram armazenadas em água deionizada a 37oC por 24 h. Metade das amostras foi submetida a ciclagem térmica (3.000 ciclos; 5ºC e 55ºC). Todas as amostras foram então submetidas ao teste de RUµC usando uma máquina de teste universal (Instron 4411) com velocidade de 0,5 mm/min. Os dados foram submetidos à Análise de Variância três fatores e ao teste post-hoc de Tukey (α = 0,05). A média de RUµC em 24 h foi significativamente maior do que após a ciclagem térmica (p < 0,05). Não houve diferença estatística entre os cimentos resinosos (p > 0,05). As médias de RUµC para grupos fotoativados através de cerâmica de 0,5 mm foram significativamente maiores do que 1,5 mm e 2,0 mm (p < 0,05). Em conclusão, o aumento da espessura da cerâmica reduziu a resistência de união dos agentes de cimentação resinosos ao dissilicato de lítio. Não foram encontradas diferenças entre os agentes de cimentação resinosos. A ciclagem térmica reduziu a resistência de união de ambos os agentes de cimentação resinosos.

Surface roughness, optical properties, and microhardness of additively and subtractively manufactured CAD-CAM materials after brushing and coffee thermal cycling.

PURPOSE: To evaluate the surface roughness, optical properties, and microhardness of additively or subtractively manufactured CAD-CAM materials after simulated brushing and coffee thermal cycling. MATERIAL AND METHODS: Two additively manufactured resins (Crowntec, CT and VarseoSmile Crown Plus, VS) and 3 subtractively manufactured materials (a reinforced composite (Brilliant Crios, BC), a polymer-infiltrated ceramic network (Enamic, VE), and a feldspathic ceramic (Mark II, VM)) were used to fabricate disk-shaped specimens (Ø10×1-mm) (n = 10). Surface roughness, Vickers microhardness, and color coordinates were measured after polishing, while surface roughness was also measured before polishing. Specimens were then subjected to 25000 cycles of brushing and 10000 cycles of coffee thermal cycling, and measurements were repeated after each time interval. Color difference (ΔE00 ) and relative translucency parameter (RTP) were calculated. Robust analysis of variance test was used to evaluate surface roughness, ΔE00 , and RTP data, while generalized linear model analysis was used for microhardness data (α = 0.05). RESULTS: Material type and time interval interaction affected tested parameters (p ≤ 0.002). In addition, material type affected all parameters (p < 0.001) other than surface roughness (p = 0.051), and time interval affected surface roughness and microhardness values (p < 0.001). Tested materials mostly had their highest surface roughness before polishing (p ≤ 0.026); however, there was no clear trend regarding the roughness of materials within different time intervals along with ΔE00 and RTP values within materials or time intervals. VS and CT had the lowest microhardness regardless of the time interval, while the remaining materials were listed as VM, VE, and BC in decreasing order (p < 0.001). Coffee thermal cycling only reduced the microhardness of VM (p < 0.001). CONCLUSIONS: Tested additively manufactured resins can be considered more susceptible to simulated brushing and coffee thermal cycling than the other materials, given the fact that their surface roughness and ΔE00 values were higher than previously reported acceptability thresholds and because they had the lowest microhardness after all procedures were complete.

Evaluation of gingival porcelains: Color change and surface properties.

PURPOSE: This in vitro study aimed to evaluate the effect of thermal cycling (TC) on the color stability, translucency, and surface roughness of two different gingival porcelain materials. MATERIALS AND METHODS: The gingival porcelains IPS e.max Ceram Gingiva (Ceram) and IPS InLine Gingiva (InLine) were tested. A total of 66 disc-shaped specimens were prepared and glazed using porcelain powders of G1, G3, and G5 colors. The samples were divided into two porcelain groups by their types and into three subgroups (n11) by their colors. Thermal cycling was performed at 6000 cycles simulating an oral environment of 5 years. The color and surface roughness measurements of the samples were made before and after the thermal cycling. Color measurements were made with a spectrophotometer. Surface roughness (mean surface roughness [Ra; µm]) was measured using a contact profilometer. Data before thermal cycling were evaluated using the Kruskal-Wallis test followed by the Dunn Bonferonni paired comparison test. Two-way ANOVA with repeated measurements and a pairwise comparison test with Bonferroni correction were used to evaluate the change in roughness and translucency parameter (TP) data between groups due to thermal cycling. RESULTS: The color change was below the clinically perceptible color change threshold (∆E00 = 2.1) in all groups after thermal cycling. However, all materials had significantly increased roughness (p < 0.05). An increase in roughness was detected in the Ceram group and was higher than that in the InLine group. The change in the translucency parameters of the samples after thermal cycling was not statistically significant; a small increase was observed in all groups. The highest translucency values ​​were seen in the G1, G3, and G5 colors. CONCLUSIONS: Thermal cycling caused a significant increase in the roughness values ​​(Ra) of all materials and a minimal increase in their translucency. The color change of gingival porcelains after thermal cycling was less than the clinically perceptible threshold.

Comparison of microleakage under orthodontic brackets bonded with five different adhesive systems: in vitro study.

BACKGROUND: Orthodontic treatment is associated with numerous adverse side effects, such as enamel discoloration, demineralization or even caries. The presence of microleakage between the enamel and the adhesive and between the adhesive and the base of the orthodontic bracket allows penetration of the bacteria, molecules, and liquids into the enamel and can lead to unpleasant "white spot lesions" or secondary caries beneath and around the brackets. The aim of this in vitro study was to evaluate microleakage in five adhesive systems commonly used in orthodontic practice for bonding brackets. METHODS: One hundred extracted premolars were divided into five groups of twenty teeth. Stainless steel Legend medium metal brackets were bonded to teeth using five adhesive systems: resin-reinforced glass ionomer cement GC Fuji Ortho LC (GCF) and composite materials Light Bond (LB), Transbond XT (TB), Trulock™ Light Activated Adhesive (TL), and GC Ortho Connect (GCO). The specimens were subjected to thermal cycling, stained with 2% methylene blue, sectioned with low-speed diamond saw Isomet and evaluated under a digital microscope. Microleakage was detected at the enamel-adhesive and adhesive-bracket interfaces from occlusal and gingival margins. Statistical analysis was performed using generalized linear mixed models with beta error distribution. RESULTS: Microleakage was observed in all materials, with GCF showing the highest amount of microleakage. Composite materials GCO, TB, and LB exhibited the lowest amount of microleakage with no statistical difference between them, while TL showed a statistically significantly higher amount of microleakage (p < 0.001). The enamel-adhesive interface had more microleakage in all composite materials (GCO, LB, TB, and TL) than the adhesive bracket-interface (p < 0.001). The highest amount of microleakage occurred in the gingival region in all materials. CONCLUSION: Composite materials showed better adhesive properties than a resin-reinforced glass ionomer cement. The presence of microleakage at the enamel-adhesive interface facilitates the penetration of various substances into enamel surfaces, causing enamel demineralization and the development of dental caries.

Industry Perspective on Temperature Cycling Studies to Meet Regulatory Temperature Excursion Support Requirements: Survey Outcome and Recommendations.

Temperature cycling stability studies can be appropriately designed and utilized to ensure that drug product quality, efficacy, and safety are not compromised when materials are subjected to short term temperature excursions from intended storage that may occur during e.g., shipping, transport, or patient use. Some countries, such as Australia and Brazil, impose specific regulations that specify the need to conduct stability studies that are supportive of "real world" excursions as part of licensing approval requirements. These temperature cycling stability studies extend beyond what is described in ICH Guidelines Q1A(R2) and Q5C, and companies may be challenged in designing studies that not only satisfy country specific regulations, but also satisfy all global regulatory health authority expectations. This article focuses on responses to a cross-industry survey conducted within the International Consortium for Innovation and Quality (iqconsortium.org) member companies, regarding practices related to temperature cycling stability studies, in order to determine how these requirements are being interpreted and met. The results indicate that while there is no one-size-fits-all approach to performing temperature cycling stability studies, there are common and best practices that can be followed to satisfy global health authority regulatory guidelines and requirements. PURPOSE: The purpose of this paper is to describe the outcome of an industry survey and common/best practices on temperature cycling stability studies performed on drug product (DP) to satisfy the requirements established for marketing authorizations in Australia and Brazil or any other countries that may have similar requirements. The framework is proposed within the context of late phase and commercial development of common biological and/or large molecule modalities, such as monoclonal antibodies (mAbs, including bispecific antibodies), fusion proteins, complex proteins, oligonucleotides, and antibody-drug conjugates (ADCs), but many of the general principles involved may be applied to other therapeutics, such as Virus Like Particles (VLP), gene or cell therapies (GTx or CTx), or vaccines. For the purposes of this paper, temperature cycling stability studies refer to studies that are designed, in part, to support short term temperature excursions that drug product may be subjected to during shipping and storage activities and is outside of the labeled storage condition of the product.

Rational PCR Reactor Design in Microfluidics.

Limit of detection (LOD), speed, and cost for some of the most important diagnostic tools, i.e., lateral flow assays (LFA), enzyme-linked immunosorbent assays (ELISA), and polymerase chain reaction (PCR), all benefited from both the financial and regulatory support brought about by the pandemic. From those three, PCR has gained the most in overall performance. However, implementing PCR in point of care (POC) settings remains challenging because of its stringent requirements for a low LOD, multiplexing, accuracy, selectivity, robustness, and cost. Moreover, from a clinical point of view, it has become very desirable to attain an overall sample-to-answer time (t) of 10 min or less. Based on those POC requirements, we introduce three parameters to guide the design towards the next generation of PCR reactors: the overall sample-to-answer time (t); lambda (λ), a measure that sets the minimum number of copies required per reactor volume; and gamma (γ), the system's thermal efficiency. These three parameters control the necessary sample volume, the number of reactors that are feasible (for multiplexing), the type of fluidics, the PCR reactor shape, the thermal conductivity, the diffusivity of the materials used, and the type of heating and cooling systems employed. Then, as an illustration, we carry out a numerical simulation of temperature changes in a PCR device, discuss the leading commercial and RT-qPCR contenders under development, and suggest approaches to achieve the PCR reactor for RT-qPCR of the future.

Comparison of the shear bond strength of new and recycled metallic brackets using different adhesive materials : an in vitro study.

Purpose: To evaluate and compare shear bond strength (SBS) of new and recycled metallic brackets bonded to conditioned and reconditioned enamel, using two different adhesive materials. Materials and methods: 72 extracted sound human premolars were randomly divided into 6 groups. Transbond XT light cured composite (LCC) and Fuji Ortho LC resin-modified glass ionomer (RMGI), were used as adhesive materials. In groups 1 and 2 (control), new brackets were bonded to sound premolars using either LCC or RMGI, respectively. In Groups 3 and 4, new brackets were bonded to reconditioned enamel; and in groups 5 and 6, sandblasted recycled brackets were rebonded to reconditioned enamel. After 5.000 thermal cycles between 5ºC and 55ºC, SBS was evaluated and adhesive remnant on the enamel assessed using the ARI index. Statistical analyses included Shapiro-Wilk, ANOVA, Fligner-Killeen ANOVA and Tukey tests. Results: The statistical analysis showed no significant difference in SBS comparing control and experimental groups for either new or recycled brackets (p = 0.848). The SBS was significantly higher in brackets bonded with LCC (15.7 MPa) than RMGI (11.6 MPa) (p = 0.006). Adhesive failure was the most frequent, with the adhesive remnant covering more than 50% of the bracket base. Conclusion: No significant differences were observed in SBS using either new or recycled brackets, regardless of the dental surface treatment (conditioned or reconditioned). Significantly higher SBS values were obtained with LCC adhesive. Adhesive failure prevails in all groups.

Long-Range Polymerase Chain Reaction.

Polymerase chain reaction (PCR) is a laboratory technique used to amplify a targeted region of DNA, demarcated by a set of oligonucleotide primers. Long-range PCR is a form of PCR optimized to facilitate the amplification of large fragments. Using the adapted long-range PCR protocol described in this chapter, we were able to generate PCR products of 6.6, 7.2, 13, and 20 kb from human genomic DNA samples. For some of the long PCRs, successful amplification was not possible without the use of PCR enhancers. Thus, we also evaluated the impact of some enhancers on long-range PCR and included the findings as part of this updated chapter.

Synergistic effects of atomic oxygen and thermal cycling in low earth orbit on polymer-matrixed space material.

Polymer-matrixed materials are widely used in the spacecrafts' structures. However, crafts located in the LEO（Low Earth Orbit） would suffer from hazardous environment factors when orbiting in the space. It has been reported that the space environment factors' integral effect (which represents the factual detriment in space) is not equivalent to the simple summation of each individual. Hence, atomic oxygen and thermal cycling were selected as the starting point for studying the typical LEO synergistic effects on polymer-matrixed space material. In this work, methods such as surface morphology observation, surface components analyzation and inter-laminar-shear strength test were embraced to gather the basic information for the study of degradation. As a result, focusing on the composites selected in this work, synergistic effects do exist between the two factors (AO&TC, representing for atomic oxygen and thermal cycling combined). Besides, a quantified index was proposed to represent synergistic characteristics，so as to lay the foundation for the scientific evolution of material characterization.

Adhesion and Surface Roughness of Apatite-Containing Carbomer and Improved Ionically Bioactive Resin Compared to Glass Ionomers.

The surface roughness of different glass-ionomer-based materials and their shear bond strength with a resin composite with and without thermal cycling were evaluated. Ketac Molar (KM, 3M ESPE, St. Paul, MN, USA), Glass Carbomer (GC, GCP Dental, Leiden, The Netherlands), Bioactive (BA, PULPDENT, Corporation, Watertown, MA, USA) and Fuji II LC (FJ, GC, Tokyo, Japan) were used to prepare the specimens and they were kept in distilled water at 37 °C for 24 h. The surface roughness of the specimens was measured with a profilometer (n = 6). A universal adhesive resin was applied on glass-ionomer materials and cylindrical universal composites were applied and polymerized, respectively (n = 16). The specimens were divided into two subgroups. The first subgroup was subjected to thermal cycling. Shear bond strength was investigated for both subgroups (n = 8). Stereomicroscopy and SEM examinations were performed. The roughest surface was obtained in the GC group (p < 0.05). The shear bond strength of the specimens without thermal cycling was higher than that of those with thermal cycling (p < 0.05). The lowest shear bond was measured in the GC group (p < 0.05). Although FJ, KM and BA have been observed to be suitable materials for clinical use, BA, in particular, is evidenced to become the best option among the materials we tested. GC cement's long-term performance needs to be improved.