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.

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.

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.

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.

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.

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.

Security Comparison of Various Surgical Knots Using Nylon Suture.

OBJECTIVE: To evaluate the strengths of various surgical knot techniques, including square knot, surgeon's knot, granny knot, and random knot with the same three throws. METHODS: The authors tested each of the four knot techniques using four different gauges of nylon (polyamide [Ethicon]): 4-0, 5-0, 6-0, and 7-0. Each knot type was tested 20 times per nylon gauge, for a total of 320 knots tested. The authors used a static pull machine to measure elongation at yield and maximal force to break. RESULTS: A comparison of elongation at yield revealed that the surgeon's knot was superior to the square knot, granny knot, and random knots across all gauges of nylons. Further, a comparison of maximal force to break revealed that the surgeon's knot was superior to the square knot, granny knot, and random knots when using 4-0, 5-0, and 6-0 nylon but not when using 7-0 nylon. CONCLUSIONS: The surgeon's knot was the strongest, and random knot was the weakest when the authors used nylon 4-0, 5-0, and 6-0. While handling fine suture materials such as 7-0 nylon, knot failure appears to be unrelated to the knot technique used. This study provides not only fundamental guidance for tying surgical knots using nylon, but also a rational basis for an adequately strong knot choice in various fields of surgery.

Mechanical properties of bulk-fill resin composites with single increment up to 4 mm: A novel mechanical strength test.

PURPOSE: To evaluate the mechanical properties of two brands of bulk-fill resin composites placed in a single increment up to 4 mm thickness via a novel mechanical strength test and provide related explanations. METHODS: Light transmission (LT), translucency parameter (TP), color difference (ΔE), Vickers hardness (HV) of two bulk-fill resin composites (Filtek Bulk Fill Posterior, Tetric N-Ceram Bulk Fill) and two conventional resin composites (Z100, Spectrum TPH) were evaluated. A novel flexural strength (FS) test method was applied for bulk-fill resin composite to determine the FS value of the bottom composites at depths of 1, 2, 3, and 4 mm after 24 hours of aging treatment (3 months water storage and 15,000 thermal cycles). The conventional resin composites were also tested for FS and all the FS results were subjected to Weibull analysis. Degree of conversion (DC) in the bulk-fill resin composites, light-cured at depths of 1, 2, 3, and 4 mm and conventional resin composites at depths of 2 and 4 mm, were assessed by FTIR. RESULTS: Both bulk-fill resin composites showed higher light transmission and translucency than that of conventional ones at each of the same thicknesses (1, 2, 3, 4 mm), wherein their flexural strength was not affected by depth. The Weibull analysis suggested both bulk-fill resin composites achieved good reliability and structural integrity under each curing thickness. Vickers hardness was affected by the material type and thickness. Bulk-fill resin composites showed a decrease in degree of conversion between 1 mm and 4 mm, but both were over 55%. CLINICAL SIGNIFICANCE: Filtek Bulk Fill Posterior, Tetric N-Ceram Bulk Fill achieved acceptable mechanical properties when cured at depths of up to 4 mm, which was beneficial from their optical and polymerized properties.

Influence of the layer thickness on the flexural strength of aged and nonaged additively manufactured interim dental material.

PURPOSE: To measure the flexural strength and Weibull characteristics of aged and nonaged printed interim dental material fabricated with different layer thickness. MATERIAL AND METHODS: Bars (25×2×2 mm) were additively fabricated by using a polymer printer (Asiga Max) and an interim resin (Nexdent C&B MFH). Specimens were fabricated with the same printing parameters and postprocessing procedures, but with 7 different layer thickness: 50 (control or 50-G group), 10 (10-G group), 25 (25-G group), 75 (75-G group), 100 (100-G group), 125 (125-G group), and 150 µm (150-G group). Two subgroups were created: nonaged and aged subgroups (n = 10). A universal testing machine was selected to measure flexural strength. Two-parameter Weibull distribution values were computed. Two-way ANOVA and Tukey tests were selected for statistical evaluation of the data (α = 0.05). RESULTS: Artificial aging methods (p < 0.001) were a significant predictor of the flexural strength computed. Aged specimens acquired less flexural strength than nonaged specimens. The Weibull distribution obtained the highest shape for nonaged 50-G and 75-G group specimens compared with those of other nonaged groups, while the Weibull distribution showed the highest shape for aged 125-G specimens. CONCLUSIONS: The flexural strength of the additively fabricated interim material examined was not influenced by the layer thickness at which the specimens were fabricated; however, artificial aging techniques reduced its flexural strength. Aged specimens presented lower Weibull distribution values compared with nonaged specimens, except for the 125-G specimens.

Comparison of animal and human blood for in vitro dynamic thrombogenicity testing of biomaterials.

BACKGROUND: To determine suitable alternatives to human blood for in vitro dynamic thrombogenicity testing of biomaterials, four different animal blood sources (ovine, bovine, and porcine blood from live donors, and abattoir porcine blood) were compared to fresh human blood. METHODS: To account for blood coagulability differences between individual donors and species, each blood pool was heparinized to a donor-specific concentration immediately before testing in a dynamic flow loop system. The target heparin level was established using a static thrombosis pre-test. For dynamic testing, whole blood was recirculated at room temperature for 1 h at 200 ml/min through a flow loop containing a single test material. Four materials with varying thrombotic potentials were investigated: latex (positive control), polytetrafluoroethylene (PTFE) (negative control), silicone (intermediate thrombotic potential), and high-density polyethylene (HDPE) (historically thromboresistant). Thrombus weight and surface area coverage on the test materials were quantified, along with platelet count reduction in the blood. RESULTS: While donor-specific heparin levels varied substantially from 0.6 U/ml to 7.0 U/ml among the different blood sources, each source was able to differentiate between the thrombogenic latex and the thromboresistant PTFE and HDPE materials (p < 0.05). However, only donor ovine and bovine blood were sensitive enough to differentiate an increased response for the intermediate thrombotic silicone material compared to PTFE and HDPE. CONCLUSIONS: These results demonstrated that multiple animal blood sources (particularly donor ovine and bovine blood) may be suitable alternatives to fresh human blood for dynamic thrombogenicity testing when appropriate control materials and donor-specific anticoagulation levels are used.

Comparative in vitro analysis of the sliding resistance of a modern 3D-printed polymer bracket in combination with different archwire types.

OBJECTIVES: To analyse the sliding resistance of a modern 3D-printed polymer bracket combined with different archwire types and to compare the results with conventionally used polymeric, ceramic and metal brackets. It was of further interest which bracket-archwire combination could be best qualified for clinical use. MATERIALS AND METHODS: The sliding behaviour was tested using an orthodontic measurement and simulation system (OMSS) for the use of two bracket types of the polymer, ceramic and metal group in combination with a 0.016 inch × 0.022 inch and 0.017 inch × 0.025 inch archwire of nickel-titanium (NiTi), titanium-molybdenum alloy (TMA) and stainless steel. Six bracket types were combined with six different archwire types and compared to each other. RESULTS: The sliding resistance showed significant differences between various the bracket-archwire complexes. The combination of 3D-printed polymer brackets with both steel archwire cross-sections showed the least values of sliding resistance (average 23-29%), while the combination of ceramic brackets with TMA archwires presented the highest (average 47%). CONCLUSIONS: The present study could show that modern 3D-printed bracket materials can have similar or even better mechanical properties than conventional ones regarding sliding resistance. Although the combination of bracket and archwire material is decisive for low sliding resistance values, the selection of the bracket material seems to have a greater influence than the selection of the archwire material or its cross section. CLINICAL RELEVANCE: It might be possible in future to combine aesthetic and biomechanical requirements for aesthetic brackets by using 3D-printing technology.

Toughening and Healing of CFRPs by Diels-Alder-Based Nano-Modified Resin through Melt Electro-Writing Process Technique.

In the current study, a novel approach in terms of the incorporation of self-healing agent (SHA) into unidirectional (UD) carbon fiber reinforced plastics (CFRPs) has been demonstrated. More precisely, Diels-Alder (DA) mechanism-based resin (Bis-maleimide type) containing or not four layered graphene nanoplatelets (GNPs) at the amount of 1 wt% was integrated locally in the mid-thickness area of CFRPs by melt electro-writing process (MEP). Based on that, CFRPs containing or not SHA were fabricated and further tested under Mode I interlaminar fracture toughness experiments. According to experimental results, modified CFRPs exhibited a considerable enhancement in the interlaminar fracture toughness properties (peak load (Pmax) and fracture toughness energy I (GIC) values). After Mode I interlaminar fracture toughness testing, the damaged samples followed the healing process and then were tested again under identical experimental conditions. The repeating of the tests revealed moderate healing efficiency (H.E.) since part of the interlaminar fracture toughness properties were restored. Furthermore, three-point bending (3PB) experiments were conducted, with the aim of assessing the effect of the incorporated SHA on the in-plane mechanical properties of the final CFRPs. Finally, optical microscopy (OM) examinations were performed to investigate the activated/involved damage mechanisms.

Effect of Different Filler Contents and Printing Directions on the Mechanical Properties for Photopolymer Resins.

Photopolymer resins are widely used in the production of dental prostheses, but their mechanical properties require improvement. We evaluated the effects of different zirconia filler contents and printing directions on the mechanical properties of photopolymer resin. Three-dimensional (3D) printing was used to fabricate specimens using composite photopolymers with 0 (control), 3, 5, and 10 wt.% zirconia filler. Two printing directions for fabricating rectangular specimens (25 mm × 2 mm × 2 mm) and disk-shaped specimens (φ10 mm × 2 mm) were used, 0° and 90°. Three-point bending tests were performed to determine the flexural strengths and moduli of the specimens. The Vickers hardness test was performed to determine the hardness of the specimens. Tukey's multiple comparison tests were performed on the average values of the flexural strengths, elastic moduli, and Vickers hardness after one-way ANOVA (α = 0.05). The flexural strengths and elastic moduli at 0° from high to low were in the order of 0, 3, 10, and 5 wt.%, and those at 90° were in the order of 3, 0, 10, and 5 wt.% (p < 0.05). For 5 and 10 wt.%, no significant differences were observed in mechanical properties at 0° and 90° (p < 0.05). The Vickers hardness values at 0° and 90° from low to high were in the order of 0, 3, 5, and 10 wt.% (p < 0.05). Within the limits of this study, the optimal zirconia filler content in the photopolymer resin for 3D printing was 0 wt.% at 0° and 3 wt.% at 90°.

Influence of the resin-coating technique on the bonding performance of self-adhesive resin cements in single-visit computer-aided design/computer-aided manufacturing resin restorations.

OBJECTIVE: This in vitro study investigated the influence of resin coating on the bonding performance of self-adhesive resin cements in single-visit computer-aided design (CAD)/computer-aided manufacturing (CAM) resin restorations. MATERIALS AND METHOD: CAD/CAM resin (1.5-mm thick) was mounted on 20 noncoated and 20 resin-coated human dentin surfaces using dual-cured self-adhesive resin cements (Panavia SA Cement Plus or Panavia SA Cement Universal, Kuraray Noritake Dental) in either self-curing or dual-curing mode. These specimens were sectioned into beam-shaped sticks and subjected to microtensile bond strength tests after 24 h of water storage. The obtained data were statistically analyzed with three-way analysis of variance (ANOVA) and t tests (α = 0.05). RESULTS: The three-way ANOVA results revealed the significant influence of resin coating, resin cement, and curing mode. Resin coating and light curing led to higher bond strengths in almost all groups. Resin-coated dentin with Panavia SA Cement Plus exhibited a mean bond strength greater than 35 MPa in both self-curing and dual-curing modes. CONCLUSIONS: In single-visit CAD/CAM resin restorations, resin coating, resin cement selection, and curing mode influenced the bonding performance of self-adhesive resin cements. In addition, resin coating and light curing increased the bond strength of self-adhesive resin cements. Resin coating and light curing are encouraged for predictable bonding performance of dual-cured self-adhesive resin cements in single-visit CAD/CAM resin restorations.

Modification of TiAlV Alloys with Hybrid Layers Containing Metallic Nanoparticles Obtained by the Sol-Gel Method: Surface and Structural Properties.

The aim of the work was to obtain hybrid coatings containing silver, copper, and zinc nanoparticles on the TiAlV medical alloy via a sol-gel process. The developed layers were designed to bring about a bactericidal and fungicidal effect, as well as for protection against surgical scratches during the implantation of implants used in veterinary medicine. In this work, the authors focused on evaluating the microstructure (SEM + EDS); the structure (XRD, FTIR); and the surface properties, such as wettability, free surface energy, and roughness of layers with various concentrations of metallic nanoparticles (2 and 5 mol %). Our results confirmed that the sol-gel method enables the easy manufacturing of hybrid layers endowed with different porosity values as well as various shapes and sizes of metallic nanoparticles. A higher concentration of nanoparticles was observed on the surface containing 5 mol % of metallic salts. The highest degree of homogeneity was obtained for the layers containing silver nanoparticles. In addition, the silver nanoparticles were round and had the smallest dimensions, even below 20 nm. The FTIR and XRD structural studies confirmed the presence of an organosilicon matrix containing all three types of the metallic particles. We conclude that the higher concentration of nanoparticles influenced the alloy surface parameters.

3D Printed Poly(𝜀-caprolactone)/Hydroxyapatite Scaffolds for Bone Tissue Engineering: A Comparative Study on a Composite Preparation by Melt Blending or Solvent Casting Techniques and the Influence of Bioceramic Content on Scaffold Properties.

Bone tissue engineering has been developed in the past decades, with the engineering of bone substitutes on the vanguard of this regenerative approach. Polycaprolactone-based scaffolds are fairly applied for bone regeneration, and several composites have been incorporated so as to improve the scaffolds' mechanical properties and tissue in-growth. In this study, hydroxyapatite is incorporated on polycaprolactone-based scaffolds at two different proportions, 80:20 and 60:40. Scaffolds are produced with two different blending methods, solvent casting and melt blending. The prepared composites are 3D printed through an extrusion-based technique and further investigated with regard to their chemical, thermal, morphological, and mechanical characteristics. In vitro cytocompatibility and osteogenic differentiation was also assessed with human dental pulp stem/stromal cells. The results show the melt-blending-derived scaffolds to present more promising mechanical properties, along with the incorporation of hydroxyapatite. The latter is also related to an increase in osteogenic activity and promotion. Overall, this study suggests polycaprolactone/hydroxyapatite scaffolds to be promising candidates for bone tissue engineering, particularly when produced by the MB method.

Influence of Test Specimen Geometry and Water Soaking on the In Vitro Cytotoxicity of Orthocryl®, Orthocryl® LC, Loctite® EA 9483 and Polypropylene.

Depending on their composition, plastics have a cytotoxic potential that needs to be evaluated before they are used in dentistry, e.g., as orthodontic removable appliances. Relevant guidelines set out requirements that a potential new resin in the medical field must meet, with a wide scope for experimental design. In the present study, test specimens of different geometries consisting of varying polymers (Orthocryl®, Orthocryl® LC, Loctite® EA 9483, Polypropylene) were soaked for different periods of time, then transferred to cell culture medium for 24 h, which was subsequently used for 24-h cultivation of A549 cells, followed by cytotoxicity assays (WST-1, Annexin V-FITC-propidium iodide (PI) flow cytometry). In this context, a reduction in the cytotoxic effect of the eluates of test specimens prepared from Orthocryl® LC and Loctite® EA 9483 was particularly evident in the Annexin V-FITC-PI assay when the soaking time was extended to 48 h and 168 h, respectively. Consistent with this, a reduced release of potentially toxic monomers into the cell culture medium, as measured by gas chromatography-mass spectrometry, was observed when the prior soaking time of test specimens of all geometries was extended. Remarkably, a significant increase in cytotoxic effect was observed in the WST-1 assay, which was accompanied by a higher release of monomers when the thickness of the test sample was increased from 0.5 to 1.0 mm, although an elution volume adapted to the surface area was used. However, further increasing the thickness to 3.0 mm did not lead to an increase in the observed cytotoxicity or monomer release. Test specimens made of polypropylene showed no toxicity under all test specimen sizes and soaking time conditions. Overall, it is recommended to perform toxicity studies of test specimens using different geometries and soaking times. Thereby, the influence of the different specimen thicknesses should also be considered. Finally, an extension of the test protocols proposed in ISO 10993-5:2009 should be considered, e.g., by flow cytometry or monomer analysis as well as fixed soaking times.

Review and demonstration of equations applied to models of filtering facepiece respirator particle capture efficiency.

The use of filtering facepiece respirators (FFRs) of various types increased dramatically by both workers and the public during the ongoing COVID-19 pandemic. This increased use has, likewise, instigated a proliferation of research on the qualities of FFRs. An aspect of FFR development and optimization involves the use of mathematical models that predict filter efficiency based on various filter characteristics while also considering a number of particle capture forces. An evaluation of current literature failed to identify a publication that provides a comprehensive assessment of the models developed to predict filter efficiency. The purpose of this review was, therefore, to describe models developed to include the forces associated with diffusion, interception, impaction, and electrostatic attraction as they contribute to the efficiency of an entire filter. The literature review was augmented with figures created with the use of many of the models discussed to compare different models of the same force as well as to illustrate the influence of electrostatic forces on overall filter efficiency.

In-house 3D-printed aligners: effect of in vivo ageing on mechanical properties.

OBJECTIVE: To investigate alterations in the mechanical properties of in-house three-dimensional (3D) printed orthodontic aligners after intraoral ageing. MATERIALS AND METHODS: Sixteen 3D-printed aligners (TC-85DAC resin, Graphy, Seoul, Korea) were used for the purpose of the study, which were divided into 10 control (not used) aligners and 6 materials retrieved from 4 patients after 1-week service (retrieved group). Samples from the control group were analysed by attenuated total reflectance-Fourier-transform infrared (ATR-FTIR) spectroscopy. Samples from control/retrieved groups were embedded resin and subjected to instrumented indentation testing (IIT) to record force-indentation depth curves, calculating the following (as per ISO 14577-1, 2002 standard): Martens hardness (HM), indentation modulus (EIT), and elastic index (ηIT), and the indentation relaxation index (RIT). Differences between control and retrieved 3D-printed aligners were checked with Mann-Whitney/t-tests at an alpha = 5%. RESULTS: ATR-FTIR analysis showed that aligners were made of a vinyl ester-urethane material. The results of the IIT testing were: HM (control: median 91.5 N/mm2, interquartile range [IQR] 88.0-93.0/as-retrieved: median 90.5 N/mm2, IQR 89.0-93.0); EIT (control, mean 2616.3 MPa, standard deviation [SD] 107.0 MPa/retrieved, mean 2673.2 MPa, SD 149.4 MPa); ηIT (control: median 28.6%, IQR 28.2-30.9%/as-retrieved: median 29.0%, IQR 28.7-29.2%); and RIT (control: median 45.5%, IQR 43.0-47.0%/as-retrieved: median 45.1%, IQR 45.0-45.3%). No differences between as-retrieved and control aligners were found for any of the mechanical properties tested (P > 0.05 in all instances). CONCLUSION: The mechanical properties of the in-house 3D-printed aligners tested were not affected after 1 week in service period.

Evaluation of the Impact of Different Disinfectants on Color Stability of Denture Base Materials: A Comparative Study.

AIM: Aim of the current research was to assess the effect of different disinfectant solutions on the color steadiness of denture base materials. MATERIALS AND METHODS: Ninety samples were made employing the Meliodent and ProBase Hot heat cure denture base resin materials. Metallic disks measuring 3 mm thick as well as 20 mm in diameter were utilized to make the samples. Forty-five samples of every denture base material were immersed in three chemical disinfectants: 2% alkaline glutaraldehyde, 0.5% chlorhexidine gluconate, 0.5% sodium hypochlorite solution as well as distilled water that served as a control. Color scoring was performed at baseline and following first, 14th as well as 21 days. Color was calculated as per CIE L*a*b* color scale as related to standard source C alongside a white background on a reflection spectrophotometer. RESULTS: Subsequent to the immersion of Meliodent heat-cured denture base resin materials within distilled water, the baseline color steadiness score was 6.16 ± 0.12, 6.12 ± 0.08 on the first day, 5.98 ± 0.06 on day 14 and 5.74 ± 0.14 on day 21. Within 2% alkaline glutaraldehyde the baseline color constancy mean value was 6.12 ± 0.28, 6.08 ± 0.04 on the first day, 5.04 ± 0.11 on day 14 and 4.22 ± 0.14 on day 21. Within 0.5% chlorhexidine gluconate the baseline color constancy mean value was 6.14 ± 0.09, 6.02 ± 0.12 on the first day, 5.38 ± 0.19 at 14th day and 4.84 ± 0.10 on day 21. In 0.5% sodium hypochlorite solution the baseline color steadiness mean value was 6.16 ± 0.18, 6.10 ± 0.06 on the first day, 4.98 ± 0.26 on 14th day and 3.14 ± 0.14 on day 21. ProBase Hot heat cure denture base resin materials after immersion in Distilled water delineated the baseline color constancy mean value was 6.48 ± 0.02, 6.34 ± 0.09 on the first day, 6.08 ± 0.14 on 14th day and 5.88 ± 0.07 on day 21. Within 2% alkaline glutaraldehyde the baseline color constancy mean value was 6.42 ± 0.16, 6.18 ± 0.11 on the first day, 5.12 ± 0.18 at 14th day and 4.24 ± 0.24 on day 21. Within 0.5% Chlorhexidine gluconate the baseline color steadiness mean value was 6.48 ± 0.10, 6.26 ± 0.08 on the first day, 5.48 ± 0.11 on 14th day and 4.88 ± 0.06 on day 21. In 0.5% sodium hypochlorite solution the baseline color steadiness mean value was 6.44 ± 0.12, 6.14 ± 0.08 on the first day, 4.98 ± 0.16 on 14th day, and 3.34 ± 0.06 on day 21. There was a statistically noteworthy difference amid the dissimilar time points in each of the three disinfectants. CONCLUSION: In the confines of the inherent limitations of this research, it can be inferred that the color steadiness of either denture base resins was enhanced following immersion in 0.5% chlorhexidine gluconate in pursuit by 2% alkaline glutaraldehyde as well as 0.5% sodium hypochlorite solution. Distilled water exerted the smallest amount of influence on the color change of the samples of denture base resins. CLINICAL SIGNIFICANCE: Techniques that help infection prevention influence denture disinfection. Currently, there is a dearth of commercially marketed agents that are specifically intended to disinfect dentures. Color constancy of the denture materials is an important parameter to be given due consideration while selecting a disinfectant. This would be a pivotal characteristic for practitioners to consider as they choose disinfectant solutions to disinfect dentures.