Simulated Clinical Conditions Research Articles

Embedded Cyber-Physical System for Physiological Control of Ventricular Assist Devices

Ventricular Assist Devices (VADs) play a crucial role in both bridging to transplantation and serving as destination therapy for congestive heart failure (CHF) management. This study aims to address the limitations of existing control strategies for VADs, specifically their inability to adapt automatically to hemodynamic changes. It proposes a novel embedded cyber-physical system (CPS) based on real-time data processing, reconfigurable architecture, and communication protocols aligned with Health 4.0 concepts to enhance physiological control over VADs (PC-VAD). The research employs a multi-objective PC-VAD approach within a hybrid cardiovascular simulator. An embedded CPS is introduced to overcome challenges related to differences in controller characteristics between computers and embedded systems. The study assesses the performance of the embedded CPS by comparing it with a computer-based control system. The embedded CPS demonstrates outcomes comparable to the computer-based control system, maintaining mean arterial pressure and cardiac output at physiological levels. Even in the face of variations in ejection fraction, the embedded CPS dynamically adjusts the pump's rotational speed based on simulated clinical conditions. Notably, there is no aortic reflux to the ventricle through the VAD during testing. These findings affirm the satisfactory control performance of the embedded CPS in regulating VADs. The study concludes that the embedded CPS effectively addresses the limitations of current VAD control strategies, exhibiting control performance comparable to computer-based systems. However, further experimentation and in vivo studies are necessary to validate and ensure its applicability in real-world scenarios.

Reentry of endodontic access cavities: composite residue and loss of tooth substance

The purpose of this study was to investigate the ability of dentists to remove composite fillings from endodontic access cavities using illumination from a conventional light source (CLS) versus the fluorescence-aided identification technique (FIT) in terms of completeness, selectivity and treatment duration. Therefore, two independent operators removed composite resin from six sets of root-filled incisors in a maxillary model under simulated clinical conditions using the CLS or FIT method (twelve teeth per operator and technique). The duration of treatment was recorded and before-after micro-CT scans were superimposed for volumetric assessment of treatment completeness and selectivity. Statistical significance was determined by t-testing and two-way ANOVA for operator comparison.Overall, there was no significant difference be- tween FIT and CLS in terms of volume, height and area of composite residues (p = 0.98/p = 0.75/p = 0.64) and regarding hard tissue loss in terms of volume, depth and area (p = 0.93/p = 0.70/p = 0.14). However, there was a significant difference between the two groups regarding treatmenttime(FIT=428s,CLS=523s;p=0.023). Significant differences between operators regard- less of method were found for volume, height and area of composite residues (p < 0.05) and also for defect area (p = 0.01) and time (p < 0.001). A significant difference between operators including the method was only found for height of composites (p = 0.037). It can be concluded, that composite remnants and tooth structure losses may occur after reentry of root-filled teeth regardless of the illumination method (conventional vs. fluorescence- aided) and operator, but preparation was less time-consuming with FIT.

The Latin Language as a Factor in the Formation of Professional and Intercultural Competencies of Medical Students in Higher Education

The article is devoted to such an important socio-cultural aspect of human life as obtaining professional and intercultural competencies in the process of educational activity. According to the author, Latin is a fusion of philological information and language skills, as well as legal norms, history, traditions, ethnic characteristics of behavior and thinking of native speakers of the language and culture. The author believes that in the long term, the task of foreign language education in an institution of higher professional education is the formation of a multilingual, well-educated person who is able to apply his knowledge in the process of professional intercultural communication. The above factors determine the relevance of the chosen topic. The subject of the study is professional and intercultural competencies formed with the direct participation of the Latin language. The object is the Latin language as an academic discipline of the curriculum of medical specialties. In the course of the research, the author aims to study the role of the Latin language in the process of professional development of medical university students as an integral part of the general humanitarian direction. For the successful realization of this goal, scientific sources of literature were analyzed. The methodological basis of the study is determined by the purpose of the work and is presented by the following methods: random sampling, definitional analysis, comparison and classification. Special attention in the successful acquisition of professional competencies of future specialists is paid to the interdisciplinary approach in training. As a result of the successful formation of competencies, students acquire not only knowledge of medical and biological terminology, but also the ability to use the acquired knowledge in simulated or real clinical conditions, as well as gain practical experience in operating with medical vocabulary in their future professional activities.

Guided endodontics versus conventional access cavity preparation: an ex vivo comparative study of substance loss

BackgroundTo compare the outcomes of conventional access cavity preparation (CONV) versus guided endodontics (GE) for access cavity preparation in anterior teeth with pulp canal calcification (PCC) regarding root canal detection, substance loss, procedural time, and need for additional radiographs.MethodsExtracted, sound human teeth with PCC (n = 108) were matched in pairs, divided into two groups and used to produce 18 models. An independent endodontist and a general dentist performed access cavity preparation under simulated clinical conditions on nine models each (54 teeth). The endodontist used the conventional technique and the general dentist GE. Time needed to access the root canals and the number of additional radiographs were recorded. Pre- and postoperative cone-beam computed tomography scans were obtained to measure substance loss. Statistical significance was tested by examining the overlap of 95% confidence intervals (CIs) between the groups.ResultsAll root canals were successfully accessed by both methods. There were no significant differences in substance loss (CI: CONV 15.9–29.6 mm3 vs. GE 17.6-27.5mm3) or procedural time (CI: CONV 163.3-248.5 s vs. GE 231.9-326.8 s). However, 31 additional radiographs were required for GE compared to none for CONV.ConclusionsFor access cavity preparation in teeth with PCC, both CONV by a specialist and GE by a general dentist produce good results in terms of substance loss and time requirements.

Effect of open windows on airborne contamination and its topographical distribution in the dental operatory.

Aerosols produced by dental handpieces represent a permanent risk of disease transmission in the dental environment. The current study evaluated the effects of natural ventilation (open windows) on Streptococcus mutans airborne contamination by dental handpieces in simulated clinical conditions. A dental phantom was placed on a dental chair at a standard university dental clinic operatory. An S. mutans suspension was infused into the phantom's mouth while an operator performed standardized dental procedures using low (contra-angle) and high speed (turbine) dental handpieces or an ultrasonic scaler, with windows open or closed. Selective medium Petri dishes were placed in 18 sites of the operatory environment to evaluate contamination topographically. Sites were clustered as: wall, floor, ceiling, dental chair, and cabinet. Contamination was expressed as log10 CFU/cm2 . A linear mixed model analysis was used, nesting the sites within each ventilation and handpiece combination. Open windows significantly reduced contamination. The high-speed handpiece provided the highest contamination, followed by the ultrasonic scaler and the low-speed handpiece. Contamination values were much smaller at the ceiling, and much larger at the chair. Opening windows produced more homogeneous contamination of the operatory compared to closed windows. Natural ventilation during dental procedures decreases contamination and affects its topographical distribution.

Accuracy of a dynamic navigation system for dental implantation with two different workflows and intraoral markers compared to static-guided implant surgery: An in-vitro study.

To investigate the accuracy of a miniaturized dynamic navigation system with intraoral markers and two different workflows for dental implantation and to compare with static computer-assisted implant surgery (sCAIS) surgery. Two operators performed a total of 270 implant insertions in polyurethane mandibular models under simulated clinical conditions. Implants were placed after CBCT-based virtual planning in three different groups: two workflows utilizing dynamic computer-assisted implant surgery (dCAIS; DG1: marker in CBCT; DG2: 3D-printed marker) and the others with sCAIS (TG: template guided). Postoperative surface scans were matched to the planning data and allowed an evaluation of the angular and spatial deviation between the planned and the actually achieved implant position. Descriptive statistics were followed by a Mixed Model Analysis to determine the influence of the operator, the method, and operating area on different accuracy parameters and the random effect of the model number. The mean angular deviation ranged from 2.26° (DG1) to 2.96° (TG). The mean 3D deviation at the implant's tip ranged from 1.08 mm (TG) to 1.51 mm (DG2) and at the implant's base from 0.69 mm (TG) to 1.49 mm (DG2). The operator showed no significant influence on the accuracy. The method showed significant influence on singular parameters and the operating area on all spatial accuracy parameters. Dynamic navigation systems with intraoral markers enable accurate implant positioning, which is comparable to the static-guided implant surgery. 3D-printed markers provide less accurate results compared to prefabricated markers, attached before CBCT scan.

Preload evaluation of 2 implant-supported fixed partial denture abutment designs

Statement of problemA hemi-engaging abutment design has been suggested to improve the stability of the implant-to-abutment interface compared with that of a fully nonengaging design to restore implant-supported fixed partial denture. However, controversy persists regarding the benefit of using a hemi-engaging abutment design and prompts the need for specific mechanical testing on the effect of these designs on screw preload under simulated clinical conditions. PurposeThe purpose of this in vitro study was to determine whether significant differences in preload values of the screw before and after cyclic loading exist between hemi-engaging and nonengaging abutment fixed partial denture designs. Material and methodsTwenty-four conical connection implants measuring 4.3×10 mm (Nobel Biocare Replace Conical Connection; Nobel Biocare) were mounted in acrylic resin blocks. Specimens were divided into 2 groups. An experimental group included 12 three-unit fixed partial dentures with a hemi-engaging design; a control group included 12 three-unit fixed partial dentures with the conventional design of 2 nonengaging abutments. A digital screw torque meter was used to measure screw torque values per the manufacturer’s recommendation of 35 Ncm. Reverse torque value was measured before cyclic loading and referred to as initial preload. After cyclic loading, reverse torque value was measured and referred to as final preload. The effect of cyclic loading was evaluated by averaging the reverse torque value across the 2 screws in each specimen and then calculating the changes between the initial preload and final preload. The difference between initial and final preload was referred to as reverse torque difference. An additional reverse torque difference, referred to as reverse torque difference-nonengaging, was calculated for the nonengaging screws in each experimental specimen and for 1 randomly selected screw of the 2 in each control specimen. Preload efficiency before and after cyclic loading was also calculated. All groups went through cyclic loading using a universal testing machine. The specimens went through axial loading first, and then the reverse torque value was measured. Twenty-four new abutment screws were then used, and the specimens then went through lateral loading at 30 degrees. Load was applied to the units (1.0×106 cycles) for each loading axis. The statistical significance of differences between the axial and lateral reverse torque difference and between the 2 groups of reverse torque difference and reverse torque difference-nonengaging were assessed using Mann-Whitney U tests (α=.05). ResultsA comparison of reverse torque difference between loading types revealed no significant difference (P=.773). Therefore, data for the 2 loading types were combined before comparing the reverse torque difference and reverse torque difference-nonengaging values between the 2 groups based on abutment design (12 hemi-engaging designs in the experimental group and 12 fully nonengaging designs in the control group). The experimental group mean reverse torque difference was -0.65 ±1.95 Ncm (range -4.0 to 2.4 Ncm), and the control group mean reverse torque difference was -2.5 ±5.44 Ncm (range -15.3 to 5.3 Ncm). No significant difference was found (P=.340). Furthermore, no significant difference was found between the reverse torque difference for the nonengaging screw in each of the 12 implants with a hemi-engaging design versus 1 randomly selected nonengaging screw in each of the 12 implants with a fully nonengaging design (P=.355). ConclusionsNo significant difference was found in screw preload between a hemi-engaging and a full nonengaging 3-unit fixed partial denture supported by conical connection implant configurations before and after cyclic loading.

Functional tumor diameter measurement with molecular breast imaging: development and clinical application

Purpose: Molecular breast imaging (MBI) is used clinically to visualize the uptake of 99mTc-sestamibi in breast cancers. Here, we use Monte Carlo simulations to develop a methodology to estimate tumor diameter in focal lesions and explore a semi-automatic implementation for clinical data. Methods: A validated Monte Carlo simulation of the GE Discovery NM 750b was used to simulate >75,000 unique spherical/ellipsoidal tumor, normal breast, and image acquisition conditions. Subsets of this data were used to 1) characterize the dependence of the full-width at half-maximum (FWHM) of a tumor profile on tumor, normal breast, and acquisition conditions, 2) develop a methodology to estimate tumor diameters, and 3) quantify the diameter accuracy in a broad range of clinical conditions. Finally, the methodology was implemented in patient images and compared to diameter estimates from physician contours on MBI, mammography, and ultrasound imaging. Results: Tumor profile FWHM was determined be linearly dependent on tumor diameter but independent of other factors such as tumor shape, uptake, and distance from the detector. A linear regression was used to calculate tumor diameter from the FWHM estimated from a background-corrected profile across a tumor extracted from a median-filtered single-detector MBI image, i.e., diameter = 1.2 mm + 1.2 × FWHM, for FWHM ≥ 13 mm. Across a variety of simulated clinical conditions, the mean error of the methodology was 0.2 mm (accuracy), with >50% of cases estimated within 1-pixel width of the truth (precision). In patient images, the semi-automatic methodology provided the longest diameter in 94% (60/64) of cases. The estimated true diameters, for oval lesions with homogeneous uptake, differed by ± 5 mm from physician measurements. Conclusion: This work demonstrates the feasibility of accurately quantifying tumor diameter in clinical MBI, and to our knowledge, is the first to explore its implementation and application in patient data.

Personalised 3D printed respirators for healthcare workers during the COVID-19 pandemic.

Widespread issues in respirator availability and fit have been rendered acutely apparent by the COVID-19 pandemic. This study sought to determine whether personalized 3D printed respirators provide adequate filtration and function for healthcare workers through a Randomized Controlled Trial (RCT). Fifty healthcare workers recruited within NHS Lothian, Scotland, underwent 3D facial scanning or 3D photographic reconstruction to produce 3D printed personalized respirators. The primary outcome measure was quantitative fit-testing to FFP3 standard. Secondary measures included respirator comfort, wearing experience, and function instrument (R-COMFI) for tolerability, Modified Rhyme Test (MRT) for intelligibility, and viral decontamination on respirator material. Of the 50 participants, 44 passed the fit test with the customized respirator, not significantly different from the 38 with the control (p = 0.21). The customized respirator had significantly improved comfort over the control respirator in both simulated clinical conditions (p < 0.0001) and during longer wear (p < 0.0001). For speech intelligibility, both respirators performed equally. Standard NHS decontamination agents were able to eradicate 99.9% of viral infectivity from the 3D printed plastics tested. Personalized 3D printed respirators performed to the same level as control disposable FFP3 respirators, with clear communication and with increased comfort, wearing experience, and function. The materials used were easily decontaminated of viral infectivity and would be applicable for sustainable and reusable respirators.

Do magnification loupes affect the precision of cavity preparations made by undergraduates? A randomized crossover study

BackgroundEvidence on the effect of magnification devices on procedure quality in restorative dentistry is scant. This study therefore aimed to assess, under simulated clinical conditions, if magnification loupes affect the quality of preparations carried out by undergraduate dental students.Methods59 undergraduate dental students underwent two visual acuity tests, based on which they were divided into a “low visual acuity group” (visus < 1) and a “good visual acuity group” (visus ≥ 1). In a randomized crossover experiment, participants performed a two-dimensional S and a three-dimensional O figure preparation with a dental handpiece on standardized acrylic blocs designed for preclinical restorative training. Each participant carried out the preparation tasks twice, once with magnification loupes (2.5×) and once without. Two blinded investigators independently evaluated parameters of preparation precision. Data were analyzed using Spearman rank correlation coefficients, intra-class correlation coefficients, and Wilcoxon rank-sum tests (α = 0.05).ResultsParticipants from the “low visual acuity group” did not show a statistically significant improvement in accuracy when they used magnification loupes for the S figure preparation (p ≥ 0.0625). Participants from the “high visual acuity group” obtained a higher level of accuracy (p ≤ 0.0012) when they used magnification loupes for the S figure preparation. The use of magnification loupes had no statistically significant effect on the accuracy parameters of the O figure cavity preparations (p ≥ 0.1865). Participants with high visual acuity achieved only a marginally better accuracy than participants with a visus < 1.ConclusionsThis study suggests that loupes with 2.5× magnification increase the accuracy of two-dimensional preparations while they have no significant effect, favorable or otherwise, on the accuracy of complex, three-dimensional cavity preparations of untrained dental students.

Biomechanical Efficacy and Effectiveness of Orthodontic Treatment with Transparent Aligners in Mild Crowding Dentition-A Finite Element Analysis.

Orthodontic treatment increasingly involves transparent aligners; however, biomechanical analysis of their treatment effects under clinical conditions is lacking. We compared the biomechanical efficacy and effectiveness of orthodontic treatment with transparent aligners and of fixed appliances in simulated clinical orthodontic treatment conditions using orthodontic finite element (FE) models. In the FE analysis, we used Model Activation/De-Activation analysis to validate our method. Fixed appliances and 0.75-mm and 0.5-mm thick transparent aligners were applied to a tooth-alveolar bone FE model with lingually-inclined and axially-rotated central incisors. Compared to the fixed appliance, the 0.75-mm and 0.5-mm transparent aligners induced 5%, 38%, and 28% and 21%, 62%, and 34% less movement of the central incisors and principal stress of the periodontal ligament and of the alveolar bone, respectively, for lingual inclination correction. For axial-rotation correction, these aligners induced 22%, 37%, and 40% and 28%, 67%, and 48% less tooth movement and principal stress of the periodontal ligament and of the alveolar bone, respectively. In conclusion, transparent aligners induced less tooth movement, it is sufficient for orthodontic treatment, but 0.5-mm aligners should be used for only mild corrections. Additionally, the Model Activation/De-Activation analysis method is suitable for FE analysis of orthodontic treatment reflecting clinical treatment conditions.

Ex Vivo Model to Assess the Exposure of Patients to Plasticizers from Medical Devices during Pre-CAR-T Cells' Apheresis.

Background: The treatment of relapsed or refractory leukemia remains a major problem. Among the new therapeutic approaches, the use of modified T lymphocytes, called chimeric antigen receptor T cells (CAR-T cells), seems promising. The first step of their preparation is leukapheresis, which involves the collection of mononuclear cells from the patient. This medical procedure requires numerous medical devices (MDs) made of plasticized polyvinylchloride (PVC). These compounds can leach out of the devices during contact with the patient’s blood. The aim of our study was to evaluate the migration of the plasticizers contained in the MD during a simulated pre-CAR-T cell leukapheresis procedure, and to measure the patient’s and their lymphocytes’ exposure to them. Methods: The qualitative and quantitative composition of the MD used for pre-CAR-T cell apheresis was determined by gas chromatography–mass spectrometry (GC–MS). Then, an ex vivo leukapheresis model using an ethanol/water simulant was performed to evaluate the plasticizers’ migration under simulated clinical conditions of pre-CAR-T cells’ cytapheresis. The plasticizers released into the simulant were quantified by GC–MS. Results: Diethylhexylphthalate (DEHP) was found in the apheresis kit, with amounts ranging from 25% to 59% (g/100 g of PVC). Bis(2-ethylhexyl) adipate was detected at trace levels. A total of 98.90 ± 11.42 mg of DEHP was released into the simulant, corresponding to an exposure dose of 1.4 mg/kg for a 70 kg patient. Conclusions: Patients undergoing a pre-CAR-T cell apheresis are mainly exposed to DEHP, which can impact their health because of its endocrine disruption effect, but could also lead to a decrease in CAR-T cells’ efficiency/quality.

Comparison of Accuracy of Dentaport ZX, Rootor and E-Pex Pro Electronic Apex Locators in Two Simulated Clinical Conditions: An In Vitro Study

Background:The aim of this in vitro study was to determine the accuracy in measuring the working length (WL) using Dentaport ZX, Rootor, and a newly introduced budget friendly electronic apex locator (EAL), E-Pex Pro in two commonly simulated clinical conditions (in the presence of irrigant and blood).Materials and Methodology:Eighty-eight single-rooted premolars were randomly assigned to two groups according to simulated clinical conditions: Group 1: Presence of irrigant (5% NaOCl) and Group 2: Presence of blood. WL was determined with all three EAL and was then compared with actual length (AL) of the tooth, which was measured using Vision Inspection System. The difference between the length measured by EAL and AL was tabulated and statistically analyzed using one-way analysis of variance (ANOVA) with post hoc Dunnett's test. All testing was done using two-sided tests at alpha 0.05 (95% confidence level). Thus, the criteria for rejecting the null hypothesis were “P < 0.05.”Results:Measurement using Dentaport ZX, Rootor, and E-Pex Pro had an accuracy of 99.79%, 99.69%, and 99.64%, respectively, in Group 1 and 99.95%, 99.7%, and 99.74%, respectively, in Group 2. ANOVA revealed that the mean error value is least for Dentaport ZX followed by Rootor and then E-Pex pro EAL.Conclusion:Dentaport ZX gave better results both in the presence of NaOCl and blood followed by Rootor and E-Pex Pro EALs.

Tapping basement membrane motifs: Oral junctional epithelium for surface-mediated soft tissue attachment to prevent failure of percutaneous devices

Teeth, long-lasting percutaneous organs, feature soft tissue attachment through adhesive structures, hemidesmosomes, in the junctional epithelium basement membrane adjacent to teeth. This soft tissue attachment prevents bacterial infection of the tooth despite the rich – and harsh – microbial composition of the oral cavity. Conversely, millions of percutaneous devices (catheters, dental, and orthopedic implants) fail from infection yearly. Standard of care antibiotic usage fuels antimicrobial resistance and is frequently ineffective. Infection prevention strategies, like for dental implants, have failed in generating durable soft tissue adhesion – like that seen with the tooth – to prevent bacterial colonization at the tissue-device interface. Here, inspired by the impervious natural attachment of the junctional epithelium to teeth, we synthesized four cell adhesion peptide (CAPs) nanocoatings, derived from basement membranes, to promote percutaneous device soft tissue attachment. The two leading nanocoatings upregulated integrin-mediated hemidesmosomes, selectively increased keratinocyte proliferation compared to fibroblasts, which cannot form hemidesmosomes, and expression of junctional epithelium adhesive markers. CAP nanocoatings displayed marked durability under simulated clinical conditions and the top performer CAP nanocoating was validated in a percutaneous implant murine model. Basement membrane CAP nanocoatings, inspired by the tooth and junctional epithelium, may provide an alternative anti-infective strategy for percutaneous devices to mitigate the worldwide threat of antimicrobial resistance. Statement of significancePrevention and management of medical device infection is a significant healthcare challenge. Overzealous antibiotic use has motivated alternative material innovations to prevent infection. Here, we report implant cell adhesion peptide nanocoatings that mimic a long-lasting, natural “medical device,” the tooth, through formation of cell adhesive structures called hemidesmosomes. Such nanocoatings sidestep the use of antimicrobial or antibiotic elements to form a soft-tissue seal around implants. The top performing nanocoatings prompted expression of hemidesmosomes and defensive factors to mimic the tooth and was validated in an animal model. Application of cell adhesion peptide nanocoatings may provide an alternative to preventing, rather that necessarily treating, medical device infection across a range of device indications, like dental implants.

Physical Properties of Modern Reciprocal Endodontic Systems and Fatigue Failure Testing in Simulated Clinical Conditions

Instrument fracture ranks among the most crucial complications during the endodontic treatment of a tooth. In order to better understand the practical limits of the instrument, the relation between the cyclic fatigue resistance and physical properties such as hardness, modulus of elasticity, creep and surface roughness were explored. Cyclic fatigue testing in an artificial root canal at intracanal temperature, nanoindentation and 3D microscopy were used for evaluation of four commonly used thermomechanically treated NiTi endodontic instruments (Unicone Plus 6/025, Unicone 6/025, Reciproc Blue R25 and WaveOne Gold Primary). Cyclic fatigue results were analyzed using the Kruskal–Wallis, Mann–Whitney and Bonferroni corrections. The wear resistance of Unicone 6/025 instruments was significantly lower compared to all other instruments (p &lt; 0.05). WaveOne Gold Primary was significantly less resistant than Unicone Plus 6/025 and Reciproc Blue R25, while the difference between Reciproc Blue R25 and Unicone Plus 6/025 was insignificant (p &gt; 0.05). These results are in correlation with measurements of local mechanical properties (hardness, elastic modulus and their ratios H/E and H3/E2). Even though surface roughness, area of cross-section and shape of instruments are important factors affecting instruments behavior, thermal processing appears to be the most important.

Establishing a protocol for the compatibilities of closed-system transfer devices with multiple chemotherapy drugs under simulated clinical conditions.

Closed-system drug transfer devices (CSTDs) are used to prevent occupational exposure to hazardous drugs in health care providers. They are considered Class II medical devices by the US FDA and are cleared but not approved before marketing. While compatibility tests are conducted by CSTD manufacturers, the procuring institution needs to consider performing its own studies before buying these devices. Herein we tested the compatibility of the components of the Needleless® DualGuard CSTD system (vial access clips, vial access spikes, and administration adaptors) with 10 antineoplastic drugs, under simulated clinical conditions, including compounding and administration, and examined drug potency maintenance, plasticizer migration, and device functionality. All drugs maintained potency within 5%. Diisononyl phthalate leakage was observed from the administration adaptors for paclitaxel and concentrated etoposide solution. In addition, white particles were discovered in CSTDs storing busulfan solution and small cracks were observed on devices which stored melphalan. Thus, it was concluded that even in simulated clinical conditions, instead of extreme conditions, there are still concerns regarding the efficacy and safety of CSTD components. The methodology may be used to implement and detect possible interactions between antineoplastic agents and CSTD components before procurement.

Stability of Pentoxifylline Injection: Application to Neonatal/Pediatric Care Setting

Pentoxifylline (PTX) is administered as 6- or 12-hour intravenous infusions in the treatment of sepsis or necrotizing enterocolitis in neonates; however, there is a paucity of formal stability data for PTX in the end-use solution. We investigated PTX stability in the simulated clinical conditions of neonatal intensive care, where PTX injection is diluted to 5 mg/mL and administered via syringe pump. A stability-indicating high performance liquid chromatography (HPLC) assay was established for PTX. The clinical simulation stability study comprised PTX 5 mg/mL in 20 mL syringes and was conducted at three temperatures, all protected from light: refrigerator (4°C); room temperature (22°C) and incubator/humidicrib (35°C). PTX stability also was evaluated at room temperature and exposed to light. Samples were drawn at pre-determined times over a 10 day period and stored frozen (-80°C) until assayed by HPLC. A single exponential equation was fitted to the concentration-time data to determine PTX stability. Forced degradation studies confirmed that PTX was stable at elevated temperature (up to 45°C), exposed to light and under acidic stress for up to 10 days, but subject to degradation under alkali and oxidative stress. PTX injection 5 mg/mL in 0.9% w/v sodium chloride or 5% w/v glucose was found to be stable when protected from light at 22°C and 35°C, and exposed to light at 22°C for at least 7 days. These data provide clinically relevant evidence that PTX injection is stable in the end-use, ICU/incubator clinical conditions for at least 24 hours.

Quantifying Viral Particle Aerosolization Risk During Tracheostomy Surgery and Tracheostomy Care

During respiratory disease outbreaks such as the COVID-19 pandemic, aerosol-generating procedures, including tracheostomy, are associated with the risk of viral transmission to health care workers. To quantify particle aerosolization during tracheostomy surgery and tracheostomy care and to evaluate interventions that minimize the risk of viral particle exposure. This comparative effectiveness study was conducted from August 2020 to January 2021 at a tertiary care academic institution. Aerosol generation was measured in real time with an optical particle counter during simulated (manikin) tracheostomy surgical and clinical conditions, including cough, airway nebulization, open suctioning, and electrocautery. Aerosol sampling was also performed during in vivo swine tracheostomy procedures (n = 4), with or without electrocautery. Fluorescent dye was used to visualize cough spread onto the surgical field during swine tracheostomy. Finally, 6 tracheostomy coverings were compared with no tracheostomy covering to quantify reduction in particle aerosolization. Respirable aerosolized particle concentration. Cough, airway humidification, open suctioning, and electrocautery produced aerosol particles substantially above baseline. Compared with uncovered tracheostomy, decreased aerosolization was found with the use of tracheostomy coverings, including a cotton mask (73.8% [(95% CI, 63.0%-84.5%]; d = 3.8), polyester gaiter 79.5% [95% CI, 68.7%-90.3%]; d = 7.2), humidification mask (82.8% [95% CI, 72.0%-93.7%]; d = 8.6), heat moisture exchanger (HME) (91.0% [95% CI, 80.2%-101.7%]; d = 19.0), and surgical mask (89.9% [95% CI, 79.3%-100.6%]; d = 12.8). Simultaneous use of a surgical mask and HME decreased the particle concentration compared with either the HME (95% CI, 1.6%-12.3%; Cohen d = 1.2) or surgical mask (95% CI, 2.7%-13.2%; d = 1.9) used independently. Procedures performed with electrocautery increased total aerosolized particles by 1500 particles/m3 per 5-second interval (95% CI, 1380-1610 particles/m3 per 5-second interval; d = 1.8). The findings of this laboratory and animal comparative effectiveness study indicate that tracheostomy surgery and tracheostomy care are associated with significant aerosol generation, putting health care workers at risk for viral transmission of airborne diseases. Combined HME and surgical mask coverage of the tracheostomy was associated with decreased aerosolization, thereby reducing the risk of viral transmission to health care workers.

The Best Dentistry Professional Visual Acuity Measured under Simulated Clinical Conditions Provides Keplerian Magnification Loupe: A Cross-Sectional Study

Visual acuity plays an important role in dentists’ vision in their daily clinical routine. This study aimed to determine dental students’ visual acuity without optical aids and when using magnification devices in simulated clinical conditions. The participants were forty-six students at the School of Dental Medicine with a visual acuity of 1.0 in decimal values or 100% in percentage. The central visual acuity was tested using a miniature Snellen eye chart placed in the molar cavity of a dental phantom, in simulated clinical conditions under five different settings (natural visual acuity, by applying head magnifying glasses x1,5 and binocular magnifying devices using Galileo’s x2,5/350 mm, Keplerx3,3/450 mm and Keplerx4,5/350 mm optical system). The Wilcoxon Signed Rank test shows that the distribution of measurements of the visual acuity undertaken by the application of magnifying devices (VNL, VGA2,5, VKP3,3, VKP4,5) contained higher values of visual acuity than those received by the use of natural vision (VSC) (p < 0.001 for the comparison to the VNL, VGA2,5, VKP3,3 and VKP4,5 groups). The highest and statistically most significant increase in visual acuity is achieved using the Keplerian telescope x4.5/350 mm. The application of magnifying devices provided dentistry professionals with better visual acuity, improving detail detection in an oral cavity during dental procedures by magnifying the oral structure. The use of magnification devices means much more precise work, decreases the operating time, improves posture and reduces muscle pain in the shoulder during dental treatment.

Influence of ultraconservative access cavities on instrumentation efficacy with XP-endo Shaper and Reciproc, filling ability and load capacity of mandibular molars subjected to thermomechanical cycling.

To evaluate the influence of ultraconservative access cavities (UltraAC) on canal shaping and filling ability and load capacity of mandibular molars after root canal preparation with XP-endo Shaper (XP) or Reciproc (RC), under simulated clinical conditions. Traditional access cavities (TradAC) were used for comparison. Forty extracted mandibular molars were scanned by micro-computed tomographic and, based on similar anatomical features, were divided into four groups (n=10), according to the type of access cavity and canal instrumentation protocol: TradAC/RC, TradAC/XP, UltraAC/RC and UltraAC/XP. All root canal procedures were performed with the teeth placed in a dental mannequin. Teeth were scanned after root canal instrumentation and filling. Unprepared canal area, dentine removed, accumulated hard tissue debris (AHTD), canal transportation, presence of voids and filling material remnants within the pulp chamber were analysed. After restorative procedures, the teeth were subjected to thermomechanical cycling and to a load capacity test. Statistical analyses were performed using two-way anova test, considering the randomized blocks design (P<0.05). The percentage of unprepared canal area was significantly lower in TradAC groups when compared to UltraAC groups (P<0.05), regardless of the instrument used. The UltraAC/XP group had significantly lower percentage of root dentine removed when compared to other groups (P<0.05). UltraAC/XP and TradAC/XP groups had significantly lower percentages of AHTD than UltraAC/RC and TradAC/RC groups (P<0.05). Regarding canal transportation, in the MB root canals, the TradAC/XP group had significantly lower values than other groups (P<0.05). In general, in ML and distal root canals, TradAC/XP and UltraAC/XP groups had significantly lower values of canal transportation when compared to other groups (P<0.05). Moreover, the UltraAC/RC had the greatest canal transportation values in MB and distal canals. The UltraAC groups had significantly greater percentages of voids and volume of remaining root filling material within the pulp chamber after cleaning procedures than TradAC groups (P<0.05). There was no difference in the load capacity amongst groups (P<0.05). The UltraAC/XP and UltraAC/RC groups had significantly greater areas of unprepared canal walls, significantly more voids and volume of root filling material remnants within the pulp chamber after canal filling. UltraAC/XP was associated with significantly less root dentine removal and significantly more AHTD whilst TradAC/XP had overall significantly less canal transportation. No differences were observed in the load capacity amongst groups.