Comparative evaluation of clinical performance, child and parental satisfaction of Bioflx, zirconia and stainless steel crowns in pediatric patients.

Background: Pediatric dental treatment is challenging in patients with early childhood caries. For clinician its difficult to manage child and provide good work at the same time. Its necessity to have the best equipments as well as materials. Nowadays, aesthetics play an important role in managing decayed teeth. Zirconia crown is better option but requires excessive preparation. As Bioflx is newly developed crown and has combined stainless steel and zirconia properties. Aim: To assess the clinical performance and child and parental satisfaction of Bioflex crowns compared to zirconia and stainless steel crowns. Methods: In this comparative study of Bioflx crowns with zirconia and stainless steel crowns, children aged three to seven years old will be selected, and 72 primary teeth requiring crowns will be randomly distributed into three groups, n = 24: Group I: Preformed stainless steel crown, control; Group II: Preformed Bioflex crown; Group III: Preformed zirconia crown. Crowns will be evaluated for recurrent caries, plaque accumulation, restoration failure, gingival status opposing tooth wear, and clinicians and parental satisfaction at zero, three, six, and 12 months. Results: Bioflx crown will have better clinical as well as parental satisfaction among zirconia and stainless steel crowns. Conclusions: The Bioflx crown can be used as an alternative economical esthetic full-coronal restoration for primary teeth. Trial registration: CTRI registration number: CTRI/2023/05/052256; Date of registration: May 03, 2023. Protocol version: Two; Date: April 22, 2023.

Time Temperature Superposition Evaluation and Modeling for Container Closure System's Seal Performance at Low Temperatures.

There has been a growing interest in the assessment of container closure systems (CCS) for cold storage and shipment. Prior publications have lacked systematic considerations for the impact of dynamic time temperature transition on sealing performance associated with the viscoelastic characteristics of rubber stoppers used in container closure systems (CCSs). This paper demonstrates that sealing performance changes inherently and is fundamentally both time- and temperature-dependent. Our research results display this critical time temperature transition impact on CCS sealing performance by applying compression stress relaxation (CSR) on a rubber stopper for experimental data collection and modeling evaluation. The experimental results agree with modeling evaluation following Maxwell-Wiechert theory and the time temperature superposition based on the Arrhenius and Williams-Landel-Ferry methods. Both testing and modeling data show good consistency, demonstrating that the sealing force inevitably changes over time together with temperature transition because of the viscoelastic nature of the rubber stoppers. Our results show that compression seal force decreases quickly as temperature decreases. The significant loss of rubber stopper sealing force at lower temperature transitions could contribute significant risk to CCI at low storage and transport temperatures. Modeling evaluation, with a powerful capability to handle actual testing data, can be employed as a predictive tool to evaluate the time- and temperature-dependent sealing force throughout the entire sealed drug product life span. The present study is only applicable before reaching the rubber glass transition temperature Tg - a critical transition phase that can not be skipped/separated from real time temperature transition, and it will further determine the CCS sealing performance while approaching cryogenic temperature. The present work provides a new, integrated methodology framework and some fresh insights to the parenteral packaging industry for practically and proactively considering, designing, setting up, controlling, and managing stopper sealing performance throughout the entire sealed drug product life span.

Failure analysis of eleven Gates Glidden drills that fractured intraorally during post space preparation. A retrieval analysis study.

The purpose of this study was to determine the failure mechanism of clinically failed Gates Glidden (GG) drills. Eleven retrieved GG drills (sizes #1 to #3) which fractured during root canal preparation were collected and the fracture location was recorded based on macroscopic observation. All fracture surfaces were investigated by a SEM. Then the fractured parts were embedded in acrylic resin and after metallographic preparation, the microstructure and elemental composition was evaluated by SEM and EDS. The Vickers hardness (HV) of all specimens was also determined. Macroscopic examination and SEM analysis showed that the drills failed near the hand piece end by torsional fatigue with fatigue cracks initiating at several locations around the circumference and propagating toward the center. Final fracture followed by a tensile overloading at the central region of cross section. Microstructural analysis, hardness measurements and EDS show that the drills are made of a martensitic stainless steel like AISI 440C. Based on the findings of this study, clinicians should expect fatigue fracture of GG drills that have small size during root canal preparation. Selection of a more fatigue resistant stainless steel alloy and enhancing the instrument design might reduce the incidence of quasi-cleavage fracture on GG drills.

Cleaning verification: Exploring the effect of the cleanliness of stainless steel surface on sample recovery.

The parameters affecting the recovery of pharmaceutical residues from the surface of stainless steel coupons for quantitative cleaning verification method development have been studied, including active pharmaceutical ingredient (API) level, spiking procedure, API/excipient ratio, analyst-to-analyst variability, inter-day variability, and cleaning procedure of the coupons. The lack of a well-defined procedure that consistently cleaned coupon surface was identified as the major contributor to low and variable recoveries. Assessment of acid, base, and oxidant washes, as well as the order of treatment, showed that a base-water-acid-water-oxidizer-water wash procedure resulted in consistent, accurate spiked recovery (>90%) and reproducible results (Srel≤4%). By applying this cleaning procedure to the previously used coupons that failed the cleaning acceptance criteria, multiple analysts were able to obtain consistent recoveries from day-to-day for different APIs, and API/excipient ratios at various spike levels. We successfully applied our approach for cleaning verification of small molecules (MW<1000Da) as well as large biomolecules (MW up to 50,000Da). Method robustness was greatly influenced by the sample preparation procedure, especially for analyses using total organic carbon (TOC) determination.

A Proposed Methodology to Assess the Accuracy of 3D Scanners and Casts and Monitor Tooth Wear Progression in Patients.

PURPOSE: The aim of this study was to detail and assess the capability of a novel methodology to 3D-quantify tooth wear progression in a patient over a period of 12 months. MATERIALS AND METHODS: A calibrated stainless steel model was used to identify the accuracy of the scanning system by assessing the accuracy and precision of the contact scanner and the dimensional accuracy and stability of casts fabricated from three different types of impression materials. Thereafter, the overall accuracy of the 3D scanning system (scanner and casts) was ascertained. Clinically, polyether impressions were made of the patient's dentition at the initial examination and at the 12-month review, then poured in type IV dental stone to assess the tooth wear. The anterior teeth on the resultant casts were scanned, and images were analyzed using 3D matching software to detect dimensional variations between the patient's impressions. RESULTS: The accuracy of the 3D scanning system was established to be 33 µm. 3D clinical analysis demonstrated localized wear on the incisal and palatal surfaces of the patient's maxillary central incisors. The identified wear extended to a depth of 500 µm with a distribution of 4% to 7% of affected tooth surfaces. CONCLUSION: The newly developed 3D scanning methodology was found to be capable of assessing and accounting for the various factors affecting tooth wear scanning. Initial clinical evaluation of the methodology demonstrates successful monitoring of tooth wear progression. However, further clinical assessment is needed.

Laboratory investigation of the microbiologically influenced corrosion (MIC) resistance of a novel Cu-bearing 2205 duplex stainless steel in the presence of an aerobic marine Pseudomonas aeruginosa biofilm.

The microbiologically influenced corrosion (MIC) resistance of a novel Cu-bearing 2205 duplex stainless steel (2205 Cu-DSS) against an aerobic marine Pseudomonas aeruginosa biofilm was investigated. The electrochemical test results showed that Rp increased and icorr decreased sharply after long-term immersion in the inoculation medium, suggesting that 2205 Cu-DSS possessed excellent MIC resistance to the P. aeruginosa biofilm. Fluorescence microscope images showed that 2205 Cu-DSS possessed a strong antibacterial ability, and its antibacterial efficiency after one and seven days was 7.75% and 96.92%, respectively. The pit morphology comparison after 14 days between 2205 DSS and 2205 Cu-DSS demonstrated that the latter showed a considerably reduced maximum MIC pit depth compared with the former (1.44 µm vs 9.50 µm). The experimental results suggest that inhibition of the biofilm was caused by the copper ions released from the 2205 Cu-DSS, leading to its effective mitigation of MIC by P. aeruginosa.

Evolution of microstructure and residual stress under various vibration modes in 304 stainless steel welds.

Simultaneous vibration welding of 304 stainless steel was carried out with an eccentric circulating vibrator and a magnetic telescopic vibrator at subresonant (362 Hz and 59.3 Hz) and resonant (376 Hz and 60.9 Hz) frequencies. The experimental results indicate that the temperature gradient can be increased, accelerating nucleation and causing grain refinement during this process. During simultaneous vibration welding primary δ -ferrite can be refined and the morphologies of retained δ-ferrite become discontinuous so that δ-ferrite contents decrease. The smallest content of δ-ferrite (5.5%) occurred using the eccentric circulating vibrator. The diffraction intensities decreased and the FWHM widened with both vibration and no vibration. A residual stress can obviously be increased, producing an excellent effect on stress relief at a resonant frequency. The stress relief effect with an eccentric circulating vibrator was better than that obtained using a magnetic telescopic vibrator.

Examination of surface conditions and other physical properties of commonly used stainless steel acupuncture needles.

OBJECTIVES: The present work examined the surface conditions and various other physical properties of sterilised single-use stainless steel acupuncture needles from two of the most popular brands widely used in many countries. METHODS: Scanning electron microscope (SEM) images were taken for 10 randomly chosen needles from each brand. Further SEM images were taken after each of these needles underwent a standard manipulation with an acupuncture needling practice gel. A comparison of forces and torques during the needling process was also carried out. RESULTS: The SEM images revealed significant surface irregularities and inconsistencies at the needle tips, especially for needles from one of the two brands. Metallic lumps and small, loosely attached pieces of material were observed on the surfaces of some needles. Some of the lumps and pieces of material seen on the needle surfaces disappeared after the acupuncture manipulation. If these needles had been used on patients, the metallic lumps and small pieces of material could have been deposited in human tissues, which could have caused adverse events such as dermatitis. Malformed needle tips might also cause other adverse effects including bleeding, haematoma/bruising, or strong pain during needling. An off-centre needle tip could result in the needle altering its direction during insertion and consequently failing to reach the intended acupuncture point or damaging adjacent tissues. CONCLUSIONS: These findings highlight the need for improved quality control of acupuncture needles, with a view to further enhancing the safety and comfort of acupuncture users.

Structural analysis and corrosion studies on an ISO 5832-9 biomedical alloy with TiO2 sol-gel layers.

The aim of this study was to demonstrate the relationship between the structural and corrosion properties of an ISO 5832-9 biomedical alloy modified with titanium dioxide (TiO2) layers. These layers were obtained via the sol-gel method by acid-catalyzed hydrolysis of titanium isopropoxide in isopropanol solution. To obtain TiO2 layers with different structural properties, the coated samples were annealed at temperatures of 200, 300, 400, 450, 500, 600 and 800 °C for 2 h. For all the prepared samples, accelerated corrosion measurements were performed in Tyrode's physiological solution using electrochemical methods. The most important corrosion parameters were determined: corrosion potential, polarization resistance, corrosion rate, breakdown and repassivation potentials. Corrosion damage was analyzed using scanning electron microscopy. Structural analysis was carried out for selected TiO2 coatings annealed at 200, 400, 600 and 800 °C. In addition, the morphology, chemical composition, crystallinity, thickness and density of the deposited TiO2 layers were determined using suitable electron and X-ray measurement methods. It was shown that the structure and character of interactions between substrate and deposited TiO2 layers depended on annealing temperature. All the obtained TiO2 coatings exhibit anticorrosion properties, but these properties are related to the crystalline structure and character of substrate-layer interaction. From the point of view of corrosion, the best TiO2 sol-gel coatings for stainless steel intended for biomedical applications seem to be those obtained at 400 °C.

Growth guidance system for early-onset scoliosis: comparison of experimental and retrieval wear.

STUDY DESIGN: Laboratory study conducted using an in vitro wear simulator with a growth guidance system. Analysis of variance performed to compare in vitro specimens (n = 6) with in vivo retrieval components (n = 5). OBJECTIVE: To characterize the stainless steel, wear debris potential of a spinal growth guidance system by developing an in vitro model and validating tested implants with retrospectively obtained retrievals. SUMMARY OF BACKGROUND DATA: Growth enabling, surgical treatments have been developed to provide fusionless options for patients with early-onset scoliosis. There exist few data regarding the wear debris associated with such spinal systems. METHODS: In this study, we determined in vitro wear from the stainless steel components of the SHILLA™ Growth Guidance System. An analogue lumbar spine model was adapted from ISO 12189:2008 to assess the growth guidance system. In a multistation wear simulator, 6 assembled constructs were tested under displacement control for 5 million cycles (Mc) with diluted bovine serum, and the wear was measured gravimetrically at end of the test. The components were compared quantitatively for wear scar depth with retrieved growth guidance implants (n = 5), and qualitatively for wear, corrosion, and other surface damage. RESULTS: The average total wear rate over 5 Mc was 0.39 ± 0.13 mm/Mc (3.12 ± 1.01 mg/Mc) with an average particle size of 1.3 µm in equivalent circular diameter. Prominent wear scars were noticed on both the tested and retrieved specimens with no statistical difference in the wear scar depths of the tested and retrieved components when set and multiaxial screws when compared collectively. CONCLUSION: An in vitro wear analysis for a spinal growth guidance system was conducted using a novel protocol and validated against retrieved implants. This is the first study establishing a baseline value for the wear of "growth enabling" devices for the treatment of early-onset scoliosis.

Would CoCr rods provide better correctional forces than stainless steel or titanium for rigid scoliosis curves?

STUDY DESIGN: Comparative in vitro, biomechanical study. OBJECTIVE: Compare the effect of rod curvature and material properties on rod flattening and correctional forces. SUMMARY OF BACKGROUND DATA: Traditional methods of correction for large progressive deformities involve 3-dimensional correction, performed with an attempt to reach a balanced correction in all planes, spinal instrumentation, and fusion. Increasing attention to the transverse plane correction has developed after the introduction of segmental pedicle screws into the treatment of idiopathic scoliosis. Approximation of the spine (pedicle screws or hooks) to the rods remains the heart of many deformity procedures. Therefore, it is crucial that the instrumentation used provide and maintain the initial correction of the spinal deformity while minimizing potential intraoperative failures. METHODS: Two experiments were performed using 80 rods made from 4 different materials namely: stainless steel (SS), titanium (Ti), cobalt chromium (CoCr), and ultrahigh strength stainless steel (UHSS). Half of the rods were contoured to 20 degrees, whereas the reaming contoured to 30 degrees. Half of the rods were approximated to a synthetic spine models to measure the flattening of the rods when approximated to highly rigid spine. The other half was used to measure the correctional forces produced by each rod type and curvature. RESULTS: For the 20-degree pre-bend rods, Ti was the best in maintaining its original shape followed by UHSS, SS, and CoCr of 90%, 77%, 62.5%, and 54.4%, respectively. The 30-degree pre-bend showed exactly a similar trend with 80.7% for Ti, 71% for UHSS, 54.6% for SS, and 48.1% for the CoCr rods. For 30-degree pre-bend CoCr and UHSS rods, the intraoperative reduction forces were almost 42% and 10% higher than the Ti and SS rods, respectively. The correctional force produced by the Ti 30-degree pre-bend rod was approximately 67% that of a CoCr and UHSS rods. CONCLUSIONS: CoCr and UHSS rods have the ability to produce the highest correction forces, however, both can plastically deform in a very rigid curves. Therefore, it is critical to have sense of the quality of the bone fixation as well as the curve flexibility when selecting for appropriate rod size material and contouring the rod to the desired shape.

Bending characteristics of polymethylmethacrylate columns, connecting bars of carbon fiber, titanium, and stainless steel used in external skeletal fixation and an acrylic interface.

OBJECTIVE: To (1) mechanically evaluate polymethylmethacrylate (PMMA) columns of various sizes and compare them to connecting bar materials (carbon fiber composite, titanium, stainless steel) and (2) compare the properties of an intact PMMA column to those of an acrylic interface. STUDY DESIGN: Experimental mechanical study. SAMPLE POPULATION: Experiment 1: 6 groups of 6 specimens each; experiment 2: 2 groups of 12 specimens each. METHODS: All specimens were tested in 3-point bending. Stiffness, yield strength, and ultimate strength values were calculated for each specimen. RESULTS: PMMA 1 columns (23.25 mm) compared favorably to titanium or stainless-steel bars. PMMA 3 columns (30.15 mm) and carbon fiber bars had similar yield strength but PMMA 3 columns were less stiff than carbon fiber bars. PMMA 3 columns had lower bending modulus and a higher variability in their mechanical properties than PMMA 1 or PMMA 2 (25.64 mm) columns. Acrylic interface specimens were less strong but as stiff as intact specimens. CONCLUSION: An acrylic interface was easily created and had acceptable biomechanical characteristics. CLINICAL RELEVANCE: PMMA 2 and PMMA 3 columns are not recommended for clinical use at this time. Further tests are needed to analyze an acrylic patch in a more clinically relevant loading model.

A novel tongue implant for tongue advancement for obstructive sleep apnea: feasibility, safety and histology in a canine model.

Obstructive sleep apnea (OSA) is a sleep related breathing disorder caused by partial or complete collapse of the upper airway during sleep. The disease is linked with important cardiovascular and cerebrovascular morbidity and mortality. Tongue base collapse is a major cause of upper airway occlusion in OSA and present surgical procedures to prevent this are invasive and inefficient. A novel implantable system to stabilize the tongue was evaluated in a canine model for feasibility, safety and histology. Successful implantation of the Advance System was performed in 21 canines and follow-up evaluations were performed at 30, 60, 90, 120 and 150 days. No technical or clinical adverse events were seen during the procedure. Minor clinical adverse events at some of the follow-up evaluations were treated successfully. Histologic evaluation of the implant was performed at different time points during follow-up and showed good biocompatibility, stability and osteointegration. The outcome of this study resulted in an implant for adjustable tongue advancement in humans with OSA.

Tissue reaction to implants of different metals: a study using guide wires in cannulated screws.

Cannulated screws, along with guide wires, are typically used for surgical fracture treatment in cancellous bone. Breakage or bending deformation of the guide wire is a clinical concern. Mechanically superior guide wires made of Co-Cr alloys such as MP35N and L605 may reduce the occurrence of mechanical failures when used in combination with conventional (316L stainless steel) cannulated screws. However the possibility of galvanic or crevice corrosion and adverse tissue reaction, exists when using dissimilar materials, particularly in the event that a guide wire breaks, and remains in situ. Therefore, we designed an experiment to determine the tissue reaction to such an in vivo environment. Implant devices were designed to replicate a clinical situation where dissimilar metals can form a galvanic couple. Histological and SEM analyses were used to evaluate tissue response and corrosion of the implants. In this experiment, no adverse in vivo effects were detected from the use of dissimilar materials in a model of a broken guide wire in a cannulated screw.

An in vivo evaluation of surface polishing of TAN intermedullary nails for ease of removal.

Fractures of the tibia and femoral diaphysis are commonly repaired by intra-medullary (IM) nailing. Currently IM nails are available in either electropolished stainless steel (SS) or in Titanium-Aluminium-Niobium (TAN). After healing, removal of the nails still is common but removal of TAN IM nails often has complications whereas SS IM nails of the same design are less often associated with problems. We believe the differences in removal are due to the ability of TAN to promote strong bone on-growth. We have previously shown in vivo that polishing cortical screws reduces removal torque and the percentage of bone-implant contact. Therefore, we postulate that bony on-growth onto IM nails can be reduced by means of surface polishing, for ease of removal. Here we aim to compare the pull-out forces for removal of standard TAN (TAN-S) compared to experimental paste polished TAN (TAN-PP) IM nails from a bilateral non-fracture sheep tibia model after 12 months implantation. Histological analysis was also performed to assess tissue on-growth to the nails. We show that polishing significantly reduces (p=0.05) the extraction force required for TAN IM nail removal. This effect in part is attributable to the distinct tissue-material reaction produced. For TAN-S nails direct bone contact was observed while for TAN-PP nails a fibrous tissue interface was noted. Since TAN is preferred over SS for IM nailing due to superior biocompatibility and mechanical properties, we believe these findings could be used to recommend changes to current surface technologies of intramedullary nails to reduce complications seen with nail removal especially in rapidly growing bone in children.

Physico-chemical and hygienic property modifications of stainless steel surfaces induced by conditioning with food and detergent.

The effect of repeated conditioning procedures (25 runs), consisting of soiling (milk and meat products) and cleaning steps, on the hygienic status, physico-chemical properties and surface chemical composition of stainless steel (SS) surfaces, was investigated. Five SSs differing in grade and finish were used. Both soiling and surface cleaning/conditioning procedures resulted in a similar increase in the surface contamination with carbon, while the changes in the basic component of the surface free energy depended on the conditioning procedure. The passive film was also affected, the Fe/Cr ratio in particular. The hygienic status was also changed, especially with milk as shown by monitoring the number of residual adhering Bacillus cereus spores after contaminating the surface with spores followed by cleaning. The results show that in food environments, the presence and the nature of conditioning molecules play a major role in the hygienic status of SS surfaces.

Forces in stainless steel, TiMolium and TMA intrusion arches, with different bending magnitudes.

The present study compared forces in stainless steel, TiMolium and TMA, V-bend intrusion arches with different magnitudes of flexion. The sample consisted of rectangular-section wires, caliber .017" x .025", with ten arches of each alloy. All V-bends were made 48 mm from the midline, using the same phantom upper jaw, maintaining the same distance between the tubes fixed to the molars and the midline. Loads necessary to deflect the arches by 5, 10, 15 and 20 mm were measured by means of an Instron dynamometer with a 1 kgf load cell. Calculations for sample size confirmed the suitability of using 10 arches of each alloy. Variance tests (ANOVA) of one factor and three levels, complemented by the Tukey test for multiple comparisons, identified that TMA(R) intrusion arches required a smaller quantity of load in relation to conventional steel and TiMolium at all levels of flexion. Furthermore, TiMolium presented intermediary characteristics between steel and TMA, and in all alloys increase in distance entailed a significant increase in force between all registered values, and that the increase in load necessary to deflect the arches at the intervals tended to decrease from first to last interval, these differences being more significant in steel, less in TiMolium and practically non-existent in TMA.

Properties of bacterial corrosion of stainless steel and its inhibition by protamine coating.

We investigated characteristics of the corrosion of stainless steel specimens by bacteria and the effects of using antimicrobial coating on the surface for inhibiting corrosion. Bacillus sp. 2-A and Staphylococcus sp. 2-1 cells adhered tightly to a stainless steel SUS304 specimen, formed a microcolony or biofilm, and had highly corrosive activities. Microbially influenced corrosion (MC) was observed under or around adhering cells. However, dead cells were markedly less active than viable cells not only in corroding the specimen but also in adhering to its surface. The culture supernatant was not able to induce the corrosion of SUS304 effectively. A protamine coating on the specimen killed bacterial cells only on its surface, interfered with cell adhesion, and inhibited MC. From these results, adhesion of viable cells to the surface of a SUS304 specimen led to the outbreak of MC. Protamine was also found to be an effective substance tested for protecting the specimen from both cell adhesion and surface MC. We suggest that a protamine coating can be applied as a convenient and inexpensive corrosion prevention method.

Titanium versus stainless steel for anterior spinal fusions: an analysis of rod stress as a predictor of rod breakage during physiologic loading in a bovine model.

STUDY DESIGN: In vitro biomechanical evaluation of rod stress during physiologic loading of anterior scoliosis instrumentation. OBJECTIVES: To determine effects of material properties and rod diameter on rod stresses in anterior scoliosis instrumentation. SUMMARY OF BACKGROUND DATA: Relationships between instrumentation dimensions, materials, and potential rod failure in anterior scoliosis instrumentation remain unclear. METHODS: Eighteen immature bovine spines were randomized to 3 groups: 1) 4.0-mm stainless steel, 2) 5.0-mm stainless steel, and 3) 4.75-mm titanium alloy. Spines underwent physiologic tests in flexion-extension, lateral bending, and torsion. Rod surface strains were converted to rod stress and normalized to each material's yield stress. Construct stiffness and the normalized rod stresses were compared with a one-way ANOVA (P < 0.05). RESULTS: The 4.0-mm steel and 4.75-mm titanium construct stiffness was similar across all tests. The 5.0-mm steel system was significantly stiffer than 4.0-mm steel (lateral bending/torsion) and 4.75-mm titanium (torsion/flexion) constructs. Rod surface stress was significantly lower for the 4.75-mm titanium rod compared with 4.0-mm and 5.0-mm steel rods for all tests. CONCLUSIONS: The percentage of yield stress was lowest for the 4.75-mm Ti rod for all tests due to titanium's greater yield stress. This suggests the 4.75-mm rod has a lower fatigue failure risk than either steel construct.