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Wear testing of materials and surfaces for total knee replacement.

A simple wear test was investigated for evaluating the wear and damage of material pairs when used in total knee replacement. The test consisted of an axially loaded metallic femoral indentor and a reciprocating ultrahigh molecular weight polyethylene (UHMWPE) flat disk that represented the tibial component. A number of variables were studied including the effect of conformity by varying the radii of the femoral surface, distilled water or serum as a lubricant, different femoral materials, and different types of UHMWPE. In general, the different morphologies of the surface wear of the UHMWPE were similar to those seen on retrieved total knee replacements. Increased conformity with a cylindrical indentor gave a reduced wear rate initially, compared with that of the lower conformity spherical indentor. However, the wear rates were similar subsequent to this initial wearing in phase. Transfer films of UHMWPE were observed on the cobalt-chrome indentors for both serum and distilled water lubrication, although this film was more extensive for distilled water. The lowest wear rate was observed when oxidized zirconium was used on the femoral side, which was attributed to greater wettability, surface hardness, and immunity to oxidative wear. Tests using cobalt-chrome femoral cylinders and different grades of UHMWPE showed different wear rates. Of these PEs, GUR 415 showed less wear than both RCH 1000 and UHMWPE containing numerous fusion defects. For the latter, wear was attributed to a fatigue mechanism, although in most cases it was associated with surface phenomena rather than subsurface cracking. However, in some specimens of UHMWPE subsurface crack propagations occurred with defects. The test method is discussed in relation to its applicability to the evaluation and comparison of bearing materials and surfaces, with particular application to total knee replacements.

Alloys↗

Estimation of relative bioavailability of lead in soil and soil-like materials using young Swine.

In this article we summarize the results of a series of studies that measured the relative bioavailability (RBA) of lead in a variety of soil and soil-like test materials. Reference material (Pb acetate) or Pb-contaminated soils were administered orally to juvenile swine twice a day for 15 days. Blood samples were collected from each animal at multiple times during the course of the study, and samples of liver, kidney, and bone were collected at sacrifice. All samples were analyzed for Pb. We estimated the RBA of a test material by fitting mathematical models to the dose-response curves for each measurement end point and finding the ratio of doses that gave equal responses. The final RBA for a test material is the simple average of the four end point-specific RBA values. Results from 19 different test materials reveal a wide range of RBA values across different exposure materials, ranging from 6 to 105%. This variability in RBA between different samples highlights the importance of reliable RBA data to help improve risk assessments for Pb in soil. Although the RBA value for a sample depends on the relative amounts of the different chemical and physical forms of Pb present, data are not yet adequate to allow reliable quantitative predictions of RBA from chemical speciation data alone.

Algorithms↗

Fluoride release and cariostatic ability of a compomer and a resin-modified glass ionomer cement used for orthodontic bonding.

OBJECTIVES: The aims of this study were to compare the local and systemic uptake of fluoride released from a compomer material (Dyract Ortho) and a resin-modified glass ionomer cement (Vitremer) with that of a conventional resin adhesive (Right-On) and to compare the cariostatic ability of each of the test materials with that of the resin control. METHODS: Twenty six patients were randomly allocated to have a bracket bonded to a premolar on one side of the arch with one of the test materials and on the opposite side with the control material. Premolars destined for extraction as part of an orthodontic treatment plan were selected for bonding. A non-fluoride toothpaste was used by all participants for 4 weeks prior to bracket bonding and throughout the 4 week trial period. Fluoride release was measured in saliva, plaque and urine samples taken pre-bonding and 4 weeks post-bonding. Enamel demineralisation was assessed by scoring the buccal surface of each extracted tooth using a caries index. RESULTS: Neither Vitremer nor Dyract Ortho altered salivary or urinary fluoride concentration significantly 4 weeks post-bonding but plaque fluoride concentration increased significantly around premolars bonded with Vitremer. The test materials as a combined group were associated with significantly less demineralisation than the control material but there was no significant difference in cariostatic ability detected between either Dyract Ortho or Vitremer when each group was compared separately with the control. CONCLUSIONS: Fluoride released from Dyract Ortho or Vitremer is likely to exert a local and not a systemic effect. In a 4-week clinical study, the cariostatic ability of the fluoride-releasing cements, as a combined group, was superior to that of the non-fluoride releasing control but there was no significant difference in cariostatic ability between the two test materials when each test group was compared separately with the control.

Adolescent↗

[Metronidazole resistance test in vitro in strains of Trichomonas vaginalis isolated from clinical material. 1. Test conditions].

Metronidazole-resistant clinical isolates of Trichomonas vaginalis display an aerobic type of resistance detectable in vitro only if some oxygen is present. Consequently, adjustment of the optimal concentration of O2 in assay system is of critical importance for dependable determination of minimal lethal concentration (MLC) of the drug. The authors demonstrated that decrease of oxygen content in assay media (from 191.2 nM to 49.5 nM O2.ml-1) resulted in increased susceptibility of the drug-resistant strain IR-78 to metronidazole (from MLC 100 micrograms.ml-1 to MLC 25 micrograms.ml-1). Different MLCs were obtained in media of different reducing capacity. Oxygen dependent variations in MLC were also observed in assay systems containing different volumes of medium. The authors discuss effect of these and other variables in methodology of susceptibility assays in order to define conditions of standard procedure.

Animals↗

Optimization of an exogenous metabolic activation system for FETAX. I. Post-isolation rat liver microsome mixtures.

The developmental toxicity of cyclophosphamide, coumarin, 2-acetyl-aminofluorine (2-AAF), and trichloroethylene (TCE) was assessed with Frog Embryo Teratogenesis Assay: Xenopus (FETAX). Late Xenopus laevis blastulae were exposed to each test material for 96-h in two separate static-renewal tests with and without the presence of five differently induced exogenous metabolic activation systems (MAS). The MAS consisted of Aroclor 1254- (Aroclor 1254 MAS), isoniazid- (INH MAS), phenobarbital- (PB MAS), or beta-naphthoflavone- (beta-NF MAS), or a post-isolation mixture (mixed MAS) of INH-, PB-, and beta-NF-induced rat liver microsomes. Addition of the Aroclor 1254 MAS bioactivated cyclophosphamide, coumarin, 2-AAF, but not TCE. Addition of the PB MAS bioactivated cyclophosphamide, weakly bioactivated coumarin and 2-AAF, but had no effect on TCE developmental toxicity. The beta-NF MAS bioactivated coumarin and 2-AAF, weakly bioactivated cyclophosphamide, but did not alter the developmental toxicity of TCE. Addition of the INH-induced MAS only bioactivated TCE, whereas the post-isolation mixed MAS bioactivated each test material. Based on LC50 and EC50 (malformation) values, embryo growth, and types and severity of induced malformations, each test material was developmentally toxic. Use of post-microsome isolation mixtures from differentially induced rat livers increased the efficacy of the exogenous MAS routinely used by FETAX.

2-Acetylaminofluorene↗

Betel quid chewing and oral cancer: experimental studies on hamsters.

Betel quid ingredients--betel nut, betel leaf, lime, catechu and tobacco--were tested separately and in various combinations for carcinogenicity, using hamster cheek pouch as the experimental site. The four modes of administration used were (1) tri-weekly painting of the cheek pouch with aqueous extracts of test materials, (2) deposition of replaceable wax pellets containing the test material, (3) gelatin capsules containing the powdered material and (4) insertion of natural material into the pouch for trauma and direct exposure. Untreated controls and standard carcinogen DMBA-treated controls were also maintained. A total of 317 young adult golden Syrian hamsters (Mesocricetus auratus) used for the experiments were killed in two age groups: 6-12 months and 13-24 months, only when signs of general debility were observed. In the untreated controls, animals were free of any malignancy. In the experimental series, various betel quid ingredient combinations under test induced both oral and gastric lesions ranging from massive atypia and precancerous lesions to frank carcinomas. Maximum lesions were observed in the groups receiving betel nut, lime and tobacco combinations and in the polyphenol fraction of betel nut containing major tannins. The mode of administration of test material resulted in distinct differences; tri-weekly paintings giving oral lesions in the range of 22-23% and gastric lesions 39-48%; the same material given either through the replaceable gelatin capsule or in natural form induced 69% oral lesions and 63 to 82% gastric lesions. Overall evaluation of the data of all the four series confirms the potent carcinogenicity of betel nut, particularly its tannin-containing polyphenolic fraction and its combination with lime and tobacco. Maximum oral lesions induced in the hamsters by continuous exposure to capsules and natural material, highlight the direct relationship of frequency of chewing in habitual chewers with oral carcinogenesis. The high incidence of gastric (forestomach) lesions invites special attention.

Animals↗

Development of pituitary lesions in ND4 Swiss Webster mice when estimating the sensory irritancy of airborne chemicals using ASTM method E981-84.

This study determined the origin of pituitary lesions found in male ND4 Swiss Webster mice following a single head-only exposure to inhaled test materials using ASTM E981-84, standard test method for estimating sensory irritancy of airborne chemicals. Necropsy and histopathology data were evaluated due to the occurrence of unexpected pituitary lesions in sham control and exposure groups. Groups of four mice were restrained in body plethysmographs and exposed for 30 min to increasing dust concentrations of one of three test chemicals to assess the ability to cause sensory irritation. Sham control and test material-exposed mice were sacrificed after a single exposure and subjected to a complete necropsy and microscopic evaluation of the pituitary gland. Control mice remained in the animal room and were not restrained in the plethysmograph. Gross observation at necropsy showed pituitary lesions in one of seven unrestrained control mice (revised to zero of seven after microscopic examination). Seven of seven sham control mice had pituitary lesions, suggesting that the lesions were not related to test material exposure. Each test material-exposed group also had pituitary lesions with high incidence (52/60 for all groups combined), which was not exposure concentration-dependent. Microscopic evaluation of the pituitary glands revealed that darkening of the gland was due to hemorrhage and confirmed that the lesions developed with 100% incidence (19/19) in plethysmograph-housed animals. The rubber neck seal used to restrict animal movement in the plethysmograph appears to have caused an increase in pressure in the blood vessels in the pituitary gland; vessels then ruptured and hemorrhaged. This finding should not adversely affect sensory irritation responses evaluated with this method.

Aerosols↗

Toward efficient sludge processing using novel rheological parameters: dynamic rheological testing.

Materials known as complex fluids exhibit a transitional behaviour between their solid and liquid states. Sludges produced at different treatment stages of wastewater treatment are examples of these materials, since they exhibit solid behaviour within shorter time frames and liquid behaviour over longer durations. These sludges can also change from solid-like to liquid-like, or vice versa, when subjected to even a slight deformation; this stems from their complex makeup, which includes both particulate materials and polymeric gels, including both biopolymers and the synthetic polymers used in conditioning them. This paper focuses on two means of quantifying dynamic rheological test results: (1) the linear viscoelastic behaviour (LVE) of sludge samples, as measured by the strain sweep analysis storage (G') and loss moduli (G"); and (2) the flow curve, which presents the relationship between the shear viscosity and shear rate and determines the yield stress values of samples using the strain sweep test mode. With these methods, sludges can be more accurately characterised, allowing better prediction of their behaviour in treatment and transport processes.

Elasticity↗

Categorical evaluation of the ocular irritancy of cosmetic and consumer products by human ocular instillation procedures.

The assessment of ocular irritation potential is an important part of safety testing for cosmetic and consumer products. The purpose of this investigation was to examine ocular irritancy levels elicited in humans by various categories of a specific class of cosmetic and consumer products that have a potential to enter the eye inadvertently during use. Test materials assessed belonged to one of seven categories, which included liquid makeup, shampoo, baby wash, mascara, eye makeup remover, powder eye shadow, and facial cleanser. These test materials were evaluated by human ocular instillation, followed by examinations, for which subjective perceptions of irritation were recorded, and component areas of ocular tissues were individually examined for inflammation and for the area and density of fluorescein staining patterns at 30 seconds and at 5, 15, 60, and 120 minutes post-instillation. Subjective and objective ocular irritation scores of 410 eyes were analyzed by product classification. Average score levels were determined for subjective responses, inflammation, and fluorescein staining patterns. This investigation determined that irritation levels of the evaluated test materials varied markedly with respect to product category, type of ocular irritation, and ocular tissue, demonstrating that these factors are important considerations for the prediction of the ocular irritancy of a test material.

Adult↗

Black Thematic Apperception Test stimulus material.

A factorial design was used to test variations of the TAT based on racial characteristics. The subjects consisted of 135 black Southern males divided into three test groups of 45 subjects each. The M-TAT, T-TAT, or an experimental version of the TAT for blacks was group administered to each test group of 45 subjects. Each of the three test groups were further divided into three age groups of 15 subjects each designated as residents, college students or high school students. Subjects' responses to the racial characteristics and needs content across tests and age groups were examined. The data revealed: (a) subjects could distinguish the racial characteristics of black and white TAT material, (b) subjects indicated that black TAT material facilitated the writing of their stories, (c) subjects viewed the black TAT characters as more like "people in general," (d) both figure and background stimuli are important to subjects, and (e) content differences on need for achievement was found between age groups.

Adolescent↗

Canine bone response to tyrosine-derived polycarbonates and poly(L-lactic acid).

Tyrosine-derived polycarbonates are a new class of degradable polymers developed for orthopedic applications. In this study the long-term (48 week) in vivo degradation kinetics and host bone response to poly(DTE carbonate) and poly(DTH carbonate) were investigated using a canine bone chamber model. Poly(L-lactic acid) (PLA) served as a control material. Two chambers of each test material were retrieved at 6-, 12-, 24-, and 48-week time points. Tyrosine-derived polycarbonates were found to exhibit degradation kinetics comparable to PLA. Each test material lost approximately 50% of its initial molecular weight (Mw) over the 48-week test period. Poly(DTE carbonate) and poly(DTH carbonate) test chambers were characterized by sustained bone ingrowth throughout the 48 weeks. In contrast, bone ingrowth into the PLA chambers peaked at 24 weeks and dropped by half at the 48-week time point. A fibrous tissue layer was found surrounding the PLA implants at all time points. This fibrous tissue layer was notably absent at the interface between bone and the tyrosine-derived polycarbonates. Histologic sections revealed intimate contact between bone and tyrosine-derived polycarbonates. From a degradation-biocompatibility perspective, the tyrosine-derived polycarbonates appear to be comparable, if not superior, to PLA in this canine bone chamber model.

Animals↗

The validity and relevance of tests used for the assessment of sports surfaces.

Inappropriate cushioning and/or tractional characteristics of sports surfaces are assumed to increase surface-related injuries in various sports activities. Various tests assessing cushioning and frictional properties are currently in use to evaluate sports surfaces with respect to their potential to reduce the number of surface-related injuries. A critical review of the currently used test procedures showed that most of them are not relevant. The main shortcomings are 1) errors in the measured test results by not correcting for inertia terms due to moving test foot or surface sample, 2) use of inadequate material test procedures where the test procedure influences significantly the test result, and 3) use of material test procedures where the used materials or the applied forces are not representative of the actual situation during sport activities. It is suggested that appropriate test batteries should include 1) test procedures that determine the material properties (stress-strain relation and traction coefficients) relevant for the surface-shoe interaction and 2) subject tests that describe the adaptation of the athlete to the surface-shoe-athlete situation.

Athletic Injuries↗

Biocompatibility of new, clinically used, and recycled orthodontic samarium-cobalt magnets.

The aim of this study was to compare the cytotoxic effect of new, clinically used, and recycled samarium-cobalt magnets (SmCO5). Cytotoxicity was assessed by two in vitro methods, the millipore filter method and an extraction method. In the filter method, the test material and the target cells are separated by a thin, permeable membrane. The test assesses the cytotoxicity of both water soluble and nonwater soluble components of the test material. The extraction test, which has a higher sensitivity, assesses the cytotoxicity of water soluble components only. According to the filter method, one magnet (new) showed a mild cytotoxic effect; all other tested magnets showed no cytotoxicity. Judged by the extraction test, new as well as clinically used magnets demonstrated a weak cytotoxic effect, suggesting the presence of a small amount of leachable cytotoxic components. The level of exerted cytotoxicity of such components was significantly lower for clinically used than for new magnets. When recycled magnets were tested, the cytotoxicity had significantly decreased, (p < 0.001), and the cytotoxicity could be considered negligible. The results thus revealed that SmCO5 magnets can be recycled with maintained good biocompatibility. Because a small amount of water soluble cytotoxic agents seem to leach out from new partially stainless steel-coated samarium-cobalt magnets, it is recommended that they be stored in water for 24 hours before clinical use, thereby conceivably decreasing the oral exposure of water soluble cytotoxic agents.

Animals↗

Efficacy of calcium sulfate plus decompression bone in lumbar and lumbosacral spinal fusion: preliminary results in 40 patients.

OBJECTIVE: To compare the efficacy of calcium sulfate pellets plus bone obtained from decompression with fresh autologous iliac crest bone in lumbar and lumbosacral spinal fusion with decompression. DESIGN: A prospective randomized clinical trial. SETTING: Four tertiary care centres in Halifax, NS. PATIENTS: All were consenting, skeletally mature and suffering from degenerative disc disease or spondylolisthesis. The first 40 patients from a single test centre are reported; 32 of these had completed 1-year follow-up. INTERVENTIONS: Posterolateral lumbar or lumbosacral spinal fusion with spinal canal decompression and randomized placement of test material (decompression bone plus an equal volume of calcium sulfate pellets) on one side and control material (autologous posterior iliac crest bone of equal volume to the test material) on the contralateral side, which allowed subjects to act as their own control. OUTCOME MEASURES: Assessment of bone formation by radiographic evaluation at 6 and 12 months after fusion by an independent musculoskeletal radiologist blinded to the placement of test material. RESULTS: At 6 and 12 months after fusion, 78% and 88% of patients, respectively, showed bone formation at the test site that was 75% to 100% of, equal to or more than that at the control site. Increases in bone formation at 6 and 12 months were almost identical at both sites. Smoking status, patient gender or age, instrumentation used and volume of graft used were not predictive of outcome. CONCLUSIONS: Calcium sulfate pellets plus decompression bone provided bone formation equivalent to autologous iliac crest bone in a majority of patients. Calcium sulfate pellets plus decompression bone may provide a viable alternative to autologous iliac crest as a graft material for spinal fusion.

Adult↗

Are circular external fixators weakened by the use of hemispheric washers?

OBJECTIVES: To compare the axial mechanical stability of 3 circular external fixators systems with and without hemispheric washers. STUDY DESIGN: Experimental study. METHODS: The axial stiffness and load necessary to produce 0.5 and 1 mm of displacement of 10 circular external fixator constructs from 3 manufacturers were tested on a materials testing machine. The constructs tested included the Small Bone fixator (SBF; Hofmann S.a.S., Monza, Italy), the IMEX ring fixator (IMEX Inc., Longview, TX), and the Multiplanar C-Fix (MCF; PanVet Distribuzione, Seriate, Italy). Five configurations were tested for each construct: (1) conventional nut fixation, (2) hemispheric washer fixation with connecting rods offset by 0, (3) 1, and (4) 2 holes, and (5) with a ring placed at maximum angulation. RESULTS: The loads resisted at 0.5 and 1 mm of displacement did not differ when frame configurations were compared (P =.25733 and.33769, respectively). The linear stiffness of the following configurations were decreasingly stiff: standard constructs, hemispheric washers with connecting rods perpendicular to rings, hemispheric washers with connecting rods offset by 1 hole, hemispheric washers with connecting rods offset by 2 holes, and ring offset in relation to bone model. The SBF constructs tested were 34% and 41% more rigid than the IMEX and MCF constructs tested despite the larger diameter of the connecting rods for the IMEX frames (6 mm) compared with the SBF frames (5 mm). The IMEX constructs tested were 6% more rigid than the MCF constructs tested. CONCLUSIONS: Adding hemispheric washers and angling connecting rods in relation to rings did not influence the loads resisted at 0.5 and 1 mm displacement but decreased construct stiffness. CLINICAL RELEVANCE: The use of hemispheric washers had minor effects on the biomechanical performance of fixator frames tested in this study when used to angle a ring in relation to connecting rods for circular external fixators.

Animals↗

A comparison of the torsional performance of stainless steel and titanium alloy tibial intramedullary nails: a clinically relevant approach.

In recent years there has been a tendency to design and manufacture intramedullary nails from titanium alloy rather than from stainless steel. The aim of this project was to compare the torsional performance of one manufacturers standard stainless steel and titanium alloy tibial intramedullary nails, using their distal locking screw holes and dedicated cross screws to secure each nail distally. A custom built test rig and materials testing machine were used to determine the torsional rigidity of the nails. Theory was used to calculate the torsional rigidity of the central parts of each nail. From the mechanical testing, the mean torsional rigidity of the titanium alloy nail system was 40.9 N m2 while that of the stainless steel nail system was 34.6 N m2, for all distal interlocking screw positions tested. Based on theoretical calculations the torsional rigidity of the central part of the nail was 83 N m2 for the stainless steel nail and 66 N m2 for the titanium alloy nail. This study shows the importance of using the distal locking screw holes and dedicated cross screws to secure intramedullary nails during mechanical testing so that clinically relevant results are obtained about the whole nail system and not just the nail.

Alloys↗

Pulpal response to a bis-acryl-plastic (Protemp) temporary crown and bridge material.

The pulpal response to Protemp (ESPE Gmbh) was compared to zinc oxide-eugenol, Super Syntrex (de Trey) and Protemp plus zinc oxide-eugenol liner in 144 vervet monkey (Cercopithecus pygerythus) incisor teeth, according to ADA Specification No. 41. Cellular displacement into dentinal tubules, superficial and deep inflammation were present only in the 3-day specimens in all materials. Mean scores for the test material were lower than both negative and positive controls. In the 30-day specimens the prevalence of reparative dentine under the test material was similar to the negative control, while at 90 days it was less than the negative control, although the severity in affected specimens was more than the positive control. Use of a zinc oxide-eugenol liner reduced the severity of reparative dentine formation.

Acrylates↗

The impact of rheologically controlled materials on the identification of airway compromise on the clinical and videofluoroscopic swallowing examinations.

Numerous studies have suggested that the clinical evaluation of swallowing fails to adequately identify those patients who aspirate or do not aspirate on a videofluoroscopic swallowing examination. These conclusions, however, are based on comparisons between swallowed materials that were not rheologically matched. The present study used a battery of rheologically matched test materials, involving thin and thick liquids and cohesive and adhesive semisolids. Using these test items, results from a clinical swallow evaluation were compared to the results of a videofluorographic evaluation using identical test materials. Results suggest that the use of three test materials, including thin and thick liquids given in volumes of 5 and 10 ml, demonstrated the strongest associations between cough on the clinical examination and aspiration on the videofluoroscopic examination.

Airway Obstruction↗