Metal hypersensitivity and pro-inflammatory cytokine production in patients with failed orthopedic implants: A case-control study.

Orthopedic implants heal well without complications in most patients but fail for unclear reasons in some individuals. This study determined the relevance of metal hypersensitivity in patients with failed orthopedic implants and those requiring orthopedic implant surgery. The study included 35 patients with failed orthopedic implants and 15 subjects scheduled for orthopedic implant surgery. The production of selected pro-inflammatory cytokines was measured in patients with failed orthopedic implants. Metal hypersensitivity was measured in all subjects using the MELISA® test. Of common metals in orthopedic alloys, the patients with failed orthopedic implants responded most frequently to nickel, chromium, titanium, iron, and molybdenum. Hypersensitivity to metals found in implants was measured in 40% of patients with failed implants. The study also showed that titanium exposure in patients with titanium hypersensitivity might lead to implant failure. Metal hypersensitivity testing should be offered to patients before surgery to minimize the risk of implant failure.

A Complex Evaluation of the In-Vivo Biocompatibility and Degradation of an Extruded ZnMgSr Absorbable Alloy Implanted into Rabbit Bones for 360 Days.

The increasing incidence of trauma in medicine brings with it new demands on the materials used for the surgical treatment of bone fractures. Titanium, its alloys, and steel are used worldwide in the treatment of skeletal injuries. These metallic materials, although inert, are often removed after the injured bone has healed. The second-stage procedure-the removal of the plates and screws-can overwhelm patients and overload healthcare systems. The development of suitable absorbable metallic materials would help us to overcome these issues. In this experimental study, we analyzed an extruded Zn-0.8Mg-0.2Sr (wt.%) alloy on a rabbit model. From this alloy we developed screws which were implanted into the rabbit tibia. After 120, 240, and 360 days, we tested the toxicity at the site of implantation and also within the vital organs: the liver, kidneys, and brain. The results were compared with a control group, implanted with a Ti-based screw and sacrificed after 360 days. The samples were analyzed using X-ray, micro-CT, and a scanning electron microscope. Chemical analysis revealed only small concentrations of zinc, strontium, and magnesium in the liver, kidneys, and brain. Histologically, the alloy was verified to possess very good biocompatibility after 360 days, without any signs of toxicity at the site of implantation. We did not observe raised levels of Sr, Zn, or Mg in any of the vital organs when compared with the Ti group at 360 days. The material was found to slowly degrade in vivo, forming solid corrosion products on its surface.

Zn-0.8Mg-0.2Sr (wt.%) Absorbable Screws-An In-Vivo Biocompatibility and Degradation Pilot Study on a Rabbit Model.

In this pilot study, we investigated the biocompatibility and degradation rate of an extruded Zn-0.8Mg-0.2Sr (wt.%) alloy on a rabbit model. An alloy screw was implanted into one of the tibiae of New Zealand White rabbits. After 120 days, the animals were euthanized. Evaluation included clinical assessment, microCT, histological examination of implants, analyses of the adjacent bone, and assessment of zinc, magnesium, and strontium in vital organs (liver, kidneys, brain). The bone sections with the implanted screw were examined via scanning electron microscopy and energy dispersive spectroscopy (SEM-EDS). This method showed that the implant was covered by a thin layer of phosphate-based solid corrosion products with a thickness ranging between 4 and 5 µm. Only negligible changes of the implant volume and area were observed. The degradation was not connected with gas evolution. The screws were fibrointegrated, partially osseointegrated histologically. We observed no inflammatory reaction or bone resorption. Periosteal apposition and formation of new bone with a regular structure were frequently observed near the implant surface. The histological evaluation of the liver, kidneys, and brain showed no toxic changes. The levels of Zn, Mg, and Sr after 120 days in the liver, kidneys, and brain did not exceed the reference values for these elements. The alloy was safe, biocompatible, and well-tolerated.

Titanium and Other Metal Hypersensitivity Diagnosed by MELISA® Test: Follow-Up Study.

This study is aimed at proving the clinical benefit of the MELISA® test in the minimization or complete elimination of health problems in patients with confirmed hypersensitivity to metals used for tissue replacements. A group of 305 patients aged 20-75 years with previously proven metal hypersensitivity (initial MELISA® test), mainly to titanium and then to another fifteen metals, was chosen from the database at the Institute of Dental Medicine. From these patients, a final group of 42 patients agreed to participate in the study, 35 of which were female and 7 were male. The patients completed a special questionnaire aimed at information regarding change of health status from their last visit and determining whether the results of the initial MELISA® test and recommendations based on it were beneficial for patients or not. They were clinically examined, and peripheral blood samples were taken to perform follow-up MELISA® tests. Questionnaire data was processed, and the follow-up MELISA® test results were compared with the results of the initial MELISA® tests. For statistical analysis, the Fisher's exact test and paired T-test were used. Thirty-two patients reported that they followed the recommendations based on the results of the initial MELISA® tests, and of these, 30 patients (94%) confirmed significant health improvement. Six patients did not follow the recommendation, and from these, only one patient reported an improvement in his health problems. By comparison of the initial and follow-up MELISA® test results, it can be stated that the hypersensitivity to the given metal decreased or disappeared after the therapeutic interventions performed based on the initial MELISA® test results. The evaluation of the data obtained from patients in this study confirmed a significant clinical benefit of MELISA® test.

Bisphenol A Release from Dental Composites and Resin-Modified Glass Ionomers under Two Polymerization Conditions.

Bisphenol A (BPA)-based monomers are commonly contained in dental resin-based materials. As BPA is an endocrine disruptor, its long-term release from restorative composites and resin-modified glass ionomers (RM-GICs) under two polymerization conditions was measured in this study. Specimens of two conventional composites containing BPA-based monomers, two "BPA-free" composites, and two RM-GICs were polymerized from one side for 20 s at 1300 mW/cm2 or for 5 s at 3000 mW/cm2. The amounts of BPA released in artificial saliva and methanol after 1, 4, 9, 16, 35, 65, 130, and 260 days were measured using liquid chromatography-tandem mass spectrometry. The highest amounts of BPA were released from conventional composites, followed by RM-GICs, while the least was released from "BPA-free" composites. Amounts of released BPA were significantly higher in methanol and decreased gradually after the first day. Fast polymerization (5 s at 3000 mW/cm2) resulted in a significantly higher release of BPA after 1 day, but the effect of polymerization conditions was not significant overall. In conclusion, fast polymerization increased the initial release of BPA, but the released amounts were significantly lower than the current tolerable daily intake (4 µg/kg body weight/day) even in methanol, representing the worst-case scenario of BPA release.

The effect of disinfectants on the accuracy, quality and surface structure of impression materials and gypsum casts: A comparative study using light microscopy, scanning electron microscopy and micro computed tomography.

The aim of this study was to compare the effect of several commercially available disinfectants on the accuracy of various types of impression materials and their compatibility with gypsum including surface quality and structure evaluation. Four alginate and three elastomeric impression materials in combination with disinfectants Aseptoprint Liquid, Zeta 7 solution, Silosept and Dentaclean Form were tested. The dimensional changes, detail reproduction, the compatibility with gypsum and surface/subsurface morphology were evaluated using light microscopy, scanning electron microscopy and micro computed tomography. Two alginate materials disinfected in Dentaclean Form exhibited the most significant differences (p<0.0001). The loss of detail on some alginate impressions in combination with this disinfectant including deterioration and change of morphology of gypsum surfaces was observed. Porosity in subsurface area and exposed large particles were detected. It was confirmed that the desired properties of impressions may be negatively affected in combination with some disinfectants.

In vivo study on biodegradable magnesium alloys: Bone healing around WE43 screws.

Introduction A standard osteosynthetic material for maxillofacial skeleton is titanium and its alloys. The convenience of degradable material is avoiding of second surgery in cases, where removal of the material is necessary. Magnesium biodegradable alloys have similar mechanic properties as cortical bone - reasonable corrosion and sufficient biologic properties. They might be used in facial skeleton fixation. Materials and methods The study included a total of 16 rabbits, and they were randomly divided into two groups. Each group received two screws (WE4 and titanium as a standard material) in artificially drilled defect into right tibia. Animals were euthanized at four-week intervals. Bone samples with implants underwent microfocus CT scans and were histologically examined. Results WE43 alloys showed fragmentation of the material on the 16th week - statistically significant volume loss was found between weeks 12 and 16. Bone healing around the WE43 screws was of similar quality as around titanium screws, and no adverse effect was noticed. Conclusion The study showed good quality of bone healing around WE43 implants. From this point of view, the WE43 alloy meets the requirements of osteosynthetic material for maxillofacial skeleton.

Formation of protective deposits by anti-erosive toothpastes-A microscopic study on enamel with artificial defects.

This study investigated formation of protective deposits on the enamel surface after application of several anti-erosive toothpastes with different active ingredients. NaF-containing Sensodyne Pronamel, SnCl2 /F-based Elmex Erosion Protection and calcium phosphate-based BioRepair Plus Sensitivity Control, SensiShield and Enamel Care toothpastes with claimed anti-erosive properties were tested. Artificial saliva and Elmex Erosion Protection mouth rinse served as control groups. The toothpastes were applied 30 times by a toothbrush for 2 min per day, mouth rinse for 30 s on polished enamel of thirty five human molars (n = 5) with series of five rhomboid-shaped indents of various length prepared by a Knoop indentor. After 15 and 30 applications, the shape of the indents and surface morphology was characterised using light and scanning electron microscopy. At the end of treatment, the samples were exposed to 0.2 wt. % citric acid (pH 3.30) to test resistance of the treated enamel to erosion. Pronounced differences were observed between protective properties of the toothpastes. While Sensodyne Pronamel and BioRepair Plus Sensitivity Control did not produce any protective deposits, Enamel Care formed a compact layer of deposits which protected the enamel surface against erosion. With Elmex Erosion Protection and SensiShield fractured indent edges and scratches on the treated enamel suggested that their abrasive properties prevailed over ability of active ingredients to form deposits. These results revealed that toothpastes with strong potential to form acid-resistant deposits on the enamel surface and of low abrasivity should be used for effective prevention of enamel erosion. SCANNING 38:380-388, 2016. © 2015 Wiley Periodicals, Inc.

Comparison of bonding performance of self-etching and etch-and-rinse adhesives on human dentin using reliability analysis.

PURPOSE: To estimate the in vitro reliability of typical self-etching and etch-and-rinse adhesives of various application protocols. MATERIALS AND METHODS: The following adhesives were applied on flat dentin surfaces of extracted human teeth (n = 223): self-etching two-step adhesives: AdheSE (AH), Clearfil SE Bond (CL), OptiBond SE (OS); one-step adhesives: Adper Prompt L-Pop (ADP), Adper Prompt (AD), and Xeno III (XE); all-in-one adhesive: iBond (IB); etch-and-rinse three-step adhesives: OptiBond FL (OF), two-step Gluma Comfort Bond (G), Excite (E) and Prime & Bond NT (PB). Composite buildups were prepared using a microhybrid composite, Opticor New. Shear bond strength was determined after 24 h of storage at 37 degrees C in distilled water. The results were analyzed with a nested ANOVA (adhesive, type of adhesive) followed by the Fisher post-hoc tests of group homogeneity at alpha = 0.05. A two-parameter Weibull distribution was used to calculate the critical shear bond strength corresponding to 5% probability of failure as a measure of system reliability. RESULTS: ANOVA revealed a significant decrease (p < 0.001) in the mean shear bond strength as follows: AH=CL=OS=G=E=OF>AD=IB=XE>PB=ADP, but no significant difference (p > 0.48) between the etch-and-rinse and self-etching adhesives. The corresponding characteristic bond strength of Weibull distribution ranged between 24.1 and 12.1 MPa, Weibull modulus between 8.3 and 2.1, and the critical shear bond strength varied from 16.0 to 3.0 MPa. CONCLUSION: Pronounced differences in the critical shear bond strength suggest reliability variations in the adhesive systems tested, which originate from chemical composition rather than type of adhesive.