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"Zirconium - chemistry"
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89ZrZr-girentuximab for PET–CT imaging of clear-cell renal cell carcinoma: a prospective, open-label, multicentre, phase 3 trial
2024
With limitations of conventional imaging and biopsy, accurate, non-invasive techniques to detect clear-cell renal cell carcinoma in patients with renal masses remain an unmet need. 89Zr-labelled monoclonal antibody ([89Zr]Zr-girentuximab) has high affinity for carbonic anhydrase 9, a tumour antigen highly expressed in clear-cell renal cell carcinoma. We aimed to evaluate [89Zr]Zr-girentuximab PET–CT imaging for detection and characterisation of clear-cell renal cell carcinoma.
ZIRCON was a prospective, open-label, multicentre, phase 3 trial conducted at 36 research hospitals and practices across nine countries (the USA, Australia, Canada, the UK, Türkiye, Belgium, the Netherlands, Spain, and France). Patients aged 18 years or older with an indeterminate renal mass 7 cm or smaller (cT1) suspicious for clear-cell renal cell carcinoma and scheduled for nephrectomy received a single dose of [89Zr]Zr-girentuximab (37 MBq ±10%; 10 mg girentuximab) intravenously followed by abdominal PET–CT imaging 5 days (±2 days) later. Surgery was performed no later than 90 days after administration of [89Zr]Zr-girentuximab. Blinded central review, conducted by three independent readers, determined the histology from surgical samples. The coprimary endpoints, determined for each individual reader, were the sensitivity and specificity of [89Zr]Zr-girentuximab PET–CT imaging to detect clear-cell renal cell carcinoma, with histopathological confirmation as standard of truth. Analyses were on the full analysis set of patients, defined as patients who had evaluable PET–CT imaging and a confirmed histopathological diagnosis. The trial is registered with ClinicalTrials.gov, NCT03849118, and EUDRA Clinical Trials Register, 2018-002773-21, and is closed to enrolment.
Between Aug 14, 2019, and July 8, 2022, 371 patients were screened for eligibility, 332 of whom were enrolled. 300 patients received [89Zr]Zr-girentuximab (214 [71%] male and 86 [29%] female). 284 (95%) evaluable patients were included in the primary analysis. The mean sensitivity was 85·5% (95% CI 81·5–89·6) and mean specificity was 87·0% (81·0–93·1). No safety signals were observed. Most adverse events were not or were unlikely to be related to [89Zr]Zr-girentuximab, with most (193 [74%] of 261 events) occurring during or after surgery. The most common grade 3 or worse adverse events were post-procedural haemorrhage (in six [2%] of 261 patients), urinary retention (three [1%]), and hypertension (three [1%]). In 25 (8%) of 300 patients, 52 serious adverse events were reported, of which 51 (98%) occurred after surgery. There were no treatment-related deaths.
Our results suggest that [89Zr]Zr-girentuximab PET–CT has a favourable safety profile and is a highly accurate, non-invasive imaging modality for the detection and characterisation of clear-cell renal cell carcinoma, which has the potential to be practice changing.
Telix Pharmaceuticals.
Journal Article
The effect of zirconia sintering temperature on flexural strength, grain size, and contrast ratio
by
Ender, Andreas
,
Özcan, Mutlu
,
Hallmann, Lubica
in
Ceramics - chemistry
,
Color
,
Dental Materials - chemistry
2013
Objective
This study investigated the effect of sintering temperatures on flexural strength, contrast ratio, and grain size of zirconia.
Materials and Methods
Zirconia specimens (Ceramill ZI, Amann Girrbach) were prepared in partially sintered state. Subsequently, the specimens were randomly divided into nine groups and sintered with different final sintering temperatures: 1,300°C, 1,350°C, 1,400°C, 1,450°C, 1,500°C, 1,550°C, 1,600°C, 1,650°C, or 1,700°C with 120 min holding time. Three-point flexural strength (
N
= 198;
n
= 22 per group) was measured according to ISO 6872: 2008. The contrast ratio (
N
= 90;
n
= 10 per group) was measured according to ISO 2471: 2008. Grain sizes and microstructure of different groups were investigated (
N
= 9,
n
= 1 per group) with scanning electron microscope. Data were analyzed using one-way ANOVA with Scheffé test and Weibull statistics (
p
< 0.05). Pearson correlation coefficient was calculated between either flexural strength or contrast ratio and sintering temperatures.
Results
The highest flexural strength was observed in groups sintered between 1,400°C and 1,550°C. The highest Weibull moduli were obtained for zirconia sintered at 1,400°C and the lowest at 1,700°C. The contrast ratio and the grain size were higher with the higher sintering temperature. The microstructure of the specimens sintered above 1,650°C exhibited defects. Sintering temperatures showed a significant negative correlation with both the flexural strength (
r
= −0.313,
p
< 0.001) and the contrast ratio values (
r
= −0.96,
p
< 0.001).
Conclusions
The results of this study showed that the increase in sintering temperature increased the contrast ratio, but led to a negative impact on the flexural strength.
Clinical Relevance
Considering the flexural strength values and Weibull moduli, the sintering temperature for the zirconia tested in this study should not exceed 1,550°C.
Journal Article
Plasma Surface Modification of 3Y-TZP at Low and Atmospheric Pressures with Different Treatment Times
by
You, Sanghyun
,
Kim, Chul-Ho
,
Kim, Seung-Joo
in
Atmospheric Pressure
,
Ceramics - chemistry
,
Collisions (Nuclear physics)
2023
The efficiency of plasma surface modifications depends on the operating conditions. This study investigated the effect of chamber pressure and plasma exposure time on the surface properties of 3Y-TZP with N2/Ar gas. Plate-shaped zirconia specimens were randomly divided into two categories: vacuum plasma and atmospheric plasma. Each group was subdivided into five subgroups according to the treatment time: 1, 5, 10, 15, and 20 min. Following the plasma treatments, we characterized the surface properties, including wettability, chemical composition, crystal structure, surface morphology, and zeta potential. These were analyzed through various techniques, such as contact angle measurement, XPS, XRD, SEM, FIB, CLSM, and electrokinetic measurements. The atmospheric plasma treatments increased zirconia’s electron donation (γ−) capacity, while the vacuum plasma treatments decreased γ− parameter with increasing times. The highest concentration of the basic hydroxyl OH(b) groups was identified after a 5 min exposure to atmospheric plasmas. With longer exposure times, the vacuum plasmas induce electrical damage. Both plasma systems increased the zeta potential of 3Y-TZP, showing positive values in a vacuum. In the atmosphere, the zeta potential rapidly increased after 1 min. Atmospheric plasma treatments would be beneficial for the adsorption of oxygen and nitrogen from ambient air and the generation of various active species on the zirconia surface.
Journal Article
Clinical evaluation of the performance and safety of a new dentine substitute, Biodentine, in the restoration of posterior teeth — a prospective study
by
Richard, Gilles
,
Lambert, Grégory
,
Franquin, Jean-Claude
in
Adult
,
Biocompatible Materials - chemistry
,
Biocompatible Materials - standards
2013
Objectives
A multicentric randomized, 3-year prospective study was conducted to determine for how long Biodentine, a new biocompatible dentine substitute, can remain as a posterior restoration.
Materials and methods
First, Biodentine was compared to the composite Z100®, to evaluate whether and for how long it could be used as a posterior restoration according to selected United States Public Health Service (USPHS)’ criteria (mean ± SD). Second, when abrasion occurred, Biodentine was evaluated as a dentine substitute combined with Z100®.
Results
A total of 397 cases were included. This interim analysis was conducted on 212 cases that were seen for the 1-year recall. On the day of restoration placement, both materials obtained good scores for material handling, anatomic form (0.12 ± 0.33), marginal adaptation (0.01 ± 0.10) and interproximal contact (0.11 ± 0.39). During the follow-up, both materials scored well in surface roughness (≤1) without secondary decay and post-operative pain. Biodentine kept acceptable surface properties regarding anatomic form score (≤1), marginal adaptation score (≤2) and interproximal contact score (≤1) for up to 6 months after placement. Resistance to marginal discoloration was superior with Biodentine compared to Z100®. When Biodentine was retained as a dentine substitute after pulp vitality control, it was covered systematically with the composite Z100®. This procedure yielded restorations that were clinically sound and symptom free.
Conclusions
Biodentine is able to restore posterior teeth for up to 6 months. When subsequently covered with Z100®, it is a convenient, efficient and well tolerated dentine substitute.
Clinical relevance
Biodentine as a dentine substitute can be used under a composite for posterior restorations.
Journal Article
Effect of different preparation designs and all ceramic materials on fracture strength of molar endocrowns
by
Haralur, Satheesh B
,
Alfarsi, Mohammed
,
Alshehri, Shatha Abdulrahman
in
Axial loads
,
Biomechanical Phenomena
,
Bone Cements
2020
Objective:
The aim was to compare the fracture strength of Molar endocrowns fabricated from different all-ceramic materials and various preparation designs.
Materials and methods:
Ninety extracted human molar teeth were root canal treated and randomly divided into three groups according to the all ceramic materials used for fabrication of the endocrowns (n = 30): (1) Lithium disilicate (IPS e.max Press); (2) Polymer infiltrated ceramic (Vita Enamic); (3) High translucency zirconia (Ceramill Zolid HT). Each group was subdivided into 3 subgroups (n = 10) according to the preparation design as 2 mm occlusal reduction, 4.5 mm occlusal reduction, and 4.5 mm occlusal reduction with 2 mm radicular extension. The endocrowns from each material were fabricated and surface treated according to the manufacturer’s recommendations. After cementation with self-adhesive resin luting cement, the specimens were stored in a humid environment for 72 hours and subsequently subjected to 5000 thermal cycles. After, a compressive, static-axial load was applied using a universal testing machine until failure. Load-to-failure was recorded (N) and the specimens were examined under a stereomicroscope to determine the failure type. The data was statistically analyzed using One-way ANOVA and Tukey HSD tests at p < 0.05.
Results:
The Lithium Disilicate endocrowns recorded the higher mean fracture strength for 4.5 mm occlusal thickness and 2 mm radicular extension at 3770.28 N and 3877.40 correspondingly. The High translucency zirconia endocrowns at conventional 2 mm thickness showed the highest mean fracture load (3533.34 N). Even though polymer infiltrated ceramic endocrowns displayed comparatively lesser fracture load; they recorded the predominantly favorable fractures.
Conclusions:
Increased occlusal thickness showed a significant improvement in fracture strength of lithium disilicate and polymer infiltrated ceramic molar endocrowns. Although the 2 mm radicular extension had the substantial enhancement of fracture strength in high translucency zirconia, it resulted in more unfavorable failure types.
Journal Article
Oxidized Zirconium Head on Crosslinked Polyethylene Liner in Total Hip Arthroplasty: A 7- to 12-year In Vivo Comparative Wear Study
by
Karidakis, George K.
,
Karachalios, Theofilos
in
Aged
,
Arthroplasty, Replacement, Hip - adverse effects
,
Arthroplasty, Replacement, Hip - instrumentation
2015
Background
Osteolysis resulting from wear debris production from the bearing surfaces is a major factor limiting long-term survival of hip implants. Oxidized zirconium head on crosslinked polyethylene (XLPE) is a modern bearing coupling. However, midterm in vivo wear data of this coupling are not known.
Questions/purposes
The purpose of this study was to investigate in vivo whether the combination of an oxidized zirconium femoral head on XLPE produces less wear than a ceramic head on XLPE or a ceramic head on conventional polyethylene (CPE) couplings and whether any of these bearing combinations results in higher hip scores.
Methods
Between 2003 and 2007, we performed 356 total hip arthroplasties in 288 patients; of those, 199 (69.1%) patients (199 hips) were enrolled in what began as a randomized trial. Unfortunately, after the 57
th
patient, the randomization process was halted because of patients’ preference for the oxidized zirconium bearing instead of the ceramic after (as they were informed by the consent form), and after that, alternate allocation to the study groups was performed. Hips were allocated into four groups: in Group A, a 28-mm ceramic head on CPE was used; in Group B, a 28-mm ceramic head on XLPE; in Group C, a 28-mm Oxinium head on XLPE; and in Group D, a 32-mm Oxinium head on XLPE. The authors prospectively collected in vivo wear data (linear wear, linear wear rate, volumetric wear, and volumetric wear rate) using PolyWare software. Preoperative and postoperative clinical data, including Harris and Oxford hip scores, were also collected at regular intervals. Of those patients enrolled, 188 (95%) were available for final followup at a minimum of 7 years (mean, 9 years; range, 7–12 years).
Results
All bearing surfaces showed a varying high bedding-in effect (plastic deformation of the liner) up to the second postoperative year. At 5 years both oxidized zirconium on XLPE groups showed lower (p < 0.01) volumetric wear (mean ± SD mm
3
) and volumetric wear rates (mean ± SD mm
3
/year) (Group C: 310 ± 55–206 ± 55 mm
3
/year, Group D: 320 ± 58–205 ± 61 mm
3
/year) when compared with ceramic on CPE (Group A: 791 ± 124–306 ± 85 mm
3
/year) and ceramic on XLPE (Group B: 1420 ± 223–366 ± 88 mm
3
/year) groups. For those patients who had completed 10 years of followup (20 patients [44.5%] of Group A, 21 [45.7%] of Group B, 23 [47.9%] of Group C, and 22 [44.9%] of Group D), at 10 years, both oxidized zirconium on XLPE groups also showed lower (p < 0.01) volumetric wear (mean ± SD mm
3
) and volumetric wear rates (mean ± SD mm
3
/year) (Group C: 356 ± 64 to 215 ± 54 mm
3
/year, Group D: 354 ± 50 to 210 ± 64 mm
3
/year) when compared with ceramic on CPE (Group A: 895 ± 131 to 380 ± 80 mm
3
/year) and ceramic on XLPE (Group B: 1625 ± 253 to 480 ± 101 mm
3
/year) groups. When wear rates of both oxidized zirconium groups were compared, no differences were found at any time interval with the numbers available. Two hips (one from Group A and one from Group B) are scheduled for revision as a result of wear and osteolysis. There were no differences in hip scores among the groups with the numbers available.
Conclusions
In this study, in vivo wear parameters were lower when the combination of an oxidized zirconium head on XLPE liner was used at an average of 9 years (range, 7–12 years) followup. Further larger-scale clinical studies should confirm these findings and evaluate osteolysis and revision rates in association with the use of this bearing coupling.
Level of Evidence
Level II, therapeutic study.
Journal Article
In vitro comparative bond strength of contemporary self-adhesive resin cements to zirconium oxide ceramic with and without air-particle abrasion
by
Mante, Francis K.
,
Blatz, Markus B.
,
Bergler, Michael
in
Composite Resins - chemistry
,
Dental Bonding
,
Dental Etching - methods
2010
This study compared shear bond strengths of six self-adhesive resin cements to zirconium oxide ceramic with and without air-particle abrasion. One hundred twenty zirconia samples were air-abraded (group SB;
n
= 60) or left untreated (group NO). Composite cylinders were bonded to the zirconia samples with either BisCem (BC), Maxcem (MC), G-Cem (GC), RelyX Unicem Clicker (RUC), RelyX Unicem Applicator (RUA), or Clearfil SA Cement (CSA). Shear bond strength was tested after thermocycling, and data were analyzed with analysis of variance and Holm–Sidak pairwise comparisons. Without abrasion, RUA (8.0 MPa), GC (7.9 MPa), and CSA (7.6 MPa) revealed significantly higher bond strengths than the other cements. Air-particle abrasion increased bond strengths for all test cements (
p
< 0.001). GC (22.4 MPa) and CSA (18.4 MPa) revealed the highest bond strengths in group SB. Bond strengths of self-adhesive resin cements to zirconia were increased by air-particle abrasion. Cements containing adhesive monomers (MDP/4-META) were superior to other compositions.
Journal Article
Randomized trial investigating zirconia electroplated telescopic retainers: quality of life outcomes
by
Séché, Anne-Christiane
,
Lehmann, Franziska
,
Rammelsberg, Peter
in
Adult
,
Aged
,
Chromium Alloys - chemistry
2017
Objectives
The study aims to evaluate the effect of electroplated telescopic removable dental prostheses (E-RDPs) with zirconia primary crowns on oral-health-related quality of life (OHRQoL).
Materials and methods
For E-RDPs, electroplating is used to produce precisely fitting gold copings on telescopic primary crowns. These copings are bonded intra-orally to the denture framework. Fifty-six participants in need of 60 removable restorations were randomly allocated one of two materials for the primary crowns: cobalt–chromium alloy or zirconia. OHRQoL was assessed by use of the 49-item Oral Health Impact Profile (OHIP-49) and by additional patient self-rating at baseline before treatment, and after 6 and 12 months. Statistical analysis was performed by use of one- and two-sample
t
-tests and analysis of covariance.
Results
Mean OHIP sum score at baseline was 53.4 (SD 37.4, 95 % CI 41.3–62). At follow-ups, it decreased significantly (after 6 months: mean 20, SD 26, 95 % CI 13–27.1; after 12 months: mean 16.4, SD 17.9, 95 % CI 11.6–21.2). The mean reduction in OHIP sum score after 12 months was 25 (SD 31.2, 95 % CI 13.1–36.9) for cobalt–chromium alloy and 44.4 (SD 32.3, 95 % CI 31.1–57.8) for zirconia. However, no statistically significant difference of the two materials on OHIP change or patient self-rating was detected.
Conclusions
Although OHRQoL was improved by using both cobalt–chromium alloy and zirconia primary crowns for E-RDPs, post-treatment differences between the groups were not statistically significant.
Clinical relevance
Zirconia E-RDPs enhance OHRQoL. However, zirconia primary crowns do not outperform cobalt–chromium alloy crowns regarding patient satisfaction—despite their tooth-like color.
Journal Article
Effect of different power settings of Er,Cr:YSGG laser before or after tribosilicatization on the microshear bond strength between zirconia and two types of cements
by
Brugnera, Aldo
,
Esteves, Camila M
,
Oliveira, Juliana A
in
Adhesive bonding
,
Bars
,
Bond strength
2018
The aim of this study was to evaluate the effect of different output powers of Er,Cr:YSGG laser and the association with tribochemical silica coating on the bond strength between zirconia ceramic and two resin cements. One hundred ninety-two zirconia ceramic bars (IPS e-max ZirCAD Ivoclar Vivadent-) were sectioned (6 × 6 × 4 mm), sintered, and randomly divided into 12 groups for each cement system according to the surface treatment (n = 8): C—without treatment (control); R—tribochemical coating + resin cement (control); 2L—laser (2.0 W) + resin cement; 2LR—laser (2.0 W) + tribochemical coating + resin cement; R2L—tribochemical coating + laser (2.0 W) + resin cement; 2.5L—laser (2.5 W) + resin cement; 2.5LR—laser (2.5 W) + tribochemical coating + resin cement; R2.5L—tribochemical coating + laser (2.5 W) + resin cement; 3L—laser (3.0 W) + resin cement; 3LR—laser (3.0 W) + tribochemical coating + resin cement, R3L—tribochemical coating + laser (3.0 W) + resin cement; and RPHO—tribochemical + resin cement + photoactivation (control). After the surface treatment, the respective primers were applied, and resin cements, Multilink N, Ivoclar Vivadent (M), and Panavia F 2.0, Kuraray Medical Inc. (P), were inserted into Tygon molds which were bonded to the zirconia bars. Each specimen received two cements bars. After 24 h of storage in a relative humidity (100%) at 37 °C, they were evaluated by the microshear test speed of 1 mm/min. The microshear values were analyzed by one-way ANOVA and Tukey’s test (α = 0.05). ANOVA showed statistically significant differences among the evaluated groups. The highest bond strength was observed in RPHO, which statistically differed from all groups. The lowest bond strength was observed in M2.5L (Multilink N) and in P3LR (Panavia F 2.0). It can be concluded that the lowest power output tested was suitable and showed bond strength values similar to tribochemical silica deposition. The light curing is important to adhesion and the tribosilicatizated surface achieves similar microshear values to untreated surface in absence of light.
Journal Article
Electroplated telescopic retainers with zirconia primary crowns: 3-year results from a randomized clinical trial
2017
Objective
The objective of the study was to investigate the clinical outcome for electroplated telescopic removable dental prostheses (E-RDPs) with zirconia primary crowns.
Materials and methods
Sixty E-RDPs, with primary crowns manufactured from either cobalt–chromium alloy or zirconia, were fabricated for 56 participants. Electroplating was used to produce gold copings directly on the telescopic primary crowns. These copings were bonded intra-orally to the prosthesis framework. After 36 months, prosthesis survival and number of complications were assessed. Statistical analysis was performed by the use of Kaplan–Meier modeling and the log-rank test.
Results
Survival of the E-RDPs, 96.4% after 3 years, was identical in both groups. The need for aftercare was high but not significantly different: technical complications were observed for 37% and 42.9% of the prostheses for the zirconia and cobalt–chromium alloy primary crowns, respectively. Fracture of composite veneer was the most frequent complication (59.1%). The incidence of fractured abutment teeth, decementation, and endodontic problems was 7.9% in the zirconia group and 14% in the control group. The majority of abutment-level complications were treated restoratively. A significant difference was found for maximum probing depth at the abutment teeth: In the zirconia group, it decreased by 0.2 mm, whereas it increased by 0.8 mm in the control group (
p
= 0.04).
Conclusions
After 3 years of observation, survival of zirconia E-RDPs was favorable and comparable with that of established double-crown-retained prostheses. Further studies must clarify whether there are benefits of zirconia primary crowns for periodontal health.
Clinical relevance
Although these results encourage the use of zirconia primary crowns, more research is necessary to reduce the number of complications observed for secondary telescopic crowns, for example, failure of the veneer.
Journal Article