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ESEM-EDX Mineralization and Morphological Analysis of Human Retrieved Maxillary Sinus Bone Graft Biopsies before Loading
This study aimed to analyze the morphology of bone graft granules, the presence of granule demineralization, and bone morphology in retrieved human maxillary sinus bone graft biopsies. Healthy patients underwent sinus bone augmentation using lateral access. Two different dimensions of the antrostomy were performed, a 4 mm or 8 mm height. After 6 months, all sites received one implant using a flap technique, crestal positioning, and submerged healing. Implant biopsies were retrieved after 3 months and were histologically processed. The ESEM analysis was performed on the entire portion of the peri-implant bone (up to 750 µm from the implant thread). Three different regions of interest (ROIs) were selected: the coronal, middle, and apical portions of the implant. In these areas, EDX was performed, and calcium (Ca), phosphate (P), nitrogen (N), and their atomic ratios (Ca/P, Ca/N, and P/N) were calculated. Different bone tissue electron-dense areas were detected through grayscale intensity quantification of ESEM images with different organic (N) or inorganic (Ca,P) compositions. A total of 16 biopsies from 16 healthy patients were analyzed. Bone graft granules were mostly detected in the apical ROI. New bone tissue bridges were detected in the apical and middle ROI. These structures, with lower Ca/N and P/N ratios, were connected and enveloped the bone graft granules. Cortical ROI revealed the most mineralized bone tissue. Conclusions: After 9 months, bone graft resorption was only partially completed and new bone tissue appeared less mineralized in the middle and apical ROI than in the coronal ROI.
Journal Article
Biomedical Applications of Titanium Alloys: A Comprehensive Review
Titanium alloys have emerged as the most successful metallic material to ever be applied in the field of biomedical engineering. This comprehensive review covers the history of titanium in medicine, the properties of titanium and its alloys, the production technologies used to produce biomedical implants, and the most common uses for titanium and its alloys, ranging from orthopedic implants to dental prosthetics and cardiovascular devices. At the core of this success lies the combination of machinability, mechanical strength, biocompatibility, and corrosion resistance. This unique combination of useful traits has positioned titanium alloys as an indispensable material for biomedical engineering applications, enabling safer, more durable, and more efficient treatments for patients affected by various kinds of pathologies. This review takes an in-depth journey into the inherent properties that define titanium alloys and which of them are advantageous for biomedical use. It explores their production techniques and the fabrication methodologies that are utilized to machine them into their final shape. The biomedical applications of titanium alloys are then categorized and described in detail, focusing on which specific advantages titanium alloys are present when compared to other materials. This review not only captures the current state of the art, but also explores the future possibilities and limitations of titanium alloys applied in the biomedical field.
Journal Article
The great nerve : the new science of the vagus nerve and how to harness its healing reflexes
\"New science reveals the groundbreaking potential of the vagus nerve to regulate your body's vital systems and heal a wide variety of medical conditions without drugs\"-- Provided by publisher.
BOOK
Phase 3, Randomized, 20-Month Study of the Efficacy and Safety of Bimatoprost Implant in Patients with Open-Angle Glaucoma and Ocular Hypertension (ARTEMIS 2)
Objective
To evaluate the intraocular pressure (IOP)-lowering efficacy and safety of 10 and 15 µg bimatoprost implant in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).
Methods
This randomized, 20-month, multicenter, masked, parallel-group, phase 3 trial enrolled 528 patients with OAG or OHT and an open iridocorneal angle inferiorly in the study eye. Study eyes were administered 10 or 15 µg bimatoprost implant on day 1, week 16, and week 32, or twice-daily topical timolol maleate 0.5%. Primary endpoints were IOP and IOP change from baseline through week 12. Safety measures included treatment-emergent adverse events (TEAEs) and corneal endothelial cell density (CECD).
Results
Both 10 and 15 µg bimatoprost implant met the primary endpoint of noninferiority to timolol in IOP lowering through 12 weeks. Mean IOP reductions from baseline ranged from 6.2–7.4, 6.5–7.8, and 6.1–6.7 mmHg through week 12 in the 10 µg implant, 15 µg implant, and timolol groups, respectively. IOP lowering was similar after the second and third implant administrations. Probabilities of requiring no IOP-lowering treatment for 1 year after the third administration were 77.5% (10 µg implant) and 79.0% (15 µg implant). The most common TEAE was conjunctival hyperemia, typically temporally associated with the administration procedure. Corneal TEAEs of interest (primarily corneal endothelial cell loss, corneal edema, and corneal touch) were more frequent with the 15 than the 10 µg implant and generally were reported after repeated administrations. Loss in mean CECD from baseline to month 20 was ~ 5% in 10 µg implant-treated eyes and ~ 1% in topical timolol-treated eyes. Visual field progression (change in the mean deviation from baseline) was reduced in the 10 µg implant group compared with the timolol group.
Conclusions
The results corroborated the previous phase 3 study of the bimatoprost implant. The bimatoprost implant met the primary endpoint and effectively lowered IOP. The majority of patients required no additional treatment for 12 months after the third administration. The benefit-risk assessment favored the 10 over the 15 µg implant. Studies evaluating other administration regimens with reduced risk of corneal events are ongoing. The bimatoprost implant has the potential to improve adherence and reduce treatment burden in glaucoma.
Clinicaltrials.gov Identifier
NCT02250651.
Journal Article
Bioresorbable Scaffolds versus Metallic Stents in Routine PCI
In a randomized trial, 1845 patients undergoing PCI were assigned to receive either everolimus-eluting bioresorbable vascular scaffolds or everolimus-eluting metallic stents. The incidence of device thrombosis was higher with the bioresorbable scaffold than with the metallic stent.
Drug-eluting stents are the standard of care in percutaneous coronary intervention (PCI).
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Nevertheless, their rigid metallic cages hamper vasomotion, and they are associated with the development of neoatherosclerosis, which results in an ongoing risk of stent thrombosis (rate of 0.1 to 0.2% per year) and repeat revascularization (rate of 2 to 3% per year).
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Bioresorbable vascular scaffolds theoretically leave no permanent implant and allow for restoration of vessel function.
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The ABSORB III trial showed the noninferiority of the bioresorbable vascular scaffold (Absorb, Abbott Vascular) to the cobalt–chromium everolimus-eluting metallic stent (Xience, Abbott Vascular) with respect to target-lesion failure . . .
Journal Article
Phantom limbs and body integrity identity disorder : literary and psychoanalytic reflections
\"Phantom Limbs and Body Integrity Identity Disorder discusses the conditions of Phantom Limb Syndrome and Body Integrity Identity Disorder together for the first time, exploring examples from literature, film, and psychoanalysis to re-ground theories of the body in material experience\"-- Provided by publisher.
Book
Laser-Modified Surface Enhances Osseointegration and Biomechanical Anchorage of Commercially Pure Titanium Implants for Bone-Anchored Hearing Systems
Osseointegrated implants inserted in the temporal bone are a vital component of bone-anchored hearing systems (BAHS). Despite low implant failure levels, early loading protocols and simplified procedures necessitate the application of implants which promote bone formation, bone bonding and biomechanical stability. Here, screw-shaped, commercially pure titanium implants were selectively laser ablated within the thread valley using an Nd:YAG laser to produce a microtopography with a superimposed nanotexture and a thickened surface oxide layer. State-of-the-art machined implants served as controls. After eight weeks' implantation in rabbit tibiae, resonance frequency analysis (RFA) values increased from insertion to retrieval for both implant types, while removal torque (RTQ) measurements showed 153% higher biomechanical anchorage of the laser-modified implants. Comparably high bone area (BA) and bone-implant contact (BIC) were recorded for both implant types but with distinctly different failure patterns following biomechanical testing. Fracture lines appeared within the bone ~30-50 μm from the laser-modified surface, while separation occurred at the bone-implant interface for the machined surface. Strong correlations were found between RTQ and BIC and between RFA at retrieval and BA. In the endosteal threads, where all the bone had formed de novo, the extracellular matrix composition, the mineralised bone area and osteocyte densities were comparable for the two types of implant. Using resin cast etching, osteocyte canaliculi were observed directly approaching the laser-modified implant surface. Transmission electron microscopy showed canaliculi in close proximity to the laser-modified surface, in addition to a highly ordered arrangement of collagen fibrils aligned parallel to the implant surface contour. It is concluded that the physico-chemical surface properties of laser-modified surfaces (thicker oxide, micro- and nanoscale texture) promote bone bonding which may be of benefit in situations where large demands are imposed on biomechanically stable interfaces, such as in early loading and in compromised conditions.
Journal Article