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Journal of Applied Oral Science :... 2024to evaluate the morphological and functional characteristics of the peri-implant bone tissue that was formed during the healing process by the placement implants using...
OBJECTIVES
to evaluate the morphological and functional characteristics of the peri-implant bone tissue that was formed during the healing process by the placement implants using two different surface treatments: hydrophilic Acqua™ (ACQ) and rough NeoPoros™ (NEO), in spontaneously hypertensive (SHR) and normotensive rats (Wistar) whether or not treated with losartan.
METHODOLOGY
In total, 96 male rats (48 Wistar and 48 SHR) were divided into eight subgroups: absolute control rough (COA NEO), absolute control hydrophilic (COA ACQ), losartan control rough (COL NEO), losartan control hydrophilic (COL ACQ), SHR absolute rough (SHR NEO), SHR absolute hydrophilic (SHR ACQ), SHR losartan rough (SHRL NEO), and SHR losartan hydrophilic (SHRL ACQ). The rats medicated with losartan received daily doses of the medication. NeoPoros™ and Acqua™ implants were installed in the tibiae of the rats. After 14 and 42 days of the surgery, the fluorochromes calcein and alizarin were injected in the rats. The animals were euthanized 67 days after treatment. The collected samples were analyzed by immunohistochemistry, biomechanics, microcomputerized tomography, and laser confocal scanning microscopy analysis.
RESULTS
The osteocalcin (OC) and vascular endothelium growth factor (VEGF) proteins had moderate expression in the SHRL ACQ subgroup. The same subgroup also had the highest implant removal torque. Regarding microarchitectural characteristics, a greater number of trabeculae was noted in the control animals that were treated with losartan. In the bone mineralization activity, it was observed that the Acqua™ surface triggered higher values of MAR (mineral apposition rate) in the COA, COL, and SHRL groups (p<0.05).
CONCLUSION
the two implant surface types showed similar responses regarding the characteristics of the peri-implant bone tissue, even though the ACQ surface seems to improve the early stages of osseointegration.
Topics: Animals; Losartan; Rats, Inbred SHR; Rats, Wistar; Male; Surface Properties; Dental Implants; Time Factors; X-Ray Microtomography; Reproducibility of Results; Immunohistochemistry; Hydrophobic and Hydrophilic Interactions; Osseointegration; Treatment Outcome; Dental Implantation, Endosseous; Microscopy, Confocal; Tibia; Analysis of Variance; Biomechanical Phenomena; Reference Values; Osteocalcin
PubMed: 38922240
DOI: 10.1590/1678-7757-2023-0374 -
AJNR. American Journal of Neuroradiology Nov 2023Vertebral compression fracture represents a major health burden for the aging populations globally. However, limited studies exist on the relative efficacy and safety of...
BACKGROUND AND PURPOSE
Vertebral compression fracture represents a major health burden for the aging populations globally. However, limited studies exist on the relative efficacy and safety of surgical interventions for vertebral compression fracture. Here, we aim to compare clinical and patient-reported outcomes following vertebral augmentation using balloon kyphoplasty, vertebroplasty, and SpineJack vertebral implant.
MATERIALS AND METHODS
An institutional review board-approved, retrospective, multi-institutional review of patients undergoing vertebral augmentation with kyphoplasty, vertebroplasty, and/or a SpineJack vertebral implant was performed between 2018 and 2021. Primary outcomes included pre- and postprocedural pain ratings and vertebral body height restoration. The secondary outcome was a change in the local kyphotic angle. The Kruskal-Wallis test was used to compare outcomes across 3 treatment options. Complications were reviewed during and 30-90 days after the procedure.
RESULTS
Vertebral augmentation of 344 vertebral compression fracture levels was performed during the study period. Sixty-seven patients had 79 kyphoplasty procedures (55% women; mean age, 64.2 [SD, 12.3] years). Seventy-four patients underwent a mean of 84 vertebroplasty procedures (51% women; mean age, 63.5 [SD, 12.8] years), and 61 patients had a mean of 67 SpineJack vertebral implant procedures (57.4% women; mean age, 68.3 [SD, 10.6] years). Following kyphoplasty, vertebroplasty, and SpineJack vertebral implant, pain scores improved significantly ( < .001). Resting pain improvement was similar across the 3 procedures, whereas improvement of "worst pain" was significantly better following a SpineJack vertebral implant compared with kyphoplasty and vertebroplasty ( < .001). Patients with a SpineJack vertebral implant had greater improvement in vertebral body height restoration and local kyphotic angle compared with those undergoing kyphoplasty and vertebroplasty. Adjacent level fractures (6.7% incidence) occurred similarly in the 3 procedure types. There were no other peri- or postoperative complications.
CONCLUSIONS
The SpineJack vertebral implant showed equivalent pain improvement compared with vertebroplasty and kyphoplasty, but it had superior vertebral body height restoration and local kyphotic angle improvement. This study supports the SpineJack vertebral implant as a safe and effective alternative (adjunct) for vertebral augmentation, especially in patients with moderate-to-severe vertebral compression fractures for greater improvement in vertebral body height restoration.
Topics: Humans; Female; Middle Aged; Aged; Male; Kyphoplasty; Fractures, Compression; Spinal Fractures; Retrospective Studies; Treatment Outcome; Bone Cements; Vertebroplasty; Pain; Osteoporotic Fractures
PubMed: 37918938
DOI: 10.3174/ajnr.A8031 -
Clinical Oral Investigations Jan 2024The occurrence of implant-associated osteonecrosis of the jaw (ONJ) has been reported in osteoporotic patients, particularly in association with bisphosphonate therapy....
OBJECTIVES
The occurrence of implant-associated osteonecrosis of the jaw (ONJ) has been reported in osteoporotic patients, particularly in association with bisphosphonate therapy. This study aimed to investigate the risk of implant surgery and implant presence for ONJ occurrence in osteoporotic patients longitudinally.
METHODS
Based on Korean National Health Information Database, subjects over the age of 65 who were diagnosed with osteoporosis between July 2014 and December 2016 were included. The implant group included subjects who had undergone dental implant surgery between January 2017 and December 2017, while the control group included those who had no history of dental implants. The primary outcome was the occurrence of ONJ, and the date of final follow-up was December 2020.
RESULTS
A total of 332,728 subjects with osteoporosis were included in the analysis: 83,182 in the implant group and 249,546 in the control group. The risk of ONJ among those who had undergone implant surgery (risk of implant surgery-associated ONJ) was not higher than that among those without implant surgery. The risk of ONJ among those with implants (risk of implant presence-associated ONJ) was lower than that among those without implants. Even in subjects with a history of bisphosphonates, steroids, periodontitis, or tooth extraction, those who had undergone implant surgery or had implants did not have a higher ONJ risk than those who had not undergone surgery or did not have implants; rather, they showed a lower risk.
CONCLUSIONS
The results may suggest that dental implants are not associated with an increased risk of ONJ. A further study on whether dental implants are associated with lower ONJ risk is needed.
CLINICAL RELEVANCE
Dental implants did not increase the risk of ONJ development in osteoporotic patients, even with a history of bisphosphonates. This may suggest that the risk profiles for ONJ occurrence between selective insertion of dental implants and other dentoalveolar surgery associated with infectious conditions are different.
Topics: Humans; Cohort Studies; Dental Implants; Diphosphonates; Osteonecrosis; Osteoporosis
PubMed: 38195947
DOI: 10.1007/s00784-023-05483-4 -
Zhongguo Xiu Fu Chong Jian Wai Ke Za... Oct 2023To review antibacterial/osteogenesis dual-functional surface modification strategy of titanium-based implants, so as to provide reference for subsequent research. (Review)
Review
OBJECTIVE
To review antibacterial/osteogenesis dual-functional surface modification strategy of titanium-based implants, so as to provide reference for subsequent research.
METHODS
The related research literature on antibacterial/osteogenesis dual-functional surface modification strategy of titanium-based implants in recent years was reviewed, and the research progress was summarized based on different kinds of antibacterial substances and osteogenic active substances.
RESULTS
At present, the antibacterial/osteogenesis dual-functional surface modification strategy of titanium-based implants includes: ① Combined coating strategy of antibiotics and osteogenic active substances. It is characterized in that antibiotics can be directly released around titanium-based implants, which can improve the bioavailability of drugs and reduce systemic toxicity. ② Combined coating strategy of antimicrobial peptides and osteogenic active substances. The antibacterial peptides have a wide antibacterial spectrum, and bacteria are not easy to produce drug resistance to them. ③ Combined coating strategy of inorganic antibacterial agent and osteogenic active substances. Metal ions or metal nanoparticles antibacterial agents have broad-spectrum antibacterial properties and various antibacterial mechanisms, but their high-dose application usually has cytotoxicity, so they are often combined with substances that osteogenic activity to reduce or eliminate cytotoxicity. In addition, inorganic coatings such as silicon nitride, calcium silicate, and graphene also have good antibacterial and osteogenic properties. ④ Combined coating strategy of metal organic frameworks/osteogenic active substances. The high specific surface area and porosity of metal organic frameworks can effectively package and transport antibacterial substances and bioactive molecules. ⑤ Combined coating strategy of organic substances/osteogenic active substancecs. Quaternary ammonium compounds, polyethylene glycol, N-haloamine, and other organic compounds have good antibacterial properties, and are often combined with hydroxyapatite and other substances that osteogenic activity.
CONCLUSION
The factors that affect the antibacterial and osteogenesis properties of titanium-based implants mainly include the structure and types of antibacterial substances, the structure and types of osteogenesis substances, and the coating process. At present, there is a lack of clinical verification of various strategies for antibacterial/osteogenesis dual-functional surface modification of titanium-based implants. The optimal combination, ratio, dose-effect mechanism, and corresponding coating preparation process of antibacterial substances and bone-active substances are needed to be constantly studied and improved.
Topics: Anti-Bacterial Agents; Coated Materials, Biocompatible; Metal-Organic Frameworks; Osteogenesis; Surface Properties; Titanium; Prostheses and Implants
PubMed: 37848328
DOI: 10.7507/1002-1892.202306025 -
Acta Biomaterialia Jan 2024The foreign body response (FBR) to implanted materials culminates in the deposition of a hypo-permeable, collagen rich fibrotic capsule by myofibroblast cells at the...
The foreign body response (FBR) to implanted materials culminates in the deposition of a hypo-permeable, collagen rich fibrotic capsule by myofibroblast cells at the implant site. The fibrotic capsule can be deleterious to the function of some medical implants as it can isolate the implant from the host environment. Modulation of fibrotic capsule formation has been achieved using intermittent actuation of drug delivery implants, however the mechanisms underlying this response are not well understood. Here, we use analytical, computational, and in vitro models to understand the response of human myofibroblasts (WPMY-1 stromal cell line) to intermittent actuation using soft robotics and investigate how actuation can alter the secretion of collagen and pro/anti-inflammatory cytokines by these cells. Our findings suggest that there is a mechanical loading threshold that can modulate the fibrotic behaviour of myofibroblasts, by reducing the secretion of soluble collagen, transforming growth factor beta-1 and interleukin 1-beta, and upregulating the anti-inflammatory interleukin-10. By improving our understanding of how cells involved in the FBR respond to mechanical actuation, we can harness this technology to improve functional outcomes for a wide range of implanted medical device applications including drug delivery and cell encapsulation platforms. STATEMENT OF SIGNIFICANCE: A major barrier to the successful clinical translation of many implantable medical devices is the foreign body response (FBR) and resultant deposition of a hypo-permeable fibrotic capsule (FC) around the implant. Perturbation of the implant site using intermittent actuation (IA) of soft-robotic implants has previously been shown to modulate the FBR and reduce FC thickness. However, the mechanisms of action underlying this response were largely unknown. Here, we investigate how IA can alter the activity of myofibroblast cells, and ultimately suggest that there is a mechanical loading threshold within which their fibrotic behaviour can be modulated. These findings can be harnessed to improve functional outcomes for a wide range of medical implants, particularly drug delivery and cell encapsulation devices.
Topics: Humans; Foreign-Body Reaction; Myofibroblasts; Foreign Bodies; Anti-Inflammatory Agents; Collagen; Fibrosis
PubMed: 37967693
DOI: 10.1016/j.actbio.2023.11.017 -
Biomaterials Science Jan 2024Implant dysfunction and failure during medical treatment can be attributed to bacterial infection with and , which are the prevalent strains responsible for implant...
Implant dysfunction and failure during medical treatment can be attributed to bacterial infection with and , which are the prevalent strains responsible for implant infections. Currently, antibiotics are primarily used either locally or systemically to prevent and treat bacterial infections in implants. However, the effectiveness of this approach is unsatisfactory. Therefore, the development of new antimicrobial medications is crucial to address the clinical challenges associated with implant infections. In this study, a nanoparticle (ICG+RSG) composed of indocyanine green (ICG) and rosiglitazone (RSG), and delivered using 1,2-dipalmitoyl-snglycero-3-phosphocholine (DPPC) was prepared. ICG+RSG has photothermal and photodynamic properties to eliminate bacteria at the infection site by releasing reactive oxygen species and increasing the temperature. Additionally, it regulates phagocytosis and macrophage polarization to modulate the immune response in the body. ICG+RSG kills bacteria and reduces tissue inflammation, showing potential for preventing implant infections.
Topics: Humans; Photochemotherapy; Photosensitizing Agents; Nanoparticles; Indocyanine Green; Staphylococcal Infections; Bacteria
PubMed: 38010155
DOI: 10.1039/d3bm01584j -
Plastic and Reconstructive Surgery Oct 2023Excess fluid accumulation (seroma/hematoma) around the breast implant after reconstruction can lead to significant complications. Topical administration of tranexamic... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Excess fluid accumulation (seroma/hematoma) around the breast implant after reconstruction can lead to significant complications. Topical administration of tranexamic acid (TXA) may reduce fluid accumulation and reduce postoperative complications. This trial aims to investigate whether TXA-treated mastectomy pockets will exhibit less postoperative fluid production and complications.
METHODS
This paired, double-blind, randomized, controlled trial enrolled patients undergoing bilateral mastectomies with immediate direct-to-implant reconstruction. In each patient, one breast was randomized to receive 3 g of TXA (100 cc), and the other received 100 cc of normal saline. The blinded solutions were soaked in the mastectomy pocket for 5 minutes before implant placement. Postoperatively, daily drain outputs, complications, and baseline demographics were recorded.
RESULTS
Fifty-three eligible patients, representing 106 breasts, were enrolled. All patients underwent bilateral nipple-sparing mastectomies. After randomization, TXA was placed in the right breast in 30 patients (56.6%). The use of topical TXA resulted in a mean drain output reduction of 30.5% (range, -83.6% to 26.6%). Drains on the TXA-treated breast were eligible for removal 1.4 days (range, 0 to 4 days) sooner than the control side. The TXA-treated group had three complications (5.67%) versus 15 (28.3%) in the control group (OR, 0.1920; P = 0.0129). Specifically, for operative hematomas, the TXA group had none (0%), versus three in the control group (5.7%) (OR, 0.1348; P = 0.18).
CONCLUSIONS
Soaking the mastectomy bed with 3% topical TXA before implant insertion leads to a decrease in drain output and a decrease in complications. Topical administration of TXA represents an option to decrease complications in alloplastic breast reconstruction.
CLINICAL QUESTION/LEVEL OF EVIDENCE
Therapeutic, I.
Topics: Humans; Female; Tranexamic Acid; Antifibrinolytic Agents; Breast Neoplasms; Blood Loss, Surgical; Mastectomy; Blood Transfusion; Administration, Topical; Mammaplasty; Double-Blind Method; Hematoma
PubMed: 36827482
DOI: 10.1097/PRS.0000000000010322 -
International Journal of Pharmaceutics Nov 2023Over 20 long-acting injectable formulations based on poly(lactide-co-glycolide) (PLGA) have been approved by the FDA to date. PLGA is a biodegradable polymer that can...
Over 20 long-acting injectable formulations based on poly(lactide-co-glycolide) (PLGA) have been approved by the FDA to date. PLGA is a biodegradable polymer that can extend drug release from these dosage forms for up to six months after administration. Despite the commercial success of several of these formulations, there are still a limited number of products that utilize PLGA, and there are currently no generic counterparts of these products on the market. Significant technical challenges are associated with preparation of chemically and structurally equivalent formulations that yield an equivalent drug release profile to the reference listed drug (RLD) both in vitro and in vivo. In this work, Ozurdex (dexamethasone intravitreal implant) was used as a model system to explore how the manufacturing process of PLGA-based solid implants impacts the quality and performance of the dosage form. Control of implant structural characteristics, including diameter, internal porosity, and surface roughness, was required to maintain accurate unit dose potency. Implants were prepared by a continuous hot-melt extrusion process that was thoroughly characterized to show the importance of precise feeding control to meet dimensional specifications. Five extruder die designs were evaluated using the same hot-melt extrusion process to produce five structurally-distinct implants. The structural differences did not alter the in vitro drug release profile when tested in both normal saline and phosphate-buffered saline (pH 7.4); however, implant porosity was shown to impact the mechanical strength of the implants. This work seeks to provide insight into the manufacturing process of PLGA-based solid implants to support development of future novel and generic drug products.
Topics: Polylactic Acid-Polyglycolic Acid Copolymer; Polyglycolic Acid; Lactic Acid; Drug Compounding; Dexamethasone; Drug Implants
PubMed: 37844672
DOI: 10.1016/j.ijpharm.2023.123515 -
Life Sciences Oct 2023PI3K/AKT/GSK-3β/β-catenin signaling pathway is a triggering factor for epithelial to mesenchymal transition (EMT) which plays a pivotal role in the pathogenesis of...
Parthenolide repressed endometriosis induced surgically in rats: Role of PTEN/PI3Kinase/AKT/GSK-3β/β-catenin signaling in inhibition of epithelial mesenchymal transition.
AIM
PI3K/AKT/GSK-3β/β-catenin signaling pathway is a triggering factor for epithelial to mesenchymal transition (EMT) which plays a pivotal role in the pathogenesis of endometriosis. Parthenolide is a sesquiterpene lactone extract that has anti-inflammatory, analgesic and anticancer properties. Hence, we investigated the effect of parthenolide against EMT in the endometrial tissue implants and immortalized epithelial endometriotic cell lines 12Z.
MAIN METHODS
Twenty- four female Rats with surgically induced endometriosis were treated with parthenolide (2, 4 mg/kg), for 4 weeks. Endometriotic cell line 12Z was used to identify the effect of parthenolide on the wound healing, cellular migration and invasion properties of endometriotic cells.
KEY FINDINGS
Parthenolide decreased the endometriotic implant tissue expression of total PI3K, PI3K-p85, p-AKT, p/total AKT, p-GSK-3β, P/total GSK-3β, and nβ-catenin, as well as increased E-cadherin and decreased vimentin mRNA expression. Parthenolide upregulated PTEN immunoreactivity as well as the endometriotic tissue caspase-3, caspase-9, BAX levels while reducing Bcl2 level. Additionally, parthenolide decreased endometriotic tissue implants surface area and histopathological score of the epithelial growth.
SIGNIFICANCE
Our findings showed that parthenolide in a dose dependent manner inhibited PI3K/AKT/GSK-3β/nβ-catenin cascade via enhancement of PTEN with subsequent inhibition of EMT evidenced by elevation of the epithelial marker, E-cadherin and reduction of mesenchymal marker, vimentin, of the endometriotic implants in addition to reversal of invasion and migration properties of epithelial endometriotic cell lines. These findings provide a valuable therapeutic approach for treatment of endometriosis.
Topics: Humans; Rats; Female; Animals; beta Catenin; Proto-Oncogene Proteins c-akt; Glycogen Synthase Kinase 3 beta; Epithelial-Mesenchymal Transition; Vimentin; Endometriosis; Phosphatidylinositol 3-Kinases; Signal Transduction; Cadherins; Sesquiterpenes; Cell Movement; PTEN Phosphohydrolase
PubMed: 37633416
DOI: 10.1016/j.lfs.2023.122037 -
Bone Research Oct 2023Eradication of MRSA osteomyelitis requires elimination of distinct biofilms. To overcome this, we developed bisphosphonate-conjugated sitafloxacin (BCS, BV600072) and...
Evidence of bisphosphonate-conjugated sitafloxacin eradication of established methicillin-resistant S. aureus infection with osseointegration in murine models of implant-associated osteomyelitis.
Eradication of MRSA osteomyelitis requires elimination of distinct biofilms. To overcome this, we developed bisphosphonate-conjugated sitafloxacin (BCS, BV600072) and hydroxybisphosphonate-conjugate sitafloxacin (HBCS, BV63072), which achieve "target-and-release" drug delivery proximal to the bone infection and have prophylactic efficacy against MRSA static biofilm in vitro and in vivo. Here we evaluated their therapeutic efficacy in a murine 1-stage exchange femoral plate model with bioluminescent MRSA (USA300LAC::lux). Osteomyelitis was confirmed by CFU on the explants and longitudinal bioluminescent imaging (BLI) after debridement and implant exchange surgery on day 7, and mice were randomized into seven groups: 1) Baseline (harvested at day 7, no treatment); 2) HPBP (bisphosphonate control for BCS) + vancomycin; 3) HPHBP (hydroxybisphosphonate control for HBCS) + vancomycin; 4) vancomycin; 5) sitafloxacin; 6) BCS + vancomycin; and 7) HBCS + vancomycin. BLI confirmed infection persisted in all groups except for mice treated with BCS or HBCS + vancomycin. Radiology revealed catastrophic femur fractures in all groups except mice treated with BCS or HBCS + vancomycin, which also displayed decreases in peri-implant bone loss, osteoclast numbers, and biofilm. To confirm this, we assessed the efficacy of vancomycin, sitafloxacin, and HBCS monotherapy in a transtibial implant model. The results showed complete lack of vancomycin efficacy while all mice treated with HBCS had evidence of infection control, and some had evidence of osseous integrated septic implants, suggestive of biofilm eradication. Taken together these studies demonstrate that HBCS adjuvant with standard of care debridement and vancomycin therapy has the potential to eradicate MRSA osteomyelitis.
Topics: Mice; Animals; Vancomycin; Methicillin; Methicillin-Resistant Staphylococcus aureus; Anti-Bacterial Agents; Methicillin Resistance; Staphylococcal Infections; Osseointegration; Disease Models, Animal; Osteomyelitis
PubMed: 37848449
DOI: 10.1038/s41413-023-00287-4