ABSTRACT
In the present study, pins made from the novel Mg-2Zn-2Ga alloy were installed within the femoral bones of six Wistar rats. The level of bioresorption was assessed after 1, 3, and 6 months by radiography, histology, SEM, and EDX. Significant bioresorption was evident after 3 months, and complete dissolution of the pins occurred at 6 months after the installation. No pronounced gas cavities could be found at the pin installation sites throughout the postoperative period. The animals' blood parameters showed no signs of inflammation or toxication. These findings are sufficiently encouraging to motivate further research to broaden the experimental coverage to increase the number of observed animals and to conduct tests involving other, larger animals.
ABSTRACT
The development direction of bioresorbable fixing structures is currently very relevant because it corresponds to the priority areas in worldwide biotechnology development. Magnesium (Mg)-based alloys are gaining high levels of attention due to their promising potential use as the basis for fixating structures. These alloys can be an alternative to non-degradable metal implants in orthopedics, maxillofacial surgery, neurosurgery, and veterinary medicine. In our study, we formulated a Mg-2Zn-2Ga alloy, prepared pins, and analyzed their biodegradation level based on SEM (scanning electron microscopy) and EDX (energy-dispersive X-ray analysis) after carrying out an experimental study on rats. We assessed the resorption parameters 1, 3, and 6 months after surgery. In general, the biodegradation process was characterized by the systematic development of newly formed bone tissue. Our results showed that Mg-2Zn-2Ga magnesium alloys are suitable for clinical applications.
ABSTRACT
Bone grafting and reconstruction are still challenging in clinical practice because of the limitations of bone autografts and the drawbacks of currently approved bone substitutes. We thus developed a gene-activated bone substitute based on octacalcium phosphate and naked plasmid DNA carrying the vascular endothelial growth factor gene. This advanced combined therapy medicinal product had no cytotoxic effects in vitro, slightly decreased bone marrow mesenchymal stromal cell (MSC) doubling time, and was characterized by a prolonged level of gene construct delivery in vivo in a luciferase bioimaging assay. In the model of critically sized cranial bone defects in rabbits, the gene-activated matrix increased bone tissue formation through angiogenesis induction. After preclinical studies, we conducted an open-label non-randomized clinical trial (NCT03076138). The primary study outcome was the proportion of patients with newly formed bone tissue within the surgical area as measured by computed tomography within 6 months after surgery. The main secondary outcomes included frequencies of adverse events (AEs) and serious adverse events (SAEs) as well as the surgical failure rate. After completing the clinical trial, the patients had dental implants placed in the bone grafting area, and trephine biopsy samples were collected. In total, 20 patients with alveolar ridge atrophy (n = 16) and jaw bone defects (n = 4) were enrolled in the study. There were no AEs or SAEs during the clinical trial or the follow-up period (30 months). In all patients, newly formed tissues with a bone density of 908.13 ± 114.40 HU were detected within the zone of bone grafting. There were no significant differences between the subgroups of patients with atrophy and bone defects: 915.28 ± 125.85 and 879.56 ± 48.36 HU, respectively (p = 0.60). Histological analysis showed that the bone grafting area comprised newly formed bone tissue with some fragments of the gene-activated bone substitute partially resorbed and integrated with bone, without fibrous tissue in between. The preclinical data and clinical trial results proved the feasibility, safety, and efficacy of the investigated material for jaw bone grafting, allowing us to bring the world's first gene-activated bone substitute from bench to bedside.
ABSTRACT
OBJECTIVE: To evaluate the psychological status and correlate it with the severity of facial deformities of patients with skeletal malocclusions before orthognathic treatment. MATERIALS AND METHODS: A total of 96 patients aged 15 to 47 with skeletal malocclusions were examined before orthognathic treatment was provided. A photographic analysis was carried out to determine the severity of facial deformity according to the Facial Aesthetic Index (FA1). All patients were divided into three groups according to the FAI score: light (0 to 9), moderate (10 to 19), and severe (>19) facial deformities. Thirty subjects aged 17 to 39 with normal occlusion and attractive harmonious faces without previous orthodontic and/or surgical history were taken as controls. Psychological testing of controls and patients in the study group was performed before orthognathic treatment was provided. RESULTS: Psychological testing showed no statistically significant differences among groups with light and moderate facial deformity and subjects in the control group. Significant differences were encountered among patients with severe facial deformities compared with controls in a series of personality traits, including introversion, neuroticism, trait anxiety, dependency, unsociability, and leadership. CONCLUSIONS: Orthognathic patients with different degrees of facial deformity have different psychological profiles. Patients with light and moderate facial deformity have no significant psychological problems. Patients with severe facial deformity show a significantly higher prevalence of emotional instability, introversion, anxiety, and unsociability. Such psychological profiles make orthognathic patients with severe facial deformity prone to psychological distress, depression, and adverse psychological reactions.
