Benefits and Biosafety of Use of 3D-Printing Technology for Titanium Biomedical Implants: A Pilot Study in the Rabbit Model

Background: Titanium has been used in osteosynthesis for decades and its compatibility and safety is unquestioned. Studies have shown that there is release and collection of titanium in the organ systems with little note of toxicity. The gold standard is considered to be titanium osteosynthesis plate produced by milling methods. The use of customized titanium plates produced with 3D printing, specifically direct metal laser sintering, have found increasing use in recent years. It is unknown how much titanium is released in these printed titanium implants, which is known to be potentially porous, depending on the heat settings of the printer. We hypothesize that the amount of titanium released in printed titanium implants may be potentially more or equal compared to the gold standard, which is the implant produced by milling. Methods: We studied the biosafety of this technology and its products by measuring serum and organ titanium levels after implantation of 3D-printed versus traditionally fabrication titanium plates and screws in a pilot study using the rabbit model. A total of nine rabbits were used, with three each in the control, milled and printed titanium group. The animals were euthanized after six months. Serum and organs of the reticuloendothelial system were harvested, digested and assayed for titanium levels. Results: Organ and serum titanium levels were significantly higher in rabbit subjects implanted with titanium implants (milled and printed) compared to the control group. However, there was no significant difference in organ and serum titanium levels of subjects implanted with milled and traditionally fabricated titanium implants. Conclusions: The biosafety of use of 3D-printed titanium implants and traditionally fabricated titanium implants are comparable. With this in mind, 3D-printed custom implants can not only replace, but will very possibly surpass traditionally fabricated titanium implants in the mode and extent of use.

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Influence of the Thermal Treatment to Address a Better Osseointegration of Ti6Al4V Dental Implants: Histological and Histomorphometrical Study in a Rabbit Model

BioMed Research International ◽

10.1155/2018/2349698 ◽

2018 ◽

Vol 2018 ◽

pp. 1-7 ◽

Cited By ~ 12

Author(s):

Antonio Scarano ◽

Ezio Crocetta ◽

Alessandro Quaranta ◽

Felice Lorusso

Keyword(s):

Thermal Treatment ◽

Dental Implants ◽

Bone Healing ◽

Rabbit Model ◽

Titanium Implants ◽

Control Group ◽

Left Femur ◽

Bone Response ◽

First Choice ◽

Significant Difference

Background. Pure titanium continues to be the first choice for dental implants and represents the gold standard for their biocompatibility and physical and mechanical characteristics, while the titanium alloy (Ti6Al4V) has good mechanical properties. The surface structure of the titanium oxide layer formation on the surface influences and improves the bone response around dental implants. Purpose. The purpose of this study is to evaluate the influence of a thermal treatment of Ti6Al4V implant surfaces and the bone healing response in a rabbit model. Methods. Altogether sixteen implants with same design were inserted into the distal femoral metaphysis. A screw (13 mm long, 4 mm in diameter) was inserted in an implant bed. Each rabbit received two implants, one in the left femur and one in the right femur. The samples were histologically and histomorphometrically evaluated at 8 weeks. Results. A statistically significant difference (p = 0.000034) was present histologically in the percentages of bone-implant contact (BIC) between the test group (BIC = 69.25±4.49%.) and control group (BIC = 56.25 ± 4.8%) by one-way analysis of variance (ANOVA). Significance was set at p ≤ 0.05. Conclusions. The outcome of the present study indicates a novel approach to improving bone healing around titanium implants.

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Bone Regeneration Capability of 3D Printed Ceramic Scaffolds

International Journal of Molecular Sciences ◽

10.3390/ijms21144837 ◽

2020 ◽

Vol 21 (14) ◽

pp. 4837 ◽

Cited By ~ 4

Author(s):

Ju-Won Kim ◽

Byoung-Eun Yang ◽

Seok-Jin Hong ◽

Hyo-Geun Choi ◽

Sun-Ju Byeon ◽

...

Keyword(s):

3D Printing ◽

Bone Regeneration ◽

Negative Control Group ◽

Negative Control ◽

Control Group ◽

Digital Light Processing ◽

Defect Sites ◽

Significant Difference ◽

Printing System ◽

3D Printed

In this study, we evaluated the bone regenerative capability of a customizable hydroxyapatite (HA) and tricalcium phosphate (TCP) scaffold using a digital light processing (DLP)-type 3D printing system. Twelve healthy adult male beagle dogs were the study subjects. A total of 48 defects were created, with two defects on each side of the mandible in all the dogs. The defect sites in the negative control group (sixteen defects) were left untreated (the NS group), whereas those in the positive control group (sixteen defects) were filled with a particle-type substitute (the PS group). The defect sites in the experimental groups (sixteen defects) were filled with a 3D printed substitute (the 3DS group). Six dogs each were exterminated after healing periods of 4 and 8 weeks. Radiological and histomorphometrical evaluations were then performed. None of the groups showed any specific problems. In radiological evaluation, there was a significant difference in the amount of new bone formation after 4 weeks (p < 0.05) between the PS and 3DS groups. For both of the evaluations, the difference in the total amount of bone after 8 weeks was statistically significant (p < 0.05). There was no statistically significant difference in new bone between the PS and 3DS groups in both evaluations after 8 weeks (p > 0.05). The proposed HA/TCP scaffold without polymers, obtained using the DLP-type 3D printing system, can be applied for bone regeneration. The 3D printing of a HA/TCP scaffold without polymers can be used for fabricating customized bone grafting substitutes.

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The Effect of Reflexology on Lactation in Women Who Had Cesarean Section: A Randomized Controlled Pilot Study

Complementary Medicine Research ◽

10.1159/000513924 ◽

2021 ◽

pp. 1-8

Author(s):

Sevde Aksu ◽

Pelin Palas Karaca

Keyword(s):

Pilot Study ◽

Cesarean Section ◽

Intervention Group ◽

Control Group ◽

Breast Pain ◽

Randomized Controlled ◽

Significant Difference ◽

The Right ◽

Documentation Tool ◽

And Control

Aim: The research was conducted as a randomized controlled pilot study to evaluate the effects of reflexology on lactation in mothers who delivered by cesarean section (CS). Methods: A single-blind randomized controlled experimental study was conducted with a total of 60 postpartum women in the reflexology application (n = 30) and control groups (n = 30). After the CS, the mothers in the control group were given approximately 3-h routine nursing care after recovering from the effects of anesthesia; the introductory information form was applied, and the Breastfeeding Charting System and Documentation Tool (LATCH) and visual analog scale (VAS) for the signs of the onset of lactation were implemented on the first and second days. Reflexology was applied to the women in the intervention group after an average of 3 h following the mother’s condition had become stable and she had recovered from the effects of anesthesia. Reflexology was applied a total of 20 min – 10 min for the right foot, 10 min for the left foot – twice a day with 8-h intervals on the first and second days after CS. After the last reflexology application, the LATCH and VAS for the signs of the onset of lactation were applied. Results: Of the women, 70% breastfed their babies within 60 min after delivery; 46.7% of the mothers received breastfeeding training and 81.7% needed support for breastfeeding after the CS. The LATCH breastfeeding scores of the women in the intervention group on both days were significantly higher compared to those of the women in the control group (p < 0.001). On the first day after the CS, apart from breast pain, there was no significant difference between the two groups in terms of breast heat and breast tension (p > 0.05). On the second day after the CS, apart from breast tension, there was no significant difference between the groups in terms of breast heat and breast pain (p < 0.05). In the study, women in the intervention group were found to have higher scores in terms of all three symptoms compared to the control group (p < 0.05). Conclusions: In the study, it was determined that LATCH scores and signs of the onset of breastfeeding increased in the mothers who received reflexology after CS.

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Investigation of three-dimensional printing materials for printing aorta model replicating Type B aortic dissection

Current Medical Imaging Formerly Current Medical Imaging Reviews ◽

10.2174/1573405617666210218102046 ◽

2021 ◽

Vol 17 ◽

Author(s):

Chia-An Wu ◽

Andrew Squelch ◽

Zhonghua Sun

Keyword(s):

3D Printing ◽

Aortic Dissection ◽

Three Dimensional ◽

Ct Images ◽

Patient Specific ◽

Type B ◽

Type B Aortic Dissection ◽

Ct Attenuation ◽

Significant Difference ◽

3D Printed

Aim: To determine a printing material that has both elastic property and radiology equivalence close to real aorta for simulation of endovascular stent graft repair of aortic dissection. Background: With the rapid development of three-dimensional (3D) printing technology, a patient-specific 3D printed model is able to help surgeons to make better treatment plan for Type B aortic dissection patients. However, the radiological properties of most 3D printing materials have not been well characterized. This study aims to investigate the appropriate materials for printing human aorta with mechanical and radiological properties similar to the real aortic computed tomography (CT) attenuation. Objective: Quantitative assessment of CT attenuation of different materials used in 3D printed models of aortic dissection for developing patient-specific 3D printed aorta models to simulate type B aortic dissection. Method: A 25-mm length of aorta model was segmented from a patient’s image dataset with diagnosis of type B aortic dissection. Four different elastic commercial 3D printing materials, namely Agilus A40 and A50, Visijet CE-NT A30 and A70 were selected and printed with different hardness. Totally four models were printed out and conducted CT scanned twice on a 192-slice CT scanner using the standard aortic CT angiography protocol, with and without contrast inside the lumen.Five reference points with region of interest (ROI) of 1.77 mm2 were selected at the aortic wall and intimal flap and their Hounsfield units (HU) were measured and compared with the CT attenuation of original CT images. The comparison between the patient’s aorta and models was performed through a paired-sample t-test to determine if there is any significant difference. Result: The mean CT attenuation of aortic wall of the original CT images was 80.7 HU. Analysis of images without using contrast medium showed that the material of Agilus A50 produced the mean CT attenuation of 82.6 HU, which is similar to that of original CT images. The CT attenuation measured at images acquired with other three materials was significantly lower than that of original images (p<0.05). After adding contrast medium, Visijet CE-NT A30 had an average CT attenuation of 90.6 HU, which is close to that of the original images with statistically significant difference (p>0.05). In contrast, the CT attenuation measured at images acquired with other three materials (Agilus A40, A50 and Visiject CE-NT A70) was 129 HU, 135 HU and 129.6 HU, respectively, which is significantly higher than that of original CT images (p<0.05). Conclusion: Both Visijet CE-NT and Agilus have tensile strength and elongation close to real patient’s tissue properties producing similar CT attenuation. Visijet CE-NT A30 is considered the appropriate material for printing aorta to simulate contrast-enhanced CT imaging of type B aortic dissection. Due to lack of body phantom in the experiments, further research with simulation of realistic anatomical body environment should be conducted.

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Effect of Titanium Implants Coated with Radiation-Crosslinked Collagen on Stability and Osseointegration in Rat Tibia

Materials ◽

10.3390/ma11122520 ◽

2018 ◽

Vol 11 (12) ◽

pp. 2520 ◽

Cited By ~ 4

Author(s):

Eun-Bin Bae ◽

Ji-Hyun Yoo ◽

Sung-In Jeong ◽

Min-Su Kim ◽

Youn-Mook Lim ◽

...

Keyword(s):

Gamma Radiation ◽

Human Mesenchymal Stem Cells ◽

Region Of Interest ◽

Bone Volume ◽

Titanium Implants ◽

Control Group ◽

Gene Expressions ◽

Significant Difference

This study aimed to evaluate the titanium (Ti) implants coated with collagen type Ⅰ crosslinked using gamma-irrigation or glutaraldehyde (GA). The in vitro surface observations, quantification assay, and cell studies using human mesenchymal stem cells (hMSCs) were conducted. For in vivo experiments, the implants were divided into three groups and inserted into the rat tibias: control group (non-treated Ti implant), GA group (Ti implants coated with GA-crosslinked collagen) and 25 kGy group (Ti implants coated with gamma-radiation-crosslinked collagen at dose of 25 kGy). The animals were sacrificed at 4 weeks after implantation and the tissue sections were obtained. New bone volume (mm3) and bone-to-implant contact (BIC, %) within the region of interest (ROI) was measured. The in vitro results showed the highest osteogenic differentiation and levels of osteogenesis-related gene expressions in the 25 kGy group without cytotoxicity. The new bone volume of GA group was significantly higher than the control (p < 0.05). In the result of the BIC, the 25 kGy group was significantly higher than the control (p < 0.05). However, there was no significant difference between the experimental groups. Within the limitations of this study, Ti implant coated with gamma-radiation-crosslinked collagen has potential utility without side effects from chemical agents.

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Oral Hygiene in a Sample of Children/Adolescents Living in Family-Homes from the Province of Milan (Italy): A Pilot Study

Dentistry Journal ◽

10.3390/dj8020033 ◽

2020 ◽

Vol 8 (2) ◽

pp. 33 ◽

Cited By ~ 3

Author(s):

Alessandro Nota ◽

Floriana Bosco ◽

Shideh Ehsani ◽

Francesca Giugliano ◽

Giulia Moreo ◽

...

Keyword(s):

Pilot Study ◽

Oral Hygiene ◽

Clinical Results ◽

Plaque Index ◽

Control Group ◽

Controlled Clinical Trial ◽

Study Group ◽

Significant Difference ◽

And Gender ◽

Oral Hygiene Instructions

Objective: This pilot study is a prospective controlled clinical trial, designed to evaluate the short-term clinical results (the plaque index) of an educational/motivational program for home oral hygiene, directed to children and adolescents who live in family-homes. Methods: The setting of the project was the province of Milan (Italy), where two family-homes were selected. The study group included 26 children (16 females and 10 males) aged between 7 and 15 years, of Italian nationality, from the family-home communities. The control group included 26 children (15 females and 11 males, aged between 7 and 15 years) of Italian nationality, matched for age and gender distribution with the study group, that were not in a socially disadvantaged condition. Collection of the plaque index (PI) was performed at t0. Then, all basic oral hygiene instructions were given to all children/adolescents and their educators. Education and motivation were repeated in the same way after 4–7 weeks (T1), and after 10–12 weeks (T2). The PI was taken also at T1 and T2. Results: An improvement in the PI was generally found in both groups, but there was no statistically significant difference between the two groups over time. Multivariate analysis of variance (MANOVA) revealed a statistically significant effect of time [F (1, 52) = 90.73, p < 0.001], regardless of the assignment group, in consequence of which the plaque index presented a moderate and significant improvement. Conclusion: The present data confirm the validity of the educational/motivational program to improve oral hygiene in children/adolescents, regardless of the assignment group.

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Vestibular rehabilitation using video gaming in adults with dizziness: a pilot study

The Journal of Laryngology & Otology ◽

10.1017/s0022215118000075 ◽

2018 ◽

Vol 132 (3) ◽

pp. 202-206 ◽

Cited By ~ 9

Author(s):

J S Phillips ◽

J Fitzgerald ◽

D Phillis ◽

A Underwood ◽

I Nunney ◽

...

Keyword(s):

Quality Of Life ◽

Clinical Trial ◽

Pilot Study ◽

Vestibular Rehabilitation ◽

University Hospital ◽

Control Group ◽

Rehabilitation Protocol ◽

Wii Fit ◽

Significant Difference

AbstractObjective:To determine the effectiveness of vestibular rehabilitation using the Wii Fit balance platform, in adults with dizziness.Methods:A single-site prospective clinical trial was conducted in a university hospital in the UK. Forty patients with dizziness, who would normally be candidates for vestibular rehabilitation, were identified and considered as potential participants. Participants were randomised into either the treatment group (the Wii Fit group) or the control group (standard customised vestibular rehabilitation protocol). Participants were assessed over a 16-week period using several balance and quality of life questionnaires.Results:Both exercise regimes resulted in a reduction of dizziness and an improvement in quality of life scores over time, but no statistically significant difference between the two interventions was identified.Conclusion:This pilot study demonstrated that use of the Wii Fit balance platform resulted in a statistically significant improvement in balance function and quality of life. Furthermore, outcomes were comparable to a similar group of individuals following a standard customised vestibular rehabilitation protocol. The study provides useful information to inform the design and execution of a larger clinical trial.

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Development of Soft sEMG Sensing Structures Using 3D-Printing Technologies

Sensors ◽

10.3390/s20154292 ◽

2020 ◽

Vol 20 (15) ◽

pp. 4292

Author(s):

Gerjan Wolterink ◽

Pedro Dias ◽

Remco G. P. Sanders ◽

Frodo Muijzer ◽

Bert-Jan van Beijnum ◽

...

Keyword(s):

3D Printing ◽

Biceps Brachii ◽

Low Cost ◽

Recognition Algorithm ◽

Practical Applications ◽

Variable Level ◽

Processing Step ◽

Significant Difference ◽

3D Printed ◽

Emg Electrodes

3D printing of soft EMG sensing structures enables the creation of personalized sensing structures that can be potentially integrated in prosthetic, assistive and other devices. We developed and characterized flexible carbon-black doped TPU-based sEMG sensing structures. The structures are directly 3D-printed without the need for an additional post-processing step using a low-cost, consumer grade multi-material FDM printer. A comparison between the gold standard Ag/AgCl gel electrodes and the 3D-printed EMG electrodes with a comparable contact area shows that there is no significant difference in the EMG signals’ amplitude. The sensors are capable of distinguishing a variable level of muscle activity of the biceps brachii. Furthermore, as a proof of principle, sEMG data of a 3D-printed 8-electrode band are analyzed using a patten recognition algorithm to recognize hand gestures. This work shows that 3D-printed sEMG electrodes have great potential in practical applications.

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Influence of Intra-Articular Administration of Trichostatin A on Autologous Osteochondral Transplantation in a Rabbit Model

BioMed Research International ◽

10.1155/2015/470934 ◽

2015 ◽

Vol 2015 ◽

pp. 1-8 ◽

Cited By ~ 1

Author(s):

Huacheng Hou ◽

Ke Zheng ◽

Guanghu Wang ◽

Shiro Ikegawa ◽

Minghao Zheng ◽

...

Keyword(s):

Articular Cartilage ◽

Cartilage Repair ◽

Trichostatin A ◽

Interleukin 1 ◽

Rabbit Model ◽

Treated Group ◽

Control Group ◽

Osteochondral Transplantation ◽

Autologous Osteochondral Transplantation ◽

Significant Difference

Autologous osteochondral transplantation (AOT) is a method for articular cartilage repair. However, several disadvantages of this method have been reported, such as transplanted cartilage degeneration and the lack of a connection between the grafted and adjacent cartilage tissues. To evaluate the effect of intra-articular administration of trichostatin A (TSA) on AOT, we conducted a case control study in a rabbit model. International Cartilage Repair Society (ICRS) macroscopic scores, the modified O’Driscoll histology scores, and real-time PCR were utilized to evaluate the results. At 4 weeks, both macroscopic and histological assessments showed that there was no significant difference between the TSA and control groups. However, the mean macroscopic and histological scores for the TSA-treated group were significantly higher than the scores for the control group at 12 weeks. TSA was shown to directly reduce collagen type II (COL2), aggrecan, matrix metalloproteinase (MMP), and a disintegrin and metalloproteinase domain with thrombospondin motifs 5 (ADAMTS-5) expression and to simultaneously repress the upregulation of MMP-3, MMP-9, and MMP-13 levels induced by interleukin 1β(IL-1β) in chondrocytes. In conclusion, TSA protects AOT grafts from degeneration, which may provide a benefit in the repair of articular cartilage injury.

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Use of N-butyl cyanoacrylate in nasal septoplasty: histopathological evaluation using rabbit nasal septum model

The Journal of Laryngology & Otology ◽

10.1017/s0022215110000095 ◽

2010 ◽

Vol 124 (7) ◽

pp. 753-758 ◽

Cited By ~ 4

Author(s):

F Aksoy ◽

F Yılmaz ◽

Y S Yıldırım ◽

K Gideroglu ◽

Z Tatar

Keyword(s):

Nasal Septum ◽

Rabbit Model ◽

Tissue Adhesive ◽

Control Group ◽

Open Approach ◽

Septal Surgery ◽

Nasal Floor ◽

Significant Difference ◽

Histopathological Evaluation ◽

Haematoma Formation

AbstractObjectives:This study was designed to investigate the effects of the tissue adhesive N-butyl cyanoacrylate on nasal septal tissues after septal surgery in a rabbit model.Methods:Forty-two adult New Zealand rabbits were randomly divided into three groups (14 in each group): septoplasty alone, septoplasty plus N-butyl cyanoacrylate, and controls. The open approach was used to explore the nasal septum. After raising mucoperichondrial and mucoperiosteal flaps on both sides of the septum, the septum was detached from the nasal floor in the septoplasty alone and septoplasty plus N-butyl cyanoacrylate groups. In the septoplasty plus N-butyl cyanoacrylate group, the mucoperichondrial and mucoperiosteal flaps were fixed to the septum and the septum was fixed lateral to the nasal spine using N-butyl cyanoacrylate; in the septoplasty alone group, the septum was packed with Merocel. In the control group, no further septal surgery was performed after flap elevation. Animals were observed for bleeding and haematoma formation over the first 24 hours. Seven animals in each group were used to evaluate early histopathological effects on the septal tissues, at four weeks post-operatively; the other seven in each group were used to evaluate late effects, at 12 weeks.Results:Haematoma formation was observed in 10 animals in the septoplasty alone group, in four animals in the control group, and in only one animal in the septoplasty plus N-butyl cyanoacrylate group. The difference in haematoma incidence between the septoplasty alone and the septoplasty plus N-butyl cyanoacrylate groups was significant (p = 0.000). Histopathological evaluation revealed no significant difference between the groups as regards granulation tissue formation at week four versus week 12; however, there was a significant difference between the septoplasty plus N-butyl cyanoacrylate group and the control groups as regards inflammation at week 12 (p = 0.038). There was a significant difference between the septoplasty plus N-butyl cyanoacrylate group and the septoplasty alone group as regards the composition of the bone–cartilage junction zone at week four (p = 0.001). There was also a significant difference between the septoplasty plus N-butyl cyanoacrylate group and the control group as regards the cellular structure of new cartilage formation at week 12 (p = 0.004).Conclusions:In this rabbit septoplasty model, N-butyl cyanoacrylate appeared to be an effective nasal tissue adhesive, with a low complication rate.

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