Follow the technical history of IBI products and keep yourself updated on new results.
Poonia N, Morales H, Mahesh L.
A patient with failed implant in relation to 44 was being referred to the dental office. Site 44 was reimplanted with AB Dent dental implants, and guided bone regeneration was done with Smartbone® bone graft and resorbable collagen membrane. Root submerged technique was followed in relation to 45. One year postoperative follow-up shows stable bone levels in relation to 44, 45, and 46.
Dr. Maurizio Martini, Dr. Anna Zazzetta (Macerata, Italy – Dubai, UAE)
Bone grafting has always been considered a challenge for dentists. Initially the diffusion of this procedure was conditioned by the need of invasive surgery, bone harvesting and the morbidity of the patient. Now its diffusion will be ever more necessary due to the spread of implantology. SmartBone allows dentists to reduce the patient’s morbidity, have an optimal osteointegration in order to achieve the best outcomes in implant surgery. In particular, the service “SmartBone on Demand” allows to obtain a custom-made graft to provide the exact required quantity of bone for the specific needs of the patient.
Delfo D’Alessandro, Giuseppe Perale, Mario Milazzo, Stefania Moscato, Cesare Stefanini, Gianni Pertici, Serena Danti
The ideal scaffold for bone regeneration is required to be highly porous, non-immunogenic, biostable until the new tissue formation, bioresorbable and osteoconductive. This study aimed at investigating the process of new bone formation in patients treated with granular SmartBone for sinus augmentation, providing an extensive histologic analysis. Five biopsies were collected at 4–9 months post SmartBone implantation and processed for histochemistry and immunohistochemistry. Histomorphometric analysis was performed. Bone-particle conductivity index (BPCi) was used to assess SmartBone osteoconductivity. At 4 months, SmartBone (12%) and new bone (43.9%) were both present and surrounded by vascularized connective tissue (37.2%). New bone was grown on SmartBone1 (BPCi = 0.22). At 6 months, SmartBone was almost completely resorbed (0.5%) and new bone was massively present (80.8%). At 7 and 9 months, new bone accounted for a large volume fraction (79.3% and 67.4%, respectively) and SmartBone1 was resorbed (0.5% and 0%, respectively). Well-oriented lamellae and bone scars, typical of mature bone, were observed. In all the biopsies, bone matrix biomolecules and active osteoblasts were visible. The absence of inflammatory cells confirmed SmartBone1 biocompatibility and nonimmunogenicity. These data indicate that SmartBone1 is osteoconductive, promotes fast bone regeneration, leading to mature bone formation in about 7 months.
E.C. Ekwueme, J.M. Patel, J.W. Freeman, S. Danti
The skeletal system provides structure, protection, and movement to the body through bones, cartilages, tendons, and ligaments. Many congenital, traumatic, and degenerative diseases may affect the function of skeletal tissues during the life span, leading to the necessity of very specific replacements and treatments. In the widespread and mechanically constraining scenario of skeletal pathologies, biodegradable polymers can play unique roles that should not only be confined to adjuvant bulk devices. Tissue engineering has recently renewed the attention towards this class of biomaterials, enchantingly exploiting their outstanding versatility to accomplish smart and biomimetic solutions to surgical and therapeutic needs. This chapter describes the most recent achievements in this field, focusing on tissue type- and subtype-specific replacements, while taking into account clinical applications and future trends.
Pertici G , Carinci F , Carusi G , Epistatus D , Villa T , Crivelli F , Rossi F , Perale G
Bovine bone xenografts, made of hydroxyapatite (HA), were coated with poly(L-lactide-co-ε-caprolactone) (PLCL) and RGD-containing collagen fragments in order to increase mechanical properties, hydrophilicity, cell adhesion and osteogenicity. In vitro the scaffold microstructure was investigated with Environmental Scanning Electronic Microscopy (ESEM) analysis and micro tomography, while mechanical properties were investigated by means compression tests. In addition, cell attachment and growth within the three-dimensional scaffold inner structure were validated using human osteosarcoma cell lines (SAOS-2 and MG-63). Standard ISO in vivo biocompatibility studies were carried out on model animals, while bone regenerations in humans were performed to assess the efficacy of the product. All results from in vitro to in vivo investigations are here reported, underlining that this scaffold promotes bone regeneration and has good clinical outcome.
Grecchi F, Perale G, Candotto V, Busato A, Pascali M, Carinci F
The repair of complex craniofacial bone defects is challenging and a successful result depends on the defect size, the quality of the soft tissue covering the defect and the choice of reconstructive method. Autologous bone grafts are the gold standard for bone replacement. Tissue engineered constructs are temporary substitutes developed to treat damaged or lost tissue. Recent advances in materials science have provided an abundance of innovations, underlining the increasing importance of polymer in this field. The Galeazzi Orthopedical institute of Milan received a Serbian soldier who reported a deep wound, due to the explosion of a grenade, during former-Yugoslavia’s war. His left cheekbone was completely lost, together with the floor of the left eye. SmartBone® technology allowed the realization of custom-made grafts which perfectly fitted the bone defect thanks to mechanical strength, also at small thicknesses, and the ability to be shaped without powder formation or unpredicted fractures. Tissue engineering approaches to regeneration utilize 3-dimensional (3D) biomaterial matrices that interact favorably with cells. The potential benefits of using a tissue engineering approach include reduced donor site morbidity, shortened operative time, decreased technical difficulty of the repair, ability to closely mimic the in vivo microenvironment in an attempt to recapitulate normal craniofacial development: this 36-month case study allowed to prove that SmartBone® custom-made bone grafts are an effective solution, gathering such benefits and being available now for daily routine.
Ilaria Zollino, Giorgio Carusi, Francesco Carinci, Giuseppe Perale
The present case reports the success rate after 8 months of follow-up in a sinus pneumatization case with maxillary sinus floor cortical bone loss due to 2.5 dental agenesis. Rehabilitation including the opportunity to insert a contextual implant during maxillary sinus lift surgery was planned, using SmartBone® Microchips heterologous bone inserted into the maxillary sinus. The newly developed bone substitute was designed starting from bovine bone derived mineral matrix, reinforced with bioresorbable aliphatic polymers and cell nutrients. SmartBone® Microchips showed a tight contact with the new bone and neither gaps nor fibrous tissues at the interface. No inflammation or foreign body reaction were observed, and these findings support the good biocompatibility of SmartBone® Microchips composite material. Moreover, new bone, thanks to its mechanical properties, consented to fix screw in combination with maxillary sinus floor elevation for a dental implant.
The newly developed bone substitute SmartBone® Microchips showed in a patient with jaw cortical pavement defect a tight contact with the new bone and neither gaps nor fibrous tissues at the interface. No inflammation or foreign body reaction were observed, and these findings support the good biocompatibility of SmartBone® Microchips composite material. Moreover, new bone, thanks to its mechanical properties, consented to fix one screw in combination with maxillary sinus floor elevation for the dental implant. All these statements showed the good suitability of SmartBone® Microchips for alveolar defect repair in sinus lift procedure
Ottardi C, Pertici G, Perale G, Vitta TMT
L. Laffranchi, B. Buffoli, R. Boninsegna, F. Zotti, F. Savoldi, P. Fontana, S. Bonetti, L. Visconti, L.F. Rodella, C. Paganelli
Purpose: Scaffolds play a critical role in tissue engineering, which aims to regenerate missing tissues or organs. For developing an effective bone regeneration strategy, we studied the efficacy of bone regeneration using the innovative bone scaffold “Reinforced Bioactive Bone Chip” (IBI SA-Mezzovico, Ticino-CH), which has been specifically developed for applications in regenerative medicine and therapy bone tissue engineering, on the calvarial defect of rats.
Methods and materials: A full-thickness defect (5mm×8mm) was created on each parietal region of Wistar rats (Harlan, Italy) by piezosurgery, a surgical technique that creates an effective osteotomy with no trauma to soft tissue and without causing bone necrosis. Bone scaffold was implanted in the right cranial defect whereas the left defect was used as control. Macroscopical evaluation of the surgical site and histological studies were performed to investigate the level of bone formation.
Results: The results confirmed that the treated defects with “Reinforced Bioactive Bone Chip” scaffold showed significant bone formation and maturation in comparison with the control group.
Conclusion: These results are promising and “Reinforced Bioactive Bone Chip” could be considered for future clinical use in human, mainly in the field of regeneration and/or replacement of bone tissue compartment of maxillofacial surgery.
G Pertici, F Rossi, T Casalini, G Perale
This study discusses composite polymer-coated mineral grafts for bone regeneration.
Bone xenografts are coated with degradable synthetic [poly(L-lactide-co-e-caprolactone)] and natural (polysaccharides) polymers in order to increase their mechanical properties, on one side, and to improve cell adhesion, on the other, with the purpose of developing a novel composite material for bone tissue engineering. In vitro assays help examine the microstructure of the scaffold by Fourier transform infrared and environmental scanning electron microscopy analyses and the porosity of the material by micro-computed tomography. The good adhesion property of polymer coated on to the mineral scaffold is deeply analysed and proved. The in vitro polymer degradation, in terms of time evolution of polymer-coating thickness, was rationalised with a mathematical model. The purpose of such modelling activity is to provide a simple but powerful tool to understand the influence of design parameters on coating behaviour.
The fabricated bone graft exhibited regular microstructure similar to healthy iliac bones with an average of 27% open porosity and an adequately rigid structure, which ensures a better osteointegration once implanted.
This approach avoids the use of trialand-error methods and consents a better a priori material design.
G. Pertici, F. Grecchi, G. Perale
Scaffolds for bone regeneration should ensure both mechanical stability and strength. Moreover, their intimate structure should have an adequate interconnected porous network for cell migration and proliferation, while also providing specific signals for bone regeneration. SmartBone® composite solution, based on a novel concept of biomaterial assembly, bearing cues from both mineral components and polymeric ones [1-3], was chosen to develop new patient-specific three-dimensional bone grafts. Indeed, thanks to mechanical performances and to full control over production, custom-made bone grafts can be produced according to the specific need of each single patient, via digital surgical planning, starting from CT scans.
Filippo Rossi, Marco Santoro, Giuseppe Perale
Although bone has a high potential to regenerate itself after damage and injury, the efficacious repair
of large bone defects resulting from resection, trauma or non-union fractures still requires the
implantation of bone grafts. Materials science, in conjunction with biotechnology, can satisfy these
needs by developing artificial bones, synthetic substitutes and organ implants. In particular, recent
advances in polymer science have provided several innovations, underlying the increasing importance
of macromolecules in this field. To address the increasing need for improved bone substitutes,
tissue engineering seeks to create synthetic, three-dimensional scaffolds made from polymeric materials,
incorporating stem cells and growth factors, to induce new bone tissue formation. Polymeric
materials have shown a great affinity for cell transplantation and differentiation and, moreover, their
structure can be tuned in order to maintain an adequate mechanical resistance and contemporarily
be fully bioresorbable. This review emphasizes recent progress in polymer science that allows relaible
polymeric scaffolds to be synthesized for stem cell growth in bone regeneration. Copyright © 2013
John Wiley & Sons, Ltd.
G. Perale, G. Pertici, A. Motroni, L. Livi, A. Busato, F. Grecchi
Industrie Biomediche Insubri SA (IBI) developed new technologies to improve the properties of natural materials for biomedical applications: indeed, IBI produces Smartbone®, a bone substitute specifically developed for orthopaedic reconstructive surgery. This innovative scaffold has a composite structure based on a bovine derived bone matrix reinforced with biodegradable polymers and bioactive agents.
The bovine derived matrix allows maintaining an adequate 3D-structure, with an open-porosity and a biomimetic chemistry (Ca and P based), biopolymers permit to achieve good mechanical properties (in the range of healthy human cortical bone), while bioactive agents promote cell adhesion, proliferation and high hydrophilicity (essential also for blood absorption and thus sparkling chemical signals cascade for regeneration). Smartbone® is produced according to GMP (Good Manufacturing Practice) standards, applying only human-use approved components and CE mark is under obtainment for both conventional and unconventional shapes.
Thanks to the very high performances of Smartbone®, particularly its impressively higher mechanical properties with respect to other bone substitutes, IBI developed and launched custom-made products, “SmartBone® on demand™”, solving single specific cases of bone reconstruction: starting from a common CT scan, IBI can provide the adequate substitute for every kind of defect.
This technology was successfully applied to a custom reconstruction of the left cheekbone portion of a young man who was hit by a grenade during former-Yugoslavian war. Patient CT scan was acquired, a 3D real model was built by stereolithography, grafts were manually shaped on the real model while planning surgery. Mathematical files of the so obtained grafts shapes were used to pilto a CAM 5-axis machine to cut the final shape of raw materials that were then reinforced with IBI’s proprietary process. Once in operatory room, present residuals, applied aside the battlefield, were removed, leaving space for the custom made graft. Surgery was fast and very precise allowing to obtain a very satisfactory result both in terms of anatomical reconstruction and also functional.
G. Pertici, M. Müller, F. Rossi, T. Villa, G. Carusi, S. Maccagnan, F. Carù, F. Crivelli, G. Perale
Scaffolds for bone tissue engineering should ensure both mechanical stability and strength. Moreover, their intimate structure should have an adequate interconnected porous network for cell migration and proliferation, while also providing specific signals for bone regeneration.
A composite solution, based on a novel concept of biomaterial assembly, bearing cues from both mineral components and polymeric ones, was here followed to develop a new three-dimensional bone scaffold. A bovine derived mineral matrix was used to provide adequate 3D structure and porosity, while a resorbable biopolymer was used to reinforce it. Bioactive agents were added to promote cell adhesion and proliferation.
Microstructure was evaluated by E/SEM and micro-CT, confirming a strong resemblance with human cortical bone in terms of open mid-sized porosity. Compression tests evidenced a maximum stress capability (20MPa av.) three times higher than best available bovine derived bone, with a four-fold improved Young’s modulus (0.2GPa av.).
Overall mechanical behaviour was typical of open cellular structures: a first pseudo-linear and pseudo-elastic behaviour, due to structural resistance, was followed by oscillating behaviour due to progressive breakage of structure and consequent matrix compacting. Moreover, it resulted feasible for reconstructive surgery, being both easy to shape and resistant to screws and fixation manoeuvres.
Citocompatibility and cell viability were positively assessed in vitro with standard SAOS-2 and MG-63 line cells. Human adipose tissue derived mesenchymal stem cells were also tested and data showed in vitro capability to properly colonize the scaffold and, once induced, to differentiate.
Tibial grafts on adult white New Zealand rabbits were performed to assess in vivo osteointegration during 4 months observations. Histological analysis proved confirmation of matrix integration with natural bone and showed cells and vessels colonizing pores within it during time.
Data collected represent a complete proof of concept for this new scaffold and its application for bone tissue regeneration.
S. Maccagnan, G. Perale, T. Cappelletti, G. Pertici
Polymer processing is at the days of the more challenging evolutions of the medical device industry. The reason of that is strongly related to the molecular characteristics of the polymer, which are able to induce unique properties in the device and in each of its components. It is obvious that if the raw material gets spoiled during the process it will differ from the expected properties in a way that will be proportional to the level of complexity of the macromolecules.
Microexrtusion is a kind of process which allows not simply to preserve such properties, but also to combine several polymers with different properties in the same volume inducing different features on the base of the relative position within the device.