Publications

Follow the technical history of IBI products and keep yourself updated on new results.

3D complex Custom-Made Bone Reconstruction with Innovative Biomaterial 3D complex Custom-Made Bone Reconstruction with Innovative Biomaterial
Date:2017
Journal:Congress SICMFS 2017, Napoli
Authors:

E. Facciuto, C. F. Grottoli, M. Mattarocci, F. Illiano, G. Perale, G. Pertici

Abstract

Grafts for bone reconstruction should ensure both mechanical stability and strength. Moreover, their structure should have an adequate interconnected porosity 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 three dimensional structure and porosity, while a combination of resorbable polymers were used to reinforce it. Bioactive agent was added to promote cell colonization and proliferation. Thanks to the very high performances of this material (SmartBone® ), particularly its impressively higher mechanical properties with respect to the other bone substitutes, Industrie Biomediche Insubri SA (IBI, Switzerland) developed custom-made products “SmartBone®  On Demand™”, solving single specific cases of bone reconstruction: starting from CT scan, IBI can provide the adequate substitute for every kind of defects. Moreover, all data reported in previous scientific papers, indicate that SmartBone is osteoconductive, promotes fast bone regeneration, leading to mature bone formation in about 7 months. This technology was successfully applied to a custom reconstruction of frontal bone and supraorbital foramen in a 30 years old male. Twelve customized grafts were designed in order to fill the complex cavity of the defect using a puzzle technique adopting SmartBone®  on demand™. During the surgery each piece were located perfectly inside the gap and fixed strongly adopting small osteosynthesis titanium screws. Surgery was fast and very precise allowing to obtain a very satisfactory results both in terms of anatomical reconstruction and functional. The surgical operation was no longer than two hours and forty-five minutes reducing dramatically the common timing for this kind of surgeries. The post-operative situation is optimal. The TC-scan after 10 months shows an impressive result. In conclusion, this technique permits a full complete restoration with custom made bone grafts.

New frontiers in bone regeneration: bone graft on-demand New frontiers in bone regeneration: bone graft on-demand
Date:2017
Journal:Poster at AEEDC 2017, Duabi, UAE
Authors:

Dr. Maurizio Martini, Dr. Anna Zazzetta (Macerata, Italy – Dubai, UAE)

Abstract

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.

Socket Preservation Using a Small Particulate Xenograft: A Case Report Socket Preservation Using a Small Particulate Xenograft: A Case Report
Date:2017
Journal:The Journal of Implant & Advanced Clinical Dentistry - Vol 9, No. 4 - Digital Edition
Authors:

Mahesh L., Aran Shetty D., Shukla S.

Abstract

Soon after tooth extraction a cascade of bone remodeling starts which result in bone resorption. Procedures such Socket Seal Surgery can be employed to preserve future implant site. There are various grafts which can used for the same purpose. The best method to observe a graft’s healing is surgical re-entry and or histopathology. The aim of this Case Report is to document the use of Smartbone® xenograft for socket preservation. After 5 months of healing, histopathological core sampling revealed good osteoconduction of the graft.

Management of a Failed Implant Site with Guided Bone Regeneration, Reimplantation, and Root Submergence Technique Management of a Failed Implant Site with Guided Bone Regeneration, Reimplantation, and Root Submergence Technique
Date:2017
Journal:International Journal of Oral Implantology and Clinical Research
Authors:

Poonia N, Morales H, Mahesh L.

Abstract

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.

Bovine bone matrix/poly(L-lactic-co-e-caprolactone)/gelatin hybrid scaffold (SmartBone) for maxillary sinus augmentation: A histologic study on bone regeneration Bovine bone matrix/poly(L-lactic-co-e-caprolactone)/gelatin hybrid scaffold (SmartBone) for maxillary sinus augmentation: A histologic study on bone regeneration
Date:2017
Journal:International Journal of Pharmaceutics
Authors:

Delfo D’Alessandro, Giuseppe Perale, Mario Milazzo, Stefania Moscato, Cesare Stefanini, Gianni Pertici, Serena Danti

Abstract

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.

Biohybrid materials: inspired by nature to repair bones Biohybrid materials: inspired by nature to repair bones
Date:2016
Journal:eCM Meeting Abtsracts 2016, Collection 4; eCM XVII (page 35)
Authors:

G. Perale

Abstract

Evidence of clinical needs related to bone reconstruction dates back to ancient Egypt. A more rigorous scientific approach has been followed since 1889, when “modern” scientists started to focus their efforts on what can be defined as the early bone tissue engineering [1]. Nature here provides the key inspiration to new generation devices, where a composite approach is taking the lead by the smart combination of bio and nano-technologies to replicate the intimate bone structure. The goal of a new approach is hence to combine the biocompatibility and tissue integration of natural materials with the possibility to tune mechanical and physical properties typical of synthetic ones: composite grafts best mimic the real nature of healthy human bone, being rigid and elastic, compact but porous, dense but viable to cells and vessels [2].

Applications of Bioresorbable Polymers in the skeletal systems (cartilages, tendons, bones) Applications of Bioresorbable Polymers in the skeletal systems (cartilages, tendons, bones)
Date:2016
Journal:Bioresorbable Polymers for Biomedical Applications - Pages 391-422 Woodhead Publishing Series in Biomaterials: Number 120 Edited by Giuseppe Perale and Jons Hilborn
Authors:

E.C. Ekwueme, J.M. Patel, J.W. Freeman, S. Danti

Abstract

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.

 

Positioning of a Contextual Implant Along with a Sinus Lift with Smartbone® Microchips of Composite Heterologous-Synthetic Bone Positioning of a Contextual Implant Along with a Sinus Lift with Smartbone® Microchips of Composite Heterologous-Synthetic Bone
Date:2016
Journal:Indian Journal Stomatology 2015/Volume 6/Issue 2
Authors:

Ilaria Zollino, Giorgio Carusi, Francesco Carinci, Giuseppe Perale

Abstract

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.

Conclusion

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

Bone matrix/copolymer/gelatin scaffold (SmartBone®) as a biomimetic graft for sinus lift procedure in dental surgery Bone matrix/copolymer/gelatin scaffold (SmartBone®) as a biomimetic graft for sinus lift procedure in dental surgery
Date:2016
Journal:10th World Biomaterials Congress, Montréal, Canada, 17 May - 22 May, 2016.
Authors:

M. Milazzo, D. D’Alessandro, S. Danti, C. Stefanini, G. Pertici, nd G. Perale

Abstract

The ideal scaffold for bone regeneration needs a number of requirements, such as biostability until the formation of mature tissue, high porosity for cell migration, extracellular matrix (ECM) deposition and vascularization, and non-immunogenicity. Moreover it should be bioresorbable, osteoconductive and possibly osteoinductive. Processed bovine spongy bone xenografts, coated with poly(L-lactic-co-ε-caprolactone) (PLCL) and added with gelatin are commercially available as a new class III medical device (SmartBone®, IBI S/A, Switzerland) [1]. This study was aimed at investigating the process of new bone formation in patients treated with SmartBone® for sinus lift procedures prior to dental implants.

Reinforced bioactive bone chip scaffold for bone regeneration: experimental study Reinforced bioactive bone chip scaffold for bone regeneration: experimental study
Date:2015
Journal:Dental Materials 3 0 S ( 2 0 1 4 ) e1–e180
Authors:

L. Laffranchi, B. Buffoli, R. Boninsegna, F. Zotti, F. Savoldi, P. Fontana, S. Bonetti, L. Visconti, L.F. Rodella, C. Paganelli

Abstract

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.

Composite polymer-coated mineral scaffolds for bone regeneration: from material characterization to human studies Composite polymer-coated mineral scaffolds for bone regeneration: from material characterization to human studies
Date:2015
Journal:
Authors:

G. Pertici, G. Perale

Abstract

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.

Reconstruction of the zygomatic bone with SmartBone®: Case Report Reconstruction of the zygomatic bone with SmartBone®: Case Report
Date:2015
Journal:Journal of biological regulators & homeostatic agents - Vol. 29, no. 3 (S1), 42-47 (2015)
Authors:

Grecchi F, Perale G, Candotto V, Busato A, Pascali M, Carinci F

Abstract

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.

Composite polymer-coated mineral scaffolds for bone regeneration: from material characterization to human studies Composite polymer-coated mineral scaffolds for bone regeneration: from material characterization to human studies
Date:2015
Journal:Journal of biological regulators & homeostatic agents - Vol. 29, no. 3 (S1), 136-148 (2015)
Authors:

Pertici G , Carinci F , Carusi G , Epistatus D , Villa T , Crivelli F , Rossi F , Perale G

Abstract

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.

SmartBone®on Demand™ applied to a post humoral large spheno-orbital reconstruction SmartBone®on Demand™ applied to a post humoral large spheno-orbital reconstruction
Date:2014
Journal:
Authors:

Abstract

After almost two years of positive clinical feedback, in November 2013, the innovative bone substitute SmartBone® made it possible to successfully engage in a great maxillo facial surgical challenge. Thanks to a profitable collaboration between the Swiss biomedical company Industrie Biomediche Insubri SA and the renowned University of Modena a complex large sphenoid orbital reconstruction case was accomplished using a revolutionary approach. The outstanding biomechanical and microstructural properties of SmartBone®, that in these last two years obtained great results in the dental field and in reconstructive surgery, have allowed the surgeons of the University of Modena to treat the case with excellency and promising results.

 

 

Composite polymer-coated mineral grafts for bone regeneration: material characterisation and model study Composite polymer-coated mineral grafts for bone regeneration: material characterisation and model study
Date:2014
Journal:Annals of Oral & Maxillofacial Surgery 2014 Feb 14;2(1):4
Authors:

G Pertici, F Rossi, T Casalini, G Perale

Abstract

Introduction

This study discusses composite polymer-coated mineral grafts for bone regeneration.

Materials and Methods

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.

Results

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.

Conclusion

This approach avoids the use of trialand-error methods and consents a better a priori material design.

Subscribe to our newsletter