How Osteopore technology is used in Oral and Maxillofacial (OMF) Surgery
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Tissue engineering is playing an increasingly major role in reconstructive, cosmetic and plastic surgeries for patients suffering head, neck, facial and oral trauma, cancer, congenital defects and even common oral problems. These surgeries can be life-changing for people of all ages, and at Osteopore we are passionate about helping patients recover in the best way available to them. Our two decades of expertise in bone regeneration means we can harness our technological capabilities to assist. Our products have been used successfully in oral and maxillofacial surgeries – including orbital floor reconstruction procedures and mandibular bone reconstructions.
What is?Oral Maxillofacial Surgery (OMF)?
Oral and Maxillofacial Surgery (OMF) is a surgical specialty covering the diagnosis and treatment of diseases, injuries and defects involving both the functional and aesthetic aspects?of the oral cavity, jaw, face, and neck regions. Training in medicine and dentistry enables OMF surgeons to treat conditions requiring expertise in both fields. These include:
- Benign pathologies (e.g., cysts and tumours of the jaws)
- Oral cancer/head and neck cancer
How can Osteopore technology help with this type of surgery?
Within the scope of treatment, bone reconstructive treatment in OMF surgery is one of the most important fields. In complex cases, defects of the jaw following tumor resection or trauma may require ‘bone grafting’ all the way to ‘transplantation of bone with blood vessels called vascularized free flap (microvascular free flap surgery)’. In smaller defects, i.e., bone reconstruction at dentoalveolar region, autografts?or alternatively bone substitutes can be selected to graft at defect sites.
The type of graft used will depend on factors including, but not limited to, the type of surgery being performed, age, medical history, and bone quantity/quality.(1) Autografts are still considered the “gold standard” due to the essential combination of osteogenic, osteoinductive, and osteoconductive properties. However, autografts have some disadvantages on donor site morbidity and limited amount of graft tissue. In some cases, bone substitutes such as allografts, xenografts, and alloplastics are used as alternatives for autologous bone grafts, but these bone substitutes lack osteogenic, osteoinductive, and angiogenic potential.(2)
Types of traditional bone material for bone grafts:
Tissue Engineering
Tissue engineering evolved from the field of biomaterials development and refers to the practice of combining scaffolds, cells and biologically active molecules into functional tissues. The goal is to assemble functional constructs that restore, maintain or improve damaged tissues or whole organs.(3)
In the past decade, tissue engineering has become?a highly active field to develop products and devices with all the required components and following all principles of regenerative medicine. This regenerated bone can be used in small or large defects, in maxillary cleft repair, maxillary and mandibular ridge augmentation, and maxillary sinus augmentation.(4)
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Osteopore Technology
The potential of our technology lies in the application of bone in situ tissue engineering, which improves on many of the limitations of conventional reconstructive practices. The technology harnesses the body’s regenerative capacity to rebuild lost tissues, by leveraging on the natural healing process to guide the functional restoration of tissues at the defect site.?Surgeons and dentists can reduce treatment time as they are not required to extensively manipulate/culture cells and material outside of the body, unlike in-vitro tissue engineering. The treatment has predictable results and good reports have resulted from Osteopore’s case series.
Osteopore has technology to produce 3D polycaprolactone (PCL) bioresorbable scaffolds which are biocompatible, proven and non-toxic. There are no animal tissue concerns such as disease transmission or cross reaction. Bone remodeling takes place before complete degradation between 18 to 24 months. The scaffold is engineered and designed with a lattice structure constructed from interconnected triangles of regular porous morphology which promote osteoblast formation within the socket and help to facilitate natural bone.(5) Satisfactory bone growth has been recorded with cranioplasty.
The printing offers a mesh structure (different thickness), block (different dimensions) and is an alternative to currently available patient specific implants (PSI). Surgeons can select the design to match the type of defect.
Osteopore Mandibular Patient Specific Implant (PSI)
Surgical reconstruction of mandibular bone defects is a routine procedure for the rehabilitation of patients with deformities caused by trauma, infection or tumour resection. The Osteopore PSI combined with biological cells and biological factors can replace or reduce the volume need of autologous bone reconstruction. Therefore, it helps reducing donor site morbidity and hospitalization periods. Osteopore’S PSI performed well for mandible defects with little or no loss of soft tissue and when placed in a well vascularized tissue bed. The adjacent bone fragments can be stripped off periosteum so that adequate bone to bone contact is established. In the case of significant soft tissue loss, the Osteopore PSI can combine with vascularized bone flap with the aim of regenerating bone. It also helps to increase bone volume at the reconstruction site and enhances bone regeneration from surrounding blood vessels.
Osteopore PSI technology can assist in this surgery, being a custom-made 3D printed bone scaffold made from polycaprolactone (PCL) using CT scan data. The PSI is designed alongside advice from the patient's surgeon and modelled according to CT scans. With the distinctive Osteopore scaffold structure, the implant can be safely combined with biologic (synthetic, autologous i.e., bone marrow aspirate, cancellous particulate bone) substances or materials to safely regrow the patient's bones. The implant is bioresorbable, biocompatible, and non-toxic. The scaffold has an excellent track record in the reconstruction of craniofacial and maxillofacial bone defects.(6) The PSI can be stabilized with reconstruction plates and screws and gives soft tissue coverage throughout the healing phase.
In the process of producing PSI, Osteopore requires two-to-three weeks from the date of design confirmation until the product’s delivery to surgeons. The detailed timeline for PSI products:
Over the past two-and-a-half-years, four cases of mandibular PSI reconstruction have been successfully implanted for patients in Australia and Singapore. These cases involved reconstruction for mandibular in mandibular hypoplasia, second degrees hemifacial microsomia, osteoradionecrosis, recurrent squamous cell carcinoma (SCC) at retromolar trigone and chin implant.
The mandibular hypoplasia patient case was included in a case series published recently and the findings reported no further inpatient and postoperative complications. A CT scan at three-to-four months showed regenerate bone adjacent to the scaffold. The patient subsequently has good mouth opening and improved facial symmetry.(7)
Overall, the surgeons’ responses to our products were excellent regarding bone replacement, avoiding large donor site bone defects and significantly reducing operation time. The case series is under review and updated results of bone regeneration will be reported soon.
Apart from mandibular PSI, we believe the same technology can be applied for maxillary bone reconstruction and we are looking forward to working with surgeons who are interested in this technology.
Osteomesh? for bone reconstruction
Osteomesh? is a biocompatible 3D-printed scaffold implant made from polycaprolactone (PCL) designed to mimic the microarchitecture of natural bone.?Being semi-flexible, it is easy to handle and enables sufficient strength to hold particulate bone grafts without collapsing, while retaining enough flexibility to be curved and moulded to the desired shape.?
Osteomesh? compared to titanium mesh
Titanium mesh has excellent mechanical properties compared with other types of materials. However, it needs a secondary surgery for removal, and the cut edges of this mesh sometimes cause mucosal irritation. This can lead to exposure of the membrane and possibly infection of the titanium framework embedded inside the membrane structure.?
Osteomesh?, which is made from PCL, slowly resorbs into the body over 18-to-24 months while it concurrently supports bone in-growth and remodeling. Since no permanent foreign object remains in the body, infection rates are low, and the need for follow-up appointments is reduced.?
Osteomesh? compared to present techniques
From a clinical perspective, PCL has a proven clinical history for maxillofacial indications, and the interconnected micro-architecture of Osteomesh? facilitates osteoblast proliferation and infiltration while enabling bone graft stability and natural bone regeneration. The Osteomesh? predictable resorption profile avoids the need for an additional procedure, thus delivering clinical ease and patient comfort.?
Successful outcomes from using Osteomesh? in OMF bone regeneration
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Orbital floor reconstruction
Orbital wall fractures are commonly encountered in the context of facial trauma and are becoming more frequent because of the increasing number of traffic accidents, industrial accidents, sport-related injuries, and physical assaults.(8) They occur because of energy transmitted directly to the orbital wall(s), indirectly from increased orbital pressure or a combination of the above. Acute mechanical orbital injuries may result in orbital rim and/or orbital wall defects, with periosteal dehiscence and herniation of extraocular muscles. This may cause entrapment of extraocular muscles and/or intermuscular septum and loss of orbital volume with resultant diplopia and enophthalmos respectively. Other possible complications include optic nerve injury, infra or supraorbital nerve injury, injury to anterior, posterior ethmoidal, infraorbital or supraorbital vessels, and injury to the lacrimal drainage system.(9)
The aim of orbital floor reconstruction is?to restore the pre-injury shape of the fractured floor to provide support of the globe and prevent herniation of the periorbital structures into the maxillary antrum. Osteomesh? is an integrating implant for the repair of orbital fractures, leading to a shift in orbital reconstructive surgery from purely repairing bony defects to functional regeneration of damaged tissues. It provides structural stability throughout fracture healing and bone remodelling. It is easy to use as it is mouldable in warm saline and shaped by surgical scissors.(10)
Osteomesh? is fully resorbed in approximately 18 to 24 months depending on the patient anatomy and metabolism. It has more than two years follow up showing host-implant compatibility with no infection and migration of implant. Its biomimetic design structure delivers predictable bone regeneration while providing structural support. The resulting regenerated bone minimizes complications, such as orbit compartment syndrome of permanent implants as evidenced by a 10-year clinical series.
A 10-year retrospective review of all patients who had undergone orbital fracture repair with Osteomesh? in a single tertiary trauma centre from January 2005 to December 2014, showed it is safe and clinically effective in the reconstruction of orbital fractures. The review supports that Osteomesh? is a useful alternative in the reconstruction of small to large, simple or complex orbito-cranial deformities.(11)
Osteomesh? and pre-formed Osteomesh? for mandibular reconstruction
In a mandibular reconstruction with our product, an alternative to a 3D PSI is using Osteomesh? as a bioresorbable bone tray. Surgeons can shape and mould Osteomesh? intra operation to fit the reconstruction site or can order a custom made pre-formed Osteomesh?, (pre-surgical outline/shaped and moulding base on patient CT scan). Successful clinical cases resulted from Osteomesh? being combined with particulate cancellous bone and marrow (PCBM). Patients have had no signs of complications, and CT scans are underway in around two months’ time.
Osteomesh? is made of PCL or PCL-TCP which is moulded in warm saline to fit the defect area and formed as a tray wherein autogenous bone is well packed inside with other biologics. It can be secured with screws and plates, if required. It is also compatible with permanent and bioresorbable fixation systems.(12)
Replacements of bone window i.e. sinus lift surgery and post cyst enucleation
Maxillary sinus floor augmentation also termed?sinus lift,?sinus graft,?sinus augmentation?or?sinus procedure is a?surgical procedure?which aims to increase the amount of bone in the posterior maxilla (upper jaw bone), in the area of the?premolar?and?molar?teeth, by lifting the Schneiderian membrane?(sinus membrane) and placing a bone graft.(13)
Post sinus augmentation, the buccal bone window can be covered by Osteomesh? and secured with a self-drilling screw before soft tissue closure.(14)
Similar procedures were applied to close the buccal after large cystic enucleation. The surgeon used Osteomesh? to cover the top of the bone defect without filling materials to prevent soft tissue in growth in the cystic cavity and to allow proper contour of bone healing. Mesh was cut into shape and moulded to fit the anatomical contour of bone with warm saline. With periosteal vertical mattress sutures, the mesh was maintained in a stable position. Primary wound closure was performed using interrupted sutures.
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Osteopore products for alveolar cleft surgery
Alveolar bone grafting involves alveolar bone repair and closing of oro-nasal fistula at the cleft site at the area of premaxilla where there is discontinuation of alveolar process and defect nasal base. The usual age for alveolar bone grafting is between seven and nine years old, before the eruption of the anterior teeth at cleft site. Late repair surgeries are possible in adult cleft cases that missed surgery at younger ages. Alveolar cleft reconstruction has historically relied on autologous iliac crest bone grafting (ICBG); however, the risk of donor site morbidity, pain, and prolonged hospitalization has prompted the search for alternative bone grafts. Earlier this year, surgeons adapted the use of Osteomesh? with the combination of autologous bone for first use in alveolar cleft cases. The alternate layered between our product and autogenous bone technique was used to enhance biologic bone cells and healing factors from autogenous bone. The honeycomb structures of Osteopore’s product enhanced permeability blood and bone factors which could stimulate cells to produce mineralized extracellular matrix (ECM). Surgeons ensured tight packing at the grafted site for future bone regeneration. According to surgeons, the Osteopore product helped lessen the amount of bone harvesting from the iliac crest, hence the patients easily recovered. The wound healing was reportedly excellent. We are in the midst of reviewing quality and quantity bone regeneration from the upcoming CT-cone beam scan.
In future work, we aim to use Osteopore products in combination with aspirated bone marrow or other growth factors to further avoid autologous bone harvesting to establish a new chapter for cleft bone regeneration.
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Osteopore products for orthognathic surgery
Osteostrip? for orthognathic surgery
Orthognathic surgery involves a spectrum of surgical procedures on the upper jaw, lower jaw and chin, to improve both form and function. The Le Fort I osteotomy of the maxilla is one of the core procedures in orthognathic surgery for the management of facial skeletal deformities.(15) Le Fort I enables realignment of the maxilla with the facial midline, correction of the cant, and allows for advancement, set back, increasing or decreasing the vertical position. If large gaps are created between the upper and lower part of the maxillary bone in large inferior or horizontal movements, bone grafts should be considered to provide for more stable movement.(16)
Osteostrip? is an integrating implant used to restore the gaps by promoting bone tissue ingrowth. It was reportedly user friendly for craniotomy cases. In OMF, Osteostrip? is an excellent alternative choice of using autologous bone (i.e., facial bones, cranial grafts, or from the iliac crest) on those gaps between the upper and lower part of the maxillary bone after Le Fort I Osteotomy. It gives a perfect fit wherein the flanges are in great position for screw fixation.
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References:
2.??????J. S. Vorrasi and A. Kolokythas, “Controversies in traditional oral and maxillofacial reconstruction,”?Oral and Maxillofacial Surgery Clinics of North America, vol. 29, no. 4, pp. 401–413, 2017.
G. Fernandez de Grado, L. Keller, Y. Idoux-Gillet et al., “Bone substitutes: a review of their characteristics, clinical use, and perspectives for large bone defects management,”?Journal of Tissue Engineering, vol. 9, 18 pages, 2018.
Vivian Wu, Marco N. Helder, Nathalie Bravenboer, Christiaan M. ten Bruggenkate, Jianfeng Jin, Jenneke Klein-Nulend, Engelbert A. J. M. Schulten,?"Bone Tissue Regeneration in the Oral and Maxillofacial Region: A Review on the Application of Stem Cells and New Strategies to Improve Vascularization",?Stem Cells International,?vol.?2019,?Article ID?6279721,?15?pages,?2019.?https://doi.org/10.1155/2019/6279721
4.??????Rai R, Raval R, Khandeparker RV, Chidrawar SK, Khan AA, Ganpat MS. Tissue Engineering: Step Ahead in Maxillofacial Reconstruction.?J Int Oral Health. 2015;7(9):138-142.
5.??????Dental Osteoplug brochure, https://www.osteopore.com/sites/default/files/support-docs/Dental%20Osteoplug%20Brochure%20%28Feb%202022%29%20v2.pdf
6.??????Schuckert KH, Jopp S, Teoh SH. Mandibular defect reconstruction using three-dimensional polycaprolactone scaffold in combination with platelet-rich plasma and recombinant human bone morphogenetic protein-2: de novo synthesis of bone in a single case. Tissue Eng Part A. 2009 Mar;15(3):493-9. doi: 10.1089/ten.tea.2008.0033. PMID: 18767969.
7.??????Regenerative matching axial vascularisation of absorbable 3D-printed scaffold for large bone defects: A first in human series George Castrisos, MBBSa , Isabel Gonzalez Matheus, MBBSa,b,d,j,? , David Sparks, MBBSa,c,d, Martin Lowe, MBBS, FRACS, FAOrthoAe, Nicola Ward, MBBS FRACS FAOrthoAe, Marjoree Sehu, MBBS, FRACP, FRCPAd,f , Marie-Luise Wille, MSc, PhDg,i , Yun Phua, MD, FRACS (Plast)h, Flavia Medeiros Savi, BBSc, PhDh,i , Dietmar Hutmacher, PhDg,i , Michael Wagels, MBBS, FRACS (Plast)a,b,d,h,
8.??????Orbit & Oculofacial Surgery, Department of Ophthalmology, NationalUniversity Hospital, National University of Singapore, Singapore
9.??????Clinical Audit, Singapore National Eye Centre, Singapore
10.??Osteopore Orbital Floor Repair Brochure
11.??Use of bioresorbable implants for orbital fracturereconstruction Stephanie M Young,1Gangadhara Sundar,1Thiam-Chye Lim,2Stephanie S Lang,3George Thomas,4Shantha Amrith1
12.??Osteopore PSI Brochure
13.??Boyne, PJ.?De novo bone induction by recombinant human bone morphogenetic protein-2 (rhBMP-2) in maxillary sinus floor augmentation.?J Oral Maxillofac Surg?2005;63:1693-1707
14.??"Sinus Lift Surgery - Sinus Augmentation | Colgate".?www.colgate.com. Archived from?the original?on 2015-07-01
15.??Buchanan EP, Hyman CH. LeFort I Osteotomy.?Semin Plast Surg. 2013;27(3):149-154. doi:10.1055/s-0033-13571
16.??Buchanan EP, Hyman CH. LeFort I Osteotomy.?Semin Plast Surg. 2013;27(3):149-154. doi:10.1055/s-0033-1357112
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