Bioactive glass S53P4 (BAG-S53P4) is a biomaterial consisting of sodium, silicate, calcium and phosphate. [1] S53P4 is osteoconductive and also osteoproductive in the promotion, migration, replication and differentiation of osteogenic cells and their matrix production. [2] In other words, it facilitates bone formation and regeneration (osteostimulation). S53P4 has been proven to naturally inhibit the bacterial growth of up to 50 clinically relevant bacteria strains. [3] [4] [5] [6]
The S53P4 bioactive glass has its roots in the bioglass 45S5 developed by Larry Hench in the late 1960s in New York. [7] A couple of decades later, in the 1980s, the compound S53P4 bioactive glass was developed in Turku, Finland. S53P4 was found to be osteostimulative (non-osteoinductive), but it also had one new additional property: the composition of 53% silica and smaller weights of sodium, calcium and phosphorus gave rise to surface reactions in vitro that appeared to inhibit bacterial growth – a material that could not be infected by bacteria was discovered. [7]
Areas of use include a wide range of indications that require the filling of bone cavities, voids, and gaps as well as the reconstruction or regeneration of bone defects. Several long-term studies have shown that mastoid cavities in both cholesteatoma, old radical cavities, and chronic otitis media can be successfully obliterated with S53P4 bioactive glass. [8] [9] [10]
Clinical application has been gained from several extensive studies where patients with bone infections have been treated. S53P4 has shown promising results in chronic osteomyelitis surgery, septic non-union surgery, segmental defect reconstructions and other infectious complications, such as sternum infections, diabetic foot osteomyelitis and spine infections. [11] [12] [13] [14]
S53P4 has gained clinical experience within spine surgery in spine fusions and spinal deformity surgery. [15] [16] [17]
S53P4 has also been used successfully in the filling of benign bone tumor cavities in both adults and children, sustaining the bone cavity volume long term. Clinical experience has been gained from aneurysmal bone cysts (ABC), simple bone cysts (UBC), enchondroma and nonossifying fibroma (NOF). [18]
When S53P4 bioactive glass is implanted into a bone cavity, the glass is activated through a reaction with body fluids. During this activation period, the bioactive glass goes through a series of chemical reactions, creating the ideal conditions for bone to rebuild through osteoconduction.
Once the hydroxyapatite layer is formed, the bioactive glass interacts with biological entities, i.e. blood proteins, growth factors and collagen. Following this interactive, osteoconductive and osteostimulative process, new bone grows onto and between the bioactive glass structures.
In the final transformative phase, the process of bone regeneration and remodeling continues. Over time, the glass is fully remodeled into bone, restoring the patient's natural anatomy.
The bacterial growth inhibiting properties of S53P4 derive from two simultaneous chemical and physical processes, occurring once the bioactive glass reacts with body fluids. Sodium (Na) is released from the surface of the bioactive glass and induces an increase in pH (alkaline environment), which is not favorable for the bacteria, thus inhibiting their growth. The released Na, Ca, Si and P ions give rise to an increase in osmotic pressure due to an elevation in salt concentration, i.e. an environment where bacteria cannot grow. [20]
Sinusitis, also known as rhinosinusitis, is an inflammation of the mucous membranes that line the sinuses resulting in symptoms that may include thick nasal mucus, a plugged nose, and facial pain.
Cholesteatoma is a destructive and expanding growth consisting of keratinizing squamous epithelium in the middle ear and/or mastoid process. Cholesteatomas are not cancerous as the name may suggest, but can cause significant problems because of their erosive and expansile properties. This can result in the destruction of the bones of the middle ear (ossicles), as well as growth through the base of the skull into the brain. They often become infected and can result in chronically draining ears. Treatment almost always consists of surgical removal.
Linezolid is an antibiotic used for the treatment of infections caused by Gram-positive bacteria that are resistant to other antibiotics. Linezolid is active against most Gram-positive bacteria that cause disease, including streptococci, vancomycin-resistant enterococci (VRE), and methicillin-resistant Staphylococcus aureus (MRSA). The main uses are infections of the skin and pneumonia although it may be used for a variety of other infections including drug-resistant tuberculosis. It is used either by injection into a vein or by mouth.
Acute septic arthritis, infectious arthritis, suppurative arthritis, pyogenic arthritis, osteomyelitis, or joint infection is the invasion of a joint by an infectious agent resulting in joint inflammation. Generally speaking, symptoms typically include redness, heat and pain in a single joint associated with a decreased ability to move the joint. Onset is usually rapid. Other symptoms may include fever, weakness and headache. Occasionally, more than one joint may be involved, especially in neonates, younger children and immunocompromised individuals. In neonates, infants during the first year of life, and toddlers, the signs and symptoms of septic arthritis can be deceptive and mimic other infectious and non-infectious disorders.
Osteomyelitis (OM) is an infection of bone. Symptoms may include pain in a specific bone with overlying redness, fever, and weakness. The long bones of the arms and legs are most commonly involved in children e.g. the femur and humerus, while the feet, spine, and hips are most commonly involved in adults.
An implant is a medical device manufactured to replace a missing biological structure, support a damaged biological structure, or enhance an existing biological structure. For example, an implant may be a rod, used to strengthen weak bones. Medical implants are human-made devices, in contrast to a transplant, which is a transplanted biomedical tissue. The surface of implants that contact the body might be made of a biomedical material such as titanium, silicone, or apatite depending on what is the most functional. In 2018, for example, American Elements developed a nickel alloy powder for 3D printing robust, long-lasting, and biocompatible medical implants. In some cases implants contain electronics, e.g. artificial pacemaker and cochlear implants. Some implants are bioactive, such as subcutaneous drug delivery devices in the form of implantable pills or drug-eluting stents.
Mastoiditis is the result of an infection that extends to the air cells of the skull behind the ear. Specifically, it is an inflammation of the mucosal lining of the mastoid antrum and mastoid air cell system inside the mastoid process. The mastoid process is the portion of the temporal bone of the skull that is behind the ear. The mastoid process contains open, air-containing spaces. Mastoiditis is usually caused by untreated acute otitis media and used to be a leading cause of child mortality. With the development of antibiotics, however, mastoiditis has become quite rare in developed countries where surgical treatment is now much less frequent and more conservative, unlike former times.
Bioglass 45S5 or calcium sodium phosphosilicate, is a bioactive glass specifically composed of 45 wt% SiO2, 24.5 wt% CaO, 24.5 wt% Na2O, and 6.0 wt% P2O5. Typical applications of Bioglass 45S5 include: bone grafting biomaterials, repair of periodontal defects, cranial and maxillofacial repair, wound care, blood loss control, stimulation of vascular regeneration, and nerve repair.
Bioactive glasses are a group of surface reactive glass-ceramic biomaterials and include the original bioactive glass, Bioglass. The biocompatibility and bioactivity of these glasses has led them to be used as implant devices in the human body to repair and replace diseased or damaged bones. Most bioactive glasses are silicate-based glasses that are degradable in body fluids and can act as a vehicle for delivering ions beneficial for healing. Bioactive glass is differentiated from other synthetic bone grafting biomaterials, in that it is the only one with anti-infective and angiogenic properties.
Bone grafting is a surgical procedure that replaces missing bone in order to repair bone fractures that are extremely complex, pose a significant health risk to the patient, or fail to heal properly. Some small or acute fractures can be cured without bone grafting, but the risk is greater for large fractures like compound fractures.
Nonunion is permanent failure of healing following a broken bone unless intervention is performed. A fracture with nonunion generally forms a structural resemblance to a fibrous joint, and is therefore often called a "false joint" or pseudoarthrosis. The diagnosis is generally made when there is no healing between two sets of medical imaging, such as X-ray or CT scan. This is generally after 6–8 months.
The alveolar process is the portion of bone containing the tooth sockets on the jaw bones. The alveolar process is covered by gums within the mouth, terminating roughly along the line of the mandibular canal. Partially comprising compact bone, it is penetrated by many small openings for blood vessels and connective fibres.
Maxillary sinus floor augmentation is a surgical procedure which aims to increase the amount of bone in the posterior maxilla, in the area of the premolar and molar teeth, by lifting the lower Schneiderian membrane and placing a bone graft.
A biomaterial is a substance that has been engineered to interact with biological systems for a medical purpose – either a therapeutic or a diagnostic one. The corresponding field of study, called biomaterials science or biomaterials engineering, is about fifty years old. It has experienced steady growth over its history, with many companies investing large amounts of money into the development of new products. Biomaterials science encompasses elements of medicine, biology, chemistry, tissue engineering and materials science.
Oritavancin, sold under the brand name Orbactiv among others, is a semisynthetic glycopeptide antibiotic medication for the treatment of serious Gram-positive bacterial infections. Its chemical structure as a lipoglycopeptide is similar to vancomycin.
Osteostimulation is a technique attempted for improving healing of bone injuries or defects. It has not however been found to be significantly effective in increasing bone healing.
A mastoidectomy is a procedure performed to remove the mastoid air cells, air bubbles in the skull, near the middle ear. This can be done as part of treatment for mastoiditis, chronic suppurative otitis media or cholesteatoma. In addition, it is sometimes performed as part of other procedures or for access to the middle ear. There are classically 5 different types of mastoidectomy:
Guided bone regeneration (GBR) and guided tissue regeneration (GTR) are dental surgical procedures that use barrier membranes to direct the growth of new bone and gingival tissue at sites with insufficient volumes or dimensions of bone or gingiva for proper function, esthetics or prosthetic restoration. Guided bone regeneration typically refers to ridge augmentation or bone regenerative procedures; guided tissue regeneration typically refers to regeneration of periodontal attachment.
Vertebral osteomyelitis is a type of osteomyelitis that affects the vertebrae. It is a rare bone infection concentrated in the vertebral column. Cases of vertebral osteomyelitis are so rare that they constitute only 2%-4% of all bone infections. The infection can be classified as acute or chronic depending on the severity of the onset of the case, where acute patients often experience better outcomes than those living with the chronic symptoms that are characteristic of the disease. Although vertebral osteomyelitis is found in patients across a wide range of ages, the infection is commonly reported in young children and older adults. Vertebral osteomyelitis often attacks two vertebrae and the corresponding intervertebral disk, causing narrowing of the disc space between the vertebrae. The prognosis for the disease is dependent on where the infection is concentrated in the spine, the time between initial onset and treatment, and what approach is used to treat the disease.
A Sinus implant is a medical device that is inserted into the sinus cavity. Implants can be in conjunction with sinus surgery to treat chronic sinusitis and also in sinus augmentation to increase bone structure for placement of dental implants.