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Use of Biodegradable Materials for the Internal Stabilization of Mandibular Fractures

ABSTRACT

     There has been little research conducted on the use of biodegradable stabilization devices for the internal reduction of mandibular fractures. In current practice clinicians use implants comprised of titanium for fracture repair in the region of the maxilla and mandible, based on its biocompatibility. However, non-weight or lesser weight bearing skeletal structures within these areas entice the use of a less rigid material for such applications. The idea that lesser foreign material in the body is better also encourages the use of polymer-based implants, which are engineered to dissolve into the body over time. Concern for the use of these materials arises from their intrinsic properties, which gives doubt that they will be able to prevent mobility of the bone fragments at the fracture site. Proper stabilization throughout the duration of the healing process is vital to achieve successful bone regrowth; hence the implant must be able to resist the anatomic forces it will be subject to. Advancements made by polymer engineers in recent years to “self-reinforce” the plate structure have made biodegradable implants appear much more attractive to clinicians. These plates have been the target of a limited number of computationally and in vivo based studies which support their use in certain situations based on stress/strain analysis and radiographic imaging. The narrow application of biodegradable implants has given rise to some complications, such as inflammatory response. ... Internal reductions of non-weight bearing structures, particularly the mandible, utilizing titanium and polymer based implants have produced nearly identical results. These results suggest biodegradable implants to be more beneficial for mandibular fracture repair. ...



Background

In the early 1900s the use of implants in organized dentistry, in the form of fixed partial dentures, was strongly opposed. Regardless of patient interest in the use of artificial replacements rather than removable prostheses implant dentistry remained a controversial field until as recently as thirty years ago. ... Over time research producing legitimate clinical data and scientific evaluations were developed, which lead to the use of implants as an accepted alternative to conventional prostheses. Implantology (the study and use of implants) has become a unique profession utilizing methods existing in no other specialty, and today its acceptance into general practice has changed many fields of dentistry forever.
     Since the 1970’s in vivo studies on biodegradable fixations systems for mandibular fractures and osteotomies have appeared in literature. The first to appear was reported by Rokkanen in “Biodegradable Implants in Fracture Fixation,” (Lancet 1985; 18:1422-4) who performed the first clinical application using biodegradable devices in orthopedic surgery. In oral and maxillofacial surgery the use of biodegradable materials was first tested in animals and later progressed to human applications for fixation techniques. The main use of these materials has been for the reconstruction of the orbital floor, and fixation of zygomatic fractures. As of September 2002 there were no existing reports on the use of biodegradable materials for the internal fixation of human mandibular fractures and few publications on their use for the fracture fixation (Yerit12).
     The three most common materials used for biodegradable fixation systems are polyglycolic acid, ploy-L-lactic acid, and poly-dioxanone-sulphate. These materials were first seen being used as sutures for various applications, but spread to many fields of surgery because of their unique intrinsic properties. The desired characteristics make the manufacturing process of these materials especially difficult; minor alterations in the formula can result in profound effects on the characteristic properties of the material. ...
      Prior to the introduction of biodegradable materials into mandibular fixation the primary material of choice was titanium, due to its high stiffness and strength. ... Although the use of titanium has radically improved the success of fixation procedures, the question remains: Are there negative consequences for the long-term presence of titanium objects in the body? ...
     The principal cause for the lack of use of biodegradable implants in mandibular reconstruction has been their mechanical weakness. The AO/ASIF recommends that sufficient internal fixation hardware be applied to resist maximum forces of mastication. ... Initial degradable implants created lacked the self-reinforcing technology, discussed in the methods section, and were deficient in mechanical strength and stiffness to insure proper internal fixation of mandibular fractures. Another reason contributing to little usage of biodegradable implants is their lack of visibility on conventional X-rays without adding radio-opaque materials. ...      
     This paper strives to determine if the use of implants created from biodegradable materials is feasible for procedures within the maxillofacial region. ... And 2) can an implant made of bioresorbable materials support the loads they will be subject to in the maxillofacial region”? With these questions answered there should be sufficient evidence to state with assurance whether or not the use of these implants is recommended in non-weight bearing structures such as the mandible. ... Many procedures used to treat these problems, such as complex preprosthetic surgeries, largely incorporate the use of dental implants for the benefit of the patient.
     In this particular study the use of biodegradable fixation implants for the repair of mandibular fractures will be studied. The types of fractures in question will be those which are full breaks, creating segmented bone fragments along the mandible (Figure 12). Considering the uneven distribution of forces exerted throughout the mandible, some effort will be given to determine locations which appear suitable for the use of biodegradable implants and those that are not. These types of fractures are most commonly treated with an open reduction of the mandible and internal fixation of the fracture site, which is performed under general anesthesia and often followed up with some sort of maxillomandibular fixation (MMF). ... These materials are known as components in the BiosorbFX 2.


Approximate Word count = 4687
Approximate Pages = 18.7
(250 words per page double spaced)
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