Abstract
Bone resorption can negatively influence the osseointegration of dental implants. Barrier membranes for guided bone regeneration (GBR) are used to exclude nonosteogenic tissues from influencing the bone healing process. In addition to the existing barrier membranes available on the market, a growing variety of membranes for GBR with tailorable physicochemical properties are under preclinical evaluation. Hence, the aim of this review is to provide a comprehensive description of materials used for GBR and to report the main industrial and regulatory aspects allowing the commercialization of these medical devices (MDs). In particular, a summary of the main attributes defining a GBR membrane is reported along with a description of commercially available and under development membranes. Finally, strategies for the scaling-up of the manufacturing process and the regulatory framework of the main MD producers (USA, EU, Japan, China, and India) are presented. The description of the regulatory approval process of GBR membranes is representative of the typical path that medium- to high-risk MDs have to follow for an effective medical translation, which is of fundamental importance to increase the impact of biomedical research on public health.
Highlights
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The aim of this review is to present the latest advancement in guided bone regeneration (GBR) membranes and to describe the process leading to the industrial development of materials for such biomedical applications
Small pores could limit cell migration and enhance collagen deposition, reducing the ability of blood vessels to infiltrate the area of interest.[25] 4) A GBR membrane would need to be handled during surgery, without being excessively rigid, which could compromise tissue integration or lead to dehiscence of the soft tissues.[2] 5) the role of the membrane was initially intended as a passive barrier, this concept could be reconsidered in the context of the next-generation membranes
Summary
Trauma, and congenital defects can lead to tissue damage or loss, the need to replace missing form and function. Small pores could limit cell migration and enhance collagen deposition, reducing the ability of blood vessels to infiltrate the area of interest.[25] 4) A GBR membrane would need to be handled during surgery (i.e., easy handling), without being excessively rigid, which could compromise tissue integration or lead to dehiscence of the soft tissues.[2] 5) the role of the membrane was initially intended as a passive barrier, this concept could be reconsidered in the context of the next-generation membranes. A growing number of studies are developing new strategies for bone regeneration incorporating bioactive compounds into the membrane, giving it an active role in the regeneration process (i.e., bioactivation friendly property).[26,27]
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