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Emdogain®Gel
Emdogain®Gel is a resorbable,
implantable material, which consists of hydrophobic enamel matrix
proteins premixed with the vehicle solution, Propylene Glycol Alginate.
It is intended as an adjunct to periodontal surgery for topical application
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Emdogain®Gel Backgroud
Emdogain®Gel found its beginnings over a decade
ago when a scientific breakthrough in the basic biology of tooth development
revealed a native complex of enamel matrix proteins and the key role
they play in the development of tooth-supporting tissues. These "matrix
proteins" mediate the formation of acellular cementum on the
root of the developing tooth, providing a foundation for all of the
necessary tissues associated with a true functional periodontal attachment.
Emdogain®Gel is comprised of enamel matrix proteins - amelogenins -
that self-assemble to create a matrix. Amelogenins are found during
initial enamel formation, as well as in the development of acellular
cementum and its associated tooth attachment apparatus. Recent studies
have shown the structure of amelogenins to have been remarkably well-conserved
throughout evolution and functionally consistent in many species.
Therefore, although the matrix proteins in Emdogain®Gel are of porcine
origin, they are considered as "self" when encountered by
the human body.
With this simple discovery, biomimicry, which has been called the
quest for innovation inspired by nature has found its way to periodontics.
Although it is a relatively new concept, products like Emdogain®Gel
are defining this exciting new field of endeavor, fueling a new generation
in periodontal therapy, and making the restoration of lost tooth support
an attainable outcome in the treatment of periodontitis.
An important benefit of Emdogain®Gel is that it forms an insoluable
matrix and exerts its influence locally. Emdogain®Gel has been
shown in in vitro research to mediate cellular interaction where favorable
growth factors are produced by participating cells. This is different
from the direct application of growth factors in which positive results
require control of concentration as well as order, time and place
for such application. |
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Safety and Efficacy
The safety of Emdogain®Gel has been thoroughly documented. A comprehensive
toxicology program including acute and chronic studies, in vitro mutagenicity
studies, reproductive toxicology tests and several additional toxicology
studies have been carried out. The potential for sensitization and other
immunological reactions in humans was also examined. No immunological or
allergic reactions were found.
Clinical documentation for Emdogain®Gel has been obtained from a series
of strictly designed studies in the U.S. and Sweden. Followed for over three
years, patients have shown clinically significant improvement in Emdogain
treated teeth compared to control surgery by achieving statistical significance
for probing pocket reduction, clinical attachment gain, and radiographic
bone gain.
Clinical studies show that patients with deep periodontal
pockets (more than 6 mm) of the 1-wall and 2-wall type may expect
to achieve significant alveolar bone regain (average of 60-70% defect
fill). In published worldwide studies with study designs that include
multicenter trials, case reports and clinical studies, significant
change in probing depth reduction, as well as clinical attachment
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and radiographic bone gain have been demonstrated involving over 400
patients and 500 defects treated with Emdogain.
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