
Detail of the period when the root sheath cells
(blue) secrete enamel matrix proteins. Following formation of the protein
matrix on the surface of the mineralizing dentin, cementoblasts (Red)
start producing cementum (Light blue) which anchors collagen fibers.
The
Next
Generation
In
the mid 1980's, a revolutionary breakthrough in the basic biology of tooth
development took place at the Karolinska Institute's department of Oral
Pathology in Stockholm. The discovery revealed a native complex of enamel
matrix proteins and the key if not crucial , role they play in the
development of tooth-supporting tissues. These enamel related 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 functional periodontal attachment.
This
groundbreaking discovery has fueled the development of a new generation in
periodontal therapy, and makes the recreation of lost tooth support an
attainable goal in the treatment of patients suffering from periodontitis.
It
Begins with a single product...
EMDOGAIN
Is an
enamel matrix protein that recreates all necessary tissues of true
functional attachment in patients presenting with moderate to advanced
peridontitis.
EMDOGAIN represents a
completely new way of thinking about the regain of functional tooth
support. Designed to be a simple adjunctive product, EMDOGAIN fits
naturally into established periodontal treatments. The EMDOGAIN product is
packaged in two vials - a vehicle solution and freeze dried enamel matrix
proteins (The amelogenin fraction). When mixed, they create a viscous,
easy to use, syringable gel that is applied quickly and easily during
normal flap surgery.
EMDOGAIN prompts a
natural biology-based response in the body.
EMDOGAIN
is resorbed naturally during the normal healing process, leaving only a
residue of enamel matrix protein on the debrided root surface. This
natural and insoluble surface layer encourages the population of cementum-forming
cells from the surrounding tissues.
The
newly created surface also functions as an interface between the tooth and
the surrounding tissues, preventing downgrowth of the epithelial tissues.
In
promoting rapid initial healing, EMDOGAIN causes little or no associated
postoperative pain and swelling.
EMDOGAIN
creates a surface for cementum production
Experimental
studies in a marginal dehiscence model in primates show that
EMDOGAIN creates a suitable surface for the colonization of cementum-forming
cells. Two weeks after application, 75% of the dentin surface is covered
with such cells. After cementum formation, the periodontal ligament and
alveolar bone are then established.

EMDOGAIN
promotes
growth of all periodontal tissues
- Acellular
cementum
- Functional
periodontal tissues
- Alveolar
bone
The
histological picture to the left shows periodontal regeneration in an
experimental dehiscence defect in a primate eight weeks after EMDOGAIN
treatment.
A
firmly attached acellular cementum (C) with collagen fibers (ARROWS) can
be seen extending over to the newly formed alveolar bone (AB).
The
polarized light also shows how the collagenus fibers extend deeply into
the newly-formed cementum.

A
product as safe as it is effective!
The
safety of EMDOGAIN has been completely documented. A thorough toxicology
program, including acute and chronic toxicity studies, in vitro
mutagenicity studies, reproductive toxicological tests, and several
additional toxicology studies has been carried out. The potential for
sensitization and other immunological reactions in humans were also
examined. No immunological or allergic reactions were found.
Clinical
documentation for EMDOGAIN has been obtained from series of strictly
designed studies involving nearly 300 patients at 15 clinics throughout
the US. and Sweden. Patients have been followed for over three years and
have shown uniform improvement in EMDOGAIN treated teeth compared to
control surgery, by achieving statistical significance for probing pocket
reduction, clinical attachment gain and radiographic bone gain.

Each patient had a test site
treated with flap surgury and adjunctive EMDOGAIN and a control site (of
similar morphology and in the same jaw) treated with an identical surgical
procedure that did not include EMODGAIN
Look
at the facts
- Female
- 51
years
- Smoker
- Generalized
adult periodontitis with horizontal & verical bone loss.
Initial
probing pocket depth-10mm
Clinical
Attachment loss - 12mm
8
months after flap surgery and single application of EMODOGAIN resulting
in:
Probing
pocket reduction - 8mm
Clinical
Attachment gain - 7mm
Radiographic
bone gain - 7mm
Clinical
trial results show that EMDOGAIN gains both clinical attachment and bone
in 93% of cases. Studies also shows that patients with periodontal pockets
(more than 6mm) of the 1-wall and 2-wall type may except to achieve
significant alveolar bone regain up to 60-70% defect fill.
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