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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