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…
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
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.
Look at the facts
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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