Emdogain US Import Ban Is Lifted

Straumann announced that the import detention on Biora products in the US, which has been in place since the beginning of 2007, has been lifted following a re-inspection of the Group’s Biora facility in Sweden by the FDA (US Food and Drug Administration).

As a result, Straumann can now supply its range of oral tissue regeneration products to dental professionals and their patients in the US again. The company’s US subsidiary is taking orders and the products concerned – Straumann® Emdogain, PrefGel® and BoneCeramic – will be available shortly.

Straumann Emdogain is an effective therapy that helps to stabilize teeth and improve the outcome of periodontal surgery by regenerating the tissue structures that anchor the tooth. Specifically, Emdogain is used as an adjunct to periodontal surgery as a topical application onto exposed root surfaces, and is indicated for the treatment of intra-bony defects due to moderate or severe periodontitis, as well as the surgical treatment of gum recessions.

Since its introduction in 1996, Emdogain has been used in more than a million patients worldwide and continues to be a leading product for periodontal regeneration. The wealth of scientific evidence supporting the product continues to grow. In the past 12 months alone, more than 40 new scientific articles have been published in peer reviewed journals, including a systematic review of 18 studies on the treatment of gum recessions.[1] This showed that Emdogain can increase the predictability of surgical outcomes by achieving equal or better root coverage and attachment.

Other recently published studies have indicated that less post-surgical discomfort is reported with Emdogain.[2],[3]

Straumann PrefGel is a convenient gel which is used to remove the smear layer on the tooth surface prior to application of Emdogain.[3] Straumann is now introducing PrefGel in the US in an easy-to-use pre-filled syringe, which has been has been well received by clinicians in Europe, where it has been available for some time.

[1] Cheng S et al. Is coronally positioned flap procedure adjunct with enamel matrix derivative or root conditioning a relevant predictor or achieving root coverage? A systemic review. J Periodontal Res. 2007; 42: 474-85.
[2] Cortellini P, Tonetti MS: A minimally invasive surgical technique with an enamel matrix derivative in the regenerative treatment of intra-bony defects: a novel approach to limit morbidity. J Clin Periodontol. 2007; 34: 87-93.
[3] Ozcelik O et al. Immediate post-operative effects of different periodontal treatment modalities on oral health-related quality of life: a randomized clinical trial. J Clin Periodontol. 2007; 34: 788-96.

Source:
Straumann Holding AG, Peter Merian-Weg 12, 4002 Basel, Switzerland

7 thoughts on “Emdogain US Import Ban Is Lifted

  1. Dr. Ben Eby says:

    Bravo. My experience with emdogain has been very favorable. With periodontal surgery, I have found a generalized increase in bone support and periodontal ligament after surgery, instead of the normal ½ to 1 mm loss of bone, after osseous recontouring, I have seen 1 to 3 mm of new periodontal ligament and supporting bone routinely. I have found that if you can stabilize the micro movement of the tooth or teeth involved, the new periodontal ligament and bone growth can be astounding. I have grown as much as 6 mm of new periodontal ligament and bone in a four walled defect. Emdogain is as close to a “silver bullet” as I have seen in treating advance periodontal disease. Of course there is no easy solution to some problems and even with Emdogain, it is better to extract, graft, and place implants.

  2. Dr. Ben Eby says:

    Sorry, my experience has been that it will regenerate new periodontal ligament and supporting bone, but I have not seen an increase of tissue height. It does not appear to have any affect on implants, and I do not believe it was designed for that purpose.

    You can increase the height and thickness of soft tissue at the time of second stage surgery. One technique I have used is to: Do a full thickness mucoperiosteal flap, release the periostium so that you can stretch the tissue over a 3 mm healing abutment. Place some Grafton around and over the top of the healing abutment. Cover the graft material with AlloDerm. Get primary closure without tension. In six weeks the healing abutment will have dehisced. Wait a couple of months and you should have restored gingival height, enough to rebuild interdental papilla, and improve esthetics.

  3. DG, DMD says:

    GEM21s is the new kid on the block. EMD is old school. Was just at a lecture with long term data. Predictable and now, priced right!

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