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Ask UsRecombinant Growth Factor for Periodontal Applications
« Dental Implant Education | One-Piece Dental Implant - Abutment Units »
GEM 21S® (Growth-factor Enhanced Matrix) has been approved by the U.S. Food and Drug Administration (FDA). GEM
21S® is a fully synthetic regeneration system for the treatment of
periodontal bone defects and associated gingival recession.
GEM 21S® is composed of the tissue growth factor, recombinant human
Platelet-Derived Growth Factor (rhPDGF-BB), and a synthetic bone
matrix, Beta-tricalcium phosphate (ß-TCP). It is the first
totally synthetic product combining a purified recombinant growth
factor with a synthetic bone matrix to be approved by the FDA for human
application. In
recognition of the unique treatment modality provided by GEM 21S®, the
FDA has established it as a first-in-class product in its treatment
category.
Read the entire press release by clicking here. Please feel free to leave your comments below.
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3 Responses to “ Recombinant Growth Factor for Periodontal Applications ”
Why would you pay more for a single growth factor when you can use Emdogain and have an up regulation of a variety of Growth factors including PDGF? Not to mention more studies supporting Emdogains use in the oral cavity. It stuns me when I find surgeons who are not using Emdogain or are not aware of the volume of research supporting the use of this product.
After reading the recent J Periodontol study (Nevins, et al)and the editorial review (same issue, Dec 2005, I think), the results seem acceptable for a radiographic analysis, and, most importantly, unbiased as described by the study design. Very commendable! I look forward to hearing more. Yes, there are at least several hundred studies produced in any search of the literature for EMD. However, serious literature reviews, using RCT’s, demonstrate only statistical superiority to open flap debridement. The clinical relevance for EMD is questionable, at best. I refer you to a recent J Periodontol issue (even non-”surgeons,” as you put it, can look at the abstracts on line). In that study, albeit with a small population including smokers (no difference, though), EMD is no different than a placebo-not even statistically as opposed to clinically. (Rosing, et al. J Periodontol 2005;76:129-133). Many “mixed” results can be found regarding this therapy.
Dr. Rosing used EMD in conjuction with Scaling and Root Planning which is not an indication for the product. Meaning he did not lay a flap. If you are using EMD in conjunction with SRP more power to you but that is not an area that has shown promise. In addition, their are numerous split mouth design clinical studies comparing EMD to Memebranes and Bone Grafts with EMD providing equivalent results. We could also talk about the Histologic results or the upregulation of growth factors, wound healing, effect on perio pathogens, etc that Membranes and Bone Graft material don’t provide. But I guess it is easier to point to an article that is outside the products indication for use or forget to note that most novel products/approaches are compared against a bench mark life OFD in randomized controlled studies including DFDBA studies back in the 80’s.
If you have found mixed results on EMD you may want to read past the abstract to discover why. For example Perio pathogen results are based on contact inhibition, but you can find studies where EMD was used in solution with no inhibition noticed. The proteins found in EMD will not stay in solution so the result of the study is hardly suprising. Of course when EMD is placed on a root surface it adhere’s to receptor sites and is not swimming around in solution. Study design and purpose of those performing the procedures are always important and are rarely discovered in the abstract.
You may also want to look at the results from Harrel and Wilson on using EMD in Minimal Invasive surgical procedures. Very interesting in regards to recession.
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