GEM 21s - First FDA approved Growth-factor in Periodontal defects
Osteohealth Company announced that 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. The combination of the two components of GEM 21S ® are key to the overall effectiveness of the product. The rhPDGF-BB provides the biological stimulus for tissue repair by stimulating the proliferation and in-growth of osteoblasts, cells responsible for the formation of bone, while the ß-TCP provides the framework or scaffold for new bone growth to occur. 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. More....
posted by Ajou Huang @ Friday, January 13, 2006
3 Comments:
I hope you can help me. This product may or may not be a protocol. I'm a 42 year old male in orthodontics for 3.5 years. 1 year ago, my ortho swithced to "heavier wires". 2 months into treatment I noticed loss of interdental papillae between my left lower incisor and lateral (black triangle/blunted papilla). He told me to stop looking into my mouth so closely that things change all the time and spaces will close in the end, that I didn't loose gum tissue. So, for the next 8 months I kep silent while the condition spread to my central inscisors, laterals and canines until I realize that my teethe were straight and the loss continued (I had 3 appointments with him since the initial complaint and he said nothing). I spoke up a month ago and he said he can strip my teeth (interproximal reduction) and move them together to improve the situation about 30%. I was shocked. 100% to 30% from 1 tooth to 7 teeth involved now (three on the uppers too). My perio (2 of them) said I've had significant bone loss as compared to xrays a year ago, that nothing can be done (no subepitheal graft, bone graft) and they do not recommend moving roots or interproximal reduction. They said it was excessive force on my teeth (trauma) and that the gums are following the bone, that's why they're low. They said I can never get interdental bone which supports interdental papilla.
I don't know what to do. I'm angry. I want my perfectly healty gums back to the way they were only 12 months ago.
Is there anythig you can do to help? I can send photo, xray - all via email - my before and afters too. I'm scared. I've read things like emdogain, 4.5 mm from crestal bone results in papilla lift but as a consumer, I'm lost.
My name is Jeff. I live in Tampa, FL USA. My email is opus at tampabay dot rr dot com.
Thank you and God bless you.
Jeff
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