Calcium Sulfate to Revolutionize Bone Augmentation?

Does anyone have any thoughts on BoneGen, a new product being marketed by Bio-Lock for bone augmentation? Given the recent concerns surrounding other regeneration materials, do you think BoneGen will make a strong impact on the market? According to the company, BoneGen is new clinically safe, nano-composite, time release calcium sulfate product for bone augmentation.
Bruce L. Hollander, BioLok's President & Chief Executive Officer, "BoneGen-TR is a nano-composite material that
fully resorbs into the body, leaving nothing but newly formed bone, which has significant advantages over many of the other products in the market. Existing natural products used in the bone augmentation and regeneration industry have for the past several months been negatively impacted by a myriad of health concerns. Among natural material sources, freeze dried bone has come under government investigation for unsafe procurement methods, while bovine-based products suggest exposure to the possibility of mad cow disease. Many ceramic substances do not fully resorb and are still questionable in their ability to grow new bone. With this backdrop, BoneGen-TR, a synthetic, should receive rapid adoption by dental professionals." Based on medical grade calcium sulfate, a product proven safe for over 100 years, BioLok's BoneGen-TR has increased the time for resorbsion of calcium sulfate from 4 weeks to 18 weeks, allowing time for full and safe bone growth in large voids.
What do you make of these claims?




Comments
hate to disappoint all these manufacturers but you can get a larger jar(not sure of the size) of calcium sulfate from your local pharmacy for significantly less. It lasts for ever and you don't need that much. Put some in a dappen dish and mix with saline. It doesn't quite set hard like Capset but does that really matter?
Been getting great results in extraction sites. I use freeze dried bone and the cover it with the Calcium Sulfate. Even without primary closure, it stays in. The epithelium grows right over it. When I re-enter for an implant, there is hard bone.
Posted by: Marc Goldman | April 25, 2006 10:37 PM
I have been using beta tri-ca phosphate and ca sulphate for 2 years now with great results and now have a synthetics only practice to ally patient concerns as to graft materials thus can now call a graft a graft again.These types of materials are the future,especially in sinus lift proceedures and defect repair.The ability of the materials to set is important as you can avoid using any membranes hence improve healing by bringing the soft tissue blood supply into contact with the graft site
Posted by: peter fairbairn | April 26, 2006 03:19 AM
I would like to thank DDS Gadget for drawing attention to the Biolok bone graft family of products and to add a slight degree of clarification to items contained within the post.
The product description given within the post actually describes our soon to be released new addition to our bone grafting line of products "BoneGen TR" which has recently received FDA approval and is scheduled for distribution July/August 2006.
The confusion lies in that the picture that was provided is for our original Calcium Sulfate Hemihydrate formulation, "Bone Gen" that is currently available. I will be happy to repost with a picture of the "Bone Gen TR" packaging once it becomes available for distribution.
While both products are Calcium Sulfate hemihydrate, "Bone Gen TR" (the "TR" indicates Timed Release) differs in that it has an additive coating of PLLA forming a nanocomposite material. The purpose of this coating is to slow dissolution time of the Calcium Sulfate to a longer period of time (18 weeks) making it useful in filling larger defects.
Calcium Sulfate has a long (over 100 year) history for bone grafting. Numerous studies have shown calcium sulfate to be highly biocompatible, biodegradeable, nontoxic, osseo-conductive, hemostatic and angiogenic. It also serves as a guided tissue regeneration material by preventing the growth of soft tissue into bone defects. When implanted into the body it is absorbed, encouraging the growth of bone as it degrades. It release calcium ions which combine with phosphorus ions from the body leaving behind a calcium phosphate trellis that supports the growth of bone in the area. Thus, it serves as a bioactive and osteoconductive bone growth scaffold. The graft material is radiopaque, allowing the clinician to make immediate as well as long-range postoperative observations using standard radiographic techniques.
Both products have a large number of applications in Oral Surgery, Periodontics, Endodontics, and Implantology while bypassing the recent complicating distubances involving allograft and xenograting materials.
Please feel free to personally contact me by phone or e-mail regarding further questions or information regarding our fine family of products at Bio Lok.
Warm Regards
Jerry P. Wildman D.D.S.
Product Manager
Bio Lok International Inc
drw@biolok.com
1-800-789-0830 ext. 44
Posted by: Jerry Wildman DDS | April 26, 2006 01:25 PM
I have begun to use beta-TCP with rpdgf growth factor. The product is named GEM21s. The soft tissue response has been great. Able to probe at three months.
Posted by: Anonymous | April 28, 2006 11:31 AM
would like to try it but not available in the UK..I think public concerns will be an issue in the future..amalgum is an great dental material but do I use it NO!!!why Patient concerns we are in the age of the internet..
Posted by: peter fairbairn | May 1, 2006 03:23 PM
the only concerns my patients have is with allografts, the media has gone main stream with the human tissue stories and now everyone is concerned. No problems with FDA approved materials.
Posted by: Anonymous | May 8, 2006 09:42 AM
To Dr. Wildman:
Can the BoneGene TR be used as the sole graft material? If I use BoneGene TR does that mean I do not need to use freeze dried bone for the graft ir cover the graft with a memberane or collagen product? Thanks
Posted by: Anonymous | May 21, 2006 06:33 AM
The tricalcium phosphats are suitable they cost only 0,25 € Kg. It is generaly used in the finishing of the walls of our homes and you can buy it in local markets. It is great material for periodontic treatments but is absorbable in 3 weeks.
Posted by: Anonymous | June 14, 2006 08:13 AM
To Dr. Wildman:
Can the BoneGene TR be used as the sole graft material? If I use BoneGene TR does that mean I do not need to use freeze dried bone for the graft ir cover the graft with a memberane or collagen product? Thanks
Dear Anonymous,
I know I'm not Dr. Jerry, but here is what I also know...
The original Bone-Gen formulation (a straight-up Calcium Sulfate Hemihydrate ) basically is a surgical grade plaster of Paris that's been filling bony defects for a century at least. Very inexpensive as well. The problem is it's rapid rate of absorption. If mixed in with
re-mineralized bone or other human/bovine grafting materials, as part of an augmentation cocktail, you would have a decent enough bone for implant placement. But placed by itself and absorbing very quickly (think about 1 mm per week) a cancelllous bone resembling Styrofoam was about the best you could hope for!
Bone-Gen TR is probably going to rule!
Seriously; a totally synthetic material that will (due to a much slower absorption rate than the original formulation) leave the patient with a type II quality bone for the osteotomy site, is a major league advancement for implant surgery! What I'm saying, is that in these days of Mad Cow Disease and questionable cadaver bone bank suppliers, having a synthetic bone augmentation product that leaves a bone that is good enough to place implants in all by itself, is a commodity that is too good to be overlooked!
That's how I see it. I'm pretty sure that Dr. Wildman might agree!
M.S.
Posted by: Mitch Slotnick | September 15, 2006 09:03 PM