Calcium Sulfate to Revolutionize Bone Augmentation?

bonegen
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?

28 thoughts on “Calcium Sulfate to Revolutionize Bone Augmentation?

  1. 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.

  2. 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

  3. 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

  4. 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.

  5. 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..

  6. 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.

  7. 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

  8. 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.

  9. No doubt Calcium Sulfate may work well, a fact that is claimed by many dentists, which remains hearsay. Research shows otherwise. If one goes to any implant associated meeting anywhere in the world, 98% of speakers will unanimously speak only about the proven clinical success of Bio-Oss.

    My point is: surely all these renowned speakers are not talking rubbish. If they did not get such documented scientifically recorded clinical success, they would not stick their neck out to recommend Bio-oss so whole-heartedly. Significantly, not one speaker/paper ever mentions to go to the neighborhood store to purchase Calcium Sulfate in bulk.

    As for the opening remarks of the President of Bio-Lok about dangers of bovine bone, he should know better than to make such baseless remarks without any supporting proof. Can he show even a SINGLE incident where a Mad Cow disease infected clinical case has been reported, especially related to Bio-oss?

    However, Human derived bone has had problems, more notably with Puros; US-FDA had banned a batch, I think a year ago.

  10. Regarding first comment, calcium sulfate bought at the local pharmacy is not FDA approved bone graft and is not meant for implantation in bone defect. Buying FDA approved calcium sulfate is a much safer bet.

    Regarding previous comment, Bio-Oss is not the only graft that works. 98% of speakers talking about BioOss at international meetings is really a strong overstatement. Good number of them talk about other bone grafts. The fact that calcium sulfate works is not only ‘hearsay’. There is a lot information in scientific literature about how well it works. In fact some literature dates back to 1890s. We should accept the fact that bone grafts other than bio-oss work well and may work better in a lot of cases.

  11. @ruumi daruwala
    i am an avid user of your lifecare products in india using their hitec and endopore system with atr300 physio and am aware of bioss well..
    .but dear ruumi i find ur statement regarding calcium sulphate not being talked about by lot of speakers out of place here coz people like us use these sites(osseonews & dds gadget) for enduser comments by professionals and not company mediated comments..so please dont misguide people like us by putting forth that not many people speak about anything but biooss…….coz many people are not sponsored to speak on calsium sulphate but they may be for biosss…..which u wuld agree……..i read a beautiful text by dr arun garg on bone grafts and membranes wuld encourage everyone to read it and make a infomed decision

  12. the book is titled BONE biology,harvesting,grafting for dental implants:quintessance by arun k garg……….,he has extensively reviewed all the bone graft materials available in the market and given them rating ranking the top with number 10 on scale of 10-1 stating the one with high rank wuld work best in situatoion with low osteogenic potential…top of the materials are autografts but among all commercially available one’s biooss is rated above capset just by a rank of 4 where as capset gets 3 ranking due to fast resorptiontime whereas bioss resorption time is more……..all this comparison is scientifically given on pg 50-51 of book….so kindly read for making choice as per case at hand,….it is not that bioss is bad but it would work well in situations like small reconstructions with high osteogenic potential in conjunction with barrier membranes like on few exposed implant threads or 4-5 wall extraction socket hwereascapset/ calcium sulphate may not need any membrane barrier .

  13. @ ruumi
    “No doubt Calcium Sulfate may work well, a fact that is claimed by many dentists, which remains hearsay. Research shows otherwise. If one goes to any implant associated meeting anywhere in the world, 98% of speakers will unanimously speak only about the proven clinical success of Bio-Oss.”
    hey ruumi….
    word hearsay is not in good taste as research very well states the conditions where they both have their specific indications……..

    98% speakers…..please thats not scientiic way of reporting…
    i expect u to enlighten us with ur knowledge in implant field due to ur interactions with great teachers and not with just “speakers”……..
    just a friend
    dr deepak rai
    noida

  14. Dear Dr. Emad Aly,

    BoneGen is now replaced with a product called DentoGen. It is exactly similar to BoneGen and is developed by the same team that developed BoneGen. DentoGen is medical grade calcium sulfate hemihydrate. And it does support maxillary ridge augmentation on its own. In fact, we are really promoting it as a highly effective and minimally expensive bone grafting alternative for ridge augmentation procedures. Right now we are working on establishing distributorships in several countries including Egypt. Please email us for more information about how to buy and what specials we currently have.

    Thanks for your interest in our product.

  15. RE. CaSO4 as a graft material, I have used it for socket preservation and as a binder with other graft materials. Does anyone have a suggestion for mixing the CaSO4 so that it doesn’t become a runny mess when placed in the socket/defect? I find that even when I make a stiff mix, the patient’s blood dilutes the mix to a thinner consistency making it hard to manage in situ. I use sterile water for mixing the CaSO4. Perhaps I should use an accelerator in the mix, such as calcium chloride.
    Another question: The directions for using ?-tricalcium phosphate (Synthograft, Cerasorb) state that it should not be mixed with ant other materials, only the patient’s blood. Does anyone have any experience with, or knowledge about, mixing ?-tricalcium phosphate with other graft materials or binders? One can use blood from the surgical site – if you can obtain enough – but usually it requires venipuncture if any appreciable volume of graft is needed (e.g., sinus elevation).

  16. Thats a very good question. Any liquid rich in protein interferes with the setting of calcium sulfate. Hence, when it comes in contact with blood, it dilutes. So you should make the site as blood free as possible. If you can not completely stop the bleeding, some doctors sprinkle calcium sulfate powder (before adding setting solution to it) on the bleeding site and that stops the bleeding. Any source of calcium controls bleeding and hence after you sprinkle calcium sulfate powder on the bleeding site, it stops bleeding.

    I do not think mixing TCP with calcium sulfate will be a problem. It should work well.

  17. We actually provide accelerating solution as part of the kit. We sell our product with 2 setting solutions, regular and fast setting solution. Regular setting solution is normal saline and fast setting solution is Potassium Sulfate solution.

    When you mix calcium sulfate with water, it takes around 15 to 20 minutes for it form a putty and around 40 to 60 minutes for it to completely harden.

    When you mix it with regular setting solution that we provide with Dentogen, initially it is in a slurry like form. By 7 to 8 minutes, it reaches a putty consistency. It is very easy to place when it reaches a putty consistency. By 15 to 20 minutes, it completely hardens.

    If you mix it with fast set, in 2 to 4 minutes, it completely hardens. So we already provide you with an accelerator.

    What we advise is mix DentoGen with regular setting solution, give it 5 to 7 minutes to form a putty, place it in the defect layer by layer. Compress every layer with a guaze piece saturated in fast set. Overfill the defect a little. Put a drop of fast set on the top layer so that it hardens completely in a couple of minutes. This saves you a lot of chair time. If you mix it with water, it will take almost an hour to completely harden.

  18. Mr Darawala, I believe you are a salesman for Bioss in India. Could that be why you are just a strong advocate for that product and are critical at others! TCP and Calcium sulphates work well also.

  19. I want to buy the bone gen but i don’t know where is the dealer i am from Cairo, Egypt. please inform me about any details for your prouduct in my country.
    thank you,
    Rania El-Said

  20. Es un gusto leer sus articulos y los comentarios sobre el sulfato de calcio grado medico, soy un alumno de prof. Gabriele Eduardo Pecora, Italia, gran promotor y de estudios del presente producto, y lo uso en Veracruz, Mèxico hace siete años, con sorprendentes resultados positivos y reportados al profesor Pecora, es mi biomaterial de elecciòn favorito aunado al cerasob m, usandolos individual,incluso combinandolos con p.r.g.f y los resulatdos obtenidos son sorprendentes y menor tiempo la regeneraciòn òsea y la calidad òsea mejor que la original.

    Sin producir al momento situaciòn de agravio al paciente, lo que NO avalo, lo de los productos biologicos, lean a Steven Prionner.Y EH RETIRADO DIVERSAS OCACIONES LOS PRODUCTOS BIOLOGICOS Y LAS MANIFESTACIONES AGRESIVAS A LOS PACIENTES.

  21. @ Dr. Rania

    We are selling this product under a new name DentoGen. We now have a distributor in Egypt. Following is their information. I think you can purchase from them.

    Prof. Dr. Wahib Moussa International center for Implants and Esthetics
    Gleem, 542El- Horreya St, Alexandria
    Ph: 03-5851433
    Fax: 03-5855058

    2 Soliman Abaza St., Behind El Seid Club, First Floor Elmohandsen, Cairo
    Ph: 02- 7600166
    Contact: Dr. Wahib Moussa
    Web: http://www.drwahibmoussa.com
    Email: wahibmoussa@yahoo.com

  22. Hello everyone,
    I am a postgraduate student of periodontology. I would very much like to use BoneGen-TR. Is this product available in India? If not, could someone be so kind as to let me know how i can get it? Thanks very much.

  23. Dentogen is reported to resorb slower than medical grade calcium hemihydrate. Can you explain how that is possible? It is amazing how well it will work, but there are instances where it fails for no known reason (in the hands of an experienced practitioner). Could this be due to a particular predominance of oral flora (Treponemes) or saliva components? NaF has been proposed as a stabilizer for other graft materials. Any suggestions?

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