Calcium sulfate based bone grafting materials have been used for 115 years with the first reported use of calcium sulfate from the German physician Friedrich Trendelenberg in Bonn. Later Dreesman in 1892 reported successful use of calcium sulfate as a bone graft material.
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Originally calcium sulfate was perceived only as a defect filler but many recent studies have shown that calcium sulfate is biocompatible, biodegradable, osteoconductive, safe and non-toxic. Upon implantation in the body, it dissolves into calcium and sulfate ions. Calcium ions combine with phosphate ions from body fluids to form calcium phosphate. This forms an osseoconductive lattice of biologic apatite that stimulates bone ingrowth into the defect. Infrared spectroscopy studies showed that the newly deposited material is mainly carbonated hydroxyapatite which is similar to the apatite naturally present in bone.
Another important event as calcium sulfate undergoes degradation in the defect is the local decrease in pH. This pH drop results in demineralization of the defect walls producing a release of bone growth factors. Recent studies indicate that there is increased expression of Bone Morphogenetic Protein-2 (BMP-2), BMP-7, TGF- ß and PDGF-BB in bone defects when calcium sulfate is used as a bone graft. All of these growth factors stimulate the formation and development of new bone.
It was shown recently that calcium sulfate also has angiogenic, hemostatic and barrier membrane properties. It can also be combined with other bone grafts materials like autografts, allografts, calcium phosphates, and bioactive glasses, to increase their binding properties, volume and effectiveness as bone grafts. Calcium sulfate has also served as an excellent delivery vehicle for growth factors and drugs like cephalexin and tobramycin.
Frequently Asked Questions:
1. What is DentoGen?
DentoGen is a Medical Grade Calcium Sulfate Hemihydrate (MGCSH). MGCSH is a highly purified form of calcium sulfate.
2. What are the indications for DentoGen?
DentoGen is allowed for marketing by USFDA as a bone graft by itself, in combination with other bone graft materials and as a barrier membrane. In other words, you can graft with any material of choice and then layer DentoGen over the graft instead of having to fit a membrane fragment. It makes covering the graft much easier. In fact, after covering the graft site with DentoGen, primary closure is not required. This makes for an easier and more cost effective bone grafting procedure.
It can also be used in combination with dental implants to improve their osseointegratation.
3. How is DentoGen packaged?
One gram of DentoGen is packaged in a cup, which is again packaged in a tyvek polyethylene pouch. This cup can be used to mix DentoGen with the liquid to form a putty that can then be delivered to the graft site. The DentoGen, liquid, powder and cup are all sterile. The kit comes with regular set and fast set liquids in separate sterile vials so the procedure can be tailored to the needs of the dentist.
4. How do you use DentoGen?
Preparing DentoGen for use is a simple 3-step process.
Step 1: Open the package and add 3-4 drops of regular set liquid to DentoGen powder in the cup.
Step 2: When the mix reaches a putty like consistency, place it in defect in thin layers. Place it slightly in excess.
Step 3: After the last layer is placed, put a drop or two of fast set liquid over the surface of the outer layer of DentoGen. Fast set liquid accelerates the hardening process to 2 minutes. This allows the graft site to be immediately closed and/or covered by the tissue flap. This saves chair time and increases patient comfort.
5. What are the advantages of calcium sulfate over other bone grafts?
All bone grafts can be categorized as either autograft, allograft, calcium phosphate based grafts, bioglass based grafts or calcium sulfate based grafts. The following table compares the characteristics of different bone grafts.
|Autograft||Allograft||Calcium Sulfate||Calcium Phosphate||Bioactive Glass|
|Degradation||Too Slow||Too Slow||Complete||Too Slow||Too Slow|
|Growth factor release||N||N||Y||N||N|
Y = Yes, N= No
This table describes the properties of different bone graft materials and demonstrates the advantages of calcium sulfate based products.
6. What properties are unique to calcium sulfate bone grafts?
Calcium sulfate is completely biodegradable. It is also angiogenic as well as hemostatic. Additionally, it can be used as a barrier membrane. These properties make calcium sulfate unique.
7. Is DentoGen the same as calcium sulfate sold in local pharmacies?
No. DentoGen is medical grade calcium sulfate; it comes in a sterile kit and is approved by FDA as a bone graft material. Calcium sulfate sold in local pharmacies is not necessarily medical grade, is not sterile and is not an approved bone graft material.
8. What are the cost advantages of DentoGen?
Two patient dedicated kits of 1-gram DentoGen sell for $80. Each kit can be used to cover one graft site. No other bone grafting materials or barrier membrane kits are this inexpensive. DentoGen can be used as the grafting material, barrier membrane or both. No other material has such versatility or is so simple to use.
9. Have you done clinical studies to test this product?
Yes. It has been used as a bone graft in sinus augmentation, molar extraction, apicoectomy, etc. The ability of DentoGen to aid in healing is well documented. It has also been used as a barrier membrane to prevent ingrowth of soft tissues with great success. Since it is completely biodegradable, there is no need to remove the barrier. It has also been used with other bone grafts to improve their binding characteristics.
In fact, we will be posting some photographs of successful cases on Osseonews.
10. Did you observe any adverse reactions?
To date, none of our users have reported adverse reactions or failure to heal.
11. How can I buy DentoGen?