The Importance of Biocompatibility
Cytotoxicity tests are used to determine the lysis (death) of cells, colony formation, inhibition of cell growth, and or other effects on cells caused by medical devices, bio-materials, or their extracts utilizing cell culture techniques.
No cytotoxicity or cell lysis was noted in any of the test wells.
No pH shift was observed at 48 hours.
The reagent control, negative control, and the positive control performed as anticipated.
The SteinerBio graft material showed no evidence of causing cell lysis or toxicity.
Genotoxicity studies are conducted to detect the risk of gene mutations, change in number or structure of a cell, and chromosomal or DNA damage caused by a medical device, bio-material, or their extracts.
The DMSO and saline test article extracts were considered to be nonmutagenic to Salmonella typhimurium tester strains TA98, TA100, TA1535, and TA1537, and to Escherichia coli tester strain WP2uvrA.
The analysis found that the SteinerBio graft material is sterile and produces no genetic changes or changes is cell structure.
Sensitization tests are utilized to evaluate the potential of medical devices, bio-materials, or their extracts tissues to cause a sensitizing effect or allergic reaction following exposure.
The SteinerBio graft material showed no evidence of causing delayed dermal contact sensitization in the guinea pig. The SteinerBio graft material was not considered a sensitizer in the guinea pig maximization test.
This study requires the use of a comparison graft that is currently on the market. The comparison graft material used was mineralized freeze dried bone allograft. The surgical phase of the study was performed at the SteinerBio vivarium. The analysis of the tissue sample was performed by an independent histopathological laboratory.
Findings: The survival rate of the implants placed in the sites of previous failure (first reimplantation) was 77.4% (137 of 177 implants). A statistically significant difference was found (P = .0001) between the survival rates of implants placed for the first time and implants placed into sites of previous failure. The survival rate of the second reimplantation was 72.7% (16 of 22). The survival rate of the third reimplantation was 50.0% (1 of 2).
What this study mentioned but failed to discuss is that all failures were grafted with allograft when the failed implant was removed. The only thing this study proves is that if you continue to graft with an allograft, you will get a progressively worse failure rate. Many clinicians have used this study to claim that reimplantation results in increased failure rates, but this is a completely inaccurate conclusion. The study only says that reimplanting in sites grafted with allografts results in increased failure rates. Allografts produce a significant area of sclerosis beyond the extraction socket and to overcome the negative effects of the allograft, the entire sclerotic bone needs to be removed and grafted with a biocompatible bone graft material.
While allografts produce sclerotic bone, Bio-Oss produces a much higher level of sclerosis. The degree of sclerosis is related to the severity of the inflammatory reaction to the non-biocompatible material. Allografts, when grafted within species, produces sclerosis because of the lack of biocompatibility of the donors proteins. Bio-Oss produces a more intense sclerosis as a result of the animal proteins contained in the mineralized structure. The mineralized portion of bone is simply a mass of mineralized proteins. Because the proteins found in the mineralized structure of Bio-Oss are cross species (animal to human), the sclerosis is greater than allografts and is commonly diagnosed by Oral Radiologists as sclerotic bone.
In the past, Bio-Oss claimed it was anorganic. This lead many dentists to believe that there were no proteins in Bio-Oss, but in our opinion, that was the intent. However, the term anorganic does not mean that the material is devoid of organic material, but instead means that the material contains inorganic material. What dentists do not understand is that the reason they use Bio-Oss is because the presence of animal proteins produces significant inflammation that results in an increase in hardness. Again, dentists do not understand that the mineralized component of bone does not contain regenerative cells that are required for integration. Sclerotic bone has a high mineral content that produces a higher degree of hardness, but that hardness is acquired by the sacrifice of bone vitality and poor reimplantation rates of success. Hard calcified bone is not healthy bone and especially not good for implants to survive for the life of the patient. This is the reason the FDA does not allow implants to be placed in sites grafted with Bio-Oss. In the US, Bio-Oss uses unsuspecting dentists to promote implant placement into their material because the FDA will not allow the company to promote their material for the support of dental implants.
SteinerBio products were designed for the field of regenerative medicine that requires a high level of biocompatibility. The current testing has found that SteinerBio bone grafts are completely biocompatible which results in normal bone but also assures your patients they are receiving the safest material for the health of their bones but also their entire body.
For those dentists that have patients who want to be assured of the safety of the material being placed in their bodies, SteinerBio biocompatibility test results are available upon request. As a dentist concerned about your patients welfare, you should also request the safety results of any graft material you are placing in your patients.