Titanium Expiration Dates?

Mark Jackson

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Study: Age of titanium key to implant success
By Rob Goszkowski, Assistant Editor

October 10, 2012 -- The strength of implant osseointegration in aged titanium surfaces was significantly less than in newly prepared titanium surfaces in the early stages of healing in an animal model, according to a new study Implant Dentistry (October 2012, Vol. 21:5, pp. 415-421).


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The study authors, from the Yonsei University College of Dentistry and the University of California, Los Angeles (UCLA) School of Dentistry, describe the phenomenon as "the time-dependent degradation of the biological capability of titanium."

"In the past, titanium aging has been overlooked," Jae Hoon Lee, DDS, MS, PhD, an assistant professor in the department of prosthodontics at Yonsei, told DrBicuspid.com. "For future clinical studies, it is important to take titanium aging into account."

“In the past, titanium aging has been overlooked.”
— Jae Hoon Lee, DDS, MS, PhD
In order to meet the standard of new techniques of implant surface rejuvenation, a new guideline of titanium preservation expiration date will become an essential part of surgery in daily practice, he added.

The osseointegration strength of aged titanium surfaces is reduced to less than 50% compared with newly prepared titanium surfaces, Dr. Lee and his fellow researcher concluded.

"Moreover, a higher than 90% bone-implant contact (BIC) obtained for new titanium surfaces can be reduced to less than 60% for the aged surfaces," they wrote. "This degradation was primarily associated with considerably reduced capability of aged titanium surfaces to attract proteins and osteogenic cells."

Importance of BIC

Understanding why BIC does not reach an ideal 100% is "a crucial unaddressed question," the researchers noted.

To better understand what holds dental implants back from achieving it, they took a step back to consider the factors of successful osseointegration. Titanium is an ideal material due to its myriad advantageous properties, such as corrosion resistance, strength, and the ability to apply surface modifications. And surfaces roughened on a micron scale can improve BIC. Beyond that, new research is examining the possibility that nano-level structures added to roughened surfaces may further improve bone-titanium integration.

While early results are promising on that front, a more urgent matter is understanding data from recent studies that "reported significant changes in osseoconductivity and other biological capabilities of titanium over time (with an increased period after processing the surface)," the study authors wrote. Understanding that data could help close the gap in our understanding of why BIC has yet to reach 100%, they added.

There were several instances where new titanium outperformed aged titanium, they found in their review of the literature. One dataset examined osteoblast differentiation and mineralization (Biomaterials, October 2009, Vol. 30:29, pp. 5352-5363). In this case, the researchers measured alkaline phosphatase (ALP) activity, since, when elevated, it is typically due to active bone deposition. So they cultured human osteoprogenitor cells and rat bone marrow-derived osteoblasts on titanium disks of different topographies and ages. In their comparison of ALP activity, they found that the ALP activity on 4-week-old surfaces was reduced compared with the new surfaces by 60%, 60%, and 70% on acid-etched, machined, and sandblasted surfaces, respectively.

In in vivo testing, which compared acid-etched implants with disparate storage times of 2 days, 3 weeks, and 4 weeks, the researchers found a statistically significant difference in osseointegration. "It was noteworthy that the 4-week-old implant showed only a less than half level of osseointegration compared with the new implants," they wrote. "Such substantial difference remained significant at later healing stage of week 4 in the model."

In the course of the same study, researchers performed a 2-week bone-healing study where they compared newly prepared acid-etched implants versus 4-week-old similarly prepared implants in a rat femur model. After 2 weeks, contiguous, extensive bone formation covered a large area of the new implants. There was little soft-tissue intervention in the new formed bone and titanium. In the old implants, the coverage was limited, fragmented, and localized. There was much more soft-tissue intervention as well.

"The BIC for the new surface reached more than 90% whereas it was lower than 60% for 4-week-old implants," the researchers noted. Additionally, there was greater BIC at 2 weeks of healing in the new implants than after 4 weeks of healing in the older implants.

There are limitations to the data, noted Garrett Cale Smith, PhD, CEO of implant company Nasseo, who has a background in surface-bonding implant technology.

"In order to evaluate how this study will impact dental implant technology, more in vivo studies in larger animal models with longer time points and with more detailed materials science analysis that highlight the cleaning steps after surface treatment are needed," Smith told DrBicuspid.com.

He also had questions about some of the procedures in the rat-healing study.

"From a materials science perspective, it was unclear how the surfaces were cleaned, which could vary the oxide properties during the wait time between implantation after 1 day or after 4 weeks," he noted. "It is known that residual acid or grit on the surface, if not removed by proper cleaning and/or heat treatment, can significantly alter the in vivo bone response."

Titanium regulation needed

Even so, the research outlined in the review should spur action and could lead to standardization of titanium products, including implants, screws, abutments and bar stock, ccording to the Implant Dentistry study authors. There are clinical implications as well.

"In fact, there is no regulation or expiration of manufacture, distribution, and storage in these products, except for the expiration of sterilization, which is normally 5 years," the researchers wrote. Given the lag between manufacture and shipping, it can be assumed that many commercial products are "uncontrollably and substantially damaged."
 
ceram1

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Study: Age of titanium key to implant success
By Rob Goszkowski, Assistant Editor

October 10, 2012 -- The strength of implant osseointegration in aged titanium surfaces was significantly less than in newly prepared titanium surfaces in the early stages of healing in an animal model, according to a new study Implant Dentistry (October 2012, Vol. 21:5, pp. 415-421).


We just bottled versatility
Scotchbond™ Universal Adhesive combines Total-Etch & Self-Etch in one adhesive - the only adhesive you’ll need. Works for direct and indirect indications. Try it and see: buy two, get one free!

The study authors, from the Yonsei University College of Dentistry and the University of California, Los Angeles (UCLA) School of Dentistry, describe the phenomenon as "the time-dependent degradation of the biological capability of titanium."

"In the past, titanium aging has been overlooked," Jae Hoon Lee, DDS, MS, PhD, an assistant professor in the department of prosthodontics at Yonsei, told DrBicuspid.com. "For future clinical studies, it is important to take titanium aging into account."

“In the past, titanium aging has been overlooked.”
— Jae Hoon Lee, DDS, MS, PhD
In order to meet the standard of new techniques of implant surface rejuvenation, a new guideline of titanium preservation expiration date will become an essential part of surgery in daily practice, he added.

The osseointegration strength of aged titanium surfaces is reduced to less than 50% compared with newly prepared titanium surfaces, Dr. Lee and his fellow researcher concluded.

"Moreover, a higher than 90% bone-implant contact (BIC) obtained for new titanium surfaces can be reduced to less than 60% for the aged surfaces," they wrote. "This degradation was primarily associated with considerably reduced capability of aged titanium surfaces to attract proteins and osteogenic cells."

Importance of BIC

Understanding why BIC does not reach an ideal 100% is "a crucial unaddressed question," the researchers noted.

To better understand what holds dental implants back from achieving it, they took a step back to consider the factors of successful osseointegration. Titanium is an ideal material due to its myriad advantageous properties, such as corrosion resistance, strength, and the ability to apply surface modifications. And surfaces roughened on a micron scale can improve BIC. Beyond that, new research is examining the possibility that nano-level structures added to roughened surfaces may further improve bone-titanium integration.

While early results are promising on that front, a more urgent matter is understanding data from recent studies that "reported significant changes in osseoconductivity and other biological capabilities of titanium over time (with an increased period after processing the surface)," the study authors wrote. Understanding that data could help close the gap in our understanding of why BIC has yet to reach 100%, they added.

There were several instances where new titanium outperformed aged titanium, they found in their review of the literature. One dataset examined osteoblast differentiation and mineralization (Biomaterials, October 2009, Vol. 30:29, pp. 5352-5363). In this case, the researchers measured alkaline phosphatase (ALP) activity, since, when elevated, it is typically due to active bone deposition. So they cultured human osteoprogenitor cells and rat bone marrow-derived osteoblasts on titanium disks of different topographies and ages. In their comparison of ALP activity, they found that the ALP activity on 4-week-old surfaces was reduced compared with the new surfaces by 60%, 60%, and 70% on acid-etched, machined, and sandblasted surfaces, respectively.

In in vivo testing, which compared acid-etched implants with disparate storage times of 2 days, 3 weeks, and 4 weeks, the researchers found a statistically significant difference in osseointegration. "It was noteworthy that the 4-week-old implant showed only a less than half level of osseointegration compared with the new implants," they wrote. "Such substantial difference remained significant at later healing stage of week 4 in the model."

In the course of the same study, researchers performed a 2-week bone-healing study where they compared newly prepared acid-etched implants versus 4-week-old similarly prepared implants in a rat femur model. After 2 weeks, contiguous, extensive bone formation covered a large area of the new implants. There was little soft-tissue intervention in the new formed bone and titanium. In the old implants, the coverage was limited, fragmented, and localized. There was much more soft-tissue intervention as well.

"The BIC for the new surface reached more than 90% whereas it was lower than 60% for 4-week-old implants," the researchers noted. Additionally, there was greater BIC at 2 weeks of healing in the new implants than after 4 weeks of healing in the older implants.

There are limitations to the data, noted Garrett Cale Smith, PhD, CEO of implant company Nasseo, who has a background in surface-bonding implant technology.

"In order to evaluate how this study will impact dental implant technology, more in vivo studies in larger animal models with longer time points and with more detailed materials science analysis that highlight the cleaning steps after surface treatment are needed," Smith told DrBicuspid.com.

He also had questions about some of the procedures in the rat-healing study.

"From a materials science perspective, it was unclear how the surfaces were cleaned, which could vary the oxide properties during the wait time between implantation after 1 day or after 4 weeks," he noted. "It is known that residual acid or grit on the surface, if not removed by proper cleaning and/or heat treatment, can significantly alter the in vivo bone response."

Titanium regulation needed

Even so, the research outlined in the review should spur action and could lead to standardization of titanium products, including implants, screws, abutments and bar stock, ccording to the Implant Dentistry study authors. There are clinical implications as well.

"In fact, there is no regulation or expiration of manufacture, distribution, and storage in these products, except for the expiration of sterilization, which is normally 5 years," the researchers wrote. Given the lag between manufacture and shipping, it can be assumed that many commercial products are "uncontrollably and substantially damaged."
Why would this affect labs and custom abutments? There is not bone contact in the trans-mucosal part of the abutment and data shows some soft tissue attachment to both ti and zir abutments. The last thing on earth needed is more regulations. I do agree on standardization of prosthetic screws but that would assume we have reached the end of innovation in that arena. I doubt it!
 
Mark Jackson

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I agree, and most of the implants have some sort of surface treatment or coating and these studies were done on machined disks or pure Ti.
 
JohnWilson

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And who funded the study? And ultimately who will pay for the regulation of something that is not needed ?

I was thinking the same thing is there any implant fixtures that are not coated? Its pretty obvious the oxidation caused the issue and I am sure the big brains that came up with the test and sparked this info have no idea what the real world ramifications could be if they start putting pull dates on metal.

Lord its been another one of those days why do I bring myself here and get all reved up on this BS.
 
Mark Jackson

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And who funded the study? And ultimately who will pay for the regulation of something that is not needed ?

We will. There will not be any additional regulatory involvement, but implant companies will make smaller runs of implants and other titanium parts so as not to be stuck with inventory that will age out of the system, and we will have to do the same thing when it comes to stocking up on parts. It's crazy.


I was thinking the same thing is there any implant fixtures that are not coated? Its pretty obvious the oxidation caused the issue and I am sure the big brains that came up with the test and sparked this info have no idea what the real world ramifications could be if they start putting pull dates on metal.

It was a bunch of students at UCLA who had nothing better to do that work on a thesis. With a better than 97% success rate, are we REALLY worrying about this?


Lord its been another one of those days why do I bring myself here and get all reved up on this BS.

Me too
.
 
DMC

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This is a paid advertisement from 3M.

Nothing more.

Everyone go buy all the scotchbond and scotchguard products you can get your hands on....and use them everywhere, all the time!

Thank you.

Mr. M
 
ceram1

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Until super scotch bond plus ultimate comes out!!
 
doug

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I guess all of those "Study photos" that I've seen of maximum integration are just some implant guru's wetdream.
 
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