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Second Opinion Doug Stegman

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Lead: What's Acceptable?

by Doug Stegman



Second opinions are common in health care; whether a doctor is sorting out a difficult case or a patient is not sure what to do next. In the context of our magazine, the first opinion will always belong to the reader. This feature will allow fellow dentists to share their opinions on various topics, providing you with a "Second Opinion." Perhaps some of these dentists' observations will change your mind; while others will solidify your position. In the end, our goal is to create discussion and debate to enrich our profession.

— Thomas Giacobbi, DDS, FAGD
Dentaltown Editorial Director 		So far, in 2008, the hot topic in dentistry has been "lead in dental work." Since February, we have seen a slew of media coverage on this, which stems from one single case. The story originally broke with WBNS-10TV from Columbus, Ohio, and most major media markets have covered this topic, including a piece on Fox News Channel in March and a story on Good Morning America in May. This is a lesson for all of us. Though the situation was isolated, it is evident that one patient can drive the train of change as it relates to anything in healthcare. In the case that started the ball rolling, in the spring of 2007, a 73-year-old Ohio woman went to a dental clinic and was prepped for a five-unit bridge. The bridge did not fit or function properly and the patient asked the dental office if she could visit the lab that made the restoration. The dental office informed the patient that would be difficult to do, since the dental laboratory was in China. This prompted the patient to get the bridge tested for unsafe materials.

The public responses by both the American Dental Association (ADA) and the National Association of Dental Laboratories (NADL) have naturally been affected both by political and economic concerns. There are many parties with a vested interest in the supply chain of dentistry and they are all wondering what will come next?

The political concerns focus on whether or not new regulations or new standards of operation are forthcoming (either at the state or federal level) that will impact dentists, dental laboratories and/or dental manufacturers.

To date, no additional federal regulations have been proposed, however, the number of inspections of domestic dental laboratories has increased compared to this time last year, according to the Centers for Devices and Radiological Health of the Food and Drug Administration. Additionally, this issue has garnered considerable interest from two Congressional Committees: the House Committee on Energy and Commerce and House Special Committee on Aging. Only time will tell how the pieces will play out in the future.

At the state level, it's a different story. Fourteen states have either filed, or are in the process of filing state legislation or administrative rules to address the issues of laboratory regulation. The two items they are most focused on are material and point-of-origin disclosure. Florida, through the efforts of the state dental laboratory association was the first state to pass legislation on this subject in early May. South Carolina also passed similar legislation in May, according to the South Carolina Dental Laboratory Association.
The economic concerns are obvious, regardless of whether claims of lead in dental work are scientifically valid or not. The result is that some patients might defer seeking or undergoing dental work until the dust settles. It's important that the general public is comfortable that the protocols in dentistry are present to deliver a safe product.

Many of the facts from the documented case in Ohio are still not public due to pending litigation. Nonetheless, we do know that this restoration exhibited not only levels of lead, but also cadmium and arsenic, with cadmium having the highest level of the three. The lead level in the Ohio case was 160 parts per million (ppm).

One pressing question still remains: What is the appropriate level of lead that is acceptable in a finished restoration? In a perfect world the answer would be black and white. In 1991, the American Dental Association/American National Standards Institute (ADA/ANSI) standard referenced 300 ppm or below of lead as "acceptable." In April 2008, the Centers for Disease Control and Prevention made a public release in response to an inquiry from the ADA, which stated that anything at or below 200 ppm was safe for use. Further guidance on appropriate lead levels in dental work is likely to come from the ADA Standard Committee on Dental Products later this year.

Dental laboratories are right in the middle of this supply-chain saga. We purchase our raw materials from dental manufacturers to facilitate the manufacture of laboratory products to fill the prescriptions requested from our client, the dentist. For this reason we have not been overly concerned or mindful of lead levels in dental materials, as the materials we buy are from widely known manufacturers that have all gone through Food and Drug Administration (FDA) product registration.

Dental manufacturers serve both dental laboratories and dentists and are the key to what happens next in terms of regulations and standards. Although the media spotlight has focused on "off-shore" dental laboratory work, the issue at hand is really one of dental materials standards and the process of how they are approved for use in the marketplace.

The ADA Standards Committee on Dental Products works with dental manufacturers on an ongoing basis to develop material standards through a formal process with the American National Standards Institute. Such standards are reviewed and updated on a regular basis by this committee, but the timeline in between updates for some materials is not consistent.

Once a manufacturer's product has met ADA/ANSI standards, the product then goes through a process to register its specific brand with the FDA. Once that is achieved, a product would usually only be recalled if there were a series of adverse incidents self reported by dentists, dental laboratories or the manufacturer themselves.

In wake of the recent events, the dental laboratory industry, the dental profession and the media have all been abuzz trying to draw comparisons between lead in dental work to other types of products. I can understand the need for comparisons but it seems that people are forgetting that dental restorations are a medical device. A comparison of a PFM to a toy is like comparing apples to oranges. The lead level for toys was lowered after the 2007 product recalls to 90 ppm and lead levels in ceramic pottery is set at around 5 ppm as regulated by the FDA. The timeline of exposure of such products in the human body is not comparable to dental work.

Lead in dental work is a different animal altogether, as the restoration is in the oral cavity, 24 hours a day and can be there for upwards of 20 years. Additionally, whether or not lead will cause any health concerns depends on the age, gender, and general health of the individual. This is an issue for toxicologists to speak to and should not be speculated on by those in dentistry.

In the Ohio case and all of the individual restorations tested by the media, the results reflected that the higher levels of lead have been present in the porcelain, most namely the ceramic glazes and/or stains. Glazes and stains of this nature are widely used by dental laboratories to help with shading. All of the products tested by WBNS-10TV in Columbus, Ohio, and WJLA 7 in Washington, D.C., whether foreign or domestic, it appears, have been restorations that used FDA-registered materials.

None of the restorations tested by the media have shown lead levels of concern in the alloy. Generally speaking, all of the cases analyzed both foreign and domestic have been tested using the IPS-MS method of testing for lead levels. The next major trial will be the results that stem from the ADA's tests of 50 domestic and 50 foreign restorations that happened this May. [Editor's note: Results of the ADA's tests were not yet released as of press time.]

Due to legal reasons, none of the media outlets have been able to publicly release the names of those materials or the manufacturers of the materials that have seen the highest readings of lead content in their glazes. Those manufacturers whose products resulted in high levels of lead in their materials have been contacted individually by the specific media outlets. A number of dental laboratories and dental manufacturers have taken it upon themselves to test a random sampling of their products to provide a clear assurance of the safety of their products. This process is similar to the Vendor Survey, which is addressed in the FDA's Good Manufacturing Processes (GMP's). This is the process where a customer performs documented due diligence on their vendors, whether foreign or local, to show they conform with the FDA's requirements.

This story is far from over, as is the determination of whether there is a concern or health risk for patients or if this is only a story of some missing puzzle pieces on dental materials standards. Regardless of the answer to this question, the lesson and opportunity that has been presented should prompt dental laboratories and dentists to work more closely together in patient care.
Authors' Bio
Doug Stegman is the owner of Stegman Laboratories in Phoenix, Arizona. Stegman Laboratories, is one of less than 100 dental laboratories in North America to achieve third-party certification through the DAMAS quality assurance process. Mr. Stegman is a past president of both the Arizona Dental Laboratory Association and the National Association of Dental Laboratories. To contact Doug Stegman, please email: doug@stegmanlabs.com, visit: www.stegmanlabs.com, or call 602-266-2001 or 877-783-4626.
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