Guest Editorial: What's in Those Wonder(ful) Restorative Materials? If labeling of ingredients can be done with foods, drugs, and cosmetics, why can't it be done with dental materials? There are desk references for physicians describing in detail prescription drugs and non-prescription drugs. Shouldn't we have a desk reference for dentists similar to the catalogs that provide chemical definitions and short descriptive terms for compounds used in formulating foods, drugs, cosmetics, sunscreen protective agents, and other consumer products? In this age of information, why must patients, dentists, dental hygienists, dental assistants, teaching staff in dental schools, research scientists, and even sales representatives ofmanufacturers who promote and demonstrate the use of dental materials at meetings be intimately involved with products of unknown composition? When we can know, and when the benefits of knowing outweigh the risks of disclosure, we should have the option of knowing. Labeling of dental materials by manufacturers was unanimously recommended by an NIH technology assessment panel that met last August to consider the effects and side-effects of dental restorative materials (see Advances in Dental Research, Volume 6, 1992). The panel called for the provision of an insert or "stickers" listing the constituents used to formulate each material. Referencing the information in each patient's chart was also recommended. Recently, renowned biochemist Bruce Ames and others have pointed out that many ofthe additives in processed foods may be less noxious than some of the natural pesticides contained in unprocessed, even "organically grown," foods. The body has multilayered defenses against very small quantities ofmany ifnot most xenobiotic materials, and probably does not respond in a linear manner to higher levels, especially maximum tolerated doses, of such substances. A recurrent unanswered question is whether a given chemical in very small quantities per time period per body mass is harmful, benign, or healthful-or more helpful than harmful. That is, what substances have thresholds only above which their net effect is harmful? For example, selenium and perhaps even arsenic are essential nutrients in extremely small quantities but very toxic at higher amounts. While the opinions and suggestions presented here do not necessarily represent any organizational view, the desire for listings of ingredients in dental materials is shared by many dental researchers and practitioners. Are we really in the information age, or are we still slogging along in a muddled age of patent medicines? Without knowing the contents of the materials we use, we are left with imagination, perhaps fictitious assumptions. We don't need fiction, especially science fiction, in the real world of dentistry. Genuine advances in dental materials are occurring so fast that practitioners must be lifelong students and constantly be on a steep learning curve to provide state-of-the-art practices. The rapid evolution of dental compositions makes it almost impossible to have pre-market clinical trials of sufficient duration to satisfy the concerns of many. There is, therefore, even more reason for people to know the contents of new materials. Even slight changes in product composition can account for significant differences not only in research data but also in biocompatibility. Take, for instance, a hypothetical case in which one or more manufacturers add some specific monomer to the other monomers in bonding resin formulations to improve some property, and no problems
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appear in pre-market evaluations. Suppose that a number of dental personnel later developed dermatitis as a result of this change in composition. Would this not cast a shadow upon the use of all bonding resins? If a list of ingredients for the old and new formulations had been provided with the kits when sold, this extra compound could be more quickly identified and eliminated. The information mightbe simply a page, suitable for filingin the dental office, with the name of the product, the lot number, and a list of all ingredients. Preferably, as with the listing in foods, the major ingredient would be listed first and the others in order of decreasing concentrations. Improvements require changes, but the changes should not be kept secret. New materials? Yes, there are indeed many things under the sun that are new these days. For example, note the tremendous improvement within the last decade in adhesive bonding of composites and other resins to dentin and enamel. There has been the development of guided-tissue regeneration materials and techniques and osseointegrated implant systems. Scientists at the National Institute ofStandards and Technology have recently filed a patent application for a metal and intermetallic direct restorative material that contains no mercury. Consider the beauty and durability of resin-bonded porcelain veneers and jacket crowns, and the promise of novel glass-ceramic compositions for use in precisioncast inlays, for crowns, and for CAD/CAM (computer-aided design and computer-aided manufacturing) applications. The list could go on.
We should know what is in these diverse materials with which millions of people will be chewingtheir health foods. More and more people are taking interest in their health and fitness, including what they are puttinginto their mouths. They and we as professionals should know what we are putting into their mouths in the way of preventive and restorative materials. How can we initiate requirements for listing ingredients in dental materials? In the US, the Food and Drug Administration must probably issue relevant regulations and guidelines (not that that agency does not have enough to do already). Other countries already have such requirements in place; shouldn't the Federal Government be able to enact and carry out this much-needed reform in the US? I'm not a politician and can only suggest this action, but if enough people-"you-all"-would express similar concerns, it would seem that in democratic societies such as ours, those who do know how to deal with policy issues and policy-makers could get this accomplished. Perhaps answering the question "what's in those wonderful) restorative materials?" will require a "two steps forward, one step back" procession (like innovative research-challenging and frustrating), but even that is a viable means to achieve a desirable objective when no other path is accessible. Churchill said success is a matter of going from failure to failure with undiminished enthusiasm. Let's continue to press on toward more completely incorporating the realm of dental materials into the age of information. -Rafael L. Bowen Director ADA Health Foundation's Paffenbarger Research Center at the National Institute of Standards and Technology Gaithersburg, MD 20899
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appear in pre-market evaluations. Suppose that a number of dental personnel later developed dermatitis as a result of this change in composition. Would this not cast a shadow upon the use of all bonding resins? If a list of ingredients for the old and new formulations had been provided with the kits when sold, this extra compound could be more quickly identified and eliminated. The information mightbe simply a page, suitable for filingin the dental office, with the name of the product, the lot number, and a list of all ingredients. Preferably, as with the listing in foods, the major ingredient would be listed first and the others in order of decreasing concentrations. Improvements require changes, but the changes should not be kept secret. New materials? Yes, there are indeed many things under the sun that are new these days. For example, note the tremendous improvement within the last decade in adhesive bonding of composites and other resins to dentin and enamel. There has been the development of guided-tissue regeneration materials and techniques and osseointegrated implant systems. Scientists at the National Institute ofStandards and Technology have recently filed a patent application for a metal and intermetallic direct restorative material that contains no mercury. Consider the beauty and durability of resin-bonded porcelain veneers and jacket crowns, and the promise of novel glass-ceramic compositions for use in precisioncast inlays, for crowns, and for CAD/CAM (computer-aided design and computer-aided manufacturing) applications. The list could go on.
We should know what is in these diverse materials with which millions of people will be chewingtheir health foods. More and more people are taking interest in their health and fitness, including what they are puttinginto their mouths. They and we as professionals should know what we are putting into their mouths in the way of preventive and restorative materials. How can we initiate requirements for listing ingredients in dental materials? In the US, the Food and Drug Administration must probably issue relevant regulations and guidelines (not that that agency does not have enough to do already). Other countries already have such requirements in place; shouldn't the Federal Government be able to enact and carry out this much-needed reform in the US? I'm not a politician and can only suggest this action, but if enough people-"you-all"-would express similar concerns, it would seem that in democratic societies such as ours, those who do know how to deal with policy issues and policy-makers could get this accomplished. Perhaps answering the question "what's in those wonderful) restorative materials?" will require a "two steps forward, one step back" procession (like innovative research-challenging and frustrating), but even that is a viable means to achieve a desirable objective when no other path is accessible. Churchill said success is a matter of going from failure to failure with undiminished enthusiasm. Let's continue to press on toward more completely incorporating the realm of dental materials into the age of information. -Rafael L. Bowen Director ADA Health Foundation's Paffenbarger Research Center at the National Institute of Standards and Technology Gaithersburg, MD 20899
