Safety

Restoration Longevity in Terms of Mechanical Integrity From both a patient’s and a clinician’s
perspective, a restoration should last a lifetime. Although some materials are expected to last more than
a lifetime, in a real-world scenario, the longevity of restorations is shorter than expected, especially for
direct restorations. According to research, dentists spend more than 50% of their time replacing failed
direct restorations. As a result, the longevity of dental biomaterials used in restorations is extremely
relevant to the profession and to patients. One of the major advances in the knowledge of dental
materials and their manipulation began in 1919, when the U.S. Army requested the National Bureau of
Standards (now known as the National Institute of Standards and Technology [NIST]) to establish
specifications for the evaluation and selection of dental amalgams for use in federal service. The dental
profession enthusiastically received these specifications, and similar specifications were subsequently
requested for other dental materials. In 1928, dental research at the National Bureau of Standards was
taken over by the American Dental Association (ADA). Standards for dental materials have been
developed to aid producers, users, and consumers in the evaluation of the safety and effectiveness of
dental products. The ADA’s Standards Committee on Dental Products (SCDP) develops specifications for
dental materials, oral hygiene products, infection-control products, dental equipment, and dental
instruments. Many countries have a dental standards organization that is charged with the development
of test standards to ensure product reliability and safety. In addition, TC 106 of the International
Organization for Standardization (ISO) develops international standards. These international standards
often require information about composition; information about physical properties, as obtained by
standard test methods; biocompatibility data; and data covering every provision of the official
specification. More discussion of these standards is provided in Chapter 18, Standardization of In Vitro
Test Methods. From a material standpoint, meeting the specification for mechanical properties means
the material possesses enough strength to withstand occlusal loading, but this does not guarantee
durability. As mentioned earlier, the placement of dental materials, or restorations, over tooth
structures leads to an interplay between solid materials and a series of linked and/or nonlinked,
complex joints. The interfacial position at or within the tooth and the physical quality of the dental
materials involved in this complex assembly have great effects on the longevity of the restoration. Other
factors, such as the selection of materials, clinical indication, patient awareness of their oral hygiene,
and manipulation of and compliance with the dental material manufacturer’s guidelines, will
undoubtedly affect the long-term clinical performance of the restorations. These aspects will be
discussed in more detail in upcoming chapters.
Safety of Dental Materials
Standards for dental materials have been developed to aid producers, users, and consumers in the
evaluation of the safety and effectiveness of dental products. As mentioned previously, national
dentistry standards/specifications have been implemented by the ADA’s SCDP, and international
standards have been implemented by the ISO’s TC 106. Manufacturers can choose between testing their
materials according to either national or international standards. However, for a manufacturer to
market its product in certain European countries, a European Conformity (CE) marking must be obtained
based on the product’s ability to meet one or more national or international standards for performance
and quality. A CE marking indicates that the product complies with European guidelines for health,
safety, and environmental protection legislation. The existence of material-evaluation standards does
not prevent the manufacturing, marketing, purchase, or use of dental or medical devices that do not
meet these standards. However, producers or marketers of products and devices are expected to meet
the safety standards established for those products in the countries in which they are sold. Thus, a
producer may be given premarket approval in the United States by the U.S. Food and Drug
Administration (FDA) to sell a dental device or restorative material without that product being tested by
the ADA or any other agency to determine whether the product is in accordance with the material’s
specifications. Nevertheless, these agencies are becoming increasingly dependent on one another to
ensure that all products marketed worldwide are safe and effective. For a dental material to be used in
the oral cavity, this material should be harmless to all oral tissues and contain no toxic, leachable, or
diffusible substance that can be absorbed into the circulatory system, causing systemic toxic responses,
including teratogenic or carcinogenic effects. The material must also be free of agents that could elicit
sensitization or an allergic response in a sensitized patient. These are considered general characteristics
of biocompatibility. Because safety is relative, no dental device (including restorative materials) is
completely safe. The selection and use of dental devices or materials assume that the benefits will far
outweigh the known biological risks. However, there is always the possibility that a patient will
experience adverse effects from dental treatment. The conceptual aspects of biocompatibility, with
specific emphasis on the solid and liquid materials of greatest relevance to dentistry, are presented in
Chapter 17

Safety

Uploaded by

Copyright:

Available Formats

Safety

Uploaded by

Document Information

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Safety

Uploaded by

Copyright:

Available Formats

Restoration Longevity in Terms of Mechanical Integrity From both a patient’s and a clinician’s

Safety of Dental Materials

You might also like