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The composition of the alloy must be within 0.5 percent of the weight reported by the manufacturer or
0.1 percent of the weight if designated a hazardous
element by the National Institute for Occupational
Safety and Health or the World Health Organization. Mechanical properties are evaluated by measuring yield strength (in megapascals), elongation
(percentage) and hardness. Annealed and hardened
samples are evaluated for yield strength and elongation. Hardness, identified by Vickers number,
must be within 10 percent of the value designated
by the manufacturer. Physical properties are determined by the melting range, which must be within
20 C of that specified by the manufacturer. The
casting temperature and color also must be
specified.
Alloys must demonstrate biocompatibility by conducting toxicity testing according to ANSI/ADA document no. 41, which describes recommended standard practices for biological evaluation of dental
materials.2 This testing requirements include cytotoxicity testing that evaluates cell death in L929 or
HeLa cell cultures exposed to the alloy, hemolysis
testing in rabbit blood and mutagenicity testing
conducted according to the Ames test.
Corrosion testing must be completed for new
alloys by comparing their performance to alloys that
have been in use successfully for at least five years.
The corrosion test is a static immersion test that is
performed by immersing samples in an acidic solution at 37 C for seven days. The sample is removed
and the residual solution is analyzed for metal ion
release. Additionally, testing must be conducted to
determine the potential of the alloy to tarnish. Tarnish testing is a cyclic immersion test conducted
using a solution of sodium sulfide hydrate. The
sample is dipped in the test solution for 10 to 15
The Dental Product Spotlight appears in JADA each month to help dentists stay current on new products entering the marketplace
and receiving the ADA Seal of Acceptance. These reports are prepared by the ADA Division of Science, in cooperation with The
Journal of the American Dental Association. All rights reserved.
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DENTAL P R O D U C T
SPOTLIGHT
restorations and frameworks for fixed and removable partial dentures. These alloys also can be used
for restoration posts and cores and for splints.
1. American National Standards Institute/American Dental Association. Specification no. 5 for dental casting alloys. Chicago: American
Dental Association; 1998.
2. American National Standards Institute/American Dental Association. Biological evaluation of dental materials. ANSI/ADA document 41
and 41a. New York: American National Standards Institute; 2001.
Biocompatibility of
dental alloys
n the early years of the ADA Acceptance program, composition was considered to be one of
the most important aspects when considering
the acceptability of a casting alloy for dental
applications. At that time, most dental alloy
compositions were based on gold, which is known to
be extremely resistant to corrosion, as discussed
below. However, advances in biomaterials research
over the past 20 years, and the increase in the price
of gold in the early 1980s, led to diversification of
the elements used in dental alloys, so that typical
alloys are now based on gold, palladium, silver,
nickel, cobalt or titanium.1,2 Because of the variety
of alloys available, it is not practical to base standards on alloy composition, and, therefore, there has
been a national and international movement toward
the establishment of standards that use performance as the criterion for evaluating alloys used in
dental applications. An important step in moving
toward a more performance-based standard for
dental alloys was to remove the composition
requirements and make the classification system
more clinically relevant. As mentioned in the Dental
Product Spotlight on page 758, the current classification system for dental casting alloys is broken
down into Types I through IV based on the alloys
mechanical and physical properties.
Before an alloy can be classified according to its
mechanical and physical properties, however, it first
must be evaluated for its reactivity in the oral
cavity, which is governed by thermodynamic principles and electrochemical reaction kinetics. This
means that when an alloy is placed in the oral
cavity, the alloy-saliva system will be driven toward
a state of equilibrium (thermodynamic equilibrium).
At equilibrium, the alloy either will remain stable in
its elemental form or oxidize into its ionic form.
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