Effects of environmental factors on maxillofacial elastomers:

Part -Literature review

Carl J. Andres, DDS, FvISD,~ Steven P. Haug, DDS,b
Garbs A. Munoz, DDS, MSD,e and Guillermo Bernal, DDSd
Indiana University, School of Dentistry, Indianapolis, Ind.

Part I of a four-part report presents a comprehensive review of the literature

pertaining to physical property testing of materials for facial and somatoprosthe-
ses. The report was conducted in preparation for testing four current maxillofacial
elastomers: MDX 4-4210, Silastic 4-4515, Medical Adhesive type A, and Epithane-3,
and two recently introdu’ced materials: Silicone A-2186 and Silicone A-102.
(J PEOSTHET DENT 1992;68:327-30.)

T he search for an ideal material for prosthetic re- In 1969, Cantor et a1.12 stated that “advances in facial
habilitation of patients with disfigured or missing facial or prostheses have paralleled deveIopment of an art form-
body features has continued from the beginnings of re- there is no scientific basis or reproducible objective method
corded history. Earliest forms of facial prostheses were for evaluation of materials used.” They studied methods of
constructed of wood, ivory, waxes, and meta1s.l In 1945, predictably and objectively measuring color analysis, du-
Clarke2 described techniques for fabricating prostheses rability, and dimensional stability of three elastomers, thus
from latex rubber, glycerin-gelatin formulations, and elec- beginning the establishment of testing criteria for maxillo-
troplated metals. facial materials. Their efforts were expanded by Sweeney
Modern materials for external. prostheses include vinyl et a1.6 in 1972, whose objectives were “to develop a series
plastisols, poly(methy1 methacrylate), polyurethanes, la- of evaluations to measure properties needed and defined in
tex, and silicone polymers. Silicone elastomers were first scientific terms so that the weakest properties can be im-
used for external prostheses by Barnhart in 1960 and have proved in the future.” As a result of their research, a pro-
since become the material of choice because of their ehem- posal was made for a tentative table of specifications for
ical inertness, strength, durability, and ease of manipula- properties of maxillofacial elastomers. This study was the
tion. Bulbulian4 tabulated and rated the essential qualities first to measure aging of materials in an artificial weather-
of materials used for facial prostheses in 1945 and further ing environment.
elaborated on these ratings in 1946.j Subsequently, many In 1974, Lontz, Schweiger, and Burger13 used the tensile
authors6-1’ have reviewed the qualities of an ideal material modulus of maxillofacial materials to match the elastomers
for facial prostheses. Lewis et a1.8 classified three categories to various tissues of the body, such as aorta, tendon, and
of ideal properties of these materials: (1) processing char- muscle fibers.
acteristics that include low viscosity, extended working In 1975, Koran and CraigI pubiished the first of a series
time, capability of intrinsic and extrinsic coloration, low of research reports evaluating currently used maxillofacial
processing temperature, and ease of molding using reusable materials. They stated that “maxillofacial materials have
molds; (2) mechanical or performance characteristics such been neglected in research investigations of dental materi-
as high tensile strength, high percent elongation, elastic als. As a result of the limited market for these products,
modulus, high tear strength, sufficient hardness, dimen- manufacturers have only a nominal interest in their pro-
sional stability, proper surface tension, coefficient of fric- duction and marketing.” This study investigated the “dy-
tion, and resistance to chemicals and ultraviolet light; and namic” properties of selected silicone elastomers, plasti-
(3) patient accommodation properties that guarantee a cized polyvinyl chloride, and polyurethane, at tempera-
product that is nontoxic, nonallergenic, noncarcinogenic, tures ranging from -15’ to 37’ C, and added another
easily cleansable, lightweight, compatible with adhesives, dimension to the scientific evaluation of maxiliofacial ma-
and that has a reasonable cost. terials.
In 1976, Firtell, Donneau, and Anderson15 introduced
the concept of combining materials to achieve improved
Presented in part before the Annual Session of the Academy of properties by mixing conventional room temperature-vul-
Prosthodontics, Palm Springs, Calif. canized (RTV) silicone with RTV silicone foam to produce
“Associate Professor and Director, Graduate Prosthodontics. a lighter weight prosthesis. However, the strength of the
hAssistant Professor, Department of Prosthodontics.
“Associate Professor, Department of Prosthodontics. elastomer decreased along with the decreased weight.
dGraduate Student, Department of Prosthodontics. In 1978, Gonzales et a1.16z17 and Goldberg et aLI inde-
10/l/37924 pendently tested polyurethane elastomers with physical

THE JOURNAL OF PROSTHETIC DENTISTRY 327

 ANDRES ET AL

properties that were modifiable by varying the amounts of 14.24% after 900 hours in the weatherometer. Polyure-
the components of the three-part system. The investigators thane had good dimensional stability before aging (0.36% ),
concluded that the physical properties could be altered by but disintegrated after 600 hours of aging in the weather-
modifying the ratio of components and that the physical ometer.
properties conformed to the table of specifications origi- Yu, Koran, and CraigZ3 proceeded to evaluate the phys-
nally proposed by Sweeney et al6 ical properties of PVC, polyurethane, three RTV silicones
In 1977, Moore et al9 conducted a survey of 75 compa- (Silastic 382, Silastic 399, and MDX 4-4210), and one HTV
nies and institutions known to be involved in polymer silicone (Silastic 4-4515; Dow Corning, Midland, Mich.)
chemistry in an attempt to uncover potential new materi- before and after accelerated aging. Ultimate tensile
als for facial prostheses. Less than half of those queried re- strength, percent elongation, shear strength, tear energy,
sponded, and only one company had products considered and Shore A hardness were measured. After 600 hours of
worthy of evaluation. Materials tested were MDX 4-4210 accelerated aging, the polyurethane elastomer was severely
elastomer (Dow Corning, Midland, Mich.), unmodified and degraded. The properties of the remaining materials were
thinned with 360 medical fluid, and Silastic 382 medical not greatly affected by 900 hours of accelerated aging. PVC
grade elastomer (Dow Corning). This study introduced the exhibited the largest change, with a decrease of 17% in
“‘O-ring” specimen for tensile stress-strain testing. Previ- shear strength. Silastic 4-4515 exhibited the best overall
ous testing had been conducted on specimens die cut from stability. When considering ease of manipulation and
sheets of polymer, which produced small nicks or flaws in processing, MDX 4-4210 was considered the best choice
the edges of the specimens, resulting in crack propagation among the products tested. Yu, Koran, and Craigz4 then
and premature specimen failure. The O-ring specimens did repeated the testing of MDX 4-4210 incorporating 11
not require the use of special clamps or end-bonded grips maxillofacial pigments. Their results indicated that addi-
that further complicated the testing process. Instead, the tion of pigments can vary physical and mechanical proper-
specimens were stretched between two freely rotating Tef- ties, but the changes observed were not large enough to
lon pulleys mounted on axles that inserted into the grips of compromise the clinical use of the material. The prepared
the tensile testing machine. samples showed little or no change in physical and me-
Craig et al.lg tested the color stability of nonpigmented chanical properties after 900 hours of accelerated aging in
polyvinyl chloride (PVC), polyurethane, and four silicone the weatberometer.
elastomers including MDX 4-4210 and MDX 4-4515 after In 1980, Wiensz5 compared accelerated aging in the
aging in a weatherometer. PVC tended to lighten in color weatherometer with outdoor aging in R.ochester, Minne-
after 100 hours. The polyurethane material was severely sota. Measurements of Shore A hardness, axial stiffness,
degraded after 300 hours. All silicone materials were color- elastic modulus, strain energy, and apparent tensile
stable, with MDX 4-4210 exhibiting the best overall prop- strength were made at 0,500,1000, and 1500 hours for ac-
erties. Koran et al.“* repeated the testing of MDX 4-4210 celerated aging and at 0,3,6,9, and 12 months for control
using 11 different maxillofacial pigments and measured and outdoor aging. Two polyurethane elastomers, Calthane
luminous reflectance, contrast ratio, dominant wavelength, and Epithane-3 (Dare Products, Inc., Butler, Wise.), were
and excitation purity. Very small changes were docu- tested along with one silicone elastomer, MDX 4-4210.
mented. They concluded that the data did not correspond Calthane specimens were severely affected by both aging
with the clinical observations of large color changes over methods. Epithane-3 specimens were disintegrated at 1500
time with the prostheses in use. Further studies were con- hours of accelerated aging. Minimal changes in dimension,
ducted on nonpigmented and pigmented materials by the color, and Shore A hardness were observed for MDX
same authorszl to determine resistance to external staining 4-4‘210. In general, accelerated weathering appeared to al-
with tea, lipstick, and disclosing solution. Materials tested ter the physical and mechanical properties sooner and with
included two RTV silicones, MDX 4-4210 and Silastic 382; greater magnitude than outdoor weathering. For some
one high temperature-vulcanized (HTV) silicone, 4-4515; properties, 1500 hours of accelerated weathering produced
and a PVC material. Tea produced the least color change; effects similar to those of 12 months of outdoor weathering
lipstick and disclosing solution produced the greatest in Rochester, Minn.
change. MDX 4-4210 was the most resistant to tea and dis- Lewis and CastleberrylO published a review of their ma-
closing solution, but showed. the greatest color change from terials research and tabulated processing characteristics
lipstick. PVC was the least resistant to staining, while all and performance characteristics of an “ideal material.”
silicones displayed good stain resistance. Craig, Koran, and Yu’r reviewed the development of max-
Yu and Korar? studied permanent deformation of four illofacial materials in the 70s concluding that based on ex-
silicone materials, PVC, and polyurethane before and after isting knowledge, RTV silicone polymers of the addition
accelerated aging. All silicones displayed excellent dimen- type (MDX 4-4210) offer optimum overall properties for
sional stability before and after aging, with permanent de- maxillofacial application.
formations ranging from 0.22 % to 0.26 % , PVC exhibited In 1982, Udagama and Drane26 introduced a new silicone
a permanent deformation of 13.80% before aging and elastomer-methyl triacetoxy silane cross-linked silicone

328 AUGUST 1992 VOLUME 68 NUMBER 2

PROPERTIES OF MAXILLOFACIAL ELASTOMERS: I
(Medical Adhesive type A, or Dow Corning A-891). No
physical property testing was reported.
In 1984, Abdelnnabi et alz7 compared a new material,
polydimethyl siloxane, with M:DX 4-4210. Polydimethyl
siloxane showed significant differences in tensile strength,
tensile modulus, tear resistance, hardness, and percent
elongation over MDX 4-4210 , but the authors concluded
that MDX 4-4210 remained the material of choice because
of ease of manipulation plus the ability to modify consis-
tency by the addition of silicone fluid.
Turner et a12* evaluated a new isophorone polyurethane
material, comparing properties elf a commercially available
polyurethane, Epithane-3, and MDX 4-4210 before and
after accelerated aging. Results indicated that the isopho-
rone polyurethane was superior in some respects to MDX
4-4210 . Epithane-3 polyurethane disintegrated after 700
hours in the weatherometer. Color stability of this new
material was reported in part II of their study.2g Four color
systems were evaluated: artist’s oil pigments, dry earth
pigments, kaolin modified with dry earth pigments, and
Daro skin pigments (produced for use with Epithane-3.)
Isophorone polyurethane with no color added served as the
control. Visual and spectophotometric observations re-
vealed no statistically significant differences for any of the
color systems before or after aging. The Daro color system
caused a decrease in tear strength after aging.
Wolfaardt, Chandler, and Smith30 compared the physi-
cal properties of a new silicone material developed specif-
ically for facial prostheses by the Institute of Maxillofacial
Technology in London, England. The properties of the new
material, Cosmesil (Cosmedica, Uwist, Cardiff, Wales,
U.K.), were compared with Silastic 382 and MDX 4-4210
and with a third silicone elastomer marketed under the
trade name Silskin (Thackray, Leeds, England). Cosmesil
was designed to be processed with varying degrees of hard-
ness and was tested in the hardest and softest consistencies.
The Cosmesil materials were superior to other materials in
all properties tested.
Kouyoumdjian et al.sl evaluated mechanical properties
of MDX 4-4210 before and after modification by the addi-
tion of 360 medical fluid. Five percent, 10%) and 15% by
weight were added to the base material. Tensile strength,
ultimate elongation, tear resistance, and hardness were
decreased in a linear fashion as the amount of additive was
increased.
Bell, Chalian, and Moore32 evaluated four experimental
RTV silicone elastomers, comparing their physical proper-
ties with those of an HTV silicone (Silastic 4-4515) and
with previous similar test results of MDX 4-4210 and Si-
lastic 4-4514. Tensile strength, tear strength, and percent
elongation of the new materials were superior to previous
test results for MDX 4-4210 and 4-4514. The new materi-
als were harder than previously tested materials.
In 1987, research turned to modification of existing ma-
terials or fabrication of composite materials to achieve
more ideal properties. Farah et al. 33 tested various ratios
THE JOURNAL OF PROSTHETIC DENTISTRY
of MDX 4-4210 base material mixed with Medical Adhe-
sive type A material in an attempt to produce a softer, more
pliable material. The technique was first applied by
Udagama.34 Physical properties were tested before and af-
ter accelerated aging. Hardness decreased proportionally
with the increase of MDX 4-4210. Tear strength was
increased for the lowest ratio (80/20) and decreased pro-
portionally as MDX 4-4210 increased. Maximum elonga-
tion nearly doubled from the 100 % type A to the 60140 and
50/50 ratios.
In 1987, Udagama34 presented a technique for bonding
a thin, prefabricated polyurethane film to silicone pros-
theses to increase tear resistance and adhesive compatibil-
ity. Various lining materials were tested, including ethyl
methacrylate, polyvinyl buteral, methyl methacrylate, and
polyvinyl acetate. Polyurethane was selected as the mate-
rial of choice because of its transparency, high tear resis
tance, moldability, and compatibility with water base skin
adhesives.
This literature review indicates that materials presently
used for maxillofacial prosthetics are improved and ade-
quate but not ideal. If a material has adequate strength and
durability, it frequently is too hard or lacking in process-
ing characteristics. Attempts to modify materials to im-
prove an undesirable characteristic have resulted in a de-
crease of desirable properties. Therefore it appears the
single “ideal” facial prosthetic material is not available.
Research trends toward development of a composite pros-
thesis constructed of two or more materials laminated and
bonded together, each having its own “ideal” characteris-
tics, must continue.
This project was designed to evaluate physical properties
of maxillofacial materials currently in use, including MDX
4-4210, Medical Adhesive type A material, Silastic 4-4515,
Epithane-3, and two recently introduced materials, A-
2186 and A-102 (Factor II Products, Lakeside, Ariz.). The
study was designed to produce baseline data for future devel-
opment of a composite or laminated facial prosthesis
technique.
Part I of this article has presented a review of the
literature pertinent to property testing of maxillofacial
materials. Part II will present the results of an interna-
tional survey of prosthodontists and prosthetists soliciting
information relating to the material(s) of choice, advan-
tages and disadvantages of the selected material(s),
methods of coloring prostheses, and properties of an
“ideal” material. Part III will present the results of phys-
ical property testing of four current materials, Silastic
4-4210, Silastic 4-4515, Medical Adhesive type A material
[A891], and Epithane-3, and two recently introduced ma-
terials, A-2186 and A102. Properties tested include tensile
strength, percent elongation, tear strength, and Shore A
hardness.
Parts III and IV will provide data indicating the effects
of seven environmental variables: passage of time, natural
weathering, two types of adhesives, two types of cleaning
329
solvents, and cosmetics (cold cream) on the materials 18. Goldberg AJ, Craig RG, Filisko FE. Polyurethane elastomers as max-
illofacial prosthetic materials. J Dent Res 197&57:563-g.
tested.
19. Craig RG, Koran A, Yu R, Spencer J. Color stability of elastomers for
Part IV will present the results of optical property test- maxillofacial appliances. J Dent Res 1978;57:866-71.
ing, including color change in nonpigmented materials and 20. Koran A, Yu R, Powers JM, Craig RG. Color stability of a pigmented
elastomer for maxillofacial appliances. J Dent Res 1979;58:1450-4.
optical density. 21. Koran A, Powers JM, Lepeak PJ, Craig RG. Stain resistance of maxil-
lofacial materials. J Dent Res 1979;58:1455-60.
REFERENCES 22. Yu R, Koran A. Dimensional stability of elastomers for maxillofacial
1. Phillips RW, Margetis PM, Urban JJ, Leonard F. Materials for the appliances. J Dent Res 1979;58:1908-9.
23. Yu R, Koran A, Craig RG. Physical properties of maxillofacial elas-
fabrication of maxillofacial prosthesis. In: Chalian VA, Drane JB,
tomers under conditions of accelerated aging. J Dent Res 1980;59:1041-7.
Standish SM, eds. Maxillofacial prosthetics: Multidisciplinary practice.
24. Yu R, Koran A, Craig RG. Physical properties of a pigmented silicone
Baltimore: The Williams & Wilkins Co, 1971:89-107.
maxillofacial material as a function of accelerated aging. J Dent Res
2. Clarke CD. Facial and body prosthesis. St. Louis: C.V. Mosby, 194513.
1980;59:1141-8.
31.
25. Wiens JP. A comparative study of selected elastomers subjected to ac-
3. Barnhart GW. A new material and technic in the art of somato prosthe-
celerated and outdoor weathering. Thesis. University of Minnesota,
sis. J Dent Res 1960;39:836-44.
1980:1-183.
4. Bulbulian AH. Facial prostheses. Philadelphia: W. B. Saunders Co.,
26. Udagama A, Drane JB. Use of a medical grade methyltriacetoxy silane
194527.
cross-linedsiliconeforfacialprostheses. JPROSTHETDENT 1982;48:86-8.
5. Bulhulian AH. Problems of facial prosthesis. Surg Clin North Am
27. Abdelnnahi MM, Moore DJ, Sakamura JS. In vitro comparison study
1946;26:846-58.
of MDX 4-4210 and polydimethyl siloxane silicone materials. J PROS-
6. Sweeney AB, Fischer TE, Castleberry DJ, Cowperthwaite GF. Evalu-
THET DENT 1984;51:523-6.
ation of improved maxillofacial prosthetic materials. J PROSTHET DENT
28. Turner GE, Fischer TE, Castleberry DJ, Lemons JE. Intrinsic color of
1972;27:297-305.
isophorone polyurethane for maxillofacial prosthetics. Part I. Physical
7. Schaaf NG. Materials in maxillofacial prosthetics. Dent Clin North Am
properties. J PROSTHET DENT 1984;51:519-22.
19’75;19:347-56.
29. Turner GE, et al. Intrinsic color of isophorone polyurethane for max-
8. Lewis DH, Cowper DR, Castleberry DJ, Fischer TE. New and improved
illofacial prosthetics. Part II. Color stability. J PROSTHET DENT
elastomers for extraoral maxillofacial prostheses [Abstract]. J Dent Res
1984;51:673-5.
1977;56(Special Issue A):l74.
30. Wolfaardt JF, Chandler HD, Smith BA. Mechanical properties of a new
9. Moore DJ, Glaser ZR, Tabacco MJ, Linebaugh MGJ. Evaluation of
facial prosthetic material. J PRO~THET DENT 1985;53:228-34.
polymeric materials for maxillofacial prosthetics. J PROSTHET DENT
31. Kouyoumdjian J, Chalian VA, Moore BK. A comparison of the physical
1977;38:319-26.
properties of a room temperature vulcanizing silicone modified and un-
10. Lewis DH, Castleberry DJ. An assessment of recent advances in max-
modified. J PROSTHET DENT 1985;53:388-91.
illofacial prosthetic materials. J PROSTHET DENT 1980;43:426-32.
32. Bell WT, Chalian VA, Moore BK. Polydimethyl siloxane materials in
11. Craig RG, Koran A, Yu R. Elastomers for maxillofacial application. Bi-
maxillofacial prosthetics: evaluation and comparison of physical prop-
omaterials 1980;1:112-7.
erties. J PROSTHET DENT 1985;54:404-10.
12. Cantor R, Webber RL, Stroud L, Ryge G. Methods for evaluating pros-
33. Farah JW, Robinson JC, Koran A, Craig RG, Hood JAA. Properties of
thetic facial materials. J PROSTHET DENT 1969;23:324-32.
a modified cross-linked silicone for maxillofacial prostheses. J Oral Re-
13. Lontz JF, Schweiger JW, Burger AW. Modifying stress strain profiles
habil 1987;14:599-605.
of polysiloxane elastomers for improved maxillofacial conformity [Ab-
34. Udagama A. Urethane lined silicone facial prostheses. J PROSTHET
stract]. J Dent Res 1974;(Special issue):53.
DENT 1987;58:351-4.
14. Koran A, Craig RG. Dynamic mechanical properties of maxillofacial
materials. J Dent Res 1975;54:216-21.
15. Firtell DN, Donneau ML, Anderson CR. Lightweight RTV silicone for Reprint requests to:
maxillofacial prostheses. J PROSTHET DENT 1976;36:544-9. DR. CARL J. AN~RES
16. Gonzales JB. Polyurethane elastomers for facial prosthesis. J PROSTHET DEPARTMENT OF PROSTHODONTICS
DENT 1978;39:179-87. INDIANA UNIVERSITY SCHOOL OF DENTISTRY
17. Gonzales JB, Chao EYS, An Kai-Nan. On physical and mechanical be- 1121 WEST MICHIGAN ST.
havior of polyurethane formulations used for facial prostheses. J PROS- INDIANAPOLIS, IN 46202
THET DENT 1978;39:307-18.

330 AUGUST 1992 VOLUME 68 NUMBER 2