Advances in Biorestorative Materials: What

Does the Future Hold?

KARL F. LEINFELDER
J Am Dent Assoc 2000;131;35-41

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Advances in
Biorestorative
Materials
What Does the Future Hold?
Editor’s note: Dr. Karl Leinfelder is
JADA’s Associate Editor for Biomaterials
and Restorative Dentistry and a noted
authority in those areas. In a conversa-
tion with him in late 1999, JADA Editor
Dr. Lawrence H. Meskin asked him to
predict what lies ahead in this most fun-
damental area of dentistry.
The safety of amalgam has been upheld
Q consistently by national health organi-
zations. What do you see as amalgam’s
future as a restorative material in the next
decade?
Although amalgam has been used by the
A dental profession for more than a century,
its use as a restorative material has been ques-
tioned a number of times. The first time, of
course, was in the middle of the 19th century
when it was introduced in the United States.
Based on the fact that it did contain mercury, the
dental profession was divided as to the profes-
sionalism of using this material. Also, as com-
pared with the exactness of the gold foil then in
use, some members of the profession considered
K A R L F . L E I N F E L D E R ,
Copyright ©1998-2001 American Dental Association. All rights reserved.
C O V E R S T O R Y
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the amalgam techniques “sloppy and unprofes-
sional.”
Then, in the 1950s, the safety of using
amalgam once more was brought under discus-
sion. This time, the charge of potential toxicity
was met with a series of research publications. In
each and every case, all the biological data
revealed no toxic response to amalgam restoration
placed into patients.1,2
During the last several years, amalgam has
been challenged once again.3,4 These more recent
objections were based not only on the potential
toxicological effects of mercury vapors from the
amalgam restorations but also on amalgam’s lack
of esthetic appeal. It is important to note that no
scientific document to date has implicated
amalgam in the development of any systemic dis-
eases. Yes, increased levels of mercury in the
blood and urine can be associated with amalgam
restorations, but the amount measured has never
been related to any specific diseases.5,6
It is interesting to note that the use of amal-
gam as a restorative material has decreased per-
ceptibly during the last half-decade. More than
concern over the use of a mercury-containing
alloy, the primary reason for this decline is
related to the use of a material that does not
resemble the physical characteristics of tooth
D . D . S . , M . S .
JADA, Vol. 131, January 2000 35
COVER STORY
structure. The use of stainless-
steel crowns on primary teeth
has been all but eliminated
because of their unnatural
appearance.
While most manufacturers
have reported a decrease in the
sale of amalgam alloys, dentists
have not refrained from using
them at all that great a rate. I
make this observation for a
number of reasons. First of all,
the only other direct restorative
material available to the gen-
eral practitioner is resin-based
composites. The restorative pro-
cess associated with resin-based
composites is considerably more
technique-sensitive and time-
consuming than that associated
with amalgam. Consequently,
many clinicians have opted to
IN SPITE OF ENCOURAGING DATA, IT IS PROBABLE THAT AMALGAM WILL
CONTINUE TO BE USED FOR A CONSIDERABLE TIME IN THE FUTURE.
continue using amalgam, at
least for the present.
It is interesting to note that
while the physical and mechan-
ical characteristics of resin-
based composites have been
improved considerably, the
same cannot be said for the
techniques associated with their
insertion and finishing. During
the last two years, however, a
number of manufacturers have
introduced posterior resin-based
composites, which are consider-
ably different. Specifically,
these materials possess han-
dling characteristics similar to
those of a freshly triturated
mass of amalgam. The material
is inserted and condensed using
procedures long familiar to the
clinician. Slight modifications
in procedural techniques allow
the clinician to complete the
restoration in considerably
36 JADA, Vol. 131, January 2000
Copyright ©1998-2001 American Dental Association. All rights reserved.
less time than was previously
possible with resin-based
composites.
In spite of this encouraging
information, it is probable that
amalgam will continue to be
used for a considerable time in
the future. In fact, it is probable
that it will be part of the dental
armamentarium for the next
decade. There are several rea-
sons for believing that its use
will continue. To begin with,
resin-based composites are as
yet more technique-sensitive
than is amalgam. Failure to
follow a number of well-
prescribed rules will all but
guarantee clinical failure in a
relatively short period. In addi-
tion, regardless of the exactness
by which the resin-based com-
posite is placed, its durability
track record has been shown to
be less than that of amalgam.
Problems that are more abun-
dant with resin-based compos-
ites include postoperative sensi-
tivity, leakage and secondary
caries.
In all likelihood, however,
amalgam’s rate of use will con-
tinue to decline appreciably.
The rate at which it will be
replaced during the next several
years will depend on how soon
the use of resin-based compos-
ites can be simplified and made
less technique-sensitive. It also
depends on when the dental
schools will take a more positive
attitude toward the potential
for resin-based composites and
include them as part of stu-
dents’ training. Amalgam is
coming to an end, but it will be
a while before that happens.
Dentin-bonding agents
Q have been improved to
a degree that allows
bonding of virtually any
resin-based material to all
tooth structures. What modi-
fications do you see occur-
ring in the next several
years in these materials?
The concept of acid
A etching and bonding resins
to enamel can be attributed to
Michael Buonocore. More than
40 years ago, he published an
article describing a method by
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which acrylic resin could be
bonded to enamel.7 Within a
decade (1963), Rafael Bowen
developed the composite resin.8
The importance of such a
material was so apparent that
it immediately replaced all
direct restorative materials that
preceded it. Unfortunately,
however, it was nearly a
quarter-century before a system
was developed that would
permit resin-based composites
to bond to enamel. The combi-
nation of all these concepts,
then, dramatically changed the
way restorative dentistry is
conducted.
Perhaps the next important
milestone in the area of esthetic
restorative dentistry was the
development of the hybridiza-
tion concept introduced by Dr.
Nobuo Nakabayashi and col-
leagues9 in 1982. Essentially,
they demonstrated that the
application of phosphoric acid to
the surface of dentin followed
by the application of a dentin-
bonding agent produced a sur-
face impermeable to caries-

producing microorganisms.10 By
sealing the dentinal tubules and
diffusing into the intertubular
and peritubular dentin, the
bonding agent protects the
pulpal tissue from the oral envi-
ronment. In addition, this pro-
cess also prevents postoperative
sensitivity; it prevents fluid flow
within the dentinal tubule and
consequently eliminates the
potential for negative pressure
on the odontoblastic process,
which in turn causes postopera-
tive pain.11,12
The adhesion of dentin-
bonding agents and the over-
lying resin-based composite can
be attributed to the interrela-
tionship between the collage-
nous fibers and the polymerized
bonding agent. The adhesion is
so effective that when it is car-
ried out properly, it becomes vir-
tually impossible to separate the
materials in the interfacial
region. Failure will occur either
cohesively in the dentinal sub-
structure or in the overlying
composite itself.
With this in mind, it is easy
to understand that improve-
ments in the adhesive qualities
of dentin-bonding agents will
not happen in the foreseeable
future. Instead, the focus will be
placed on simplifying the appli-
cation process itself. Consider-
able progress has already been
made in this. For example, while
the dentin-bonding agents of
Copyright ©1998-2001 American Dental Association. All rights reserved.
yesterday consisted of two or
more components, current for-
mulations contain only one. The
chemistry of the two- or three-
bottle systems has been incorpo-
rated into one bottle. Unfortu-
nately, however, some clinicians
have experienced problems with
this consolidated system, such
as lack of consistency in bonding
effectiveness and increased post-
operative sensitivity.
Major efforts to improve the
bonding process in the future
will consist in trying to accom-
plish a number of things. The
first will be to eliminate the
need for etching the preparation
before applying the dentin-
bonding agent. Already, a lim-
ited number of systems permit
the procedure to be carried out
without a separate acid-etching
procedure. In such systems, a
conditioner that does in fact con-
tain some type of organic acid
first is applied. Other systems
contain the acid in the dentin-
bonding agent but are effective
only in conjunction with dentin.
Furthermore, the newer sys-
tems will be more conveniently
packaged so that application of
the bonding agent can be carried
out in a simpler fashion. The
process will consist simply of
removing the applicator from
the container, applying the
agent to the tooth surface and
then immediately applying the
bonding agent. Already, at least
COVER STORY
one system now on the market
is approaching this concept. The
greatest improvement in the
future will consist of a simple
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one- or two-application process
that carries with it full assur-
ance that the resilient adhesion
will be optimized and consistent
from patient to patient.
Q There has been concern
that some of the resin-
based composite materials
may prove to be either toxic
or allergenic. What are your
thoughts regarding this
issue?
Over the years, a limited
A number of people have sug-
gested that resin-based compos-
ites may be toxic in one way or
another to the patient. But at
present, none of the reports
related to potential allergy
resulting from exposure to
resin-based composite restora-
tions has demonstrated cause
and effect. While some of the
ingredients in the unpolymer-
ized material may have some
allergenic potential, the amount
necessary to cause a reaction is
substantially greater than the
amount available in even mul-
tiple restorations. Perhaps the
greatest concern about possible
allergenic responses can be
related to the inhalation of the
fine particles during cutting and
finishing procedures.
JADA, Vol. 131, January 2000 37
COVER STORY
Whenever cutting or re-
moving an existing resin-based
composite, the dentist is
strongly urged to ensure that
water spray and an evacuation
device are held adjacent to the
restoration. Incidentally, it is
very important that the dentist
polymerize the resin-based
composite restoration as much
as possible, to minimize the
percentage of the unreacted
and, therefore, possibly aller-
genic components. On the
patient’s first recall visit, the
dentist should evaluate the
condition of the gingival tissue
to eliminate the (extremely
small) possibility that the
patient may be allergic.
TODAY IT IS POSSIBLE TO GENERATE VENEERS, INLAYS, ONLAYS AND CROWNS
BY MEANS OF A COMPUTER.
Could you comment on
Q the future of computer-
generated restorations?
Research by numerous
A investigators, both indus-
trial and academic, has been
directed toward the develop-
ment of systems that could gen-
erate restorations by means of a
computer. After years of investi-
gation, a number of practical
systems have been developed.
Although numerous problems
were in evidence at the time of
introduction, continued
research has resolved many of
them.13,14 Today it is possible to
generate veneers, inlays, onlays
and crowns by means of a com-
puter. Restoration of other
classes of cavity preparations,
such as II and V, also can be
readily achieved in this way.
One of the greatest advan-
tages of such a system is that
restorations can be accom-
plished in one appointment.
38 JADA, Vol. 131, January 2000
Copyright ©1998-2001 American Dental Association. All rights reserved.
Furthermore, no physical im-
pressions or temporary restora-
tions are necessary. Finally, the
entire procedure can be carried
out without the assistance of a
laboratory technician at chair-
side. Time for completion of a
ceramic restoration commonly
averages one hour.
Clinical research has demon-
strated that the marginal in-
tegrity of the ceramic restora-
tions produced with the use of
computers has improved with
some modification of the cutting
or milling device.15,16 It should
be pointed out that the quality
of the restorations generated in
this manner also improves with
clinical experience. The mar-
ginal gap between the restora-
tion and the margins of the
cavity preparation easily can be
less than 100 micrometers.
Continued research is
directed at generated systems
that would effectively and effi-
ciently generate bridges, as well
as crowns. There is every
reason to believe that such
efforts will bear fruit within the
next four or five years. It is
interesting to note that such
technology already has been
made available to the dental
profession. Unfortunately, the
complexities of generating mul-
tiple units from a solid piece of
ceramic material so far have
kept the quest from reality.
The computer-assisted de-
sign–computer-assisted manu-
facture, or CAD–CAM, system
certainly has other uses. From a
surgical point of view, it offers
the technology for generating
osseous structures such as por-
tions of the mandible and even
the calvaria. Reconstructive
surgery related to repositioning
or remodeling of various facial
bones certainly would be within
the realm of possibility with the
CAD–CAM system. Devices for
computer generation will con-
tinue to develop over the fol-
lowing decade and ultimately
will result in a significant
change in the way in which clin-
ical dentistry is practiced.
Do you foresee any
Q totally new restorative
materials emerging in the
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future?
The development of any
A totally new restorative
material in the near future is
quite unlikely for a number of
reasons. First, creating new and
innovative systems requires a
tremendous amount of time and
research effort, as well as
money. The time from initial
conception to marketing of such
an idea commonly is at least
five years and more typically is
10 years. As totally new con-
cepts are kept in secret while
they are being developed, there
does not appear to be anything
brand-new on the horizon.
There is still another major
reason why totally new restora-
tive materials will not be gener-
ated for the foreseeable future.
The stringent requirements set
down by the U.S. Food and
Drug Administration for the
introduction of new materials
make it extremely expensive
and time-consuming to market
systems that are major devia-
tions from traditional materials.
It is not surprising that the

basic formulation of bis-glycidyl
dimethacrylate, or Bis-GMA,
still serves as the backbone of
all new and modified resin-
based restorative systems.
Introduced to the profession
nearly 35 years ago, the Bowen
resin8 (or modifications thereof)
continues to be the basic compo-
nent in nearly all polymeric
restorative systems based on
esthetics.
On the other hand, what I
can foresee is the introduction
of techniques that will make the
success of restorations more
constant and uniform. The
introduction of the packable
composite, for example, has
allowed many more clinicians to
place the material without the
many problems associated with
conventional posterior resin-
based composites. Dentin-
bonding agent delivery and ap-
plication will be made consider-
ably easier and faster. Comput-
erized clinical techniques
associated with the fabrication
of restorations will be improved
to the point that many more
clinicians will make them part
of their daily practice.
Q Truth in advertising of
dental products
appears to be a growing
issue in the profession. What
are your thoughts on this
potentially controversial
issue?
It would appear that there
A have been some disap-
pointing changes in the fields of
marketing and advertising.
Some manufacturers of restora-
tive materials advertise their
products using testimonials of
clinicians with national reputa-
tions. In some ways, the tech-
nique approaches that of hiring
sports superstars to promote
Copyright ©1998-2001 American Dental Association. All rights reserved.
the use of high-fiber breakfast
cereals, although the superstar
may know very little about
nutrition, diet or much of any-
thing that relates to good
health. The idea, of course, is
that a person with great public
recognition should get the
attention of those who are in
the market for a new and better
product.
Such a concept may sell
products—but, unfortunately,
this approach tells clinicians
little that they need to know as
it relates to performance and
efficacy. It attracts on the basis
of emotion rather than facts
and science.
Before a clinician decides on
the acquisition of a new system
or material, it is very important
that he or she request docu-
mentation related to the pro-
duct. Without doubt, the prefer-
ence should be for clinical data.
While data on laboratory and
mechanical properties are very
important, they do not predict
clinical performance. Such
numbers are quite important to
the manufacturer, which is
trying to improve its product;
unfortunately, however, the
resultant modification of prop-
erties is no guarantee that the
restorative system will behave
better. In fact, the improved
properties, ironically, may
move clinical performance in
the opposite direction. Finally,
it should be kept in mind that
it would be somewhat unusual
for the person making the rec-
ommendation to do so without
any strings attached.
Controlled, independently per-
formed clinical research studies
are the only basis for dependable
clinical claims made by a manu-
facturer. One reason there is not
more research-based product
information available to the
COVER STORY
practitioner is that such investi-
gations are timely and expensive.
Under most conditions, it is vir-
tually impossible for reliable data
to be generated in less than two
years—sometimes three.
If the manufacturer has clin-
ical data, the clinician probably
will not have to request them. In
light of the importance of such
documentation, the manufac-
turer will take the initiative and
offer it even before the clinician
has the opportunity to request it.
Incidentally, the report by itself
is not as important as is the
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manner in which the study was
accomplished. It is important for
the reader to evaluate how the
study was conducted, the number
of restorations included in it, and
the techniques used for mea-
suring the results. Finally, the
reader should make an effort to
determine if the results justify
the claims being made by the
report’s author.
During the last several
Q years, a number of man-
ufacturers have introduced
metal-free bridges. How suc-
cessful do you believe they
have been and what changes,
if any, do you see in them in
the future?
The development of resin-
A reinforced fibers has opened
the door of opportunity for many
clinicians, permitting the devel-
opment of fiber-reinforced posts
and metal-free bridges, to name
two examples. Both systems
have been quite successful in
restorative dentistry.
The metal-free bridge offers a
number of advantages over the
conventional porcelain-fused-to-
metal restoration. To begin with,
the absence of a metal substrate
provides a greater opportunity
for increasing translucency and
JADA, Vol. 131, January 2000 39
COVER STORY
natural appearance. Porcelain-
fused-to-metal restorations
commonly require considerable
opaquing, which may lead to
loss of translucency. In addi-
tion, the marginal integrity and
adaptation of a metal-free
bridge can be considerably
better than those of a porcelain-
fused-to-metal-bridge. With
metal-free restorations, mar-
gins frequently are placed above
the gingival crest. Adaptation
can be resolved in part by adhe-
sive bonding.
There have been increasing
concerns about the potential for
metal sensitivities. Metals
giving rise to this concern
include nickel, beryllium, mer-
cury, palladium and copper. A
metal-free bridge obviously
sidesteps this issue. Another
positive feature of this novel
WITH A METAL-FREE BRIDGE, THERE IS LESS POTENTIAL FOR WEAR OF THE
OCCLUDING STRUCTURE, WHICH OBVIOUSLY HAS BEEN A MAJOR SHORTCOMING
OF THE CERAMIC RESTORATIVE SYSTEMS.
restorative system is that it has
better shock absorption capabil-
ities than a porcelain system,
regardless of what the substrate
may be. A polymer occlusal sur-
face will absorb considerably
more masticatory energies,
thereby reducing the potential
for osseous degradation at the
implant/bone interface.
Finally, with a metal-free
bridge, there is less potential
for wear of the occluding struc-
ture, which obviously has been
a major shortcoming of the
ceramic restorative systems.
And such a bridge offers the
clinician the ability to repair
fractured surfaces intraorally
without removing it for labora-
tory processing—certainly an
advantage.
40 JADA, Vol. 131, January 2000
Copyright ©1998-2001 American Dental Association. All rights reserved.
The number of clinicians
using metal-free bridges has
been growing. While the cost to
either the patient or the practi-
tioner in terms of laboratory
fees is not less than that of con-
ventional systems, the proper-
ties discussed previously cer-
tainly have encouraged the
acceptance of this relatively
new system. While some clini-
cians have experienced great
success with this concept,
others have been somewhat
disappointed, for a couple of
reasons.
dFirst, there appear to be dif-
ferences in wear resistance
among the various materials
currently on the market; some
are significantly more resistant
to degradation than others.
dSecond, some of those using
the system have experienced
sensitivity and debonding of
the prosthetic device from the
retainers or abutment teeth.
This debonding can be related
to one of two things. The first is
the use of the wrong type of
luting agent for cementing the
appliance. It is absolutely
mandatory that a resin-based
composite luting agent is used;
no other material will suffice.
Zinc phosphate cement and
glass ionomer cements are defi-
nitely contraindicated. The
reason for this, of course, is
that the elastic modulus (or
stiffness) of the metal-free
bridges is only 40 percent that
of gold-based alloys and per-
haps as much as 20 percent
that of base-metal composi-
tions. This simply means that
the metal-free restorations can
bend under occlusal load as
much as 2.5 times as much as
gold-based alloys. Therefore, it
is mandatory to use a technique
that will ensure adhesive
bonding of the appliance to the
surface of the prepared re-
tainers. Failure to achieve this
objective will result in the sepa-
ration of the appliance from one
or more of the retainers. The
possible cause of debonding is
the preparation. Inlay-retained
preparations may offer insuffi-
cient surface area for long-term
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retention. In this regard, a full
coronal preparation is
suggested.
The concept of metal-free
bridges is here to stay. Un-
doubtedly, gradual changes will
be made in the fibers now being
used, as well as in the polymers
with which they are being man-
ufactured. Fibers with different
mechanical characteristics and
morphology will increase these
bridges’ potential for extended
applications.
For the last 50 years,
Q zinc phosphate cement
has been the luting agent of
choice for all indirectly
placed restorations.
Recently there has been an
emphasis on resin-based
composite and glass
ionomer systems. In the
future, what changes can
we expect?
Zinc phosphate cement has
A been used continuously for
a little more than 100 years.

During this time, only one
major modification was made to
this material: the addition of
magnesium oxide to the formu-
lation to better control the rate
of reaction. Nearly five decades
ago, acrylic resin was intro-
duced as a possible substitute
for the zinc oxide–containing
cement. While initial retention
was encouraging, the concept
failed almost immediately.
Leakage, secondary caries and
loss of retention caused its
demise.
Since then, glass ionomers
have been added to the list of
possible luting agents. In addi-
tion, the resin-based cement
has returned, but with different
techniques and overall composi-
tion. The new luting agents
were based not on acrylic resin,
but on Bowen’s formulation,
which consisted basically of Bis-
GMA. Both the glass ionomers
and the resins were successful.
In fact, today, the majority of
all indirectly placed restora-
tions are cemented with glass
ionomers, resin-based composite
cements or a combination of the
two.
The advantage of the glass
ionomers is that they, more
than any other type of luting
agent, release sufficient fluoride
to render the tooth less prone to
secondary caries. The resin-
Copyright ©1998-2001 American Dental Association. All rights reserved.
based composite cements offer
numerous advantages. These
include adhesion, insolubility,
ease of mixing and excellent
color-matching ability. The com-
bination of all these characteris-
tics substantially increase
resin-based composite’s poten-
tial for extended longevity. The
techniques associated with the
resin-based composite cements
enhance the longevity of the
pulpal tissue.
The future of cement will
undoubtedly witness vast
improvements in terms of effec-
tiveness, ease of handling and
reduction of technique sensi-
tivity. I predict, however, that
little change in the basic formu-
lations will occur within the
next 10 years. ■
Dr. Leinfelder is professor emeritus,
Department of Biomaterials, University of
Alabama School of Dentistry, Birmingham.
Address reprint requests to Dr. Leinfelder at
207 Helmsdale Dr., Chapel Hill, N.C. 27514.
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