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Filtek ™ Supreme XT Universal Restorative System Filtek technical product profile TM TM
Filtek™ Supreme XTUniversal Restorative System
Filtektechnical product profile
TMTM
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Table of ContentsIntroduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5
Product Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5
Composition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5
Shades . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5
Shade Basics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6
Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9
Background . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9
Nanotechnology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9
Filler Development . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9
Dentist-Guided Development . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
Shade Development . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
Physical Properties . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .18
Polish Retention . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .18
Volumetric Shrinkage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .22
Fracture Toughness . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .24
Flexural Modulus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .24
Flexural Strength . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .25
Compressive and Diametral Tensile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .26
Independent Investigations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .27
Polymerization Shrinkage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .27
Wear . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .27
Technique Guides . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .31
Instructions For Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .35
Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .39
Limitation of Liability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .39
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IntroductionProduct Description3M ESPE Filtek™ Supreme XT Universal Restorative material is a visible-light activated, directrestorative nanocomposite designed to deliver optimized esthetic properties for both single ormulti-shade restorations. As with its predecessor, Filtek Supreme Universal Restorative, FiltekSupreme XT universal restorative is offered in dentin, body, enamel and translucent opacities. Allshades, with the exception of translucent, white and extra-white shades, have been enhanced tohelp the clinician more easily recreate the lifelike appearance of natural dentition.
As described on page 12, optimization of the shading system has been achieved through anintensive analysis of how the three color attributes - value, hue and chroma, contribute to thevisual perception of an esthetic composite restoration. The result are more vibrant, lifelikerestorations created, in part, by a slight increase in the value or brightness of these shades.
To aid in the shade selection process, a shade selection wheel is available with recommendationsfor both unsupported (e.g. Class III, IV) and supported (e.g. Class I, II and V) restorations.
All other compositional parameters of Filtek Supreme XT universal restorative are identical to theoriginal formula. Material properties such as handling, strength, polish retention and polymeriza-tion shrinkage are unchanged. Therefore, much of the data related to these properties as describedin the Filtek Supreme universal restorative product profile has been retained as originally presented.
Filtek Supreme XT universal restorative is designed for use in anterior and posterior restorations.All shades, except for the Translucent shades, are radiopaque. A Clear Translucent shade is alsonow available.
Composition• The resin system is the same reduced shrinkage resin as found in 3M ESPE’s Filtek™ Z250
Universal Restorative and Filtek™ P60 Posterior Restoratives: BIS-GMA, BIS-EMA (6),
UDMA with small amounts of TEGDMA.
• Translucent shades contain a combination of a non-agglomerated/non-aggregated, 75 nm
silica nanofiller, and a loosely bound agglomerate silica nanocluster consisting of agglomer-
ates of primary silica nanoparticles of 75 nm size fillers. The cluster size range is 0.6 to 1.4
microns. The filler loading is 72.5% by weight. The Translucent shades are not radiopaque.
• All of the remaining shades contain a combination of a non-agglomerated/non-aggregated, 20 nm
nanosilica filler, and loosely bound agglomerated zirconia/silica nanocluster, consisting of agglom-
erates of primary zirconia/silica particles with size of 5-20 nm fillers. The cluster particle size range
is 0.6 to 1.4 microns. The filler loading is 78.5% by weight. These shades are radiopaque.
Shades • Dentin opacity (Highest opacity): A1D, A2D, A3D, A4D, A6D, B3D, C4D, C6D
• Body opacity: A1B, A2B, A3B, A3.5B, A4B, B1B, B2B, B3B, C1B, C2B, C3B, D2B
• Enamel opacity: A1E, A2E, A3E, B1E, B2E, D2E
• Specialty shades: WE (White Enamel), WB (White Body), WD (White Dentin), XWB(Extra White Body), XWD (Extra White Dentin)
• Translucent opacity: V(iolet), G(ray), Y(ellow), C(lear)
• Shade selection is accomplished referencing the VITAPAN® classical shade guide.
• A Shade Selector Wheel, developed for use with Filtek Supreme XT universal restorative, isused to provide guidance in choosing multiple shades to build a restoration.
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Shade Basics Color
• Hue – Describes whether the color appears red, yellow, blue, etc..
Shade Family (Hue)A shades Red-brown characterB shades Red-yellow characterC shades Grey character (lower value)D shades Red-grey character (lower value)
• Chroma is the intensity of the shade. The higher the number, (e.g. A3 vs. A1) within a shade
family, the more intense the color (A3 is more intense than A1).
• The value (amount of white or black) is higher (whiter) for the A and B shades. The C and D
shades have lower value (grayer) than the equivalently numbered A and B shades.
Studies have indicated that tooth color, in adult teeth, is determined primarily by dentin.
The enamel layer plays a very minor role in the actual tooth color.
• In young patients, teeth are brighter (higher value)
and less translucent. With age, the enamel layer
thins and becomes more translucent, exposing more
dentin so teeth appear darker (lower value) particu-
larly in the gingival third.
• Areas of highest intensity of color (chroma) will be
in the gingival region of the tooth due to a thinner
enamel layer so the dentin is more visible.
• The body shade is a combination of the dentin color
and the slight contribution by the enamel layer color
and surface morphology. Literature suggests that the intensity of the body is 1-2 shades
lighter than the gingival area.
• The incisal area exhibits a high degree of translucency as the amount of dentin present is
decreased towards the incisal edge.
Opacity
Dentin shades are the most opaque (lowest translucency), Body shades are less opaque (more
translucent), then Enamel shades, and finally the Translucent shades are almost transparent.
1. When light contacts a tooth:
• Enamel diffuses and transmits light. If the dentin
layer is very thin or if there is no dentin behind the
enamel layer (as in the incisal edge) some of the
light is transmitted through the tooth to the oral cav-
ity. The oral cavity can reflect light back through the
enamel.
• Enamel also scatters blue light preferentially and
this provides an opalescent effect at the incisal edge.6
Color Regions
• When light encounters dentin, some of the light is absorbed and some is reflected back
through the enamel.
• The light that is reflected and refracted back to the eye produces the color of the tooth.
• The surface texture of a tooth plays a role in the perceived color, i.e., a smoother surface
will appear whiter (or higher value) than an irregular surface.
Shade Selection Tips and Hints for Filtek™ Supreme XT Universal Restorative
1. After pumicing the surface to remove any extrinsic stains, determine the shades needed for
the restoration prior to tooth preparation or rubber dam placement. A tooth that is desiccated
will be lighter than normal. Therefore, a shade taken on a desiccated tooth will be lighter than
the tooth upon rehydration.
2. During shade selection,
If one shade is to be used:
• Select the Body shade by examining the center (body) portion of the tooth. Choose the
composite shade most closely approximating the center portion of the VITAPAN®
classi-
cal tooth tab.
If more than one shade is to be used (This technique can mimic actual tooth structure and
increase the vitality of the final restoration):
• Select the Dentin (or Body) shade by examining the exposed dentin or the gingival area
of the tooth. Choose the composite shade most closely approximating the cervical por-
tion (grinding off the neck of the tab has been recommended by some) of the VITAPAN
classical tooth tab.
• Select the Body shade by examining the center (body) portion of the tooth. Choose the
composite shade most closely approximating the center portion of the VITAPAN classi-
cal tooth tab.
• Select the Enamel shade by examining the proximal or incisal area of anterior teeth or
from the cusp tips of posterior teeth. Choose the composite shade most closely approxi-
mating the incisal portion of the VITAPAN classical tooth tab.
• A Translucent shade (in the same color family) may be used to impart high translucency
and increase the “depth” of the restoration.
3. Do a mock up of the restoration prior to etching. The color of a composite will be affected by
its thickness. Composites may change color upon curing. Place and cure composite material
in the approximate thickness and area of the planned restoration. Obtain agreement with the
patient of shade match. Remove mock-up easily by flicking it off the tooth with an explorer.
4. Evaluate shade match of the tabs and mock-up under different lighting conditions.
5. When finishing and polishing the restoration, mimic the surface morphology of adjacent
teeth.
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Shade Wheel
To aid in the shade selection process, 3M ESPE Filtek™ Supreme XT incorporates a unique
(patent applied for) shade selector wheel. Once a shade has been selected using the Vita®
Classical guide, the selector offers recommendations for single shade, two-shade, or multi-shade
restorations.
The figure at right indicates the proposed shade combina-
tions for a Class IV restoration determined to be shade
A1. Several options are offered, with final choice depend-
ing upon the size and esthetic requirements of the restora-
tion.
Simpler shade recommendations are given for restora-
tions that are supported by tooth structure as shown in the
upper right figure. Posterior restorations are an ideal place
to start exploring the esthetic options offered by the shade layering technique.
It should be noted that this tool is a guide only. Final results will be influenced by the thickness of
composite layers, surrounding tooth structure, adjacent teeth, etc. Further, the layering diagrams
depicted on the shade guide are offered as potential solutions in creating certain esthetic effects.
For instance, the translucent shade may be applied internally as indicated to create translucency at
the incisal third of a Class IV restoration. Alternatively, while not diagrammed, the translucent
shade may be applied as the last facial or occlusal increment to create depth. As using the translu-
cent shade in this manner may tend to decrease the overall value of the restoration, choosing a
shade one step lighter for the increment immediately below the translucent shade may moderate
this effect.
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Indications for Use3M ESPE Filtek™ Supreme XT Universal Restorative is indicated for use in the following types of
restorations.
• Direct anterior and posterior restorations
• Sandwich technique with glass ionomer resin material
• Cusp buildup
• Core buildup
• Splinting
• Indirect anterior and posterior restorations including inlays, onlays and veneers
BackgroundNanotechnology “Nanotechnology is offering us the ability to design materials with totally new characteristics.”
(Ottilia Saxl, CEO of the The Institute of Nanotechnolgy) Worldwide government sponsored R&D
has been steadily increasing. Expenditures in western Europe, Japan, US and other countries grew
almost 3.5 times between 1997 and 2002, the year Filtek™ Supreme Universal Restorative was
introduced. In 2005, expenditures in these same countries have increased five times over that spent
in ’97 with the US leading the way with over a billion dollars budgeted for nanotechnology
research by the National Science Foundation for 2005.
A nanomer is 1/1,000,000,000 (one-billionth) of a meter or 1/1000 of a micron. This is about 10
times the diameter of a hydrogen atom or 1/80,000 of a human hair. Frequently, nanotechnology is
used to describe research or products where critical component dimensions are in the range of 0.1
to 100 nanomers. In theory, nanotechnology can be used to make products lighter, stronger, cheap-
er, and more precise. If this type of material was used to make an airplane instead of metal, the air-
plane could weigh 50 times less but be just as strong.
One of the major initiatives of this technology is in creating value-added products. From scratch-
resistant lacquers and UV protective coatings for the automobile industry to stain free clothing,
nanotechnology is enhancing the products we use everyday. For 3M ESPE, the goal was to use
nanotechnology to create a composite that offers the polish retention of a microfill with the
strength of a hybrid composite. The result was the introduction of Filtek Supreme Universal
Restorative.
Filler DevelopmentThese TEMs show the difference in filler particle size between traditional hybrid composites and
the nanofillers used in Filtek Supreme XT universal restorative. The relatively large filler particle
in hybrids allow for high filler loading which increases the strength of the composite. 3M ESPE
has developed fillers from a liquid form (sol-gel chemistry) since the zirconia/silica filler was used
in 3M ESPE P50 Restorative. The Filtek Supreme XT universal restorative nanocomposite con-
tains a unique combination of two types of nanofillers (5-75 nm) and nanoclusters. Nanoparticles
are discrete nonagglomerated and nonaggregated particles of 20-75 nms in size. Nanocluster fillers
are loosely bound agglomerates of nano-sized particles. The agglomerates act as a single unit
enabling high filler loading and high strength.
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Traditional microfills are made from fumed silica with an average particle size of 40 nm.
Typically, the primary particles tend to aggregate (the degree of aggregation varies depending on
the filler used in the microfill product). Further breakdown of any aggregated particles into smaller
entities is difficult if not impossible to achieve. Fumed silica is prepared by a pyrogenic process.
The structure of the microfill fillers results in relative low filler loading. Most manufacturers add
prepolymerized filled resin particles to increase filler loading. This prepolymerized filler is made
by adding the fumed silica filler to resin. The mixture is polymerized, then ground to form small
particles. These particles are then added to more resin and silica filler. Even using this process,
microfills have a substantially lower filler loading than hybrids resulting in lower strength.
Additionally, residual methacrylate groups bind the prepolymerized particles to the resin matrix.
The effectiveness of this bond is impacted by the amount of residual double bonds on the surface
of these particles. During the polymerization of the prepolymerized filler the reaction is driven to
near completion. Hence the bond of the prepolymerized filler particles to the resin is weaker than
desired and breakdown frequently occurs at this interface. Microfills containing only silica filler
are not radiopaque. These properties have limited the usefulness of microfills, particularly in the
posterior area.
Hybrids and microhybrids contain a broad range of particle sizes. A wide range of particle sizes
can lead to high filler loading with resultant high strength. While they may contain a small fraction
of filler particles in the nanomer particle size range, they also contain a range of substantially larg-
er filler particles which influences the optical properties of these composites and detracts from pol-
ish retention. The average particle size of hybrids and microhybrids is typically below 1 micron
but above 0.4 microns. The upper particle size range can extend to well over 1 micron as the
SEMs reveal below.
(left to right) Hybrid,Nanoparticle,Nanocluster
SEM ultramicrographs ofhybrid and microhybridcomposites (courtesy ofDr. J. Perdigao,University of Minnesota)
4 Seasons™, EsthetX™,Premise™, Tetric™ EvoCeram and Grandio®25,000x (courtesy of Dr.J. Perdigao, University ofMinnesota)
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These SEMs and graphics reveal the mechanism of
abrasion and loss of gloss (polish) for composite prod-
ucts. When hybrids are subjected to abrasion, the resin
between and around the particles is lost leading to pro-
truding filler particles (bumps). Eventually the filler par-
ticles are plucked from the surface resulting in craters.
These bumps and craters create a roughened surface
resulting in loss of reflectivity (loss of polish retention)
of the composite surface.
Microfills have proven to retain their polish (surface
reflectivity) over time. As the surface of a microfill
becomes abraded, the primary filler particles (40 nm
silica particles) are lost at a similar rate as the surround-
ing resin. However, since prepolymerized filler particles
are only marginally stronger than the matrix resin, the
overall composite is not very resistant to fracture.
The graphic (below left) is a composite made using nanoclusters alone. Since the nanocluster filler
particles consist of loosely bound agglomerates of nano-sized filler particles, during abrasion, the
primary particles, (nanomer-sized) not the clusters themselves, can be worn away. This increases
the polish retention of the cured composite when compared to traditional hybrid composites. 3M
ESPE Filtek™ Supreme XT Universal Restorative is formulated using both nanoparticle and
nanocluster fillers (below right, courtesy of Dr. J. Perdigao, University of Minnesota). The combi-
nation of nanomer sized particles to the nanocluster formulations reduces the interstitial spacing
of the filler particles. This provides for increased filler loading, better physical properties and
improved polish retention when compared to composites containing only nanoclusters.
The Dentin, Enamel and Body shades are formulated with zirconia/silica nanocluster, which
imparts the radiopacity. However this formulation could not provide the high translucency option
required in many incisal areas. The use of silica nanoclusters instead of zirconia/silica in the
Translucent shades formulations provided a very highly translucent composite. Additionally, the
combination of silica nanoparticles with the silica nanocluster imparted gloss retention even
greater than the Dentin, Enamel and Body shades.
Resin System
Examination of the 3M ESPE Z100™ Restorative compo-
sition established the belief that modifying the resin sys-
tem could result in enhanced properties. The Z100 resin
system consists of BIS-GMA (Bisphenol A diglycidyl
ether dimethacrylate) and TEGDMA (tri[ethylene glycol]
dimethacrylate). Many other commercially available composites
contain these two components in varying concentrations.
O O
OH
O
OOOH
O
bis-GMA
O
O
O
O
OO
TEGDMA
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The high concentration of a low molecular weight component, TEGDMA resulted in a system that
offered the following advantages:
• The resultant high number of double bonds per unit of weight on a flexible backbone afford-
ed the opportunity to have a high conversion of double bonds during polymerization.
• The low viscosity of the resin permits higher filler loading than with BIS-GMA alone.
• The high degree of crosslinking and compact molecule creates a very hard resin matrix.
However, the TEGDMA concentration also allows for some opportunities for improvements.
• The relatively low molecular weight of TEGDMA contributes to the aging of an uncured
composite especially in capsules where there is a high ratio of surface area to volume of
paste. This material is labile enough to migrate into the capsule walls leading to a thickening
of the composite.
• The low molecular weight and resultant high number of double bonds per unit of weight cre-
ates a high degree of crosslinking creating a very rigid, stiff composite with a relatively high
amount of shrinkage.
A resin system introduced with 3M ESPE Filtek™ Z250 Universal Restorative is now being used
in Filtek Supreme XT universal restorative. The resin consists of three major components. The
majority of TEGDMA (in the Z100™ restorative system) was replaced with a blend of UDMA
(urethane dimethacrylate) and Bis-EMA(6)1 (Bisphenol A polyetheylene glycol diether
dimethacrylate). TEGDMA is used in minor amounts to adjust the viscosity. UDMA and Bis-
EMA(6) resins are of higher molecular weight and therefore have fewer double bonds per unit of
weight. The high molecular weight materials also impact the measurable viscosity. However, the
higher molecular weight of the resin results in less shrinkage, reduced aging and a slightly softer
resin matrix.
Dentist-Guided DevelopmentShade Development Extensive surveys of dentists showed they desire a close match of a composite to the VITAPAN®
classical shade guide. During development of the original 3M ESPE Filtek™ Supreme Universal
Restorative, extensive work was carried out to establish color targets based on the VITAPAN
shade guide to meet this expressed need. This effort proved beneficial, as determined in the orginal
field evaluation, as the shade match of Filtek Supreme universal restorative to the VITAPAN clas-
sical shade guide was rated higher than other composites match to either the Vita® shade guide or
their own shade guide. Further, the chameleon effect of Filtek Supreme universal restorative was
rated better than their current composite.
Within two years of its introduction in 2002, Filtek Supreme universal restorative became one of
the best selling universal composites in the US market, and one of the leading composites in the
world. Clinicians appreciated the range of shades and opacities, excellent esthetics and polish
retention, and the universal indications of this nanocomposite. Filtek Supreme XT Universal
Restorative builds on this success but makes the excellent esthetics even easier to obtain.
OO
ON H
O
OO
ON H
O
UDMAOO
O
O
OO O
O
OO
bis EMA6bis-EMA(6)
1 Bis-EMA(6) contains, on average, 6 ethylene oxide groups per Bisphenol A grouping.
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Measuring color
The “color” of a composite can be modeled in terms of “tri-chromatic” color theory —a theory
based on the physiologic response of the three major types of color receptors in the human eye
including the transformation of this response into six channels of color perception. Two of the
channels are achromatic and represent lightness (or value) from white to black (L*). The other
four channels are chromatic as represented by the red-green axis (a*) and yellow-blue axis (b*)
(below left). We can measure and describe the color of a surface spectroscopically in similar
terms.
The model that has gained the most use throughout various industries for the spectroscopic charac-
terization of color, is the CIELAB model (below left). Any surface color can be defined in “color
space” by the their L*a*b* coordinates as shown. The three color attributes described earlier, hue,
value and chroma, can also be represented in this model (below right).
Although many composites on the market use shade designations based
on the Vita® system, it is not true that similar shades from different manu-
factures share the same color coordinates when measured spectroscopi-
cally. The diagram on the right reveals the large variation in A3 shades as
represented by the a*/b* color plane. We can describe differences such as
those represented here by calculating ΔE, the difference between two sets
of L*a*b* coordinates. Generally, for most people, perceived differences
between two colors occur at a threshold around ΔE of 3. For the A3 shades examined, the maxi-
mum color difference, ΔE, was over 14, a very perceptible difference.
Consultation with Clinicians
While there has been great acceptance among clinicians of the shade matching ability of 3M
ESPE Filtek™ Supreme Universal Restorative, 3M ESPE set out towards the goal of increasing the
satisfaction of those already using Filtek Supreme universal restorative and making it easier for
those new to Filtek Supreme universal restorative to transition from their current composite.
Over a period of two years, 3M ESPE worked with clinicians in the US and Europe to optimize
the shading of Filtek Supreme universal restorative. The key determinant in this process was the
translation of the clinicians perceptual characterization of the color attributes, hue, value and chro-
ma into the colorometric terms L*a*b*. This afforded an iterative shade optimization involving
the clinician and our 3M ESPE laboratory that could be repeated for various indications, from
unsupported (Class III and IV) to supported (Class V, I/II) restorations.
The result of this collaboration is realized, as
shown at right for the A-Body shades, primarily
as a slight increase in value, a broader differen-
tiation in chroma and, for some of the shades,
small changes in hue.
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The optimization can be appreciated by the figure at right where
the current and new shades are applied to a Vita® shade tab. The
improvement is most readily noticed in unsupported areas (those
areas of a restoration that are not backed by tooth structure such as
occurs with Class III and IV restorations).
The figure illustrates the difference between 3M ESPE Filtek™
Supreme and Filtek™ Supreme XT universal restorative applied to
a shade tab. Note the improvements, especially on the unsupported
areas of the tab. This means better results in the critical Class III and
IV restorations. The second illustration was made by using a filter to
force the image to be made of only 4 colors. This technique, know as
posterizing, highlights both the difference between the two products
as well as the blend achieved with Filtek Supreme XT universal restorative.
Once the shade targets were defined, a field evaluation was conducted with over 250 clinicians in
the US and Europe who were currently using Filtek Supreme Universal Restorative. Clinicians
were asked to place the new shades in anterior and posterior restorations using both single shade
and multi-shade techniques. Over 6,000 of these were placed in Class III, IV and V restorations
which allowed a critical assessment of the esthetic capabilities of the new shades. Upon analyzing
the results, a majority of the dentists responded that the optimized shades yielded an overall better
esthetic result and their desired esthetic result was easier to achieve. This was true whether they
were using a single shade or multi-shade technique.
Shade System, Shade Selection and Customer Defined Handling
Various customer focused tools were used in defining the shading system and handling for Filtek™
Supreme Universal Restorative. The following summarizes the customer research applicable to
Filtek™ Supreme XT Universal Restorative.
Conjoint and Focus Panel
One hundred four dentists in three locations across the US participated in this study. Dentists were
screened to ensure esthetics was a key factor of their practice. There were three objectives in this
initial customer research activity.
• To determine and understand what constitutes esthetics and how dentists articulate these
attributes
• To determine procedures dentists undertake to achieve acceptable esthetics
• To design a product that would suit their needs
During the focus groups it was clear that dentists who market their practices as esthetic fall into
one of two categories. Both groups of dentists provide the level of esthetic result demanded by
their patient base. However, the detail and average time spent generating these esthetic results
varies greatly. One group approaches dentistry as almost an art form. They require more options in
shades and opacities frequently using multiple shades (and opacities) in one restoration. The other
group most frequently uses one shade or possibly two shades for a restoration. Both groups of
these dentists buy hybrids, microhybrids and microfills for their esthetic composites of choice. The
difference lies in how they use the products to create the restorations.
Most of the dentists interviewed felt comfortable with their knowledge and understanding of the
VITAPAN® classical shade guide for their shade selection. There were positive and negative fea-
tures associated with shades guides currently available from composite manufacturers. Frequently,
attributes that were considered positive (a shade recipe to build a restoration) by some dentists,
15
were considered a negative by others. Most of the dentists interviewed also agreed that most cur-
rent composite manufacturers shade guides do not match the composite.
Finally, a conjoint study was used to assist dentists in product design. It was interesting to note that
their stated composite product preference did not necessarily reflect the importance of the attrib-
utes indicated by the study. Most notably, polymerization shrinkage was found to be the most
important attribute, however many of the participants used composites that had shrinkage in the
range these dentists deemed unacceptable. However, it was clear that dentists desired a universal
product that offered improved polish retention, low shrinkage with short cure times.
Opinion Leaders
Eighteen opinion leaders were invited to share their views regarding case presentations (what they
would do and how), education methods, strengths and weaknesses of current composite and shade
guide offerings, and finally the nanocomposite system under development. Key findings are
detailed below.
• It is important to gain agreement between patient and dentist as to the level of esthetics
required.
• Shade guides can be used to start the shade selection process, however shade mock-ups using
the composite in-vivo are the best way to determine which composite shades are needed to
blend with surrounding dentition.
• The acceptability of the resultant restorations can be influenced by many factors including
shades selected, depth of color and re-creation of the natural tooth appearance (e.g., provided
by layering translucent materials over less translucent materials or creating appropriate
translucency along incisal edge), surface polish and surface morphology and patients’ and
dentists’ preferences.
Several opinion leaders were consulted during the entire development process to provide guidance
regarding shade and opacity offerings, handling and shade guide needs.
Shade Guide Discussions
Throughout the development process, discussions were held with dentists (and opinion leaders)
regarding shade guide usage. Generally speaking, current shade guides provided by composite
manufacturers do not satisfy needs of dentists.
Plastic shade guides cannot accurately match the composite and, therefore, the final restoration.
Most of these guides are monochromatic (1-color) shade tabs made of plastic. A mismatch
between composite and shade tab is inherent due to metamerism (materials may appear to match
under certain lighting conditions but not match under other lighting conditions). Frequently the
plastic used does not represent the difference in opacity levels that may impact the perceived color.
Shade tabs made from actual composite are expensive to manufacture. Ultimately, it was found
that dentists do not perceive a price/value relationship with shade guides.
Some shade guides provide polychromatic tooth tabs. These tabs may or may not provide the
recipe to create the actual shade depicted by the tab. Matching this polychromatic tab with a
monochromatic material is difficult. The final color of a restoration is influenced by the shades
chosen, the thickness of the layers and the background color (tooth or mouth). So even if the den-
tist attempts to recreate the tab with shades indicated by the manufacturer, a mismatch will most
likely occur. A commonality that was frequently cited was that dentists felt they were well
acquainted with the VITAPAN® classical shade guide. This is the guide the dentists refer to even
if the manufacturer provides its own shade guide. These tabs are comprised of 3 different layers
built on an opaque background. So an A2 shade tab is actually three different shades of material.
16
Simulated Operatory
A Simulated Operatory study was conducted to determine final handling specifications for 3M
ESPE Filtek™ Supreme Universal Restorative. Eighty-four dentists participated in a blind study
(dentists did not know what materials they were handling). The dentists selected were currently
using a variety of materials to produce their aesthetic restorations (Figure 1). Less than 30% of the
dentists included were 3M ESPE composite users. The study included six experimental pastes, 3M
ESPE Filtek™ Z250 Universal Restorative, EsthetX™ and Point 4™. Each participant evaluated four
of the nine pastes by placing them in anterior and posterior restorations in a mannequin heated to
37°C.
• After placing each paste in anterior restorations, dentists were asked if they “Liked” or
“Disliked” the handling and a series of questions asking for a rating of specific handling
attributes. This procedure was repeated for posterior restorations.
• The rating scale for Viscosity, Stickiness to instrument, Flow and Resistance to Slump was 1-
7 with the ideal rating being a rating of 4.
• The 7-point rating scale for Ease of shaping, Ease of veneering, and Cavity and marginal
adaptation had a rating of 7 indicating highest level of satisfaction or ease. For Ability to
pack, the higher the rating the more packable the composite is.
• Each dentist was asked to state their preferred formulation (of the 4 they tested) for anterior,
posterior, universal applications and also extrusion force.
The Filtek™ Supreme Universal Restorative formulation garnering the greatest “Like” response is
depicted in the following charts (Figures 2-6). The overall acceptability of Filtek Supreme univer-
sal restorative was greater than other leading products included in the study (Filtek Z250, EsthetX
and Point 4) in either anterior or posterior restorations. Dentists rated the flow and the ability to
hold shape ideal. Dentists rated the viscosity and level of stickiness as close to ideal. 3M ESPE
composites, Filtek Z250 and Supreme were preferred in all categories over EsthetX and Point 4
(Figure 7).
Figure 1. Most frequently usedcomposite
Figure 2. Handling - Dentin,Enamel and Bodyshades
17
Finally, each dentist was asked to evaluate translucent shades formulations. In this case, three
experimental pastes, EsthetX™ and Vitalescence® were included in this part of the study. Each
dentist evaluated three of the five pastes by placing the composites in Class V and veneer restora-
tions (in a mannequin heated to 37°C). After placing each paste in anterior restorations, dentists
were asked if they “Liked” or “Disliked” the handling and a series of questions asking for a rating
of specific handling attributes. Each dentist was asked to state his or her preferred formulation (of
the three they tested) for handling.
The overall acceptability of 3M ESPE Filtek™ Supreme Universal Restorative Translucent shades
handling was comparable to other leading products included in the study (EsthetX™ and
Vitalescence®). The stickiness of Filtek Supreme universal restorative translucent shades was
comparable to other leading products included in the study (Figures 8-11).
®
Figure 3 (at left). Dentin, Enamel and Bodyshades formulationAnterior; 4 is ideal
Figure 4 (at right). Dentin, Enamel and Bodyshades formulationAnterior; 7 is preferred
Figure 5 (at left). Dentin, Enamel and Bodyshades formulationPosterior; 4 is ideal
Figure 6 (at right). Dentin, Enamel and Bodyshades formulationPosterior; 7 is preferred
Figure 7. Handling preferencesDentin, Enamel and Bodyshades
Figure 8. Handling - Translucentshades
18
Physical PropertiesThe objective of 3M ESPE in designing composites has always been to deliver both high strength
and the best possible esthetic result. Resin and filler technology, however, has limited our ability to
deliver both of these requirements in a single product.
Microfills have been known for excellent polish and, perhaps more important, polish retention.
While excellent for certain indications, most manufacturers limit the indications for use because
the strength characteristics of microfills are not up to the excellent levels achieved by today’s
hybrid composites.
Hybrids, on the other hand, have proven track records in all areas of direct restorative dentistry.
While the new hybrids display excellent clinical performance, including very low wear, the good
initial polish can dull with time in a clinical setting.
3M ESPE chose to take a radically different approach in the design of Filtek™ Supreme Universal
Restorative, using novel (and patented!) techniques in nanotechnology to create a composite that
displays the polish and polish retention of a microfill while maintaining the strength and wear
properties of a modern hybrid.
Polish RetentionStandard Test Method for SpecularGloss (ASTM D 523-89)
A rectangular sample was cured with a
Visilux™ 2 unit for 80 seconds followed by
additional curing for 90 seconds in a
Dentacolor™ XS light box (Kulzer, Inc.,
Germany). Samples were mounted with
double sized adhesive tape (Scotch™ Brand
Tape, Core series 2-1300, St. Paul, MN) to a
holder. The mounted examples were pol-
ished using a Buehler ECOMET 4 Polisher
Figure 9 (at left). Translucent shades - 4is ideal
Figure 10 (at right). Translucent shades - 7is preferred
Figure 11. Preferences -Translucent shades
®
19
with an AUTOMET 2 Polishing Head. The following sequence of abrasive was used for each
sample – 320 grit, 600 grit silicon carbide abrasive, 9mm diamond polishing paste, 3mm diamond
polishing paste and finally a Master Polishing Solution.
A micro-tri-gloss instrument (BYK Gardner, Columbia, MD) was used to collect photoelectric
measurements of specularly reflected light from the sample surface after polishing and after tooth
brushing. The procedure described in ASTM D 523-89 (Reapproved 1994) Standard Test Method
for Specular Gloss, for measurements made at 60A1 geometry was followed. Initial gloss after
polishing was measured for initial sample. Gloss readings were recorded after 500 toothbrushing
cycles. Each sample was brushed with an ORAL B™ 40 medium Straight toothbrush (Oral B
Laboratories, Belmont, CA.) using CREST™ Regular Flavor (Proctor & Gamble, Cincinnati, OH)
toothpaste. The toothbrush and sample were mounted on a device that controlled the stroke length
and force on the toothbrush head.
The polish retention of 3M ESPE Filtek™ Supreme Universal Restorative is similar to traditional
microfill type products.
The polish retention of Filtek Supreme Universal Restorative is improved versus hybrid and
microhybrid type products (Figures 12, 13).
Figure 12. Polish retention
Figure 13. Polish retention
0 500 1000 1500 20000
20
40
60
80
100
%
Filtek Supreme - Translucent
Filtek
™
Supreme - All other shades
Filtek A110
Durafill
Heliomolar
Renamel Microfill
1
0 500 1000 1500 20000
20
40
60
80
100
%
Filtek Supreme - Translucent
Filtek Supreme - All other shades
EsthetX
EsthetX
Point 4
Vitalescence®
Renamel Hybrid
Tetric Ceram
TPH
Herculite XRV™
Filtek Z250
™
™
™
™
™
™
™
™
™
™
™
™
™
™
0 500 1000 1500 20000
20
40
60
80
100
%
Filtek™ Supreme -DEB Shades
Filtek™ Supreme -Trans Shades
Microfill
Microhybrid
Hybrid
20
Surface SEMs After Toothbrush Abrasion
The SEMs below were taken of the sample surfaces after toothbrush abrasion. These SEMs
support the gloss retention data reported above.
Filtek™ Supreme – Translucent shades formulation
The surface maintains surface smoothness even after abrasion.
This surface is even more smooth than the surfaces of abraded
microfills. Individual nanoparticles of the silica nanoclusters
have sheared off at a rate similar to the surrounding silica
nanoparticle filled resin matrix.
Filtek Supreme – Dentin, Enamel and Body shades formulation
The surface isn’t as smooth as the translucent sample. However,
it is apparent that individual nanoparticles have sheared off of the
zirconia/silica nanoclusters. The colored cluster surfaces are still
flat. Filler particle “plucking” is not noticeable as there are no
craters evident.
Microfills – (Filtek™ A110 Anterior Restorative, Durafill™, Renamel™ Microfill, Heliomolar®)
The surfaces have remained relatively smooth. However, indications of the toothbrush abrasion
are more apparent than Filtek Supreme translucent shades formulation. The prepolymerized filler
particles are perceptible as they are slightly more abrasion resistant than the surrounding resin
matrix.
Hybrids and Microhybrids (EsthetX™, TPH™ Spectrum, Vitalescence®, Renamel™ Hybrid,Point 4™, Herculite XRV™, Tetric® Ceram)
The surfaces of these composites are markedly different than Filtek Supreme universal restorative
or microfills. Surfaces are rough. Filler particles are protruding above the resin matrix. Craters are
evident as a result of the loss of individual filler particles (plucking). The resin matrix is clearly
lost at a different rate than the fillers.
Filtek™ A110 AnteriorRestorative, Durafill™
Renamel™ Microfill,Heliomolar®
21
Atomic Force Microscopy
The objective was to measure polish retention of various composites via atomic force microscopy
and compare to a specular gloss test method. Highly polished samples were tooth-brushed (TB)
for 2000 strokes and the resulting gloss retention (GR) at 60°was measured by a micro-tri-gloss
instrument. The same samples were then subjected to topographical study using an Atomic Force
Microscope (AFM) operated in contact-mode. For each sample, the AFM topographical data was
used to determine what the far-field optical intensity pattern would be if the sample were illumi-
nated with an ordinary plane wave. The total intensity of the central peak (TIC) corresponds to the
specular reflection. The TIC value was compared with the corresponding peak for a perfectly
smooth sample to provide the Strehl ratio.
Results - The table shows the gloss retention at 2000 strokes of tooth-brushing and the Strehl ratio,
both measured at 60°.
Sample Filtek™ Supreme Filtek™ Supreme TPH™ Tetric® Filtek™Translucent Standard shades Spectrum Ceram EsthetX™ A110
GR@2000 94.1 64.7 37.0 9.2 14.0 71.4 Strehl ratio 0.978 0.464 0.186 0.143 0.197 0.902
Higher gloss retention was measured for 3M ESPE Filtek™ Supreme Universal Restorative
translucent shade compared to the microfill.
Both translucent and standard shades of Filtek Supreme universal restorative retained glossbetter than the microhybrid composites.
Gloss retention via atomic force microscopy shows excellent correlation to specular reflec-tion.
EsthetX™, TPH™Spectrum, Vitalescence®
Renamel™ Hybrid, Point 4™, Herculite XRV™
Tetric® Ceram
22
Volumetric ShrinkageA method for determining polymerization shrinkage was described by Watts and Cash (Meas. Sci.
Technol. 2(1991) 788-794). In this method, a disc shaped test specimen and uncured paste is sand-
wiched between two glass plates and light cured through the lower rigid plate. The flexible upper
plate is deflected during the polymerization of the test specimen. The less the flexible plate bends,
the lower the shrinkage. Deflection is measured and recorded as a function of time. Although this
process actually measures linear shrinkage, volumetric shrinkage was closely approximated due to
the fact that the dimensional changes were limited to the thickness dimension. The lower the
value, the less the shrinkage.
In this test, samples were exposed for 60 seconds to a 3M ESPE Visilux™ 2 Visible Light Curing
Unit. The final shrinkage was recorded 4 minutes after the end of light exposure.
The polymerization shrinkage of 3M ESPE Filtek™ Supreme Universal Restorative Dentin,
Enamel and Body shades is statistically lower (less shrinkage) than EsthetX™, Renamel™ Hybrid,
Renamel Microfill, Point 4™, Tetric® Ceram, TPH™ Spectrum, Vitalescence®, and Herculite XRV™.
The polymerization shrinkage of Filtek Supreme universal restorative translucent shades is statisti-
cally lower (less shrinkage) than EsthetX, Renamel Hybrid, Renamel Microfill, Point 4, TPH
Spectrum, Vitalescence, and Herculite XRV (Figure 14).
Atomic Force Microscopyused to image the sur-faces of a microhybid(left) and Filtek™Supreme UniversalRestorative translucentshade after toothbrushabrasion.
Figure 14. Shrinkage
110
urafill™
olar™icr
ofill
. shades
shades
sthetX
™oint 4
italesc
ence®
ybrid
eram™PH™
™XRV
Z250
Hybrids and Microhybrids
23
Wear3-Body (generalized) Wear
The wear rate was determined by an in-vitro 3-body wear test. In this test, composite (1st body) is
loaded onto a wheel, which contacts another wheel, which acts as an “antagonistic cusp” (2nd
body). The two wheels counter-rotate against one another dragging an abrasive slurry (3rd body)
between them. Dimensional loss during 156,000 cycles is determined by profilometry at regular
intervals (i.e., after every 39,000 cycles). As the wear in this method typically follows a linear pat-
tern, the data is plotted using linear regression. The wear rates, i.e., the slope of the lines, are deter-
mined. The comparison of rates reduces some of the variability in the test due to sample prepara-
tion and can be predictive of anticipated wear beyond the length of the actual test.
The in-vitro 3-body wear of 3M ESPE Filtek™ Supreme Universal Restorative Dentin, Enamel
and Body shades is statistically lower (more wear resistant) than 3M ESPE Filtek™ A110 Anterior
Restorative, Durafill™ VS, Renamel™ Hybrid, Heliomolar®, Renamel™ Microfill, EsthetX™, TPH™
Spectrum, Tetric® Ceram and Herculite XRV™.
The in-vitro 3-body wear of Filtek Supreme universal restorative translucent shades is statistically
lower (more wear resistant) than Durafill VS, TPH Spectrum, Tetric Ceram and Heliomolar
(Figure 15).
2-body (localized) Wear
2-body wear estimates were measured at the MDRCBB (University of MN). In this test a stylus
(Enamel Cusp) was placed on the restorative material and dragged across the surface. Generally
speaking, any volume wear loss less than 0.1mm3 is acceptable. A wear volume at 0.05mm3 would
be rated good. A wear of 0.05mm3 for the composite and 0.05mm3 enamel cusp would be consid-
ered well balanced. The conclusion drawn by the MDRCBB is that the wear performance appears
satisfactory both numerically and microscopically.
Sample Filtek™ Supreme Enamel Cusp
Volume loss Mean depth Volume loss Mean depth (mm3) loss (m) (mm3) loss (m)
Filtek Supreme 0.068 + .014 32-44 0.047 + .009 39-46Dentin, EnamelBody shade formulation
Filtek Supreme 0.082 + 0.029 36-50 0.042 + 0.009 27-44Translucent shade formulation
®
Figure 15. 3-body wear
24
Fracture ToughnessThe values reported for fracture toughness (K1c) are related to the energy required to propagate a
crack. In this test a short rod of material is cured. A chevron or notch is cut into the cylinder and
the parts on either side of the chevron are pulled apart.
Below are the values for wet fracture toughness. The fracture toughness of 3M ESPE Filtek™
Supreme Universal Restorative Dentin, Enamel and Body shades is comparable to Filtek™ Z250,
EsthetX™, TPH™ Spectrum and Vitalescence®.
The fracture toughness of Filtek Supreme universal restorative Dentin, Enamel and Body shades is
higher than 3M ESPE Filtek™ A110 Anterior Restorative, Durafill™, Heliomolar®, Renamel™
Microfill, Point 4™, Tetric® Ceram and Herculite XRV™.
The fracture toughness of Filtek Supreme universal restorative translucent shades is higher than
Filtek A110, Durafill, Heliomolar, and Renamel Microfill (Figure 16).
Flexural ModulusFlexural modulus is a method of defining a material’s stiffness. A low modulus indicates a flexible
material. The flexural modulus is measured by applying a load to a material specimen that is sup-
ported at each end.
The flexural modulus of Filtek Supreme universal restorative Dentin, Enamel and Body shades is:
• statistically higher than Filtek A110 Anterior Restorative, Durafill VS, EsthetX, Renamel
Hybrid, Heliomolar, Renamel Microfill, Point 4, Vitalescence and Tetric Ceram,
• statistically equivalent to Herculite XRV and TPH,
• statistically lower than Filtek Z250 universal restorative.
The flexural modulus of Filtek Supreme universal restorative translucent shades is;
• statistically greater than Filtek A110 anterior restorative, Durafill VS, Heliomolar, Renamel
Microfill, and Point 4,
Figure 16. Fracture toughness
®
Hybrids and Microhybrids
25
• statistically equivalent to EsthetX™, Renamel™ Hybrid, Tetric® Ceram and Vitalescence®,
• statistically less than TPH™ Spectrum, Herculite XRV™ and Filtek™ Z250 Universal
Restorative (Figure 17).
Flexural Strength Flexural strength is determined in the same test as flexural modulus. Flexural strength is the value
obtained when the sample breaks. This test combines the forces found in compression and tension.
The flexural strength of 3M ESPE Filtek™ Supreme Universal Restorative Dentin, Enamel and
Body shades is statistically higher than Filtek A110 anterior restorative, Durafill VS, Renamel
Hybrid, Heliomolar, Renamel Microfill, and Tetric Ceram.
The flexural strength of Filtek™ Supreme universal restorative Translucent shades is statistically
greater than Filtek A110 anterior restorative, Durafill™ VS, EsthetX, Renamel Hybrid, Heliomolar,
Renamel Microfill, Point 4, TPH Spectrum, Vitalescence and Tetric Ceram (Figure 18).
®
Hybrids and MicrohybridsFigure 18. Flexural strength
®
Hybrids and Microhybrids Figure 17. Flexural Modulus
26
Compressive and Diametral Tensile Compressive strength is particularly important because of chewing forces. Rods are made of the
material and simultaneous forces are applied to the opposite ends of the sample length. The sam-
ple failure is a result of shear and tensile forces.
The compressive strength of 3M ESPE Filtek™ Supreme Universal Restorative Dentin, Enamel
and Body shades is statistically equivalent to all other materials tested.
The compressive strength of the Translucent shades is statistically higher than 3M ESPE Filtek™
A110 Anterior Restorative, Tetric® Ceram and TPH™ Spectrum (Figure 19).
Diametral tensile strength is measured using a similar apparatus. Compressive forces are applied
to the sides of the sample, not the ends, until fracture occurs.
The diametral tensile strength of Filtek Supreme universal restorative Dentin, Enamel and Body
shades is statistically higher than Filtek A110 anterior restorative, Durafill™ VS, EsthetX™,
Heliomolar®, Renamel™ Microfill, and Tetric® Ceram.
The diametral tensile strength of Filtek Supreme universal restorative translucent shades is statisti-
cally higher than Filtek A110 anterior restorative, Durafill VS, EsthetX, Renamel Hybrid,
Heliomolar, Renamel Microfill, Point 4™, Tetric Ceram, TPH Spectrum and Vitalescence®
(Figure 20).
®
Hybrids and MicrohybridsFigure 19. Compressive strength
Figure 20. Diametral tensile strength
®
Hybrids and Microhybrids
27
Independent InvestigationsNumerous independent studies have been performed using 3M ESPE Filtek™ Supreme Universal
Restorative. This includes four in vivo studies that are tracking the performance of Filtek Supreme
universal restorative in a variety of indications that challenge the esthetic and strength capabilities
of this nanocomposite.
Polymerization ShrinkageThe polymerization shrinkage of Filtek Supreme universal restorative was measured in a study
conducted at Louisiana State University (LSU), New Orleans. LSU uses the AccuVol technique to
measure volumetric shrinkage. A wide variety of products were evaluated, with results given
below. Filtek Supreme universal restorative displayed very low shrinkage, averaging 2.09%.
Wear The measurement of wear is critical as an indicator of longevity in posterior restorations. While
3M ESPE uses the three-body wear machine for internal measurements, Creighton University uses
a device developed by Leinfelder et al that was designed to simulate both generalized and local-
ized wear. Some feel that localized wear from direct contact is a more important contributor to
breakdown than generalized wear as generated by a food bolus during mastication.
Composites are placed incrementally into 6mm diameter, 3mm deep cavities in acrylic fixtures.
After curing, composites were polished using a sequence of SiC paper and finally a 0.05 micron
polishing paste. Samples are held in a cylinder containing a slurry of PMMA beads. A conical
stainless steel stylus, mounted on a spring-loaded piston, produces the localized wear. Both volu-
metric loss and maximum depth were determined using a profilometry technique. Results are pre-
sented in Figures 22 and 23.
l
®
Figure 21. Volumetric shrinkage(Burgess, JO; Xu, X., Xin,X; LSU)
28
Clinical StudiesKatholieke Universiteit Leuven, Belgium
In this 5 year study, 3M ESPE Filtek™ Supreme Universal Restorative is being compared to
3M ESPE Z100™ Restorative and enamel for occlusal contact wear in class I and II restorations.
Previous studies at this university has shown Z100 Restorative wearing equivalent to enamel in
occlusal contact areas through 4 years of clinical service.
Eighteen restorations of each material were placed, using a split mouth model, in upper or lower
molars. 3M ESPE Adper™ Single Bond adhesive was used as bonding agent for both materials.
Gypsum replicas were made at baseline, six and 12 months for laser scanning contact areas for
composite and enamel wear. Epoxy replicas were used for SEM analysis. At each recall, restora-
tions were evaluated per USPHS criteria for posterior restorations.
Results through one year:
Material/Time Z100™ Filtek™ Supreme Enamel
6m -50 (SD-19) (n-30) -48 (SD-17) (n=35) -46 (SD-24) (n-115)12m -59 (SD-20) (n-40) -64 (SD-31) (n-52) -58 (SD-19) (n-144)
The mean occlusal vertical and volumetric loss were equivalent for all materials at each recall.
After one year, the polish of Filtek Supreme Universal restorative was significantly better thanZ100 Restorative.
Figure 22. Localized wear: volumeloss (Barkmeier, WW;Latta, MA)
Figure 23. Localized wear: maxi-mum depth (Barkmeier,WW; Latta, MA)
Mean vertical OCA wear(microns)
29
Manitoba University Dental School - Winnipeg, Canada
3M ESPE Filtek™ Supreme Universal Restorative is being evaluated in Class I and II restorations
over three years. 60 restorations were placed in adult patients with 75% of these representing a
Class II preparation design. Several large, multi-surface restorations were included per ADA study
design parameters. All restorations were bonded using Adper™ Single Bond Adhesive manufac-
tured by 3M ESPE.
Restorations were evaluated at baseline, six months, one and two years by two calibrated examin-
ers. Replica models were evaluated for wear using ML scale.
All restorations were judged clinically acceptable at all recalls (criteria rated either alpha or
bravo). After 2 years of service, generalized wear was measured at 36 microns.
The evaluators noted a high degree of polishability was achieved with Filtek Supreme universal
restorative and that after two years the surface texture remained smooth and shiny. It was conclud-
ed that, “…the clinical performance of Supreme placed in the posterior dentition continued to be
excellent at 2 years.”
Johannes Gutenberg-University – Mainz, Germany
Filtek Supreme universal composite (FS) is being evaluated in Class II, stress bearing restorations
together with Tetric® Ceram (TC) in a split mouth design. 112 restorations were placed in 50
patients using Adper Single Bond adhesive as the bonding agent for both materials. After two
years the restorations were recalled and evaluated according to Ryge/CDA Criteria.
No significant differences were noted between the two materials evaluated at the two year recall.
Filtek Supreme universal restorative was judged efficacious for clinical use including placement in
larger stress bearing posterior restorations.
Two Year Results
Percent Alpha
Baseline 6 Months One Year Two Year
Margin Discoloration 100 100 100 97Margin Integrity 100 100 93 91Color Match 100 100 98 98Anatomic Form 100 100 100 97Surface Texture 100 100 100 97Secondary Caries 100 100 100 100Post-operative Sensitivity 100 100 100 100Contact Wear 100 100 100 100Recall Rate 100 100 98 97
Oscar Alpha Bravo Charlie DeltaFS TC FS TC FS TC FS TC FS TC
Margin Adaptation – – 96 96 2 2 2 0 0 2Anatomic Form – – 98 98 0 0 2 2 0 0Secondary Caries – – 100 100 0 0 0 0 0 0Margin Discoloration – – 98 100 2 0 0 0 0 0Surface Texture – – 95 95 4 4 0 0 2 2Color Match 46 57 50 39 2 4 2 0 – –
30
Loma Linda University – Loma Linda, California
The clinical performance of 3M ESPE Filtek™ Supreme Universal Restorative is being studied in
anterior restorations encompassing Class IV and V restorations, diastema closures, incisal edge
repair and facial veneers. 44 restorations were placed in maxillary incisors and canines in 28
patients.
At the two year recall, 37 restorations were evaluated using a modified USPHS grading criteria.
It was reported that the overall clinical performance of Filtek Supreme universal restorative is
acceptable for routine clinical use.
The results of this study are significant in that the design challenges the esthetic capabilities of
Filtek Supreme universal restorative in various anterior indications as well its strength capabilities
in incisal edge repair and Class IV restorations.
2 year recall results Alpha Bravo Charlie DeltaBL / 2Yr BL / 2Yr BL /2 Yr BL /2 Yr
Margin Adaptation 98/97 2/3 0/0 0/0Anatomic Form 100/97 0/3 0/0 0/0Color Match 80/ 78 18/14 2/8 0/0Secondary Caries 100/ 100 0/0 0/0 0/0Margin Discoloration 100/95 0/5 0/0 0/0Polishability 100/97 0/3 0/0 0/0
31
Technique Guides
1
2
4 5
6
3
Direct CompositeRestorative AnteriorRestorations-SimpleFiltek™ Supreme XTUniversal RestorativeAdper™ Adhesive SystemsSof-Lex™ Discs and Strips
32
1
2
4 5
6 7 3M ESPE ©2005 44-0007-4310-2
3
Direct CompositeRestorative AnteriorRestorations- Multi-ShadeFiltek™ Supreme XTUniversal RestorativeAdper™ Adhesive SystemsSof-Lex™ Discs and Strips
Enamel and/or Translucent
Dentin
Body
33
1
2
4 5
3
Body
Direct Composite RestorativePosterior Restorations-SimpleFiltek™ Supreme XT Universal RestorativeVitrebond™ Light-Cure Glass IonomerLiner/BassAdper™ Adhesive SystemsSof-Lex™ Discs, Strips and Finishing Brush
34
1
2
4 5
6 7 3M ESPE ©2005 44-0007-4311-0
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Direct Composite RestorativePosterior Restorations-Multi-ShadeFiltek™ Supreme XT Universal RestorativeVitrebond™ Light-Cure Glass IonomerLiner/BassAdper™ Adhesive SystemsSof-Lex™ Discs, Strips and Finishing Brush
Dentin (or Body)
Body (or Dentin) Enamel and/or Translucent
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Instructions For Use 3M ESPE Filtek™ Supreme XT Universal Restorative
General
Filtek Supreme XT universal restorative material, manufactured by 3M ESPE, is a visible-light
activated, restorative composite designed for use in anterior and posterior restorations. All shades
except for the translucent shades are radiopaque. The fillers for the radiopaque shades are a com-
bination of aggregated zirconia/silica cluster filler with an average cluster particle size of 0.6 to 1.4
microns with primary particle size of 5-20 nm and a non-agglomerated/non-aggregated 20 nm s
ilica filler. The translucent shades are not radiopaque. The fillers for non-radiopaque translucent
shades are a combination of aggregated silica cluster filler with an average particle size of 0.6 to
1.4 microns and a primary particle size of 75 nm and a non-agglomerated/non-aggregated 75 nm
silica filler. The inorganic filler loading is about and 72.5% by weight (57.7% by volume) for the
translucent shades and 78.5% by weight (59.5% by volume) for all other shades. Filtek Supreme
universal restorative contains bis-GMA, UDMA, TEGDMA, and bis-EMA resins. A 3M ESPE
dental adhesive is used to permanently bond the restoration to the tooth structure. The restorative
is available in a wide variety of dentin, body, enamel and translucent shades. It is packaged in tra-
ditional syringes and single-dose capsules
Indications
Filtek Supreme XT universal restorative is indicated for use in:
• Direct anterior and posterior restorations (including occlusal surfaces)
• Core Build-ups
• Splinting
• Indirect restorations including inlays, onlays and veneers.
Precautions for Patients and Dental Personnel
Composite Paste Precaution: Filtek Supreme XT universal restorative contains acrylate resins.
Avoid use of this product on patients with known acrylate allergies. To reduce the risk of allergic
response, minimize exposure to these materials. In particular, avoid exposure to uncured resin.
Use of protective gloves and a no-touch technique is recommended. If skin contact occurs, wash
skin with soap and water. Acrylates may penetrate commonly used gloves. If restorative material
contacts glove, remove and discard glove, wash hands immediately with soap and water and then
re-glove. If accidental contact with eyes or prolonged contact with oral soft tissue occurs, flush
with large amounts of water. If irritation persists, consult a physician.
Instructions for Use
Preliminary
A. Prophy: Teeth should be cleaned with pumice and water to remove surface stains.
B. Shade Selection: Before isolating the tooth, select the appropriate shade(s) of restorative
material using a standard VITAPAN® Classic shade guide. Shade selection accuracy can be
enhanced by the following hints.
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1. Shade: Teeth are not monochromatic. The tooth can be divided into three regions, each
with a characteristic color.
a. Gingival area: Restorations in the gingival area of the tooth will have various amounts
of yellow.
b. Body area: Restorations in the body of the tooth may consist of shades of gray, yellow
or brown.
c. Incisal area: The incisal edges may contain a blue or gray color. Additionally, the
translucency of this area and the extent of the translucent portion of the tooth to be
restored and neighboring teeth should be matched.
2. Restoration depth: The amount of color a restorative material exhibits is affected by its
thickness. Shade matches should be taken from the portion of the shade guide most simi-
lar to the thickness of the restoration.
3. Mock-up: Place the chosen shade of the restorative material on the unetched tooth.
Manipulate the material to approximate the thickness and site of the restoration. Cure.
Evaluate the shade match under different lighting sources. Remove the restorative mate-
rial from the unetched tooth with an explorer. Repeat process until an acceptable shade
match is achieved.
C. Isolation: A rubber dam is the preferred method of isolation. Cotton rolls plus an evacuator
can also be used.
Direct Restorations
A. Cavity Preparation:
1. Anterior restorations: Use conventional cavity preparations for all Class III, IV and V
restorations.
2. Posterior restorations: Prepare the cavity. Line and point angles should be rounded. No
residual amalgam or other base material should be left in the internal form of the prepa-
ration that would interfere with light transmission and therefore, the hardening of the
restorative material.
B. Pulp Protection: If a pulp exposure has occurred and if the situation warrants a direct pulp
capping procedure, use a minimum amount of calcium hydroxide on the exposure followed by an
application of Vitrebond™ Light Cure Glass Ionomer Liner/Base, manufactured by 3M ESPE.
Vitrebond liner/base may also be used to line areas of deep cavity excavation. See Vitrebond
liner/base instructions for details.
C. Placement of Matrix:
1. Anterior restorations: Mylar strips and crown forms may be used to minimize the
amount of material used.
2. Posterior restorations: Place a thin dead-soft metal, or a precontoured-mylar or a precon-
toured-metal matrix band and insert wedges firmly. Burnish the matrix band to establish
proximal contour and contact area. Adapt the band to seal the gingival area to avoid
overhangs.
Note: The matrix may be placed following the enamel etching and adhesive application
steps if preferred.
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D. Adhesive System: Follow the manufacturer’s instructions regarding etching, priming,
adhesive application and curing.
E. Dispensing the Composite: Follow the directions corresponding to the dispensing system
chosen.
1. Syringe:
Dispense the necessary amount of restorative material from the syringe onto the mix pad
by turning the handle slowly in a clockwise manner. To prevent oozing of the restorative
when dispensing is completed, turn the handle counterclockwise a half turn to stop paste
flow. Immediately replace syringe cap. If not used immediately, the dispensed material
should be protected from light.
2. Single-Dose Capsule: Insert capsule into 3M ESPE Restorative Dispenser. Refer to
separate restorative dispenser instructions for full instructions and precautions. Extrude
restorative directly into cavity.
F. Placement:
1. Place and light cure restorative in increments as indicated in Section G.
2. Slightly overfill the cavity to permit extension of composite beyond cavity margins.
Contour and shape with appropriate composite instruments.
3. Avoid intense light in the working field.
4. Posterior placement hints:
a. To aid in adaptation, the first 1mm layer may be placed and adapted to the proximal
box.
b. A condensing instrument (or similar device) can be used to adapt the material to all of
the internal cavity aspects.
G. Curing: 3M ESPE Filtek™ Supreme XT Universal Restorative will cure only by exposure to
light. Cure each increment by exposing its entire surface to a high intensity visible light source,
such as a 3M ESPE curing light. Hold the light guide tip as close to the restorative as possible
during light exposure.
Shade Increment depth Cure timeBody, Enamel and Translucent shades 2.0mm 20 secDentin shades 1.5mm 40 sec
H. Contouring: Contour restoration surfaces with fine finishing diamonds, burs or stones.
Contour proximal surfaces with Sof-Lex™ Finishing Strips, manufactured by 3M ESPE.
I. Adjust Occlusion: Check occlusion with a thin articulating paper. Examine centric and lateral
excursion contacts. Carefully adjust occlusion by removing material with a fine polishing diamond
or stone.
J. Finish and Polishing: Polish with the 3M ESPE Sof-Lex™ Finishing and Polishing System.
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Indirect Procedure For Inlays, Onlays Or Veneers
A. Dental Operatory Procedure
1. Shade selection: Choose the appropriate shade(s) of 3M™ ESPE™ Filtek™ Supreme
XT Universal Restorative prior to isolation. If the restoration is of sufficient depth, use of
an opaque shade is recommended. Use of a translucent shade on the occlusal surface will
help to achieve esthetic appearance.
2. Preparation: Prepare the tooth.
3. Impressioning: After preparation is complete, make an impression of the prepared tooth
by following the manufacturer’s instructions of the impressioning material chosen. A 3M
ESPE impressioning material, manufactured by 3M ESPE, may be used.
B. Laboratory Procedure
1. Pour the impression of the preparation with die stone. Place pins at the preparation site at
this time if a “triple tray” type of impression was used.
2. Separate the cast from the impression after 45 to 60 minutes. Place pins in die and base
the cast as for a typical crown and bridge procedure. Mount or articulate the cast to its
counter model on an adequate articulator.
3. If a second impression was not sent, pour a second cast using the same impression regis-
tration. This is to be used as a working cast.
4. Section out the preparation with a laboratory saw and trim away excess or, expose the
margins so they can be easily worked. Mark the margins with a red pencil if needed. Add
a spacer at this time if one is required.
5. Soak the die in water, then with a brush, apply a very thin coat of separating medium to
the preparation, let it dry somewhat, then add another thin layer.
6. Add the first third of composite to the floor of the preparation, stay short of the margins,
light cure for 20 seconds.
7. Add second third of composite. Allow for the last third (incisal) to include the contact
areas, light cure for 20 seconds.
8. Place the die back into the articulated arch add the last third of Translucent composite to
the occlusal surface. Overfill very slightly mesially, distally, and occlusally. This will
allow for the mesiodistal contacts and the proper occlusal contact when the opposing
arch is brought into occlusion with the uncured Translucent increment. Light cure for
only ten seconds, then remove the die to prevent adhering to adjacent surfaces. Finish the
curing process.
9. With the occlusal contacts already established, begin removing the excess composite
from around the points of contact. Develop the inclines and ridges as per remaining
occlusal anatomy.
10. Care must be taken when removing the prosthesis from the die. Break off small amounts
of the die from around the restoration, the die stone should break away cleanly from the
cured restoration, until all of the restoration is recovered.
11. Using the master die, check the restoration for flash, undercuts, and fit. Adjust as neces-
sary, and then polish as noted above on page 41, steps H through J.
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C. Dental Operatory Procedure
1. Roughen the interior surfaces of the indirect restoration.
2. Clean the prosthesis in a soap solution in an ultrasonic bath and rinse thoroughly.
3. Cementation: Cement the prosthesis using a 3M ESPE resin cement system by following
manufacturer’s instructions.
Storage and Use
A. Do not expose restorative materials to elevated temperatures or intense light.
B. Unopened kits should be refrigerated (40°F or 4°C) to extend shelf life. Allow to come to
room temperature for use.
C. Do not store materials in proximity to eugenol containing products.
D. The composite pastes are designed for use at room temperature of approximately 21- 24°C or
70 - 75°F. Shelf life at room temperature is 3 years. See outer package for expiration date.
No person is authorized to provide any information, which deviates from the information provided
in this instruction sheet.
Warranty3M ESPE warrants this product will be free from defects in material and manufacture. 3M ESPE
MAKES NO OTHER WARRANTIES INCLUDING ANY IMPLIED WARRANTY OF MER-
CHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. User is responsible for
determining the suitability of the product for user’s application. If this product is defective within
the warranty period, your exclusive remedy and 3M ESPE’s sole obligation shall be repair or
replacement of the 3M ESPE product.
Limitation of Liability
Except where prohibited by law, 3M ESPE will not be liable for any loss or damage arising from
this product, whether direct, indirect, special, incidental or consequential, regardless of the theory
asserted, including warranty, contract, negligence or strict liability.
Dental Products
3M CenterBuilding 275-2SE-03St. Paul, MN 55144-1000USA
3M Canada
Post Office Box 5757London, Ontario N6A 4T1Canada1-800-265-1840 ext. 6229
3M, ESPE, Adper, Filtek, Sof-Lex, Visilux,Vitrebond and Z100 are trademarks of 3MESPE or 3M ESPE AG. Scotch is a trade-mark of 3M. EsthetX and TPH are trade-marks of Caulk/Dentsply. 4 Seasons, Tetricand Heliomolar are registered trademarks ofIvoclar/Vivadent. Point 4, Premise, Prodigyand Herculite are trademarks of Kerr.Renamel is a trademark of Cosmedent, Inc.Charisma, Dentacolor and Durafill are trade-marks of Heraeus Kulzer. Vitalescence is atrademark of Ultradent Products, Inc.Grandio is a trademark of VOCO, Oral-B is atrademark of Oral-B Laboratories. Crest is atrademark of Proctor and Gamble. Vita andVITAPAN are registered trademarks ofZahnfabrik H Rauter GmbH & Co KG
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