Ketac™ Universal

Glass Ionomer Restorative

Technical
Product Profile
2

Table of Contents

Introduction..................................................................................................................3

Product Description....................................................................................................3

Product Features..........................................................................................................3

Indications for Use.......................................................................................................4

Composition.................................................................................................................4

BPA-free.................................................................................................................4

Shades....................................................................................................................5

Procedure......................................................................................................................5

Simplified Dental Treatment...............................................................................5

Adhesion........................................................................................................................6

Physical Properties...................................................................................................... 7

Mechanical Properties Overview...................................................................... 7

Compressive Strength.................................................................................. 7

Flexural Strength...........................................................................................8

Surface Hardness..........................................................................................9

In vitro, 3-Body Wear................................................................................. 10

Fluoride Release................................................................................................... 11

Humidity Tolerance............................................................................................ 12

Resistance to Staining........................................................................................ 13

Clinical Performance...........................................................................................14–15

Clinical Case............................................................................................................... 16

Questions and Answers.............................................................................................17

Space for Your Notes..........................................................................................18–19

 3

Introduction
Ketac™ Universal Glass Ionomer Restorative is the latest development in a long
history of proven glass ionomer technology from 3M. It’s designed to save steps
for a faster procedure, so it’s ideal for treating pediatric, geriatric and teenage
patients—who can be the most caries-prone and the most restless. Ketac Universal
restorative offers low stickiness for easy handling AND reduces chair time with a
simple one-step placement … so you can finish faster. The material can be used
without preconditioning the cavity and without a coating, so it eliminates steps—yet
still delivers the compressive strength and surface hardness that are higher than
several clinically proven glass ionomers that require a coating. Ketac Universal
restorative is mixed by hand to initiate the acid-base setting reaction of the
glass ionomer. The powder in the vial is not prone to humidity. The material is
indicated for an extended range of indications, making it a universal solution
for the dental practice.

Product Description
Ketac Universal restorative is a radiopaque glass ionomer restorative which can be mixed by hand; it is used for
bulk fill placement. The ability of the material to bond chemically to enamel and dentin ensures gentle preparation
and excellent sealing on the margins of fillings. Ketac Universal restorative can be applied without lining.
It releases fluoride ions and is available in various shades corresponding to the VITA® classical color system.

Product Features
• Packaged in 12.5g powder vials and 8.5ml liquid • Extended indications for use compared to other
bottles – Vial and bottle are transparent with glass ionomer materials
turquoise labels
• Continuously releases fluoride for over 24 months
• Six shades – A1, A2, A3, A3.5, A4 and White
• Low stickiness for an easy placement
• Long-term Class I and Class II with restrictions*
• Self-adhesive
• No need for conditioner or coating
• Self-cure
• Bulk fill—no need for layering
• Radiopaque
• Humidity tolerant
• Enables fast, one-step, stress-bearing
restorative solutions

*Refer to the Instructions for Use for more information.

4

Indications for Use

• Linings for single- and multi-surface composite fillings
• Core build-up prior to crown placement
• Primary tooth fillings
• Stress-bearing Class I restorations with at least one additional support outside of the filling area
• Stress-bearing Class II restorations when the isthmus is less than half of the intercuspal distance and with
at least one additional support outside of the filling area
• Cervical fillings
• Single- and multi-surface temporary fillings
• Fissure sealing

Composition
Ingredients*

Powder
Oxide glass

Liquid
Water
Copolymer of acrylic acid—maleic acid
Tartaric acid

BPA free
None of the ingredients present in the composition of Ketac™ Universal Glass Ionomer Restorative are
BPA or substances using the BPA backbone in their structure. There are no BPA derivatives present, either.

*Refer to MSDS for more information

 5

Shades
Ketac™ Universal Glass Ionomer Restorative is available in six shades: White, A1, A2, A3, A3.5 and A4.

White A1 A2 A3 A3.5 A4

Procedure
Simplified Dental Treatment
Glass ionomer restoratives have a long history of being an economical, tooth-colored solution for treating caries.
Currently, most traditional glass ionomer restoratives on the market require a conditioner and/or coating.
Ketac Universal restorative takes ease of use one step further by eliminating these steps.

Fewer steps = a simple, faster procedure

GC Fuji IX GP®
Ketac™ Universal
Radiopaque Posterior
Glass Ionomer Restorative
Glass Ionomer Restorative Cement
Steps after cavity preparation* only 4 steps 11 steps
Cavity conditioner
Rinse
Air dry
Dose material
Mix
Place in bulk
Coating
Light cure/air dry
Finishing
Coating
Light cure/air dry
*Clinical steps according to manufacturer’s Instructions for Use
6

Adhesion
To evaluate the influence of the conditioning step, adhesion was tested with and without
a conditioner. Bond strength on human teeth was measured using a Shear Bond Test.
The material was cured on exposed human enamel/dentin. Specimens were then kept
at a relative humidity of over 95% for 24 hours. Adhesion was subsequently tested in
a universal testing machine cell until failure.

Bond strength to enamel and dentin of

Ketac™ Universal Glass Ionomer Restorative
12

10
Bond Strength [MPa]

0
Enamel Dentin
Ketac™ Universal Glass Ionomer Restorative without Ketac™ Conditioner
Ketac™ Universal Glass Ionomer Restorative with Ketac™ Conditioner
Ketac™ Molar Easymix Ionomer Filling Material with Ketac™ Conditioner

Figure 1: Adhesion to enamel and dentin. Source: 3M internal data

The adhesion values of Ketac™ Universal Glass Ionomer Restorative without a conditioner
are comparable to the adhesion values of Ketac™ Universal Glass Ionomer Restorative
and Ketac™ Molar Easymix Glass Ionomer Filling Material with a conditioner. Therefore,
the application of a conditioner prior to placement of Ketac™ Universal Glass Ionomer
Restorative is not necessary.

The results are in line with multiple in vivo and in vitro studies, which have shown that using a conditioner
does not necessarily improve the adhesion of glass ionomers to the natural tooth structure. Literature shows
that application of a conditioner prior to placement of the filling is successful in removing the “smeared” layer.
However, this step is not necessary, possibly because there is adequate free acid in glass ionomers to dissolve
the smear layer at the time of the restoration placement.*

*Yassen, G. (2009). One-year survival of occlusal ART restorations in primary molars placed with and without cavity conditioner. Journal of Dentistry for
Children. 76:136-141.
van Dijken, J. W. V. (1996). Four-year evaluation of the effect of 10% polyacrylic acid or water rinsing pretreatment on retention of glass polyalkenoate cement.
European Journal of Oral Sciences. 104:64-66.
Tyas, M. J. (1994). The effect of dentine conditioning with polyacrylic acid on the clinical performance of glass ionomer cement—3-year results. Australian
Dental Journal. 39:220-221.
Bortoletto, C. C., Junior Miranda, W. G., Motta, L. J., Bussadori, S. K. (2013). Influence of acid etching on shear strength of different glass ionomer cements.
Brazilian Journal of Oral Sciences. 12: 11-15.
 7

Physical Properties
Mechanical Properties Overview
The mechanical properties of Ketac™ Universal Glass Ionomer Restorative are comparable to clinically effective
high-viscous materials such as Ketac™ Molar Glass Ionomer Restorative.

Ketac™ Universal Ketac™ Molar

Properties Glass Ionomer Restorative Glass Ionomer Restorative
Compressive strength 249 + 14 MPa 255 + 12 MPa
Flexural strength 51 + 7 MPa 49 + 5 MPa
Surface hardness 679 + 152 MPa 536 + 89 MPa
Wear resistance 3-body wear 65 + 2 µm 79 + 3 µm
Source: 3M internal data

Compressive Strength
Compressive strength is particularly important because of chewing forces. To test this,
simultaneous forces are applied to the opposite ends of a rod-shaped sample of material.
The sample failure is a result of shear and tensile forces.

Compressive Strength
Ketac™ Universal
Glass Ionomer Restorative
riva self cure
Glass Ionomer Restorative
GC Fuji IX GP® Radiopaque
Posterior Glass Ionomer Restorative Cement
GC Gold Label Glass Ionomer
Universal Restorative
GC Gold Label Glass Ionomer
High Strength Posterior Restorative
Ketac™ Molar Easymix
Glass Ionomer Restorative
Ketac™ Molar
Glass Ionomer Restorative

0 50 100 150 200 250 300

Compressive Strength [MPa]

Figure 2: Compressive strength of common glass ionomer restoratives. Source: 3M internal data

The compressive strength of Ketac Universal restorative is higher than several

competitive glass ionomer restoratives (GC Fuji IX GP, GC Gold Label Universal
Restorative, riva self cure Glass Ionomer Restorative) and comparable to GC Gold Label
High Strength Posterior Restorative, Ketac™ Molar Glass Ionomer Restorative and
Ketac™ Molar Easymix Glass Ionomer Restorative.
8

Flexural Strength
Flexural strength is measured by applying a perpendicular load to a material specimen that
is supported at each end. Flexural strength is the value obtained when the sample breaks.

Three-Point Flexural Strength

Ketac™ Universal
Glass Ionomer Restorative

riva self cure

Glass Ionomer Restorative

GC Gold Label Glass Ionomer

High Strength Posterior Restorative

GC Gold Label Glass Ionomer

Universal Restorative

GC Fuji IX GP® Radiopaque Posterior

Glass Ionomer Restorative Cement

Ketac™ Molar
Glass Ionomer Restorative

Ketac™ Molar Easymix

Glass Ionomer Restorative

0 10 20 30 40 50 60 70 80
Flexural Strength [MPa]

Figure 3: Three-point flexural strength of common glass ionomer restoratives. Source: 3M internal data

The flexural strength of Ketac™ Universal Glass Ionomer Restorative is higher than riva
self cure Glass Ionomer Restorative and comparable to all other restorative materials
shown in the graph (GC Fuji IX GP, GC Gold Label Universal Restorative, GC Gold Label
High Strength Posterior Restorative, Ketac™ Molar Glass Ionomer Restorative and
Ketac™ Molar Easymix Glass Ionomer Restorative).
 9

Surface Hardness
Surface hardness was measured on disc-shaped specimens (diameter 6 mm) 24 hours
after mixing the restorative. A testing machine with a ball-shaped indenter
(diameter 5 mm) was used. Samples were loaded with a force of 357.9 N for 30 seconds.
Thereafter, depth of penetration was measured and the surface hardness calculated.

Surface Hardness
Ketac™ Universal
Glass Ionomer Restorative

riva self cure

Glass Ionomer Restorative

GC Gold Label Glass Ionomer

High Strength Posterior Restorative

GC Gold Label Glass Ionomer

Universal Restorative

Ketac™ Molar
Glass Ionomer Restorative

Ketac™ Molar Easymix

Glass Ionomer Restorative

GC Fuji IX GP® Radiopaque Posterior

Glass Ionomer Restorative Cement

0 100 200 300 400 500 600 700 800 900

Surface Hardness [MPa]

Figure 4: Surface hardness of common glass ionomer restoratives. Source: 3M internal data

The surface hardness of Ketac™ Universal Glass Ionomer Restorative is higher than riva
self cure Glass Ionomer Restorative and comparable to all other restorative materials
shown in the graph (GC Fuji IX GP, GC Gold Label Universal Restorative, GC Gold Label
High Strength Posterior Restorative, Ketac™ Molar Glass Ionomer Restorative and
Ketac™ Molar Easymix Glass Ionomer Restorative).
10

In vitro, 3-Body Wear

The wear rate was determined by an in vitro 3-body wear test. In this test, the restorative
material (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 abrasive slurry (3rd body) between them. Wear is measured as dimensional loss
during 200,000 cycles, which is determined by profilometry at the end.

3-body wear abrasion

Ketac™ Universal
Glass Ionomer Restorative

GC Fuji IX GP® Radiopaque Posterior

Glass Ionomer Restorative Cement

GC Gold Label Glass Ionomer

High Strength Posterior Restorative

Ketac™ Molar Easymix

Glass Ionomer Restorative

Ketac™ Molar
Glass Ionomer Restorative

riva self cure

Glass Ionomer Restorative

GC Gold Label Glass Ionomer

Universal Restorative

0 10 20 30 40 50 60 70 80 90
Wear µ [µm]

Figure 5: 3-body wear abrasion of common glass ionomer restoratives. Source: 3M internal data

The lower the wear, the better the wear resistance. The wear resistance of
Ketac™ Universal Glass Ionomer Restorative is comparable to the wear resistance of
GC Fuji IX GP and lower than the wear resistance of the other glass ionomer restorative
materials shown (GC Gold Label Universal Restorative, GC Gold Label High Strength
Posterior Restorative, Ketac™ Molar Glass Ionomer Restorative, Ketac™ Molar Easymix
Glass Ionomer Restorative and riva self cure Glass Ionomer Restorative).
 11

Fluoride Release
Fluoride release was determined by storing cured material samples in distilled water and measuring the
concentration of fluoride ions released into the water using a fluoride ion-selective electrode.

Ketac™ Universal Glass Ionomer Restorative releases fluoride continuously for over 24 months.

Fluoride Release
80

70 Ketac™ Universal Glass Ionomer Restorative

Ketac™ Molar Easymix Glass Ionomer Restorative
Accumulated Release [ppm]

60
Ketac™ Molar Glass Ionomer Restorative

50

40

30

20

10

0
0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24
Time [Months]

Figure 6: Fluoride release over 24 months. Source: 3M internal data

Ketac Universal restorative releases a higher amount of fluoride than previous glass
ionomer restoratives, such as Ketac™ Molar Glass Ionomer Restorative and
Ketac™ Molar Easymix Glass Ionomer Restorative.
12

Humidity Tolerance
Powders for glass ionomer restoratives that are mixed by hand are usually stored in glass vials. Depending on
the geographic region and individual climate conditions in dental offices, the glass ionomer powder can be exposed
to humidity by opening and closing the glass vials. The air in the glass vial is at least partly exchanged with humid air
from the surroundings. Water uptake by the powder can have an effect on the mixing and curing properties of the
glass ionomer restorative, making it harder to mix and accelerating the curing process of the paste.

To simulate a long-term use in a dental office with high humidity, samples were stored in open glass vials
at elevated temperatures (30°C/86°F) and high humidity (relative humidity 80%). Humidity Tolerance was
determined by measuring the uptake of water relative to the original mass of the powder. The lower the relative
uptake of water, the more resistant the glass ionomer powder was to humidity.

Water Uptake
1.4
Water uptake in % in relation

1.2 1 week 3 weeks

1 2 weeks 4 weeks
to powder weight

0.8
No water
0.6 uptake
in the first
0.4 2 weeks
0.2
0
-0.2
Ketac™ riva self cure Ketac™ Molar
GC Gold Label GC Gold Label Ketac™ Molar
Universal Glass Glass Ionomer Glass Ionomer
Glass Ionomer Glass Ionomer Easymix Glass
Ionomer Restorative
Universal Restorative
High Strength Ionomer
Restorative Restorative Posterior Restorative
Restorative
Figure 7: Water uptake by different glass ionomer powders over 1, 2, 3 and 4 weeks. Source: 3M internal data

Ketac™ Universal Glass Ionomer Restorative powder is not prone to humidity. As can be
seen in the graph above, there is no water uptake by the Ketac Universal restorative powder.
The other materials tested show a higher increase in weight, hence an uptake of water.

Humidity Tolerance
100%

80%
Very important
60% Somewhat important
Not important
40%
Do not know/No answer
20%

0%
Important Not important No answer

Figure 8: The powder is not prone to humidity once the glass vial is unsealed. How important is this humidity tolerance of the
powder to you? Source: 3M internal data

90% of dentists who used Ketac Universal restorative believe that this humidity tolerance
is an important feature.*
*Refer to section “Clinical Evaluation” for results from the application test.
 13

Resistance to Staining
To test stain resistance, samples were kept in water for 24 hours and then placed in a standardized tea solution
for 7 days at 36°C. By comparing the color values after the storage in water with the values measured after
storage in tea, the difference—or ∆E value—is determined for each group.

Resistance to Staining Test

20

16

12
∆E

0
Ketac™ Universal GC Fuji IX GP®
Glass Ionomer Restorative Radiopaque Posterior Glass Ionomer
Restorative Cement

Figure 9: Change in color due to storage in tea solution for 7 days. Source: 3M internal data

To maintain their aesthetics, restoratives must be resistant against staining.

Food and beverages can be a major source of staining.

Compared to GC Fuji IX GP, Ketac™ Universal Glass Ionomer

Restorative resists tea staining better.
14

Clinical Performance
Application Test Results
3,510 restorations were placed by 59 dentists from Poland and India using Ketac™ Universal Glass Ionomer
Restorative in their offices. The dentists then evaluated the in vivo performance of the material after the trial
period of six weeks.

Overall Handling
100%

80%
Very satisfied

60% Satisfied
Neutral
40% Dissatisfied
Very dissatisfied
20%

0%
Satisfied Neutral Dissatisfied

85% of dentists who used Ketac Universal restorative clinically are satisfied with the
overall handling of the material.

Ease of Placement
100%

80%
Very satisfied

60% Satisfied
Neutral
40% Dissatisfied
Very dissatisfied
20%

0%
Satisfied Neutral Dissatisfied

81% of dentists who used Ketac Universal restorative clinically stated that they are
satisfied with the ease of placement (no conditioner, no glaze needed).
 15

Marginal Adaptation
100%

80%
Adapts easily
60%
Neutral
Is difficult to
40%
adapt
Is very difficult
20% to adapt

0%
Easy Neutral Difficult

86% of dentists who used Ketac™ Universal Glass Ionomer Restorative clinically felt that
the material easily adapted to the cavity walls.

Easy One-Step Bulk Placement

100%

80%
Fully agree

60% Agree
Disagree
40% Totally disagree
No answer
20%

0%
Agree Disagree No answer

According to 88% of dentists who evaluated Ketac Universal restorative clinically, Ketac
Universal restorative enables an easy one-step bulk placement.

Time-Saving
100%

80%
Fully agree

60% Agree
Disagree
40% Totally disagree
No answer
20%

0%
Agree Disagree No answer

According to 83% of dentists who evaluated Ketac Universal restorative clinically, the
material provides time savings compared to glass ionomer restoratives that require
conditioning and coating.
16

Clinical Case
Replacement of a carious restoration on a first premolar under local anesthesia.*

Figure 1. Initial situation in vivo before treatment. Figure 2. Caries removal. Minimally invasive
preparation.

Figure 3. Sectional matrix system in situ. Figure 4. Bulk placement of Ketac™ Universal
Glass Ionomer Restorative into cavity.

Figure 5. Sculpting the occlusal surface. Figure 6. Final Ketac™ Universal Glass Ionomer
Restorative restoration.

*Photos courtesy of Dr. Gunnar Reich, Munich, Germany.

 17

Questions and Answers

1. W
 hat are the benefits of Ketac™ Universal Glass Ionomer Restorative vs. conventional glass
ionomer restoratives?
• One-step placement: No need for conditioner/coating
• Extended indications for use: Long-term restricted stress-bearing Class I and Class II restorations*
• Lower stickiness to metal instruments allows easy placement
• Better cavity adaptation

2. How is Ketac Universal restorative different than previous Ketac™ products?

• No need for conditioner/coating
• Extended indications for use: Long-term restricted stress-bearing Class I and Class II restorations*
• Improved filler composition, leading to high mechanical properties even with lower viscosity
(compared to Ketac™ Molar Glass Ionomer Restorative)

3. W
 hy doesn’t Ketac Universal restorative need a conditioner?
Ketac Universal restorative has comparable adhesion values when used with or without a Ketac™ Conditioner.
Furthermore, adhesion tests performed in-house show that these adhesion values are statistically comparable
to the adhesion values of the clinically proven Ketac Molar Glass Ionomer Restorative with Ketac Conditioner.

4. Can I still use a conditioner? Does it have any negative effects?

Ketac Universal restorative is compatible with Ketac Conditioner. Using a conditioner does not lead to negative
effects; however, it does not significantly change the adhesion values.

5. Why doesn’t Ketac Universal restorative need a coating?

The special filler composition in combination with the co-polymeric acid used and the accelerated setting
performance lead to high compressive and flexural strength. In addition, the material exhibits high surface
hardness values even in early maturation stages (within 10 minutes after the start of setting), thus surface
hardness is high regardless of using a coating or not.

6. Can I use a coating? Does it have any effects?

Ketac Universal restorative is compatible with Ketac™ Glaze, Scotchbond™ Universal Adhesive and Single
Bond Universal Adhesive. Applying a coating will make the surface of the restoration glossier for the first hours,
nevertheless, the performance of the material will remain unchanged.

7. Do I need to light cure Ketac Universal restorative?

No, Ketac Universal restorative is a traditional glass ionomer restorative with a self-cure (acid-base)
mechanism, so light curing is not necessary.

8. What are the mixing and working times?

45 seconds of mixing time and 3 minutes of working time.

9. How long is the shelf life of the material?

36 months of shelf life.

*Refer to the Instructions for Use for more information.

18

Space for Your Notes

 19

Space for Your Notes

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