ketac™ universal

Ketac™ Universal Glass Ionomer Restorative

Technical Product Profile

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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

IntroductionKetac™ 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 DescriptionKetac 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.

*Refer to the Instructions for Use for more information.

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Product Features• Packaged in 12.5g powder vials and 8.5ml liquid

bottles – Vial and bottle are transparent with turquoise labels

• Six shades – A1, A2, A3, A3.5, A4 and White

• Long-term Class I and Class II with restrictions*

• No need for conditioner or coating

• Bulk fill—no need for layering

• Humidity tolerant

• Enables fast, one-step, stress-bearing restorative solutions

• Extended indications for use compared to other glass ionomer materials

• Continuously releases fluoride for over 24 months

• Low stickiness for an easy placement

• Self-adhesive

• Self-cure

• Radiopaque

BPA freeNone 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.

CompositionIngredients*

PowderOxide glass

LiquidWater

Copolymer of acrylic acid—maleic acid Tartaric acid

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

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*Refer to MSDS for more information

White A1 A2 A3 A3.5 A4

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

ProcedureSimplified Dental TreatmentGlass 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.

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Steps after cavity preparation*


GC Fuji IX GP® Radiopaque Posterior

Glass Ionomer Restorative Cement

only 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

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*Clinical steps according to manufacturer’s Instructions for Use

Fewer steps = a simple, faster procedure

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.

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.

0

Bond

Str

engt

h [M

Pa] 10

8

12

6

4

2

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

Bond strength to enamel and dentin of Ketac™ Universal Glass Ionomer Restorative

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

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.

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.

Physical PropertiesMechanical 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.

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 [MPa]

250 300200150100500

Ketac™ UniversalGlass Ionomer Restorative

riva self cureGlass Ionomer Restorative

GC Fuji IX GP® RadiopaquePosterior Glass Ionomer Restorative Cement

GC Gold Label Glass IonomerUniversal Restorative

GC Gold Label Glass IonomerHigh Strength Posterior Restorative

Ketac™ Molar EasymixGlass Ionomer Restorative

Ketac™ MolarGlass Ionomer Restorative

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

Source: 3M internal data

PropertiesKetac™ Universal

Glass Ionomer RestorativeKetac™ Molar

Glass Ionomer RestorativeCompressive strength 249 + 14 MPa 255 + 12 MPa

Flexural strength 51 + 7 MPa 49 + 5 MPaSurface hardness 679 + 152 MPa 536 + 89 MPaWear resistance 3-body wear 65 + 2 µm 79 + 3 µm

Compressive Strength

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).

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

Flexural StrengthFlexural 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.





GC Fuji IX GP® Radiopaque PosteriorGlass Ionomer Restorative Cement



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

70 80

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Three-Point Flexural Strength

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).








Surface Hardness [MPa]0 100 200 300 400 500 600 700 800 900

Surface HardnessSurface 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.

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

Surface Hardness

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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).

In vitro, 3-Body WearThe 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.

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








0 10 20 30 40 50 60 70 80 90

Wear µ [µm]

3-body wear abrasion

Fluoride ReleaseFluoride 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.

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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.

0

10

20Acc

umul

ated

Rel

ease

[ppm

]

Time [Months]

30

0 1 2 3 4 95 6 7 8

40

50


Ketac™ Molar Glass Ionomer Restorative

Ketac™ Molar Easymix Glass Ionomer Restorative60

70

80

10 11 12 13 14 15 16 17 18 19 20 21 22 23 24

Fluoride Release

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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 TolerancePowders 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.

-0.2

0

0.2

Wat

er u

ptak

e in

% in

rela

tion

to p

owde

r wei

ght

0.4

0.6

0.8

1.2

1.4

11 week2 weeks

3 weeks4 weeks

Ketac™ Universal Glass

Ionomer Restorative

Ketac™ Molar Easymix Glass

Ionomer Restorative

riva self cure Glass Ionomer

Restorative

GC Gold Label Glass Ionomer

Universal Restorative

GC Gold Label Glass Ionomer High Strength

Posterior Restorative

Ketac™ Molar Glass Ionomer

Restorative

No wateruptakein the first2 weeks

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

0%Not important No answerImportant

20%

40%

60%

80%

Very important

Somewhat important

Not important

Do not know/No answer

100%

Water Uptake

Humidity Tolerance

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.

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Resistance to StainingTo 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.

0

16

12

8

4

20

∆E


GC Fuji IX GP®

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.

Resistance to Staining Test

Compared to GC Fuji IX GP, Ketac™ Universal Glass Ionomer Restorative resists tea staining better.

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Clinical PerformanceApplication Test Results3,510 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.

0%Neutral DissatisfiedSatisfied

20%

40%

60%

80%Very satisfied

Satisfied

Neutral

Dissatisfied

Very dissatisfied

100%

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

0%Neutral DissatisfiedSatisfied

20%

40%

60%

80%Very satisfied

Satisfied

Neutral

Dissatisfied

Very dissatisfied

100%Ease of Placement

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

Overall Handling

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0%Neutral DifficultEasy

20%

40%

60%

80%

Adapts easily

Neutral

Is difficult toadaptIs very difficult to adapt

100%

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

Marginal Adaptation

0%Disagree No answerAgree

20%

40%

60%

80%Fully agree

Agree

Disagree

Totally disagree

No answer

100%Easy One-Step Bulk Placement

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

0%Disagree No answerAgree

20%

40%

60%

80%Fully agree

Agree

Disagree

Totally disagree

No answer

100%Time-Saving

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.

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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.

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

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

Questions and Answers1. What 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. Why 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.

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Space for Your Notes

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Space for Your Notes

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3M, ESPE, Ketac and Scotchbond are trademarks of 3M or 3M Deutschland GmbH. Used under license in Canada. © 3M 2016. All rights reserved. VITA is not a trademark of 3M. All other trademarks are not trademarks of 3M.

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Phone 1-800-634-2249Web 3M.com/dental

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Phone 1-800-328-3908Fax 1-800-328-3909Email [email protected] mmm.com/areaofexpertise

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ketac™ universal

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