Unicem Tp Ebu

8/18/2019 Unicem Tp Ebu

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RelyX™ Unicem Clicker™

RelyX™ Unicem Aplicap™/Maxicap™

RelyX UnicemTechnical Product Profile

TM


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Table of Contents1. Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3

2. Indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4

3. History of Dental Cements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4

4. Chemical Composition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5

4.1. New Monomers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5

4.2. New Fillers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6

4.3. New Initiator Systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6

5. Setting Reactions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6

6. Active Transformation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8

6.1. Hydrophilic – Hydrophobic . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8

6.2. Acidic – Neutral . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8

7. Mechanical Properties . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9

7.1. Linear Expansion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9

7.2. Mechanical Properties Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9

8. Clinical Application of RelyX™ Unicem Cement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10

9. Pretreatment of Restorative Materials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11

10. Official Ratings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11

11. Study Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12

11.1. Clinical in vivo Studies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13

Clinical Performance of Ceramic In- and Onlays after 3 years . . . . . . . . . . . . . . . . . . . . .13

Clinical Performance of Ceramic In- and Onlays after 1 year . . . . . . . . . . . . . . . . . . . . . .14

Clinical Performance of Composite, All-ceramic,

and PFM Restorations after 4 years . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15

Clinical Performance of Metal, Ceramic, and PFM Restorations after 2 years . . . . . . . .16

Clinical Performance of Endodontic Posts after 3 years . . . . . . . . . . . . . . . . . . . . . . . . . .17

Human Pulp Response to Resin Luting Cements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17

11.2. In vitro Studies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .18

Measuring Bond Strength . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .18

Shear Bond Strength of Different Classes of Luting Cements to Human Dentin . . . . . .22Shear Bond Strength to Human Dentin and Enamel and Lava™ Ceramic

Immediately and After 24 Hours . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .23

Tensile Bond Strength to Human Dentin and Enamel . . . . . . . . . . . . . . . . . . . . . . . . . . . .24

Shear Bond Strength to Human Dentin and Enamel after 24 hours and

Thermocycling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .25

Microtensile Bond Strength to Human Dentin and Enamel . . . . . . . . . . . . . . . . . . . . . . .26

Tensile Bond Strength to Human Dentin and Enamel . . . . . . . . . . . . . . . . . . . . . . . . . . . .27

Immediate Shear Bond Strength to Bovine Dentin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .28

Tensile Bond Strength to Bovine Dentin and Enamel . . . . . . . . . . . . . . . . . . . . . . . . . . . .29

Retentive Bond Strength of Lava™ Zirconia Crowns on Human Dentin . . . . . . . . . . . . .30

Shear Bond Strength to Zirconia Ceramic . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .31Shear Bond Strength to Lava™ Zirconia Ceramic and Glass Ceramic . . . . . . . . . . . . . . .32

Shear Bond Strength to Alumina Ceramic . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .33

Retention Strength of Fiber Posts Cemented with two Different Cements . . . . . . . . . . . .34

Shear Bond Strength to Fiber Post . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .35


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Table of ContentsMarginal Sealing in Fiber Post Treated Teeth . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .36

Marginal Adaptation of Ceramic Inlays . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .37

Interfacial Adaptation of Partial Ceramic Crowns . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .38

pH Profile of Various Luting Cements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .39

Shear Bond Strength to Core Build-Up Materials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .40

Shear Bond Strength to CAD/CAM Glass Ceramics . . . . . . . . . . . . . . . . . . . . . . . . . . . . .41Shear Bond Strength to Metal, Composite, and Ceramic Restorative Materials . . . . . . .45

12. RelyX™ Unicem Field Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .46

13. Excerpt from the Instructions For Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .47

14. Technique Guides . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .49

14.1. RelyX™ Unicem Aplicap™ / Maxicap™ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .49

14.2. Technique Guide RelyX™ Unicem Clicker™ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .50

14.3. Technique Guide RelyX™ Fiber Post / RelyX™ Unicem Aplicap™ . . . . . . . . . . . . . . . . . . .51

15. Frequently Asked Questions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .52

16. Literature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .55

17. Product Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .56


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1. IntroductionRelyX™ Unicem cement is a dual-curing, self-adhesive universal resin cement for adhesive

cementation of indirect ceramic, composite or metal restorations. When using RelyX Unicem

cement, bonding and conditioning of the tooth are no longer necessary. The cement is charac-

terized by a higher moisture tolerance, as compared to multi-step composite cements. RelyX

Unicem cement releases fluoride ions and is available in various shades. Among others, its

essential characteristics are high dimensional stability and very good adhesion to the toothstructure.

RelyX Unicem cement is available in 3M™ ESPE™ Aplicap™ and Maxicap™ capsules and the

Clicker™ Dispenser.

Aplicap™ Capsules

Ideally suited for inlays,onlays, crowns and posts

Hygienic unidose (295 mgper capsule)

Consistent mix with triturator

RelyX™ Unicem Aplica p™

Elong a tion Tip ava ilable forvirtually vo id-free cementa tionof posts

Available shades: A1, A2Universal, A3 Opaque,White Opaq ue a nd Trans lucent

RelyX™ Unicem - Delivery choices

Maxicap™ Capsules

Ideally suited for multiple-unit b ridg es

Hygienic unidose (936 mgper capsule)

Consistent mix with triturator

Longer working time (2:30 min)

Availab le s had es:A2 Universal, A3 Opaqueand Trans lucent

Clicker™ Dispenser

Suited for all sizes ofrestorations

Choose a mount dispensed;11 g dispensable in 80 clicks(approx. 40 applications)

Delivers premeasured dosesfor consistent ratio of pastes;eas y, eco nomical mixing

No need for mixer, activator,appliers, mixing tips or otherdevices

Availab le s had es:A2 Universal, A3 Opaqueand Trans lucent

RelyX™ Unicem - Benefits

• Eliminates the need for etching, p riming a nd b onding ste ps

• Strong, a dhes ive, es thetic a nd mo isture-tolerant

• Easy to use for virtually all indications (except veneers and Maryland bridges)

• Low risk of postoperative sensitivities

• Clinically proven with years of scientific data and independent university studies available

• Releases fluoride over a long period of time


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2. IndicationsRelyX™ Unicem Self-Adhesive Universal Resin Cement is indicated for the permanent cemen-

tation of inlays, onlays, crowns, bridges, posts, and screws made of ceramics, composite or

metals.

3. History of Dental Cements Today’s dental cements can be traced back to the 19th century. As early as 1856, Sorel was put-ting together formulations for magnesium chloride cement. The continuous search for better

materials led to numerous developments over the years.

According to their chemical composition, today’s commonly used dental cements are classified

into the following groups:

•Zinc phosphate cements

•Polycarboxylate cements

•Glass ionomer cements

•Resin-modified glass ionomer cements•Compomer cements

•Adhesive resin cements

•Self-adhesive resin cements

While conventional cements offer easy handling, adhesive resin cements (also referred to as

composite resin cements) are highly versatile and provide strong adhesion and high esthetics

which is especially important for the cementation of state-of-the-art all-ceramic restorations.

However, this comes at the expense of easy and fast application. Various pretreatment steps

(etching, priming, bonding) and the absolute exclusion of moisture (rubber dam) are necessary

to successfully use adhesive cements. Therefore, adhesive cementation is much more technique

sensitive than conventional cementation and the clinical success may be compromised by thetechnical challenges it imposes on the dentist.

These drawbacks were resolved with the introduction of the first self-adhesive universal resin

cement RelyX Unicem in 2002.

Table 1: Strength and weak-

nesses of commonly used dentalcements.

Conventional cements

Hybrid cements}

}

} Composite resin cements

General overview of cement classes. Specific products may exhibit deviating characteristics.1

Ratings here refer to RelyX Unicem cement. Some other so-called self-adhesive cements may not exhibit the same characteristics.2 For some products a conditioning step is recommended.3 Some products belonging to this class may include a self-etch primer / bonding system.4 Not all resin cements are recommended for dark cure only.5 Not applicable / not recommended.

Bond strength

Typica l pretreatmentsteps

Metal

Composite

Indications Glass-ceramic

High strength

ceramics

Low solubility (insoluble)

Mechanical properties

Esthetics

Zinc

phosphate

cements

★

–

★★★

n. a.5

n. a.

n. a.

★

★

★

Cement classes

Properties

Polycar-

boxylate

cements

★

–

★★★

n. a.

n. a.

n. a.

★

★

★

Glass

ionomer

cements

★★

–

2

★★★

n. a.

n. a.

★★

★

★★

★

Resin-modified

glass ionomer

cements

★★

–

★★★

n. a.

n. a.

★★

★★

★★

★

Adhesive resin

cements

★★★

etching

3

,priming, bonding

★4

★★★

★★★

★★★

★★★

★★★

★★★

Self-adhesive

universal resin

cements1

★★★

–

★★★

★★★

★★★

★★★

★★★

★★★

★★★

Compomer

cements

★★

conditioning

★★

★

n. a.

★

★★

★★

★★


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4. Chemical CompositionRelyX™ Unicem cement is available in two formulations: as a powder / liquid system in the

3M ESPE Aplicap™ and Maxicap™ Capsules, as a paste / paste system in the 3M ESPE

Clicker™ Dispenser. The qualitative composition of both formulations is shown in Table 2.

The ideal combination of easy handling known from conventional cements plus a bond strength

comparable to that of adhesive resin systems demanded developing new monomers, new fillers,

and new initiators.

Fig. 1: RelyX™ Unicem cementcombines glass ionomer, adhe-sive and composite technology.

Table 2: Chemical composition ofRelyX™ Unicem cement in thecapsule and the Clicker version.

Bond strength value see chapter 11.2(p. 22)

•alkaline (basic) fillers•silanated fillers

•phosphoric acid modified methacrylate monomers•methacrylate monomers

•initiators

RelyX™ UnicemSelf-Adhesive Universal Resin Cement

Glass ionomertechnology

Adhesivetechnology

Composite cementtechnology

Powder

Alkaline (ba sic) fillers

S ilana ted fillers

Initiator components

Pigments

Base paste (white)

Methacrylate monomers c onta ining phos phoricacid groups

Methacrylate monomers

S ilana ted fillers


Stabilizers

Liquid

Methacrylate monomers c ontaining phos phoricacid groups



Stabilizers

Catalyst paste (yellow)


Alkaline (ba sic) fillers

Silana ted fillers


Stabilizers

Pigments


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4.1. New Monomers

Dental cements have to excel in the following areas: adhesion, mechanical properties, long-

term stability, esthetics and biocompatibility. In order to provide RelyX™ Unicem cement with

optimal properties and self-adhesion, the adhesive monomers were optimized. Several phos-

phoric acid groups and carbon double bonds per molecule are characteristic for the acidic

methacrylate monomers in RelyX Unicem cement. Whereas the phosphoric acid groups con-

tribute to self-adhesion, the carbon double bonds bring about a high reactivity of the methacry-

late monomers with each other. Thus after setting of RelyX Unicem cement, the resin matrix

shows a high degree of cross-linking between the particular mono-mers. In this way good

mechanical properties (e.g. high compressive and flexural strength) and adhesive bonding with-

out pretreatment of the tooth structure can be achieved. Furthermore, a high degree of cross-

linking is one essential requirement for the long-term stability of the cement which is met by

RelyX Unicem.

4.2. New Fillers

Fillers have also an important impact on the cement’s properties. One part of the fillers in

RelyX Unicem cement is silanated and, thus, is chemically embedded into the cement matrixduring setting. Another part is alkaline (basic) and thereby able to react with the phosphoric

acid groups of the methacrylate monomers in a neutralization reaction. Therefore, during set-

ting the pH-value increases and lifts the initially acidic RelyX Unicem cement paste to a neutral

level. This avoids hydrolysis processes in the cement in the long run and is therefore another

important prerequisite for the long-term stability of any initially acidic cement. Additionally,

during the neutralization reaction fluoride ions are released from the fillers. RelyX Unicem

cement provides these ions to the tooth structure without containing soluble fluoride salts in the

cement matrix. The amount of inorganic fillers contained in RelyX Unicem cement approxi-

mates 70 percent by weight and 50% by volume with the grain particle size (d[90]=90% of the

fillers) being


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Acidic methacrylate

monomers containphosphor-

ic acid groupsandreactive

carbon double bondswhich

are connected with each other

via a carbon backbone.

The main components of

RelyX™ Unicem cement are:

•Methacrylate monomers,

partially containing phos-

phoric acid groups

•Fillers, one part releasing

ions, another part is silanated

•Chemical initiator system

•Light initiator system

1

4

2

5

3

6

The remaining phosphoric

acid groups of the methacry-

late monomers areneutral-

izedby ions, which are

released from thefillersdur-

ing the setting reactions.

After mixing, RelyX™ Unicem

cement is very acidic (low

pH-value) andhydrophilic

(water binding). Upon contact

with thetooth surfacethe

negatively charged phosphoric

acid groups of the methacry-

late monomers bond toCa2+-

ionsin the tooth structure.

Thus, the phosphoric acid

groups areneutralized(i.e.

pH rises) and anchored at the

tooth surface.

Next to the restoration materi-

al enamel and dentin are the

substrates to which dental

cement has to show safe and

reliable adhesion. The tooth

substance (enamel and dentin)

consists of inorganicapatite-

crystalscontaining calcium

and organic collagen fibers.

Additionally, the tooth struc-ture containswater.

The released fluoride ions are

absorbed by the tooth struc-

ture.

Methacrylate-monomers

Initiators

Fillerscontaining

Calcium-Ions

Alumina-Ions

Strontium-Ions

Fluoride-Ions

Calcium-Ionson tooth substance(apatite)

Reactive carbondouble bond

Phosphoric acidgroup

Carbon-

backbone

The methacrylate monomers

are chemically cross-linked

with each other through the

interaction of reactive carbon

double bonds.

Simultaneously, setting of the

cement takes place through

theradical polymerization

reactionof the methacrylate

monomers.

The initiator system generates

the necessary starter radicals

throughlight-induced or

chemical activation.

The methacrylate monomers

and fillers are firmly linked

and permanently embedded in

the three-dimensional network

of the cement matrix.

RelyX™ Unicem cement is

curedby the radical polymer-

ization reaction. Thus, succes-

sively a highly cross-linked

three-dimensional network

is formed consisting of

methacrylate molecules and

fillers. During this process the

cement matrix changes froman initially hydrophilic to a

hydrophobiccondition.

7 8

109

Fig. 2: Simplified depiction of the setting reactions of RelyX™ Unicem cement.


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6. Active Transformation

6.1. Hydrophilic – Hydrophobic

Immediately after mixing RelyX™ Unicem, the cement paste is very acidic and has hydrophilic

properties. Therefore it shows a higher moisture tolerance than multi-step composite cements.

This together with the good adaptation to the hydrophilic tooth surface is the immediate advan-tage for the dentist during the very first steps of the clinical cementation procedure. The result-

ing high bond strength is one prerequisite for a long-lasting success of the restoration. During

setting of RelyX Unicem cement a strongly cross-linked cement matrix with hydrophobic pro-

perties develops through the proceeding radical polymerization and the subordinate neutraliza-

tion reactions. A low linear expansion and low solubility are the results and lead to the clinical-

ly proven, long-term stability which plays a central role especially for all-ceramic restorations.

Thus, RelyX Unicem cement automatically changes its properties from hydrophilic to

hydrophobic during setting.

6.2. Acidic – Neutral

Parallel to the change from a hydrophilic to a hydrophobic state the pH-value increases during

the setting of RelyX Unicem cement. Immediately after mixing RelyX Unicem, the cement

paste is very acidic. Within a few minutes the pH-value starts to increase and within 24 hours

reaches a neutral level. After application to the tooth, the low pH-value of RelyX Unicem

cement is pivotal for the self-adhesive mechanism, whereas the pH increase as well as the

hydrophobic condition are essential prerequisites for the long-term hydrolytic stability of thecement.

p h

alkaline

acidic

time after mixing [days]

RelyX™ Unicem Aplicap™


0

1

2

3

4

5

6

7

8

9

10

11

12

13

14

0 1 2 3 4 5 1 6 30

time after mixing [hours]

HydrophilicGood adaptation tothe tooth surfacemoisture tolerance

Low expansionLow solubilityHigh long-term stability

Hydrophobic

Polymerization andneutralization reactions

Hydrophilic: water binding

Hydrophobic: water repelling

Fig. 3: RelyX™ Unicem cementchanges its properties fromhydrophilic to hydrophobicduring setting.

Fig. 4: pH-profile of RelyX™

Unicem cement (3M ESPEinternal lab data, 2007).


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7. Mechanical Properties

7.1. Linear Expansion

Dimensional stability of a cement is an important consideration especially when cementing all-

ceramic restorations. In order to simulate the worst case scenario specimens of the cement to be

tested are immersed in water over months or years. In this way the counteracting effect of even-tual initial polymerization shrinkage can be ruled out. RelyX™ Unicem cement both in the

Aplicap™ and in the Clicker™ Dispenser show comparable and low expansion values that prove

it to be safe for the cementation of all-ceramic restorations.

7.2. Mechanical Properties Overview

[ % ]

0,0

0,2

0,4

0,6

0,8

1,0

1,2

1,4

1,6

0 6 12 18 24 30 36 42 48 54

time [months]



LIGHT / SELF cure

Fig. 5: Linear expansion ofRelyX™ Unicem cement(3M ESPE internal lab data, 2007).

Table 3: Mechanical propertiesof RelyX™ Unicem cement.

Flexural strength [MPa]

Compressive strength [MPa]

Modulus of elas ticity [GP a]

Surface hardness [MPa]

Ra diopa city [mm Al]

Film thickness [µm]

Water sorption [µg/mm 3]

S olubility [µg/mm 3]

RelyX™ Unicem

Aplicap™ – Maxicap™

(S ELF – LIG HTc ure)

48 /75

188 /236

4.9 /8.4

202 /280

2.43

18 /-

39 /25

15 /-3

RelyX™ Unicem

Clicker™

(SELF – LIGHTcure)

60 /71

216 /244

3.9 /6.3

195 /220

1.79

17 /-

42 /25

12 /1

Delivery versions

Properties


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8. Clinical Application of RelyX™

Unicem CementAs discussed earlier, adhesive cementation poses a recurring technical challenge for dentists

and dental assistants. In comparison to RelyX Unicem cement, a composite cement with an

adhesive bonding system requires many more steps to securely bond a restoration to the tooth

structure.

Typical total-etchresin cement system

Cementing Steps

Initial s ituation:P rovisional restorationremoved and preparedtooth cleaned.

Thoroug hly rinse withwater.

Etch with a phosphoricacid etching gel.

Lightly dry with oil-free andanhyd rous air or blot dryexcess water. Do not overdry.

Apply primer with a dis-posable applicator and rubin thoroug hly.

Dry primer in a light air stream.Avoid direct b lowing, a s exc essmay coagulate.

Apply adhesive with adisposable applicatorand rub in thoroughly.

Light c ure a dhes ive ifindicated.

Mix cement and apply to theprepared restoration and /orthe prepared tooth. (Direct apli-cation with Applicap™ or Maxica p™

Capsule system possible)

Lightly thin or air dry adhesi-ve evenly with an a ir stream.Avoid coa gulation of theadhesive.

Place the restoration.

Remove excess.

Light c ure or a llow to s elf

cure.

Final situation:Adhes ively ceme ntedceramic crown.

Not Applica ble

Not Applica ble

Not Applica ble

Not Applica ble

Not Applica ble

Not Applica ble

Not Applica ble

Not Applica ble

Cementation withRelyX™ Unicem Cement


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9. Pretreatment of RestorativeMaterials

To assure optimal bond strength to the restoration 3M ESPE recommends the following proce-

dures for the cementation with RelyX™ Unicem cement as long as not stated differently by the

manufacturer of the restorative material.

Please refer to the instructions for use supplied with each package of RelyX Unicem cementbefore usage.

*While these pretreatment steps are essential for many composite resin cements, RelyX™ Unicem cement exhibits sufficient bond

strength also with the more simple alternative 1 (see study results, page 27 fig. 29).

10. Official RatingsSince its market introduction in 2002 RelyX Unicem cement continually received high ratings

from several independent research institutes. Listed is a selection of the more recent awards:

RelyX Unicem Self-Adhesive Universal Resin Cement was selected “Most Innovative NewProduct of the Year” for 2004 byREALITY .

RelyX Unicem Self-Adhesive Universal Resin Cement was rated 4-STARS byREALITY

since its first evaluation in 2003

(Reality Now, Vol. 17, No. 153, June 2003)

4-year Clinical Performance

4,000 indirect restorations of different types were cemented with RelyX Unicem cement and

evaluated after 4 years in service. THE DENTAL ADVISOR reconfirmed its top rating of 5+,which were already awarded for the 1-, 2- and 3-year recall. It reports on outstanding results in

all evaluated categories: handling, sensitivity, microleakage and retention.

(THE DENTAL ADVISOR, Vol. 24, No. 4, May 2007)

Bond strength value see page 22

Restorative material type

Metal (precious and non-precious)

Etchable G las s Ceramics(e.g. ParadigmTM C, 3M ESPE;Vitablocs® Mark II, Vident;Authentic® , Microsta r® ;IPS-Empress® , Ivoc la r Vivadent;ProCAD® , Ivocla r Vivadent)

Non-etchable Zirconia and Alumina

Ceramics(e. g. Lava TM, 3M ESPE;Cercon® , Dentsply; Procera ® AllCeram,Nobel Biocare)

Composite(e. g. ParadigmTM MZ100, 3M ESPE;Artglass, Heraeus Kulzer;belleGlassTM NG, Kerr)

RelyXTM Fiber Post (3M ESPE)

Other glass fiber reinforced pos ts

Pretreatment

Sandblast with aluminum oxide 40 µmClean with alcohol

Etch with hydrofluoric acidSilanate (e. g. RelyXTM Ceramic Primer, 3M ESPE)

Alternative 1:

Sandblast with aluminum oxide 40µmClean with alcoholAlternative 2:*Coa t (silica te) (e. g . C oJ etTM Prep and CoJ etTM Sand,3M ESPE)Silanate (e. g. RelyXTM Ceramic Primer, 3M ESPE)

Sandblast with aluminum oxide 40µmClean with alcohol

No pretrea tment neces sa ry if cemented with RelyX Unicemcement

Clean with alcoholSilanate


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14

11. Study ResultsAlong with the dentist's technical expertise and the restorative material's properties, the per-

formance of the cement contributes significantly to the clinical success of indirect restorations.

The following properties are especially important for a universal cement, which is indicated for

cementation of metal, composite and ceramic restorations:

•High adhesion to the tooth structure and restorative materials•High marginal quality

•Very good mechanical properties

•Low risk of postoperative sensitivities

•Very good long-term stability

Since the market introduction of RelyX™ Unicem cement in 2002 more than 80 studies have

been carried out internationally, which investigate these and other properties. The most impor-

tant results are presented and discussed in the following chapter. It provides an overview on

clinical as well as in vitro studies.

11.1. Clinical in vivo Studies

Although in vitro tests are helpful in comparing and assessing a material’s properties, the final

proof for a dental material’s performance is clinical trials. The following pages provide an

overview of the clinical performance of RelyX Unicem cement.

Clinical Performance of Ceramic In- and Onlaysafter 3 Years

Study design and results:

Posterior class I and II restorations in 30 patients were restored with ceramic in- and onlays

(Authentic®, Microstar) using either RelyX™ Unicem Self-Adhesive Universal Resin Cement

(Aplicap™) or the multi-step bonding system Syntac®Classic and Variolink® II incl. the multi-

step bonding system Syntac Classic (both Ivoclar Vivadent). Cementation was done according

to the cement manufacturers’ instructions for use. For the 3-year recall, 50 restored teeth were

evaluated following the modified Ryge criteria for clinical evaluations (see table 5).

Marginal adaptation Color match Marginal

discoloration

Surface roughness Absence of caries

0

20

40

[ % ] 60

80

100

Variolink II ®

alpha scores

delta scores

RelyX™ Unicem alpha scores bravo scores

bravo scores

RelyX™ Unicem Collection of ScientificResults

Clinical Outcomes of Ceramic Inlays /Onlays Luted With Two BondingSystems.Denehy G., Stanford C., Cobb D.,Vargas M. et al. 2007University of Iowa, USA

unpublished study

Fig. 6: Clinical performance after3 years of ceramic in- and onlaysseated with RelyX™ Unicem ce-ment (Aplicap™ ) and Variolink ® II.


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15

Conclusions:

The authors of the study state: "The three year outcomes of this study suggest that there is

equivalent clinical performance of the self etching RelyX™ Unicem system relative to the com-

parison group. These clinical efficacy outcomes are important since the RelyX Unicem cement

system uses a simplified clinical set of procedures while providing equivalent outcomes to the

more complex, multi-step set of clinical procedures used in the Variolink® II group."

Clinical Performance of Ceramic In- and Onlaysafter 1 Year


IPS-Empress®(Ivoclar Vivadent) restorations (70 Class 2 inlays, 13 onlays / 47 premolars,

36 molars) were placed in 30 patients in a split mouth design. 43 inlays/onlays were seated with

RelyX Unicem cement (Maxicap™). The multi-step adhesive Syntac®Classic and Variolink II

low (both Ivoclar Vivadent) served as a control (n=40). The inlays were pretreated according to

the cement manufacturers’ instructions for use (HF-etching and silanating). Additionally, in the

Variolink group Heliobond

™

(Ivoclar Vivadent) was applied to the restorations. After one yearthe restorations were evaluated using modified Ryge criteria.

0

20

40

[ % ]

60

80

100

Marginal integrity Integrity of tooth Surface roughness Proximal contact

Variolink II ®

alpha 1 scores alpha 2 scores bravo scoresRelyX™ Unicem

alpha 1 scores alpha 2 scores bravo scores

Table 5: Modified Ryge criteriafor the clinical evaluation of in-and onlay restorations

Ceramic Inlays Luted with a Self-Adhesive Cement After one YearTaschner M., Frankenberger R.,Petschelt A., Krämer N.University of Erlangen, GermanyPublished at the AADR 200 6abstract #13 61

Fig. 7: Clinical performance ofceramic in- / onlays seatedwith RelyX™ Unicem cement(Maxicap™ ) and Variolink ® IIlow after 1 year.

Criteria

Marginal adaptation

Color match

Marginal discoloration

Surface roughness

Absence of caries

Alpha scores

Explorer does not catch

Good match in color,

shad e, and translucency

No disco loration evident a t

margin

Smooth s urface

Alpha scoresNo caries

Bravo scores

Explorer ca tches

Slight mismatch in color,

shade, and translucency

Slight s taining at margin

Slightly rough or pitted

Delta scoresCaries evident at the

margins of the restoration


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16

Criteria

Marginal integrity

Integrity of tooth

Proximal contact

Surface roughness

Alpha 1 scores

Margin matchesrestoration andtooth perfectly inshape and color

Complete integrity

Physiologicalcontact

Smooth andpolished surface

Alpha 2 scores

Margin does notmatc h perfectly butcan be polishedwithout causingdamage to do so

Minor enamel crackor ha ir-line s plit

Contact is too weakor too strong

S lightly roug hsurface; can bepolished

Bravo scores

Marginal ga p w ithno negative long-term co nsequences

Clear enamel crackwith no nega tivelong-term conse -quences

Contac t is far toowea k; but no indi-cation of tissuedamage

Rough surface; ca nnot be polishedwithout ca usingdamage

Table 6: Modified Ryge criteria forthe clinical evaluation of in- andonlay restorations

Conclusions:

After one year RelyX™ Unicem cement (Maxicap™) performed similar to the control.

Furthermore, this study highlights the lack of hypersensitivities both in the control group aswell as with RelyX Unicem cement.

Clinical Performance of Composite, All ceramic, andPFM Restorations after 4 Years


Over 4,400 restorations have been cemented with RelyX Unicem cement (Aplicap™/Maxicap™)

between 2003 and 2006 by the evaluators of THE DENTAL ADVISOR. The distribution of

indications and materials was as shown in the chart below. 1,560 restorations were available for

recall and 230 of these have been cemented for 4 years.

Conclusions:

According to THE DENTAL ADVISOR “RelyX Unicem cement has proven to be an excellent

and reliable self-adhesive resin cement in the four years since its introduction”.

Overall, RelyX Unicem cement showed 98% positive clinical performance and received

5 plus – the highest rating by THE DENTAL ADVISOR.

0% 20% 40% 60% 80% 100%

Microleakage

(based on 1,560 restorations)

no microleakage

95,8%

microleakage

4,2%

Post-Operative Sensitivity


post-operative

sensitivity 1,6%

no post-operative

sensitivity 98,2%

Debonding


debondingno debonding

99,3% 0,7%

PFM

crowns/bridges

all-ceramic

crowns/bridges

all-ceramic

in-/onlays

posts

3M ™ ESPE™ RelyX™ Unicem Self-Adhesive Universal Resin Cement4-year Clinical PerformanceTHE DENTAL ADVISOR, Vol. 4, No. 4,May 2007

Fig. 8: Indications and restora-tive material types cementedwith RelyX™ Unicem cement(Aplicap™ ).

Fig. 9: Clinical performance ofrestorations cemented withRelyX™ Unicem cement (Aplicap™ )after 4 years.


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17

Clinical Performance of Metal, Ceramic and PFMRestorations after 2 Years


90 restorations (mean age 21-months) in 82 patients have been seated by general dental practi-

tioners and were available for recall. Four restorations were reported to have failed for reasons

(root fracture, porcelain fracture, and unrelated enamel chipping), deemed by the operator,

unconnected with the use of RelyX™ Unicem cement (Aplicap™).

Conclusions:

Over a mean 21-month observation time the RelyX Unicem self-adhesive universal resin

cement (Aplicap) was rated to perform well and no cement-related failures were observed.

[%]

0 20 40 60 80 100

No discoloration

Marginal staining

present

Slight staining present,

can be polished away

Obvious staining,

cannot be polished away

Gross staining‡ *

* none detected‡ clinically unacceptable

[%]

Marginal adaptation0 20 40 60 80 100

Explorer does not

catch

Explorer catches, no

crevice visible

Crevice at margin,

enamel margin exposed‡

Obvious crevice at

margin, dentine or lute

exposed‡

* none detected‡ clinically unacceptable

*

0% 20% 40% 60% 80% 100%

all-metal PFM fiber post all-ceramic

Two-year Performance of RestorationsPlaced with a Self-Adhesive LutingMaterialCrisp R.J., Burke F.J.T., University ofBirmingham, UKPublished at the IADR 200 6, abstract#2098

Fig. 10: Types of restorativematerials used for restorationsseated with RelyX™ Unicemcement (Aplicap™ ).

Fig. 11: Marginal adaptation ofvarious restorations 2 years aftercementation with RelyX™ Unicemcement (Aplicap™ ).

Fig. 12: Marginal staining of variousrestorations 2 years after cementa-

tion with RelyX™ Unicem cement(Aplicap™ ).


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Clinical Performance of Endodontic Posts after 3 Years


45 patients were treated using a titanium post (Fiberpoints Root Pins Titanium) and 46 patients

received a glass fiber post (Fiberpoints Root Pins Glass, both Schuetz Dental Group). All posts

had a diameter of 1.4mm and a length of 13mm and were cemented with RelyX™ Unicem

cement (Aplicap™). All teeth received a core build-up. Patients were observed in regular inter-

vals after post placement.

Conclusions:

After 1 to 3 years of clinical service all the restorations were still in place and no difference was

observed between the two post materials tested. Therefore, RelyX Unicem cement (Aplicap) is

very well suited for any kind of post cementation.

Human Pulp Response to Resin Luting Cements


Deep Class V cavities were prepared on the buccal surface of 34 sound human premolars.Inlays were fabricated and cemented with either RelyX Unicem cement (Aplicap) or

Variolink® II / Excite®DSC (Ivoclar Vivadent). 60 days after cementation the teeth were

extracted and processed for histological assessment. In both control groups (group 1: cavity

was lined with Dycal®, Dentsply Caulk prior to cementation with RelyX Unicem cement;

group 2: teeth were left untreated), normal histological characteristics were observed.

Conclusions:

Teeth that had received an inlay cemented with the one-step RelyX Unicem cement showed a

lower inflammatory cell response than teeth treated with a multi-step resin cement.

11.2. In vitro Studies

Measuring Bond Strength

The following chapter provides an overview on in vitro studies mainly measuring bond strengthvalues to tooth structure or various restorative materials.

Although the output of most measurements is given in MPa (i.e. mega Pascal; Pascal is a meas-

ure for pressure equaling Newton (N) per m2) absolute numbers resulting from different studies

cannot simply be compared for severeal reasons. First and foremost, bond strength can be

FRC vs. Titanium Posts-PreliminaryResults of a RCTNaumann M .1, Sterzenbach G.2,Blankenstein F.2,Lange K.-P.21Humboldt-University Berlin, Charite -University Medicine, Germany2Humboldt-University Berlin, Germany;Published at the IADR 2006 , abstract#0077

Human Pulp Response to ResinCements Used to Bond InlayRestorationsCosta C.A. de S.1, Hebling J.2,Randall R.C.2

1University Sao Paulo State-UNESP,Sao Paulo, Brasilia23M ESPE, St. Paul, USAJournal of Dental Materials, No. 22,2006, 954–962

Fig. 13: Inflammatory cellresponse in the pulp area 60 daysafter cementation of an inlay(teeth per group = 6).

[ % ]

0

20

40

60

80

100

none slight moderate severe


Variolink II

* none detected

* *

®


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19

determined using methodologies that differ in their experimental set-up. Second, even if the

same set-up is used, experimenters can come to differing results due to the influence of a num-

ber of factors such as:

• teeth from different species and / or different individuals

• way of securing the teeth for preparation and testing

• kind of surface preparation (grit of sandpaper)

• geometry of the substrate and the sample

• differences in the handling between operators

• cross-head speed of the testing machine

Therefore, absolute numbers should only be compared if retrieved in the same experiment. In

general, this calls for study designs where a broad range of products is investigated side by side

under the same conditions.

To determine the bond strength of a cement at different points of time after seating of the

restoration test samples can be subjected to different treatments. To examine immediate bond

strength, the cement is cured and the samples are tested. Simulation of long-term clinical per-

formance and aging can include one or a combination of the following treatments:

• water storage over an extended period of time

•

thermocycling• mechanical loading.

The principle of a number of test methods is described briefly in the following. Only the very

basics of the particular method are given here and numerous modifications exist according to

requirements of the aim of the study and the operator.

Shear Bond Strength

In the studies cited here, the shear bond strength has been determined using two different

experimental set-ups. One set-up uses a wedge-like instrument (fig. 14) to shear off the lutedcomposite sample. The other method uses a wire loop (fig. 15). In both cases the shear force

is applied parallel to the sample surface.

• Extracted teeth are embeddedinto resin or impression material.

• Teeth a re cut w ith sa ws and /orground with sandpaper to obtaina flat surface in either dentin orenamel.

• The too th structure is preparedfollowing the Instructions for Usegiven by the ma nufac turer of theparticular cement to be tested.

• Alternatively, bo nd streng th toresto rative ma terials (e. g . meta ls,

ceramics, composite) can bedetermined if the tooth isreplaced by a specimen of thematerial under investigation.

• A button like spec imen (e. g .mad e from compo site) with adefined bonding surface area iscemented to the tooth surface.In a n a lternative s et-up thebutton–like s pec imen itself ismade o f the cement to be test-ed. To this end a cylindrica l orbutton-like mold is placed ontothe too th surface and filled withthe cement.

• Sa mples ma y be stored for dif-

ferent lengths o f time and /orthermocycled according to thedes ign o f the experiment tosimulate ag ing.

• For determining the shea rbond strength of the cementthe test sample is mountedinto a universal testingmachine.

• If a w edg e-like instrument isused the force needed to shearoff the composite specimen ata given speed is recorded andthe corresponding bondstrength (pressure) is calcu-lated.

Fig. 14: Simplified depiction of aset-up to determine the shearbond strength using a wedge

shaped instrument. The cementis shown as red line.


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The force need ed to b reak offthe composite specimen isrecorded accordingly if a wireloop is used.

see above see above

Fig. 15: Simplified depiction of aset-up to determine the shearbond strength using a wire loop.

Fig. 17: Simplified depiction ofa set-up to determine the tensilebond strength on root canalposts.

Fig. 16: Simplified depiction of aset-up to determine the tensilebond strength.

Tensile Bond Strength

For tensile testing samples are prepared as described above for determining shear bond

strength. In this test, however, specimens are pulled off with the force applied perpendicular to

the sample surface.

The tensile bond strength test method can be modified to determine the bond strength of

cements to root canal posts.

The force need ed to pull offthe composite specimen isrecorded and the correspon-ding bo nd s trength (press ure)calculated.

A plastic carrier is slipped ontothe conical end of the post. Eachsa mple shows the same length ofthe post tip.

A standardized mold on theplas tic c arrier is used to a pplythe same a mount of cement toeach of the sa mples.

After curing, the cement disc ispulled off in a universal testingmachine.

see above see above


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Fig. 18: Simplified depiction of aset-up to determine the m icroten-sile bond strength.

Fig. 19: Simplified depiction of aset-up to determine retentivebond strength using full crowns.

The cement is shown as red line /surface.

Microtensile Bond Strength

Retentive Bond Strength of Full Crowns

This test is a variation of the tensile bond strength test.

Retentive Bond Strength of Fiber Posts

Similar to a full crown test, the retention of a root canal post can be simulated. After extraction,

teeth are endodontically treated and the root canal is filled with guttapercha. In the second

preparation step the guttapercha filling is removed and a post is cemented into the root canal in

a standardized way. The force needed to extract the post from the tooth is recorded.

• Extracted (human) teeth are pre-pared for full crow ns in a sta n-da rdized m anner. The root a reaof the teeth is embedded into aresin block for mounting into auniversal testing machine.

• Crowns with external reten-tions a re fabrica ted a nd ce-mented using the cements tobe tested.

• The force necess ary to pull offeach crown is measured. Afterdetermining the retention sur-face of ea ch individual tooththe retentive bond strength iscalculated.

• The too th is cut to either show enamel or dentin surfac e. A com-posite block is then cemented tothe exposed tooth surface usingthe cement to be tested.

• After setting recta ngular b ea msare cut out with a diamondsaw.

• Each beam is mounted into auniversal testing ma chine a ndbond strength is d etermined.


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Shear Bond Strength of Different Classes of Cementsto Human Dentin


The dentin of extracted human molars was prepared by grinding with sandpaper (600 grit).

Each cement system was used according to the manufacturer’s instructions for use. One half of

the samples was tested at 30 minutes the other half after 14 days of water storage and subse-

quent thermocycling (1,000 x 5/55°C) (experimental set-up see chapter 11.2.).

Conclusions:

The one-step RelyX™ Unicem Self-Adhesive Universal Resin Cement (Aplicap™) shows

comparable results as the multi-step adhesive bonding system Panavia™ F. This is true for both

curing modes and for bond strength values measured 30 min after cementation and after

simulated aging.

Shear Bond Strength to Human Dentin and Enamel andLava™ Ceramic Immediately and after 24 Hours


Polished surfaces (1,000 grit) of human dentin, enamel and Lava zirconia ceramic samples

were prepared. The Lava surface was sandblasted (50µm Al2O3). Composite inlays (Filtek™

Z250, 3M ESPE) were fabricated and luted to the substrate samples using the three resin

cements (RelyX Unicem cement (Aplicap), 3M ESPE; Maxcem™, Kerr; Panavia F 2.0,

Kuraray). The shear bond strength of the cementation was measured using a universal testing

machine immediately and after one-day storage (experimental set-up see chapter 11.2.).

[ M P a ]

F l e c k ’ s ™

c e m e

n t F u

j i 1

K e t a c

™ C e m

A p l i c a p ™

F u j i P

l u s

F u j i C

E M

R e l y X

™ L u t i n

g ( S C ) ( L C

)

R e l y X

™ U n i c

e m A p l i c a p ™ ( S

C ) ( L C )

P a n a v i a ™

F / E D P r i m

e r ™

V a r i o l i n k ®

I I / S

y n t a c

®

C l a s s i c

( L C ) ( S

C ) ( L C )

R e l y X

™ A R C

/ S c o t c h

b o n d ™

10

2

4

6

8

10

12

14

16

18

20

22

30 min

14d / thermocycling

* zinc phosphate cement

LC: LIGHT cure

SC: SELF cure

Dentin Shear Bond Strength of VariousLuting CementsPiwowarczyk A.1, Lauer H.-Ch.1,Sorensen J.A.21Johann Wolfgang Goethe-University,Frankfurt, Germany2Oregon Health & Science University,Portland, USAPublished at the CED 200 2, abstract#0215

Fig. 20: Shear bond strength tohuman dentin after 30 min and14 days / thermocycling.

Effect of One-day Storage on Bondingof Self-Adhesive Resin CementsIrie M.1, Richter B.2, Suzuki K.11

Okayama University Graduate School,Okayama, Japan23M ESPE, Seefeld, GermanyPublished at the AADR 2006 abstract#1839


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Conclusions:

RelyX Unicem cement (Aplicap) shows bond strength values that are comparable to the multi-

step cement Panavia F2.0 and superior to Maxcem on dentin. Generally, cement bond strength

values improve after 24 hours storage making differences to Maxcem more obvious.

Tensile Bond Strength to Human Dentin and Enamel


Extracted human third molars were grinded with sandpaper (600 grit) to expose dentin and

enamel surfaces. Composite specimens (Filtek™ Supreme, 3M ESPE) were cemented onto the

tooth structure following the cement manufacturers’ instructions for use. Three different self-

adhesive resin cements were used: RelyX Unicem cement (Aplicap™) (3M ESPE), Maxcem™

(Kerr), and Embrace™ Wetbond™ (Pulpdent). After storing in water for 24 hours the tensile

bond strength was measured using a universal testing machine (experimental set-up see

chapter 11.2.).

Conclusions:

RelyX Unicem cement showed the same bond strength values in both curing modes. On human

dentin RelyX Unicem cement performed better than Embrace Wetbond and Maxcem.

[ M P a ]

0

5

10

15

20

25

immediately 24hrs immediately 24hrs immediately 24hrs

Maxcem™

Panavia™ F 2.0 / Porc. Activ. / Mega Primer


Enamel Dentin Lava™

0

10

20

30

40

50

Embrace™*

Wetbond™

Maxcem™ RelyX™

Unicem

Aplicap™

Embrace™

Wetbond™

Maxcem™ RelyX™

Unicem

Aplicap™

SELF cure

LIGHT cure

Human DentinHuman Enamel

[ M P a ]

* Enamel cemented with Embrace Wetbond (Pulpdent) was etched with phosphoricacid following manufacturer’s directions

Fig. 21: Shear bond strength tohuman enamel and dentin, andLava™ ceramic immediately andafter 24 hours.

In Vitro Bond Strength of AdhesiveCements to Tooth Structure.Pinzon L.M., Powers J.M.University of Texas Dental branch atHouston, USATHE DENTAL ADVISOR, ResearchReport, No. 1, June 2005

Fig. 22: Tensile bond strength tohuman enamel and dentin after24 hours.


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Shear Bond Strength to Human Dentin and Enamel after24 Hours and Thermocycling


Extracted human molars were ground flat with sandpaper (600 grit) to expose dentin and

enamel surface. For cementation, RelyX™ Unicem cement in the Aplicap™ Capsule and the

Clicker™ Dispenser (3M ESPE) as well as Maxcem™ (Kerr) were used both in self and light

cure mode. One subgroup was tested after 24 hours water storage at 37°C; the other subgroup

was stored 14 days and subsequently thermocycled (1,000 x 5/55°C). Shear bond strength was

determined in a universal testing machine (experimental set-up see chapter 11.2.).

Conclusions:

RelyX Unicem cement both from the Aplicap Capsule and the Clicker Dispenser show similar

performance. RelyX Unicem cement bond strength values do not decrease after thermocycling.

Microtensile Bond Strength to Human Dentin andEnamel


Extracted human third molars were flattened using a diamond bur to expose enamel or dentin

surfaces. Composite specimens (Paradigm™ MZ100, 3M ESPE) were luted to the tooth sub-strate using four different cements requiring an adhesive bonding system: Linkmax (GC),

Nexus®2™ (Kerr), Variolink® II (Ivoclar Vivadent), Panavia™ F (Kuraray) and one self-adhesive

universal resin cement: RelyX Unicem (Aplicap). All cementations were done following the

manufacturers' instructions for use. The specimens were stored for 24 hours in distilled water

at 37°C prior to testing in a universal testing machine (experimental set-up see chapter 11.2.).

R e l y X ™ U

n i c e m

C l i c k e r ™

R e l y X ™ U

n i c e m

A p l i c a p ™

M a x C e m ™

R e l y X ™ U

n i c e m

C l i c k e r ™

R e l y X ™ U

n i c e m

A p l i c a p ™

M a x C e m ™

R e l y X ™ U

n i c e m

C l i c k e r ™

R e l y X ™ U

n i c e m

A p l i c a p ™

M a x C e m ™

R e l y X ™ U

n i c e m

C l i c k e r ™

R e l y X ™ U

n i c e m

A p l i c a p ™

M a x C e m ™

0

2

4

6

8

10

12

SELF cure LIGHT cure

24hrs

14d+TC

24hrs

14d+TC

0

2

4

6

8

10

12

SELF cure LIGHT cure

TC: thermocycling (1,000x 5/55°C)

Human Enamel Human Dentin

TC: thermocycling (1,000x 5/55°C)

[ M P a ]

[ M P a ]

Bond Strength of Self-AdhesiveCementing Agents to Dentin andEnamelPiwowarczyk A., Bregulla J., Lauer H.-C.Johann Wolfgang Goethe-UniversityFrankfurt, GermanyPublished at the IADR 2007 , abstract#1540

Fig. 23: Shear bond strength tohuman enamel (left) and dentin(right) after 24 hours and thermo-cycling

Hikita K.1,2 , De Munck J.1,2 , Ishijima T.2,Maida T.2, Lam-brechts P.1,2 , VanMeerbeek B.1,21Catholic University of Leuven,Netherlands2Health Sciences University ofHokkaido, Sapporo, JapanPublished at the IADR 2004,

abstract #317 5Bonding Effectiveness of AdhesiveLuting Agents to Enamel/Dentin


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Conclusions:

All cements in the test showed equally good adhesion to dentin (see note for Variolink®).

All luting cements that require additional priming / bonding pretreatment steps showed higher

adhesion values to enamel.

Tensile Bond Strength to Human Dentin andEnamel


Enamel and dentin specimens were prepared from non-carious third human molars (600 grit).

Composite cones (Filtek™ Z250, 3M ESPE) were cemented according to the cement manufac-

turers’ instructions for use using two resin cements that use adhesive bonding systems

(Calibra®) and the self-adhesive resin cement RelyX™ Unicem (Aplicap™). Cements were light

cured (40 sec) or self cured (15 min at 37°C). Tensile bond strength was determined using a

universal testing machine after 24 hours storage (experimental set-up see chapter 11.2.).

Conclusions:

The bond strength of RelyX Unicem cement is almost independent of the curing mode. RelyX

Unicem cement shows an especially high performance on dentin.

[ M P a ]

0

10

20

30

40

50

60

70

Linkmax Nexus® 2™ Variolink® II Panavia™ F RelyX™Unicem

Aplicap™

Human Enamel

[ M P a ]

0

10

20

30

40

Linkmax Nexus® 2™ Variolink® II Panavia™ F RelyX™Unicem

Aplicap™

Human Dentin

* 10 out of 12 smaples failed before testing (Variolink II)** 1 out of 10 samples failed before testing (RelyX Unicem)

*

**

[ M P a ]

[ M P a ]

0

40

35

30

25

20

15

10

5

RelyX™ Unicem

Aplicap™

Calibra®/

Prime & Bond® NT™

Variolink® II/

Syntac® Classic

0

40

35

30

25

20

15

10

5

RelyX™ Unicem

Aplicap™

Calibra®/


Variolink® II/

Syntac® Classic

LIGHT cure

SELF cure

LIGHT cure

SELF cure

Human Enamel Human Dentin

Fig. 24: Microtensile bondstrength to human enamel (left)and dentin (right) after 24 hours.

Fig. 25: Tensile bond strength tohuman enamel (left) a nd dentin(right) after 24 hours.

Bonding of a Novel Self-Adhesive

Cement to Tooth SubstratesTrajtenberg C.P., Pinzon L.M., PowersJ.M.University of Texas Dental Branch atHouston, USAPublished at the AADR 20 03, abstract#119 7 revised


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26

Immediate Shear Bond Strength to Bovine Dentin


Bovine anterior teeth were ground flat with sandpaper (320 grit). Composite discs (Paradigm™

MZ 100, 3M ESPE) were cemented to the dentin according to the cement manufacturers’

instructions for use. All cements were light cured for 20 sec from each side. 5 minutes after

cement mixing the shear bond strength was measured using a universal testing machine

(experimental set-up see chapter 11.2.).

Conclusions:

RelyX™ Unicem cement in the Aplicap™ Capsule and the Clicker™ Dispenser show the same

shear bond strength which prove to be among the highest of the cements tested.

Tensile Bond Strength to Bovine Dentin and EnamelStudy design and results:

Bovine teeth were ground flat with sandpaper (320 grit) to expose dentin and enamel surface.

The cements tested were applied to the tooth structure according to the cement manufacturers’

instructions for use forming a button-like structure. Tensile bond strength was determined after

24 hours storage using a universal testing machine (experimental set-up see chapter 11.2.).

[ M P a ]

0

2

4

6

8

10

Maxcem™ Monocem Multilink Automix

Calibra® Panavia™ F2.0

RelyX™Unicem

Clicker™

RelyX™Unicem

Aplicap™

[ M P a ]

0

1

2

3

4

5

6

7

Harvard Fuji I FujiCEM Maxcem™ RelyX™

Unicem

Aplicap™

RelyX™

Unicem

Clicker™

LIGHT cureSELF cure

n.a. n.a. n.a.

self-adhesive cementsconventional cements

Bovine Enamel

3M ESPE internal lab data (2006)

Fig. 26: Shear bond strength tobovine dentin 5 min after cemen-tation.

3M ESPE internal lab data (2006)

Fig. 27: Tensile bond strength ofdifferent luting cements to bovineenamel after 24 hours.


27/60

27

Conclusions:

RelyX™ Unicem cement in the Aplicap™ Capsule and the Clicker™ Dispenser show far superior

bond strength compared to the conventional cements tested.

Retentive Bond Strength of Lava™ Zirconia Crowns onHuman Dentin


Full crown preparations were performed on extracted human teeth in a standardized manner

simulating clinical conditions (experimental set-up see chapter 11.2.). The resin cements and

the adhesive system were used according to manufacturers' instructions for use. With dual-

curing systems, only the self-curing approach was conducted. The crowns inner surfaces were

sandblasted (Rocatec™ Pre, 3M ESPE). After thermocycling (5,000 x 5/55°C), the bond

strength of 50% of the cemented ceramic crowns was determined using a universal testing

machine. The remaining samples were tested after 1 year of water storage. The retention sur-

face was determined individually for each tooth and retentive strength was calculated.

Conclusions:

Lava™ crowns cemented with RelyX Unicem cement showed the highest median retentive

strength initially and after 1 year in this clinically relevant study design. (Rocatec™ pretreatment

is not needed to improve RelyX Unicem cement retentive strength.)

[ M P a ]

0

1

2

3

4

Harvard Fuji I FujiCEM Maxcem™ RelyX™

Unicem

Aplicap™

RelyX™

Unicem

Clicker™

n.a. n.a.n.a.

LIGHT cure

SELF cure

Bovine Dentin

self-adhesive cementsconventional cements

[ M P

a ]


I I / S y

n t a c ®

P a n a v i a ™

F 2 . 0

M u l t i l i n k

A u t o

m i x /

M e t a l

P r i m

e r

M u l t i l i n k

A u t o

m i x /

M o n o b o

n d S M a

x c e m

™

R e l y X

™

U n i c e

m A p l i c

a p ™

R e l y X

™ U n i c

e m

A p l i c

a p ™

/ R o c a t e

c ™ P l u s

F u j i C

E M0

1

2

3

4

5

6

7

8

9

10

TC

TC+1yr water storage

columns show median values bars represent 25th and 75th percentile TC: thermocycling (5,000x 5°C/55°C)

Fig. 28: Tensile bond strength ofdifferent luting cements to bovinedentin after 24 hours.

In Vitro Retentive Strength of Zircon-Oxide all Ceramic CrownsErnst C.-P., Askoy E., Stender E.,Willershausen B.Johannes Gutenberg University Mainz,GermanyPublished at the IADR PEF 2006,abstract #02 48

Fig. 29: Retentive strength ofLava™ crowns on human dentinafter thermocycling and 1 yearwater storage


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28

Shear Bond Strength to Zirconia Ceramic


Zirconia specimens (Cercon®, Dentsply) were bonded to metal (CoCr) cylinders. All bonding

areas were first sandblasted (110µm Al2O3). Alloy-Primer (Kuraray) was applied on all metal

bonding surfaces. The following resin cements and bonding agents were used: Calibra® / Silane

/ Prime & Bond®NT™ and SRC (Dentsply), Maxcem™ (Kerr), Multilink®Automix / SR-Link

(Ivoclar Vivadent) , Multilink®Xpress (Ivoclar Vivadent), Panavia™ F 2.0 (Kuraray), RelyX™

Unicem cement in the Aplicap™ Capsule and the Clicker™ Dispenser (3M ESPE), Rocatec™ sili-

coating (3M ESPE). All cements were self cured at 37°C. The shear bond strength was deter-

mined after 24 hours, 30 days of water storage, and after 12,000 thermal cycles (5/55°C, 17d)

(experimental set-up see chapter 11.2.).

Conclusions:

Regarding the shear bond strength of the zirconia / resin cement interface, both RelyX Unicem

self-adhesive universal resin cement in the Aplicap capsule and the Clicker dispenser per-

formed at a similarly high level. The shear bond strength of RelyX Unicem cement is less

susceptible to change after thermocycling and long-term water storage than most other

cements tested.

Shear Bond Strength of theZirconia/Resin InterfaceBehr M., Rosentritt M., Kolbeck C.,Lang R., Handel G.University of Regensburg, GermanyPublished at the IADR 2007 #2627

Fig. 30: Shear bond strength ofvarious resin cements (self cure)to zirconia ceramics at 24 hours,after thermocycling, and after30 days w ater storage.

C a l i b

r a ® ( S

i l a n e +

P r i m

e & B o n

d ® N T ™ + S

R C )

M a x c e m ™

( n o p r i m

e r )

M u l t i l i n k

A u t o m i x

( S R - L i n

k ) M u

l t i l i n k

X p r e s s

( n o p r i m

e r )

P a n a

v i a ™ F

2 . 0

( n o p r i m

e r )


( R o c a t

e c )

c o n t r

o l ( V a

r i o l i n k

® ,

n o p r i m

e r )

R e l y X

™ U n i c e

m

C l i c k

e r ™ ( n o p r i m

e r )

R e l y X

™ U n i c e

m

A p l i c

a p ™

( n o p r i m

e r )

R e l y X

™ U n i c

e m

A p l i c

a p ™

( R o c a t e c

s i l i c o

a t i n g )

[ M P a ]

0

5

10

15

20

25

30

35

40

45

24 hrs thermocycling (12,000 x 5/55°C) 30 d water storage


29/60

29

Shear Bond Strength to Lava™ Zirconia Ceramic andGlass Ceramic


Lava™ (3M ESPE) zirconia samples were air-abraded (100µm Al2O3). IPS Empress®2 (Ivoclar

Vivadent) leucite-reinforced glass ceramic samples were etched with hydrofluoric acid and

silanated (Monobond S, Ivoclar Vivadent). Composite samples were cemented onto the speci-

mens using different luting cements according to the cement manufacturers’ instructions for

use. Shear bond strength was tested in a universal testing machine after 30 min and after

14 days water storage and subsequent thermocycling (1,000 x 5/55°C) (experimental set-up

see chapter 11.2.).

Conclusions:

Within the group of cements tested the shear bond strength of RelyX™ Unicem cement to zirco-

nia and glass ceramic is among the highest when light cured. Light curing is the preferred cur-

ing mode for all-ceramic restorations.

[ M P a ]

0

2

4

6

8

10

12

14

16

18

20

22

F u j i P

l u s

F u j i C

E M

R e l y X

™ L u t i n

g

R e l y X ™

A R C

( S C )

R e l y X ™

A R C

( L C )

P a n a v i a ™

F ( S C )

P a n a v i a ™

F ( L C

)


I I ( S C )


I I ( L C

)

R e l y X

™ U n i c

e m ( S C )

R e l y X

™ U

n i c e m

( L C )

30 min

14d / thermocycling

LC: LIGHT cure

SC: SELF cure

The Shear Bond Strength BetweenLuting Cements and Zirconia Ceramicafter two Pretreatments.Piwowarczyk A., Lauer H. C.,Sorensen J. A.Oper Dent. 2005 May-Jun; 30(3):382-8

In Vitro Shear Bond Strength ofCementing Agents to Fixed Prost-hodontic Restorative MaterialsPiwowarczyk A., Lauer H. C.,

Sorensen J. A.; Johann WolfgangGoethe University of Frankfurt,GermanyJ Prosthet Dent. 2004 Sep; 92(3):265-73

Fig. 31: Shear bond strength ofdifferent luting cements toleucite-reinforced glass ceramicIPS Empress ® 2 (Ivoclar Viva-dent) initially and after 14 dayswater storage and thermocycling(1,000 x 5/55 °C).

[ M P a ]

0

2

4

6

8

10

12

14

F l e c k ’ s ™

c e m e

n t *

F u j i 1

K e t a c

™ C E M

F u j i P

l u s

F u j i C

E M

R e l y X

™ L u t i n

g ( S C ) ( L C

)

R e l y X

™ U n i c

e m A p l i c a p ™ ( S

C ) ( L C )

P a n a

v i a ™

F ( S C ) ( L C

)


I I ( S C ) ( L C

)

R e l y X

™ A R C

LC: LIGHT cure

SC: SELF cure

30 min

14d / thermocycling

* zinc phosphate cement Fig. 32: Shear bond strength ofdifferent luting cements to Lava™

zirconia ceramic initially and after14 days w ater storage and ther-mocycling (1,000 x 5/55°C).


30/60

30

Shear Bond Strength to Alumina Ceramic


Procera®AllCeram (Nobel Biocare) specimens were air-abraded (100 µm Al2O3). Composite

samples were cemented onto the specimens using different luting cements according to the

cement manufacturers’ instructions for use. Dual cure cements were light cured. Shear bond

strength was tested in a universal testing machine at 30 min and after 14 days water storage and

subsequent thermocycling (1,000 x 5/55°C) (experimental set-up see chapter 11.2.).

Conclusions:

After 14 days water storage and thermocycling Panavia™ F and RelyX™ Unicem cement

(Aplicap™ Capsule) showed the strongest bonding to air-abraded alumina ceramic among the

cements tested.

Retention Strength of Fiber Posts Cemented with2 Different Cements


Human teeth were decoronated and roots received endodontic treatment using guttapercha. Post

spaces were prepared using the RelyX™ Fiber Post system drills (3M ESPE). RelyX Fiber Posts

were cemented using RelyX ARC (n=20) and RelyX Unicem cement (Aplicap) (n=20) accord-

ing to the cement manufacturer's instructions for use. Pull-out force was determined at 30 min-

utes and at 24 hours using a universal testing machine (experimental set-up see chapter 11.2.).

Conclusions:

The multi-step RelyX ARC cement and the one-step RelyX Unicem cement (Aplicap) show

similar retentive strengths to RelyX Fiber Post and the tooth structure.

In Vitro Shear Bond Strength ofCementing Agents to FixedProsthodontic Restorative MaterialsPiwowarczyk A., Lauer H. C.,Sorensen J. A.; Johann WolfgangGoethe University of Frankfurt,GermanyJ Prosthet Dent. 2004 Sep; 92 (3):265-73

Fig. 33: Shear bond strengthof different luting cements tohigh-strength alumina ceramics

initially and after 14 days waterstorage and thermocycling(1,000 x 5 /55 °C).

Retention of Fiber Posts Cementedwith a New Delivery SystemDel Mastro M., Armoush Z.,Aboushala A., Doherty E., Kugel G.Tufts University, Boston, MA, USAPublished at the IADR 2007 , abstract#1553

Fig. 34: RelyX™ Fiber Post reten-tion values in human teeth 30 min

and 24 hours after cementation.

[ M P a ]

F u j i 1

K e t a c

™ C e m

F u j i P

l u s

F u j i C

E M

R e l y X

™ L u t i n

g

R e l y X

™ A R C

P a n a

v i a ™

F


I I

R e l y X

™ U n i c

e m

A p l i c

a p ™

0

1

2

3

4

5

6

7

8

9

10

F l e c k ’ s ™

c e m e

n t *

30 min

14d / thermocycling

* zinc phosphate cement

[ N ]

0

50

100

150

200

250

RelyX™ ARC RelyX™ Unicem Aplicap™

30 min

24 hrs


31/60

31

Tensile Bond Strength to Fiber Post


For determining the bond strength to RelyX Fiber Post the cements were applied to the post

surface in a disc shape at the conical part of the post. RelyX™ Fiber Post was either left untreat-

ed pretreated as described in the chart: etching, silanating (e. g. RelyX Ceramic Primer,

3M ESPE, or Monobond S, Ivoclar Vivadent), or a combination of silicatization (Rocatec

System, 3M ESPE) and silanating. Cements were either light cured for 40 seconds (RelyX

Unicem Aplicap and Clicker, 3M ESPE; Maxcem™, Kerr) or for 60 seconds (Multilink

Automix and Variolink® II, Ivoclar Vivadent) or self cured (1 hr at 36°C / >95% r. h.). After

water storage (24 hrs at 36°C) bond strength was measured in a pull-off test (experimental set-

up see chapter 11.2.).

Conclusions:

RelyX Unicem cement shows consistently same high bond strength to RelyX Fiber Post, inde-

pendent of curing mode and pretreatment steps - even without any pretreatment. Thus pretreat-

ment such as silanisation is not necessary for this system.

[ M P a ]

0

5

10

15

20

25

30

No

Pretreatment

RelyX™ Ceramic

Primer

Rocatec™

System &

RelyX™ Ceramic

Primer

Phosphoric

Acid Etching

Gel

Monobond S

[ M P a ]

* The manufacturer does not recommend self curing for Variolink II

0

5

10

15

20

25

30

Maxcem™ (no pretreatment)

Variolink® II &

Monobond S

Multilink Automix &

Monobond S

RelyX™ Unicem

Aplicap™ (no pretreatment)

RelyX™ Unicem Clicker ™ (no pret reatment )

SELF cure

LIGHT cure

*

3M ESPE internal lab data (Dec 2007)

Fig. 35: Tensile bond strength ofdifferent cements to RelyX™ FiberPost after light and self curingand with different post pretreat-ments.

Fig. 36: Tensile bond strength (24hrs) of RelyX™ Unicem Cement toRelyX™ Fiber Post with and with-out fiber post pretreatment.

For further information see RelyX™

Fiber Post Technical Product Profile


32/60

32

Marginal Sealing in Fiber Post Treated Teeth


Extracted human anterior teeth were endodontically treated with guttapercha and a resin sealer

(AH-25, DeTrey). Post spaces were prepared using the RelyX™ Fiber Post system drills.

Cementation of the post was done according to the cement manufacturers’ Instructions for Use

using the following resin cements: RelyX™ Unicem cement (Aplicap™) (3M ESPE), Multilink

Automix / Primer A&B (Ivoclar Vivadent), Maxcem™ (Kerr), and Calibra® / Prime & Bond®

NT™ (Dentsply). RelyX Unicem cement was applied directly into the root canal using the

RelyX Unicem Aplicap Elongation Tip (3M ESPE). All other cements were applied to the post

and/or the root canal using a lentulo spiral. After one week water storage microleakage between

the canal wall and the cement layer was determined using methylene blue dye. Additionally,

SEM pictures of the cement layer were taken.

Conclusions:

RelyX Unicem cement in combination with RelyX Unicems Aplicap elongation tip and RelyX

Fiber Post shows a marginal sealing superior to other cement systems tested in this study.According to the authors a good marginal seal is pivotal for the long-term success of the

endodontic and the prosthetic restoration by inhibiting bacterial infiltration.

Sealing Ability and MicroscopicAspects of a Self-adhesive ResinCement used for Fiber Post Luting intoRoot CanalsSimonetti M., Coniglio I., Magni E.,Cagidiaco M.C., Ferrari M.Dept. Dental Materials, Faculty ofDentistry, University of Siena, ItalyInternational Dentistry SA Vol. 8, No.5, Sept./Oct. 2006

Fig. 37: SEM pictures of the canalwall (top) / cement (middle) /fiber post (bottom) interface. Left:RelyX™ Fiber Post cemented withRelyX™ Unicem cement (Aplicap™ )Right: RelyX™ Fiber Post cement-ed with Multilink Automix

Fig. 38: Microleakage betweenthe cement layer and the canalwall at the apical level of the root.

0 1 2 3 4

Maxcem™

Calibra® /


Multilink / Primer A&B


microleakage (median scores)

0: no leakage 1: < 0.5mm 2: 0.5 - 1mm 3: 1 - 2mm 4: > 2mm

dentin

RelyX Unicem cement

RelyX Fiber Post

dentin

Multilink Automix

RelyX Fiber Post


33/60

33

Marginal Adaptation of Ceramic Inlays


All-ceramic inlays (IPS Empress®2, Ivoclar Vivadent) were cemented in MOD Class 2 cavi-

ties with cervical margins located both in dentin and in enamel. Three cements were tested:

Panavia™ F 2.0 / ED Primer (Kuraray), RelyX™ Unicem cement in the Aplicap™ Capsule and

the Clicker™ Dispenser (3M ESPE), and Maxcem™ (Kerr). Marginal adaptation was determined

using scanning electron microscopy (SEM) before and after thermocycling / mechanical load-

ing (TCML 6,000 x 5/55°C, 2min each cycle; 1,200,000 x 50N).

Conclusions:

Both RelyX Unicem cement in the Aplicap capsule and the Clicker dispenser show both very

good marginal adaptation before and after thermocycling/mechanical loading.

[ % ]

[ % ]

0

20

40

60

80

100

Maxcem™ Panavia™ F2.0 RelyX™ Unicem

Clicker™

RelyX™ Unicem

Aplicap™

before TCML

after TCMLTCML: thermocycling (6,000x 5/55°C) &

mechanical loading (1,200,000x 50N)

Perfect Margin to Enamel

before TCML

after TCMLTCML: thermocycling (6,000x 5/55°C) &

mechanical loading (1,200,000x 50N)

Perfect Margin to Dentin

0

20

40

60

80

100

Maxcem™ Panavia™ F2.0 RelyX™ Unicem

Clicker™

RelyX™ Unicem

Aplicap™

Marginal Adaptation of Ceramic InlaysUsing Different CementsRosentritt M .1, Hahnel S.2, Behr M.1,Handel G.11University of Regensburg, Germany2University Medical CentreRegensburg, GermanyPublished at the IADR 2007 , abstract#1516

Fig. 39: Marginal adaptation (% per-fect margin) of ceramic inlays toenamel before and after TCML.

Fig. 40: Marginal adaptation (% per-fect margin) of ceramic inlays todentin before and after TCML.


34/60

34

Interfacial Adaptation of Partial Ceramic Crowns


Partial ceramic crown preparations were performed on 48 extracted human molars. Crowns

were fabricated using the CEREC®3 system and Vitablocs®Mark II (Vident). Cementation

was done according to the manufacturers’ instructions for use using different luting systems:

Syntac®Classic / Variolink® II, Multilink Primer A&B / Multilink Automix (Ivoclar Vivadent)

and RelyX™ Unicem cement (Aplicap™). All cements were light cured. Thermocycling/

mechanical loading (TCML) was applied (5,000 x 5/55°C, 30s/cycle; 500,000 x 72.5N/1.6Hz).

Marginal adaptation was assessed by SEM margin analysis on replicas and by silver staining on

multiple tooth sections.

Conclusions:

Among the cements tested in this study, RelyX Unicem self-adhesive universal resin cement

showed the best interfacial adaptation, while being the least technique sensitive.

Proximal Adaptation of Partial CeramicCrowns with Different LutingTechniques/MaterialsFederlin M., Hiller K.-A., Reinhard H.,Fritzsch D., Schmalz G.University of Regensburg, GermanyPublished at the IADR PEF 2006,abstract #056 2

Fig. 41: Perfect margin of partialceramic crowns before and afterthermocycling and mechanicalloading determined by SEManalysis.

[ % ]

0

20

40

60

80

100

Syntac® Classic &

Variolink® II

Multilink Primer A,B &

Multilink Automix


columns show median values

bars represent 25th and 75th percentile

TCML: thermocycling (5,000x 5°C/55°C) &

mechanical loadi

Unicem Tp Ebu

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