TARGIS/VECTRIS

Materials with very different physical properties are used in the conventional crown and bridge technique. The thermal

and elastic properties are the most important ones to observe. Metal alloys are most often used for frameworks. These materials, however, cannot always be used, since they are

biologically incompatible and they compromise the aesthetics of the restorations. In addition, metal veneered restorations are complex systems with a number of interfaces between a variety of materials. These areas are the potentially weak points of the restoration and are often the cause of clinical

failure.

Tension in materials• Materials expand when heated. When their are left to cool, they take

on their original dimensions. The degree of this behaviour differs from one material to the other. It is represented by the particular coefficient of thermal expansion (CTE). The CTEs of conventional crown and bridge materials are listed in the table. The difference between the CTEs of metals and resins is considerably greater than that between metals and ceramics. Metal-ceramics are exposed to high temperatures during the production procedure. Lightcuring veneering composites, however, are only exposed to then-nocycles when they come in contact with foods with different temperatures. Despite the use of special adhesive systems that produce a bond between metals and resins, chipping off of the material is often observed.

• Materials demonstrate different degrees of deformation when subjected to load. Their particular trend to deformation is determined with the modulus of elasticity. Metals also clearly differ from popular veneering materials in this respect. As a result, tension is produced in the interface areas when load is applied. This tension can cause the bond to fail.In contrast to metal, the CTE and modulus of elasticity of the new Vectris framework material is coordinated with the new Targis complete veneer material. Furthermore, the properties of this material correspond to those of human dentin. As a result, tension is minimized in teeth restored with this system

MaterialMaterial CTE (20-60-C) CTE (20-60-C) Modulus of elasticity Modulus of elasticity [ttm/(-*K)] [N/mm [ttm/(-*K)] [N/mm22]]

Conventional veneering resins 40 2 - 20'000

Veneering ceramics 6 - 12 50 - 70'000

Dental alloys 10 - 14 200'000

Tarais (Dentin) 40 12'300

Vectris (Single) 24 2 l'000

Vectris (Pontic) 6 (Iangs)/51 ( quer) 36'000

Human Dentin 7 - 9 16 - 18'000

Aesthetics

Special shoulder materials and opaquers considerably improve the aesthetic properties of metal restorations. However, there is no technique that can compensate for the opacity of these restorations. The new tooth-coloured, translucent, highly aesthetic Vectris framework material offers optimum prerequisites for true-to-nature restorations.

Vectris fibre-reinforced material• Fibre-reinforced technology is being used in various

industries (e.g. aeronautical and shipbuilding industries). The material is used in situations where permanent loads are applied and light weight is required. Vectris is a fibre-reinforced material used to fabricate metal-free, translucent frameworks for crowns and bridges. The fibres and the matrix of the material have different basic physical properties. The fibres demonstrate high tensile strength, a high tensile modulus, and low shear strength, while the matrix demonstrates a higher degree of toughness.

An optimum composite material should combine the favourable properties of both components to form a material that is superior to the components themselves. This goal is achieved by optimizing the fibre-matrix bond. This bond is achieved chemically. The glass surface demonstrating silanol groups is conditioned with silane. In the processes of condensing on the glass surface, the silane produces a covalent bond. In turn, the silane contains a functional methacrylate group which copolymerizes with the methacrylate of the matrix. Consequently, a chemical bond is achieved between the matrix and the fibres.

Surface conditioning Mixing

itioned fib Matrix

F- lamination

M> Vectris PonticPR> Vectris SingleM> Vectris Frame

Pressing and curing Eg> Vectris VS-1

Finished product M> Fibre reinforcedcomposite

Veneering material Targis

The veneering material is visible and comes in contact with adjacent and antagonist teeth. Therefore, the properties of the veneering material are decisive for the surface quality and the aesthetic effect of restorations, as well as for their interaction with the surrounding teeth and gingiva. Targis is a highly filled (up to 75-85% inorganic fillers) material. The high content of fillers provides aesthetic properties similar to those of ceramics, while the organic matrix assures the ease and accuracy of processing of resin materials. The matrix is formed upon polymerization of monomeres (chemical bond via free double bonds) and the filter particles are chemically linked via silane to the matrix'. The wear resistance has been coordinated with that of natural enamel to protect antagonists. Furthermore, the Targis/Vectris Systems allows gentle preparation of teeth. Preparation margins may be supergingival. Furthermore, bridges anchored by inlays are possible.

Tempering (final curing)

• Once restorations have been fabricated, they are tempered in the Targis Power. During this controlled process involving heat and light, the properties of the materials are optimized (stability in mouth, colour stability, wear resistance, adhesion of plaque).

Bond• The followig materials are bonded in dentistry and dental

technology:resin - resinmetal - resinmetal - ceramicceramic- resin

resin - enamel and dentin

• Based on the content of organic molecules in Targis and Vectris resin-resin bond is found. Due to the high content of inorganic part in Vectris (fiber) and Targis (filler) also the resinceramic and when Targis is used on metall the metal-resin bond must be considered.

1.6.1. Resin-resin bond

Light-curing resins establish a real chemical bond between

different layers. This bond is promoted by the very thin surface

layer that does not thoroughly cure during exposure to light, since ambient oxygen in these layers inhibits polymerization

(Janda, 1992). The free methacrylates contained in this layer chemically react with the monomers of the applied resin. Consequently, a strong, durable

chemical bond forms between the layers. This reaction is

effectively utilized during the layering of the Targis material.

During this procedure intermediate curing is possible.

The same is valid for the layering of direct composite restorations.

This bonding mechanism also plays an important part in light-

curing Targis restorations (inlays, onlays and anterior crowns) and restorations supported by Vectris (posterior crowns and bridges). This reaction alone mediates a

chemical bond between Targis/Vectris restorations and

luting composites.

1.6.2. Resin-nietal bond

For decades, research has been conducted in the field of dental

lab technology with the objective of creating a bond between

metals and resins, which would be resistant to the oral

environment. Two issues, however, have not been solved:

1. After only a short time in the mouth, discolouration is visible

between the metal and the resin. As a result, the aesthetic quality

of the work is compromised.

2. Relatively large retentive elements have to be included in the metal framework to support the resin. Consequently, thicker

layers of the veneering resin have to be applied to successfully

mask these elements.

In the past few years, systems that permit a durable bond

between metals and resins have been developed (Silicoaterl&, Rocatec, OVS, Spectra Link). All these systems involve the conditioning of the substrate

(metal) to produce bifunctional molecules that adhere to the

metal surface (often silane) and that contain a polymerizable

double bond. These molecules react with the methacrylate

groups contained in the monomers of the applied resin in a radical polymerization process.

Targis Link is a bonding agent based on phosphoric acid ester with a methacrylate function.

The phosphoric acid ester group of the molecule is a strong acid that reacts with the metal or the

metal oxides' and forms a phosphate. This compound

forms passivation layers on the metal surface. After the reaction with the metal oxide, the layer is inert. The methacrylate group in the phosphoric acid reacts with the monomer contained in the Targis Opaquer and forms a

copolymer. As a result, a bond with the veneering material is

assured. The hydrolytic stability (insensitivity towards moisture) is achieved, since Targis Link

contains a monomer with aliphatic hydrocarbon that is

highly water-repellent.

1.63. Vectiris-Targis bond

The Vectris-Targis bond is basically a resin-resin bond.

However, the oxygen inhibited layer is very thin as a result of the

foil covering (Therefore, the number of free double bonds is

low.). Furthermore, the thin inhibited layer is removed when

the framework is ground. Consequently, the finished

Vectris frameworks are silanized (Targis Wetting Agent). The

silane condenses on the surface of the exposed fibres and bonds with the monomers of the Targis veneering material with the help

of the methacrylate groups (resin-ceramic bond). The bond

Vectris-Targis is therefore based on two mechanisms:

1. bond matrix Vectris - matrix Targis

2. fiber Vectris- silan - matrix Targis

1.7. Competitive materials1.7.1. Vectiris

Vectris is unmatched in the dental industry. The material and

the procedures have been developed specifically for dental applications. As a result, there are no real competitors. Vectris

can be used for the same indications as metal frameworks and the "core" materials from all-

ceramic systems (In-Ceram, Dicor, Optec, IPS Empress).

1. 7.2. Targis

Targis is classified as belonging to the following types ofmaterials

(Touati, 1996):

- Second-generation laboratory composites

- Ceramic polymers- Polyglasses- Ceromers

These materials are:- highly filled (mineral fillers);

- demonstrate improved physical and mechanical

properties;- mediate an excellent bond

with metals.

Distinguishing features:- Easy processing (photo

polymerisation and tempering)- Improved flexural strength

- Increased elasticity and reduced susceptibility to fracture

(resilience)- More freedom in preparation- Reduced risk of fracture during

try-in- Easy surface conditioning

prior to cementation (sandblasting without

hydrofluoric acid etching)

Filler FlexuralModulus of

wt/wt strengthelasticity[MPal [MPal

Artglass (Kulzer) 72 12091000

Conquest (Jeneric Pentron)79 155 8'500

Columbus (Cendres et Metaux) 77 160 12'000Targis (Ivoclar) 80 150-160

10,000BelleGlass HP (Belle de St. Claire) 74 150 9'655

Touati, 1996

This document addresses the following aspects of the new

TargisNectris System:

- Composition- Physical properties

- Studies on the material (in vitro)

- Clinical investigations (in vivo)

- Toxicological data- Literature references

2. Technical data sheets

TECHNICAL DATA SHEET IVCCLAR

Product: TARGIS DENTINType of material: Veneering

material

Standard - C omposition: (Specification in @eight %)

is-GMA 9.0

Decandiol dimethacrylate 4.8

Urethane dimethacrylate 9.3

Bariumglassfiller, silanized 46.2

Mixed oxide, silanized 18.2

High dispersed silica 11.8

Catalysts and Stabilizers 0.6

Pigments 0.1

Physical properties

In accordance with ISO 10477 - Dentistry - Polymer

based crown and bridge materials

Flexural strength 170 + 20 MPa

Flexural modulus 12300+ 900 MPa

Ball indentation (36.5/30) 560 + 40 MPa

Vickers hardness (HV 0.2/30) 640 + 60 MPaWater absorption 16.5 + 1.2 tig/mm'Water solubility

2.0 + 0.8 Ag/MM3 Depth of cure

>- 2 mmConsistency (Penetrometer)

3 + 0.2 mmFiller content 76.2 weight %

55.9 volume %

R+D / Scientific ServiceVisa: P. Oehri

Date of issue / Reference: April 1997 - PO Ima T-

DENT-E.DOCReplaces version of-

February 1996

TECHNICAL DATA SHEET

IVCCIAR

Product: TARGIS INCISAL

Type of material: Veneering material

Standard - Composition: (Specifictation in weight %)

Bis-GMA 8.7

Decandiol dimethacrylate 4.6

Urethane dimethacrylate 9.0

Bariumglassfiller, silanized 72.0

High dispersed silica 5.0

Catalysts and Stabilizers 0.6

Pigments 0.1

Phvsical Properties:

In accordance to ISO 10477 - Dentistry - Polymer based crown

and bridge materials

Flexural strength

200 + 20 MPaFlexural modulus

11000 + 1200 MPaBall indentation (36.5/30)

640 + 30 MlPaVickers hardness (HV

0.2/30) 700 + 60 MPaWater absorption

16.5 + 1.2 jig/nun3 Water solubility

2.0 + 0.8 pg/mm'Depth of cure

>- 2 mmConsistency (Penetrometer)

3 + 0.2 mmFiller content

77.0 weight %

55.5 volume %

R+D / Scientific ServiceVisa: P. Oehri

Date of issue / Reference: April 1997 - PO Inia T-

SCHN-E.DOCReplaces version of:

February 1996

TECHNICAL DATA SHEET

IVCCLAR

Product: VECTRIS SINGLE, FRAME, PONTIC

Type of material: Fibre reinforced metal-free frame work

material for the veneering technique

Standard - Composition: (Specificati.n in weight %)

Single Frame Pontic

Bis-GMA 38.6 35.2 24.5

Decandiol dimethacrylate 0.5 0.4 0.3

Triethyleneglycol dimethacrylatr 9.7 8.8

6.2Urethane dimethacr-ylate

0.1 0.1 0.1High dispersed silica

5.5 5.0 3.5Catalysts and Stabilizers

< 0.5 < 0.4 < 0.3Pigments < 0.1 < 0.1

< 0.1Glass fibres 45.0 50.0

65.0

Physical properties:

In accordance to ISO 10477 - Dentistry - Polymer based crown

and bridge materials

Single Frame Pontic

Flexural strength [Mpa] 700 + 70 700 + 70

1300 + 60

Flexural modulus [MPa] 21000 + 1800 21000 + 1800

36000 +2500

Water absorption [mpg/mm']18.8 + 0.8 18.8 + 0.8

---

Water solubility [mpg/mm'] 0.8 + 0.25 0.8 + 0.25

---

R+D / Scientific ServiceVisa: P. Oehri

Date of issue / Reference: April 199 7 - PO Ima V-

SPF-E.DOC

Replaces version of: May 1996

Scientific Documentation Targis/Vectis

Page 13 of3l

3. Physical properties

Material FlexuralModulus of Water Water

Curing

strengthelasticityabsorption solubility depth

[N/mm'] [N/mm']lttg/mm'] [fig/mm,] [MM]

Targis Dentin 170 _ 2012'300 900 16.5 _ 1.2 2.0 _ 0.8

2

Targis Incisal 200 _ 201 l'OOO 1200 16.5 _ 1.2

2.0 _ 0.8 2

Targis Base 145 _ 156'000 500 27.8 _ 0.9 < 5 >-

1.5

Targis Gingiva 200 _ 2011,000 1200 16.5 _ 1.2 2.0 _

0.8 >- 2

Targis Molar Incisal200 _ 201 l'OOO 1200 16.5 _

1.2 2.0 _ 0.8 2

Targis Occlusal Dentin 170 _ 20 12'300 1000 16.5 _

1.2 2.0 _ 0.8 2

Targis Transparent 200 _ 201 l'OOO 1200 16.5 _

1.2 2.0 _ 0.8 2

Vectris Single 700 _ 702l'OOO 1800 18.8 _ 0.8 0.8 _

0.25

Vectris Pontic 1300_ 6036'000 2500

Vectris Frame 700 _ 702l'OOO 1800 18.8 _ 0.8 0.8 _

0.25

Vectris Glue 140 _ 207-600 300

In-house test, R&D Ivoclar Schaan

Scientific Documentation Targis/Vectis

page 14 of 31

4. Studies on the material (in vitro)

4.1. Shear strength of TargisNectris in combination

with various cements

Experimental: Test discs were produced of Targis, Vectris and Base No. 1. These discs were

conditioned according to various methods. Subsequently, test cylinders were bonded to the

discs. After 24 hours the cylinders were sheared off.

Results:

Material Bonding agentCement Curing Shear strength

Type of fracture

after 24h

[MPa]

VectrislMo.obo.d S Variolikself-curing 21.6 _ 3.4 cohe

ive Vect,is

dual-curing 23.5 _ 4.1 cohe:ive Vectris

1'.ght-curing22.9 _ 5.8 cohesive Vectris

Vectris2 Monobond SDual Cement dual-curi.g 22.9

_ 3.5 cohesive Vectris

self-c.ring 20.3 _ 3.8 cohesive Vectris

Ve,!trisl Monobond SVivaglass Line, dual-curing 14.0

_ 3.0 cohesive/adhesive

in pat, cement

fracture

Ve,!tri!; 2 Mon.bond SAdvance (DeTr@y) self-curing

14.9 _ 2.0 cohesive Vectis

VectrislMonobo.d SPhosphacap self-curing no

adhesion

Vectris 2 Monobond SVivaglass Ce. self-curing no

adhesion

Vectrisl, 4 Monobond SVariolink self-curing 23.3 _

4.2 cohesive Vectris

dual-curing 23.1 _ 3.8 cohesive Vectris

light-curing 21.6 _ 4.4 cohesive Vectris

Targis Denti.3, 1Mo.obond S Variolink dual-

curing 22.3 _ 6.3 cohesive Targis

light-curing 16.1 _ 7.8 cohesive Targis

Targis Dentin3, I Monobond S Dal Cement dual-

curing 22.1 _ 8.2 cohesive Targ@s

self-curing9.16.4 cohesive/adhesive

Targis Denti.3, IMo.obond S Vivaglass Linerdual-curing 16.4 3.3 cohesive

Tagis

T.,gis D@nti.3, 1Monobond S Advance

(DeTrey) dual-curing 12.1 3.3 cohesive/adhesive

Base No. 13, 2 Monobond SVariolink d.al-curing 41.4

14.4 cohesive Base

light-,curing31.3 16.3 cohesive Base

Base No. 13, 2 Mo.obond SDual Cement dual-curing22.7 _ 11 cohesive Base

self-curing 33.3 _ 9.6 cohesive Base

Base N.. 13, 2 Mo.obo.d SAdvance (DeTrey) self-curing 14.8 _ 4.4 coh s@ve/adhesive

Base clear3, 1 Monob.nd SVa,iolink d.al-curing 30.4

_

7.7 cohesive Base

In-house test. R&D Ivoclar Scha.n

Discussion: The shear strength of 20-30 MPa registered for

Variolink and Dual Cement on Targis Dentin, Targis Base and

Vectris is very high.

The specimens demonstrate a cohesive fracture, that is, the substrates of Dentin,

Base and Vectris

broke rather than the bond.

I ground (lvomill) 3 Targis Pover Program 1

2 sandblasted 4 5 min. saliva; r'@nse; 60

sec. Email Prepaatr

Scientif,c Documentation Tagis/Vectris

Pge 15 of3l

The light-curing glass ionomer cement Vivaglass Liner as well as the hybrid ionomer cement

Advance (De Trey) demonstrated considerably lower bond

strengths of approx. 15 MPa compared with composite cements. Some adhesive fractures were also noted.

Phosphacap and the self-curing glass ionomer cement Vivaglass Cem failed to mediate adhesion.

Adhesive luting with a composite cement gives best bond to Targis Base' and Vectris and is therefor

recommended.

4.2. Bonding tests with Targis Link

4.2.1. Shear- strength: Long-term test following immersion in

water

Experimental: The metal was ground while wet (I 000 grit SiC

paper) and then sandblasted using Special Jet Medium and 4 bar pressure. After having been

dried, the metal was coated with Targis Link and two layers of Targis Opaquer (polymerized

twice). The inhibited layer was removed with an acrylic sponge and a Targis Dentin cylinder was grafted to the surface. The shear strength was determined with a

mechanical testing machine (Zwick).

Results:

Duration of Wiron 88Aurofluid 3 Titan Aquarius

PaHiag M

immersion in IMPal[MPa] [MPal [MPal [MPal

Water [37'C]

1 day 17.3 _ 3.5 17.8 _ 5.7 16.9 _ 4.9 9.9 _ 1.8 10.5

_ 3.0

1 week 14.7 _ 5.7 17.1 _ 2.8 17.6 _ 7.5 11 _ 1.513.1

_ 3.5

1 month 14.2 _ 2.9 14.5 _ 2.1 16.5 _ 4.6 8.8 _ 2.3

15.4 _ 4.6

3 months 11.6 _ 1.7 16.5 _ 2.1 15.3 _ 4.1 9.8 _ 4.1

14.8 _ 1.5

6 months 14.0 _ 4.7 18.1 _ 2.6 15.9 _ 4.1 9.3 _ 1.2

17.9 _ 3.2

12 months 11.7 _ 1.5 17.4 _ 3.4 14.3 _ 1.8 9.4 _ 2.6

12.5 _ 3.2

In-house test, R&D Ivocla, Schaan

Discussion: The Targis Link bonding agent mediated a sound, hydrolytically stable bond to the metal. The strength of the bond

depends on the alloy used.

The weak bond to Aquarius (86% Au, I 1% Pt) and Palliag M (58% Ag) is explained

by the

composition of the alloys. Both alloys do not correspond to the recommendations for Targis:

Gold, palladium and platinum < 90 %

Copper and/or silver <50%

3Targis Base is the base for all Targis restorations. Targis Base is less filled than Targis Enamel

and Targis

Dentin. Hence it contains more polymerizable monomers, which

results in a better bond.

Scientific Documentation Targis/Vectris

Page 16 of 3 1

4.2.2. Flexure-shear test according to Schwickerath

Experimental: The flexure-shear test was first described by

Schwickerath (1980).

Schwarz et al. (I 992) modified this method to evaluate

resin-metal bonds.

Results:

80

70.1 72.95

70 67--

60

7, 50 46.4

4

42

38.6 40

40 -a-7.7

34.5

30

0

2

0

Est@tic.r VisionNeocst 3 Pr.tor 3 Naovhite

(All.ys)

Columbus Artglass-Kevloc Targis-Targ'@s Lik

Allemend M., Cend,es & M6tau.

Discussion: Of the systems studied, Targis in combination

with Targis Link demonstrates by far the best bond on three

different alloys.

4.3. Tempering (final curing)

4.3.1. Effects ofthe tempering time on the physical properties

Results:

Tempering Flexural Modulus of Extension of Ball Vickers

time strengthelasticity outer fibres hardness hardness

[Min] [MPal [MPa] 1%] [MPaj [MPa]

0 115 _ 11 7302_ 6662.1 _ 0.3 248 8 363 14

3 160 _ 23 9587_ 5752.0 _ 0.4 509 36 558 5

5 166 _ 14 9902_ 6031.9 _ 0.3 337 41 937 70

10 154 _ 19 9742 _ 4801.9 _ 0.3 375 31 956 70

15 151 _ 24 9851 _ 6991.8 _ 0.3 444 1-5 941 22

31 178 _ 33 10800_ 6952.0 _ 0.5 412 45 685 37

Targ'is Dentin, in-house tests, R&D Ivoclar Schaan

Scientific Documentation Targis/Vectris

Page 17 of 31

Discussion: The maximum flexural strength and ball

hardness are achieved as early as after three minutes of tempering.

4.3.2. Effects ofthe tempering time on the bond with cements

Results:

Material Bonding agentCeme.t Tempering Shea,st,,ength

Typeoffracture

Variolink after 24h

[MPa]

Targis Dentin 1, 2 Monobo.d Sdual-cu.'ng tempered 2x

14.57.7 cohesive Dent'

dual-,!u,i.g tempered 3x 9.6 3.2

cohesive, Dentin

dual-cu,i.g tempered 4. 8.4 5.7 cohesive

Dentin

Targis Base 1, 2Mo.obo.d S dual-curing tempered 2x 29.0

16.5 cohesive Base

d.al-cu,ing tempered 3. 16.7 _ 7.9 cohesive Base

du.1-curi.g tempered 4x24.4 _ 7.1 cohesive Base

In.-house test, R&D Ivocla, Schaan

Discussion: The bond strength between Variolink and Dentin

and Base diminishes with increased tempering of the Dentin and Base materials.

The use of Targis Base produces higher bond strengths and hence better marginal seal

compared with

Targis Dentin. Therefore, Targis Base should be used in the

area facing the cement.

2 sandblasted 3 Targis Power Program 2

Scientific Document Targis/Vectris

Page 18 of 31

4.4. Wear in the masticatory simulator

Experimental: The materials were subjected to a combined

stress test that consisted of toothbrush and toothpaste wear, rapid temperature changes, and

cyclical occlusal stress (antagonist of natural enamel). The five-year values correspond to 300 minutes of brushing teeth, 1,200,000 masticatory cycles (49

N 1.7 Hz), and 3000 then-nal cycles (5 - 55 'C).

Results:

160

140 -

120-

E

100-

806040-

20-1

5

0 -

5

0.5

[Annual equivalents]

In-house test, R&D I,ocla,, S,2h,,a. cco,ding to Y,,ajzi et al.,

1990

Discussion: Tragis demonstrates the lowest abrasion of the materials examined. The

abrasion values measured are comparable to those of natural

enamel. This property is necessary for asstiring a stable

occlusion and for preserving the antagonists.

Scientfic Documentation Targis/Vectris

Page 19 of 3 1

4.5. Compliance of Targis Dentin, Incisal, and Base with

ISO standards

Targis can be classified as a composite material that must

comply with the requirements of

ISO 10477 (Dentistry - Polymer-based crown and bridge

materials).

ISO 10477 DentinIncisal Base

Curing depth 1%] > 70110: 94 95 85

120: 80

Flexural strength [MPa]> 50 170 _ 20 200 _ 20

145 _ 15

Water absorption [pg/mm']<3216.5 _ 1.2 16.5 _ 1.2

27.8 _ 0.9

Water solubility[@ig/mm']< 5 2.0 _ 0.8 2.0 _ 0.8 < 5

Shade, translucencyshade sample fulfilledfulfilled

fulfilled

Stability of shade 24h /fulfilledfulfilledfulfilled

150,000 lux'

In-house test. R&D I,ocla,, Schaan

Summary: Targis Dentin, Incisal, and Base comply with

ISO 10477.

4.6. Comparison of Targis with competitive materials

4.6.1. Water absoiptioii according to ISO 10477

1.8

1.6

1.4

1.2

0.8

0.6

0.4

0 ?

0

A,tglass S.1'.d@@ Th@rm.,es'@. 1-c,o. PE

Ta,gis

LC 11

lc'.s.1 Denti.

Institute for dental material science and technology (Institut

fur zahnarztliche Werkstoffkunde nnd Technologie),

University of Mainz

5 No isible change in shade

Scientific Documentation Targis/Vectris

Page 20 of 3 1

4.6.2. Flexural strength according to ISO 10477

200

180

160

140

120

100

80 -- - ------4

6 0

40

20

_ Atglass Conq.est Sol'@de. Tbe,mor@si. locro. PE T,,rgis

LC H

Incisal IM Dentin

Institute for dental material science and technology (Institut

fur zahnarztliche Werkstoffkunde und Technologie),

University of Mainz

4.63. Modulus of elasticity according to ISO 10477

12000

10000

8000

6000

4000

2000

_

Artgl@ss Conquest Solide,, The,.o,esi. 1-cro. PE Targ'@s

LC 11

Mcisal F, Dentin

Institute for dental material science and technology (Institut

fur zahnarztliche Werkstoffkunde und Technologie),

University of Mainz

Scientific Docuementation Targis/Vectis

Page 21 of 31

4.6.4. Depth of cure according to ISO 4049

7

6

5

4

3

2

0

Artglass Coquest Solide. The,moresin

Ta,gis

LC 11

Incisal IM Dentin

Institute for dental material science and technology (Institut fur zahnartliche Wekstoffkunde

und Technologie),

University of Mainz

Scientific Documentation Targis/Vectris

Page 22 of 31

5. Clinical investigations (in vivo)

5.1. Targis inlays /onlays

Head of study: Prof. F. Lampert, Dr. C. Kuntze, Dr. D

van Gogswaardt

Clinic for Operative Dentistry, Periodontology, and

Preventive Dentistry,

R.W.T.H. Aachen, Germany

Subj ect: Clinical testing of Targis for onlays bonded with the

adhesive technique

(partial crowns). In this clinical investigation,

- patients between 18 and 65 years

- who require 1-3 restorations in premolars or

molars are examined.

Experimental:Following preparation, impressions are

taken of the teeth (no liners/bases are placed). The lab-fabricated

onlays are inserted with the adhesive technique using Syntac

("total etch technique") and Variolink. After 6, 12, 24 and 48

months the restorations are examined according to the Ryge criteria (I 9 80). Impressions are taken for the SEM examinations.

Status: By January 1996, patients had been provided with 52 onlays, 4 inlays, and I crown

made of Targis. In summer 1996, the six-month follow-up and in January 1997 the twelfe-month follow-up examinations

were conducted. The results are very promising. A detailed

report is being prepared.

5.2. Targis Vectris crowns

Head of study: Dr. 1. Krejci, Dr. Besek, Prof. F. Lutz

Clinic for Preventive Medicine, Periodontology, and

Cariology

Centre for Operative Dentistry of the University of

Zurich, Switzerland

Subject: In this clinical study anterior and posterior teeth are

restored with TargisNectris crowns. Patients have one to six

teeth that require a crown.

Experimental: Lab-fabricated crowns are seated on the

prepared teeth (no linersibases are placed) with Syntac ("total

etch technique") and an experimental luting composite (Vivadent). After 12 and 24 months, the restorations are

examined. Abrasion (OCA/CFA), marginal quality and discolouration, sensitivity, surface texture and porosity,

secondary caries, shade adaptation, shade stability, and

condition of the gingiva are examined.

Status: Thirteen crowns have been in place for one year. They were examined in the autumn of 1996. A detailed report is being

prepared.Scientific Documentation

Targis/Vectris Page 23 of 31

5.3. Targis veneers

Head of study: Dr. R. Welbury MB BS, BDS PhD FDSRCS

Mr A. Shaw BDS, FDSRCS

The Dental Hospital, Department of Child Dental

Health

Newcastle upon Tyne, Great Britain

Subject: In this study, the following types of patients of the

Child Dental Health

Clinic are treated with veneers:

- Patients with severely discoloured anterior teeth

- Patients whose lost tooth structure cannot be restored

withcomposites

- Patients who do not wish to have orthodontic

treatment

Experimental: Once the patients have been registered for the

study, their affected teeth are prepared. Subsequently,

impressions are taken. During a second appointment, the lab-fabricated Targis veneers are

seated using the adhesive technique. In the course of two years, a total of 200 restorations will be placed and evaluated in

follow-up examinations.

Status: By April 1997, 18 patients had received a total of 56

veneers.

5.4. Vectris bridges: short-term study

Head of study: Prof. K.H. Kbrber, S. K,5rber, G. Johnke

Clinic for Dental Prosthetics, University of Kiel,

Germany

Subj ect: Preliminary investigation of the clinical suitability of Vectris bridges

Experimental: Thirteen patients were temporarily provided with 36 Vectris bridges (veneers of

Chromasit/Spectrasit (Ivoclar). The wearing time up until the examination lasted an average

7.7 weeks.

Results:The results were highly satisfactory. Consequently,

additional investigations have been initiated.

Status: This preliminary study has been concluded. Additional investigations have commenced in the following long-term study.

5.5. Targis/Vectris bridges: long-term study

Head of the study: Prof. K.H. K6rber, S. K6rber, G. Johnke

Clinic for Dental Prosthetics,

University of Kiel, Germany

Subj ect: Examination of the clinical suitability and the period

of undisturbed wear of TargisNectris bridges

Experimental: A total of 32 patients are taking part in this

clinical study. Of these patients, 17 patients required preprosthetic

restorations, 12 required therapeutic vertical increase of

occlusion, and three demonstrated an incompatibility to metal. A total of 66 bridges

with different widths were incompati 1 avalable (There are nine anterior and 57 bridges in the premolar and molar region.

Twenty-six of these bridges have two pontics and three have three pontics. The anterior bridges are divided into three bridges with one incisal and three with two incisals. One bridge has three

Scientific Documentation Targis/Vectis

Page 24 of 31

anteriors and two bridges four anteriors). In a follow-up

examination, the restorations were evaluated according to

clinical criteria: marginal periodontium, oral hygiene,

status of the alveolar periodontium of the abutments,

basic shape of the bridge, aesthetics, occlusion. The

accuracy of the crown margin was deten-nined with an

electrical probe.

Status: By October 1996, the patients had been wearing the

bridges for 14 months.

Results:

Accuracy of the crown margin

Region 0-100 pm "excellent"100-200 Jim "Satisfactory" 200

pm- "unsatisfactory"

[%] margin 65% 28%7%

Patient response rates, in percentages, after 7 to 9 months

of wearing Targis/Vectris bridges

Questions excellent goodaverage poor

Handling of the bridge 86.310.6 3.0 0.0

Appearance 100.0 0.00.0 0.0

Chewing 24.2 74.21.5 0.0

Feel of bridge on tongue92.4 4.5 1.5 0.0

Fit with teeth 96.9 3.00.0 0.0

Cleaning 1 84.8 15.51 0.0 0.0

none littleaverage a lot

Pressure after seating 92.46.0 1.5 0.0

Irritating taste 93.9 6.00.0 0.0

Chewing same as in the past0.0 0.0 4.5 95.4

Good feeling about oneself0.0 0.0 1 3.0 96.9

Discussion:

The clinical investigators have come to the following

conclusions based on this study:

l The bridge method features negligible deficiencies in

practical applications

l The glass fibre structure allows a basic shape to be

modelled, which is appropriate to tongue and masticatory

movements

l The fit of the crown margins corresponds to today's quality

requirements

l The material that comes in contact with gingival tissue does

not cause reactions

l Although accuracy of fit and occlusion were given priority

during fabrication, no aesthetic defects were observed

l The occlusion and masticatory functions can be

effectively restored with VECTRISbridges.

After a short period of wear, almost perfect results were

achieved with only four local defects in the veneering material on 182 abutments or crowns (2.1

%). The light weight, fracture resistance, and the aesthetics of

the bridges are impressive. Eighty-four percent of the

patients were very satisfied with this type of restoration.

Publication:Jonke et al., 1996; K6rber and K,5rber 1996

5.6. Targis/Vectris bridges

Head of study: Prof. R. Slavicek

University Clinic in Vienna, Austria

Subject: Effects of cementation (conventional

(Phosphacap) or adhesive luting (SyntacNariolink) on the clinical success of TargisNectris bridges.

Experimental: Patients are provided with long-term

temporary bridges. Ten bridges each are conventionally placed

with a phosphate cement or with a composite cement using the

adhesive technique. After a six-month wearing period, five

bridges each are removed and examined extraorally. The

remaining bridges are clinically evaluated over a period of two

years.

20 TargisNectris Bridges

10 Conventi al cementation10 Adhesive cementation

5 Removal after 6 months5 Removal after 6 months

5 Follow-up examinations over 2 years5 Follow-up

examinations over 2 years

Status: The study commenced in September 1996.

5.7. Targis/Vectris crowns: developmental investigation

Head of study: Dr. B. Clunet-Coste

Grenoble, France

Experimental: Vectris crowns have been fabricated in

combination with various resin materials (e.g.

Chromasit/Spectrasit) and used in clinical situations since 1989.

The glass fibres, the manufacturing process of Vectris, the lab techniques, as well as the veneering materials have all been consistently optimized. Although

only developmental materials were available, the low rate of

failure has been most impressive.

Results:

Year No. of crownsFailuresComments

1989 9 4 after I year

1990 12 3

1991/1992 21 0

1993/1994 173 1

1994/1995 1279 2 1 0 loss of retention

Total 1494 10 0.7% errors

5.8. Targis/Vectris bridges: developmental investigation

Head of study: Dr. B. Clunet-Coste

Grenoble, France

Experimental: Vectris crowns have been fabricated in

combination with various resin materials (e.g.

Chromasit/Spectrasit) and used in clinical situations since 1989.

The glass fibres, the manufacturing process of Vectris, the lab techniques, as well as the veneering materials have all been consistently optimized. Although

only developmental materials were available, the low rate of

failure has been most impressive.

Results:

Year No. of bridgesFailuresComments

1992 2 0

1993 2 0

1993/1994 15 1

1994/1995 149 3 1 loss of retention

Total 168 4 2.4% errors

A CRA clinical study on TargisNectris crowns (Dr. G.

Christensen, Provo, Utah, USA) will

begin in December 1996.

Scientific Documentation Targis/Vectfis

Page 27 of 3 1

6. Toxicological data

6.1. Introduction

In the biological evaluation of medical devices, the chemical

composition of materials, as well as the type and duration of their

contact with the human body must be examined. The

procedure required is described in ISO 10993 "Biological

evaluation ofmedical devices" [1]. The suitable tests are deten-

nined on the basis of this standard. In addition to the

10993 series, ISO/DIS 7405 [2] must also be used for the

biological testing of dental materials.

The release of soluble substances presents possible risks.

According to ISO 10993 and ISO/ DIS 7405, the following biological effects should be

examined in detail:

cytotoxicity

Sensitization

Irritation

Geiiotoxicity

6.2. Toxicological evaluation for patients

6.2.1. Targis

6.2.1.1. Cytotoxicity

Cytoxicity, the inhibition of cell proliferation, and other effects of the medical device on cells are determined with cell cultures. These tests provide an initial

evaluation of the biocompatibility of the material.

A direct cell contact test with Targis [3, 6] determined that this

material does not demonstrate cytotoxic potential.

6.2.1.2. Sensitization and irritation

These test results are used with suitable models to estimate the contact sensitizing potential of

medical devices. In a maximization test on guinea pigs [4], Targis was demonstrated to be non-sensitizing. An irritant

effect can also be ruled out on the basis of the test used.

6.2.1.3. Genotoxicity

These tests are used to determine gene mutation, possible changes in the chromosome structure, or

gene defects in cell cultures. The Ames Test is always used as the

screening test. In this type of back mutation test [5], Targis

Dentin and Incisal demonstrated no mutagenic changes.

6.2.2. Vectris

Vectris is a fibre-reinforced, metal-free framework material for veneering purposes. The framework material is not in

direct contact with living tissue in the mouth. It is first covered with Targis and then bonded to

dentin with cement. The substances of the monomer

matrix are well-known. They are comparable to those in Hellobond

and Helioseal/Helioseal F. An adequate number of tests [7, 8, 9, 1 0], expert opinions [ 1 1 ], and clinical results are available for

these materials. The glass fibres [12] are considered to be biologically inert. Direct

exposure to the material in the event of the veneering material

chipping off and related mechanical irritation can be

practically excluded.

Based on this information, individual testing of Vectn's

according to ISO 10993-1 was consi 'dered to be unnecessary.

Adequate data is available for the individual substances and

comparable products. There is no indication that these materials are toxicologically han-nful on

the basis ofthese results.

6.3. Supplementary toxicological evaluation for dental technicians

6.3.1. All light-ctiring materials

All light-curing materials in the TargisNectris-System contain dimethacrylate. Based on our

literature and experiences, these products are non-irritant, even in an uncured state. The materials

may cause irritation or an allergy or sensitization to

dimethacrylates in hypersensitive people. This type of reaction can

be avoided to a large extent if clean working conditions are

assured and the uncured materials are not brought in contact with

the skin. The working technique for these materials is state-of-the-art for dental technicians. Hence,

working with these materials does not present a heightened risk. Information about the

minimization of risks is contained in the Instructions for

Use.

63.2. Vectris

When working with glass fibre-reinforced materials, glass fibre dust may be produced. Special precautions must be observed,

since fibre particles on the whole should not be inhaled. Even though the size of the dust

particles produced during the finishing of Vectris frameworks

is not within the international values given as presenting a high

risk [12, 13, 14], the use of protective equipment (dust mask

and vacuum extraction equipment, generally required

when working with fine dust) is recommended in the Instructions for Use to minimize the risk of

exposure.

Summary

The toxicological risk of exposure to Targis/Vectris has

been carefully examined to r both dental technicians and patients.

The exposure of the dentist is not an issue in this connection.;

On the basis of the available data and the latest findings, there is no

indication thatTargisNectris present a hei htened or

unacceptable risk if used according to the Instructions for

Use

Scientific Documentation Targis/Vectris

Page 29 of 31

6.4. Literature on toxicology

[1] ISO 10993-1: Biologische WErkstoffprOfung von

Medizinprodukten (1993)

[2] ISO/DIS 7405: Preclinical evaluation of biocompatiblity of medical devices used in dentistry

(1995)

[3] In Vitro Cytotoxicity Test: Evaluation of materials for medical devices (Direct cell

contact assay)

CCR Project 534701

[4] Contact Hypersensitivity to C+B 90 Schneide + Dentin in

Albino Guinea Pigs (MaximizationTest)

RCC Project 608646

[5] Salmonella Typhimurium Reverse Mutation Assay with

C+B 90 Schneide + Dentin (AmesTest)

CCR Project 534702

[6] In Vitro Cytotoxicity Test: Evaluation of materials for medical devices (Direct cell

contact assay)

CCR Project 534800

[7] Primary eye irritation study with Helloseal in Rabbits

RCC Project 034604

[81 Salmonella Typhimurium Reverse Mutation Assay with

Helioseal F (Ames-Test)

CCR Project 427206

[9] Contact Hypersensitivity to Helioseal F in Albino Guinea

Pigs

RCC Project 347095

[10] Cytotoxicity Test in Vitro: Agar Diffusion Test with

Helloseal F

CCR Project 409904

[I 1] Toxlkologisches Sachverstdndigen-Gutachten

fiber Helloseal nach AMG _ 24, Abs. 1, Nr. 2

[12] Est-11 dangereux de manipuler la fibre de verre?, Dr. Esquevin, M6decin du Travail

[13] DFG: @- und BAT-Werte-Liste, 1996

[14] Gutachterliche Stellungnahme betreffend das

gesundheiliche, Inhalative Risiko beim Verarbeiten vom

GerilstwerkstoffVectris der Firma Ivoclar

RCC Projekt 620280

Scientific Docmentation Targis/Vectris

Page 30 of 31

7. Literature

Janda R

Kleben und Klebetechniken. Teil 1: Aligemeine Prinzipien der

Klebetechnik

Dent Labor 40, (1992) 409-415

Janda R

Kleben tind Klebetechniken, Teil 2: Adhdsiv-Systemefiir

Zahntechnik und Zahnmedizin

Dental Labor 40 (1992) 615-628

Krejci I, Reich T, Lutz F, Albertoni M

In-vitro-Testverfahren zitr Evahiation dentaler

Restaurationssysteme

1. Computer-gesteuerter Katisimitlator

Schweiz Monatsschr Zahnmed 100 (I 990) 953-960

Schwarz S, Lenz J, Melers H

Zur Anwendting des Dreipiinkt-Biegetests beim Metall IKunststoff-Verbund

Dtsch Zahn5rztl. Z 47 (1992) 299-302

Schwickerath H

Zur Verbundfestigkeit von Metallkeramik

Dtsch Zahndrztl. Z 35 (1989) 910-912

Tiller H-J, Magnus B, G6bel R, Musil R

Der Sandstrahlprozess und seine Einwirkung aufden Oberfa-

chenzustand von Dentallegierungen

(I)

Quintessenz 10, (1985) 1927-1934

Tiller H-J, G6bel R, Magnus B, Musil R

Der Sandstrahlprozess und seine Einwirkung aufden

Oberfdchenzustand von Dentallegierungen

(II)

Quintessenz 10, (1985) 2151-2158

Publications for Targis/Vectris:

Bischoff HE,ste Erfahrungen mit

metallfreien Ceromer-BriickenDent Labor 44, (1996) 1807-

1815

Bourrelly GCompreiidre les composites de

laboratoireProth Dent 121, (1996) 29-31

Cadiou D, Grundler TLe concept Targis/Vectris, 2eme

partieProth Dent 124, (1997) 27-31

Clunet-Coste BTargis/Vectris

Proth Dent 124, (1997) 33-37

Johnke G, K6rber K-H, K6rber SDie Glasfuserverstirkte Briicke

ZM 86, (1996) 38-43

Korber KH, Korber S, Ludwig KMetallfrei Briieken fur die restaurative Zahnheilkunde

Dent Labor 45, (1997) 465-476

Korber KH, Korber S, Ludwig KExperimentelle Untersuchungen liber den Versteiftingseffekt von

faserverstfirktenBriiekengeriisten Vectris nach Vollverblendting mit Ceromer

TargisQuintessenz Zahntech 11, (1996)

1343-1354

Korber KH, Kbrber SMechanische Festigkeit von

Faserverbund-Briicken Targis-Vectris

ZWR 105, (1996) 693-702

Korber S, Korber KHGlasfaser-Briicken-Zahnersatz

Zahnarzt Magazin 3, (1996) 32-42

Touati BThe evolution of aesthetic

restorative materials for inlays and onlays: a review

The Int Aesth Chron 8, (1996) 657-666