scientific documentation...1.2 shade systems dental materials are predominantly described in terms...

Artemis®

Scientific Documentation

Scientific Documentation Artemis® of 19

Table of contents

1. Introduction........................................................................................................................3 1.1 Tooth structure...........................................................................................................................3 1.2 Shade systems ...........................................................................................................................4 1.3 Optical properties of teeth ........................................................................................................5 1.4 The Artemis system ...................................................................................................................6

2. Technical data....................................................................................................................7

3. In vitro investigations........................................................................................................8 3.1 Colour, opacity and translucency ............................................................................................8 3.2 Filler composition ......................................................................................................................8 3.3 Fracture resistance of Artemis .................................................................................................9 3.4 Wear - Willytec......................................................................................................................... 10 3.5 Wear - OHSU............................................................................................................................ 11 3.6 Marginal quality of Class V restorations .............................................................................. 11 3.7 Marginal behaviour in Class IV restorations after masticatory loading............................ 12

4. Clinical investigations.....................................................................................................14 4.1 Prof. Dr. Pier Nicola Mason, University of Padua, Italy ....................................................... 14 4.2 Prof. Dr. Marcos Vargas, College of Dentistry, University of Iowa, USA .......................... 14 4.3 Prof. Dr. Gerard Kugel, Tufts University, Boston, USA....................................................... 15 4.4 Dr. Arnd Peschke, Internal Clinic, R&D Ivoclar Vivadent, Schaan, Liechtenstein ........... 15 4.5 Prof. Dr. Knut Merte, University Clinic Leipzig, Germany................................................... 16 4.6 Prof. Dr. Joseph Dennison, University of Michigan, USA................................................... 16 4.7 Summary .................................................................................................................................. 17

5. Toxicological evaluation.................................................................................................17 5.1 Introduction ............................................................................................................................. 17 5.2 Toxicity of Artemis.................................................................................................................. 17 5.3 Mutagenicity of Artemis ......................................................................................................... 17 5.4 Irritation and sensitization ..................................................................................................... 18 5.5 Conclusion............................................................................................................................... 18 5.6 Literature on toxicology ......................................................................................................... 18

6. Literature ..........................................................................................................................18


1. Introduction The increasing demand for invisible restorations and the search for amalgam replacements have led to a boom in composite materials in the past few years. The dental manufacturers have developed modern composite- and ceramic-based materials, which are hardly distinguishable from natural teeth. These possibilities have not only caused patients to raise their expectations, but they have also spurred the ambitions of aesthetically aware dentists. Consequently, dentists specializing in aesthetic dentistry are calling for materials which offer a larger range of design possibilities than the current composite materials do.

A tooth is simply more than a small white ‘tile’. Teeth are composed of dentin and enamel, embedded in pink soft tissue. Light passes through them, entering them from the front. Some light is reflected from the surface of the tooth, some of the remainder penetrates the surface and is either reflected, refracted or absorbed by the inner layers of the tooth and the rest passes through the entire tooth into the dark oral cavity. The typical colour and light effects, which are created in the process, constitute the hallmark of the natural appearance of teeth. It goes without saying that restorations which mimic only the shade and shape of natural teeth are easily recognized as foreign even by the untrained human eye.

Bearing the structure of teeth in mind, we realize that truly indiscernible, lifelike restorations can only be fabricated if an adequate range of dentin, enamel and characterization materials is available – materials that allow not only the reconstruction of the external shade and shape but also the reproduction of the inner tooth structure and the resultant optical effects.

The following section will explore the natural structure and optical properties of teeth and provide an introduction to the Artemis system of materials.

1.1 Tooth structure

The outermost layer of the exposed tooth consists of enamel, the hardest component of the tooth. The bulk of the tooth is dentin, which is softer and has less minerals than the enamel. In the centre is the pulp, a living tissue (Fig. 1a). Most restorations involve the replacement of lost tooth structure with a suitable material. The aim of aesthetic dental reconstructions is to replace lost tooth structure in as lifelike a manner as possible.

Enamel

Enamel is extremely hard, consisting of 96 wt-% hydroxyapatite and 4 wt-% organic material and water (Eisenmann, 1998). Enamel is made up of rod-like prisms of approximately 5 µm in diameter (Fig. 1b). The hydroxyapatite crystals are packed together in the prisms in parallel order to the longitudinal side of the rods. The enamel rods are aligned roughly at right angles to the amelo-dentinal junction, whereas angles ranging from 55 to 100° are measured between the prisms and the outer tooth surface. The only areas where the enamel rods are arranged vertically to the tooth surface are the cusp tips and proximal edges (Fernandez and Chevitarese, 1991). The enamel prisms do not run a straight course from the amelo-dentinal junction to the outer surface. Groups of prisms make a series of bends along the course. This gives rise to what is known as the Hunter-Schreger bands (Fig. 1c). Thus, the enamel is characterized by a subtle, intricate substructure. This well-ordered structure is also responsible for the typical etching pattern, which forms in the course of etching the enamel with acid (Fig. 1b, 1c).


Fig. 1a: Schematic structure of a molar.

S, enamel; D, dentin; SD, amelo-dentinal junction; P, pulp; Z, gingiva; L, periodontal membrane; K, bone.

Fig. 1b: Scanning electron micro-graph showing etched enamel.

The enamel rods are cut in an oblique manner.

Fig. 1c: Scanning electron micro-graph showing etched enamel

The enamel rods are cut longitudinally.

Dentin

The bulk of the human tooth is dentin. Dentin consist of 45 % mineral and up to 30 % organic material by volume. Water makes up approximately 25 vol-% of the dentin (Schroeder, 1991). The inorganic components are mainly hydroxyapatite and the organic material is predominantly collagen (Torneck, 1998).

A characteristic feature of dentin is the dense arrangement of dentin tubules that traverse its entire thickness. A density of 59,000 to 76,000 tubules per mm2 can be observed in the vicinity of the pulp (Torneck, 1998). The diameter of dentin tubules is approximately 2.5 µm near the pulp and 0.9 µm at the amelo-dentinal junction (Garberoglio and Brännström, 1976).

1.2 Shade systems

Dental materials are predominantly described in terms of their shade and transparency. Shade guides are used to help dental professionals select the appropriate shade or inform the laboratory about the shades selected. The Chromascop (Ivoclar Viadent) and A-D (Vita) shade guides are examples of such shade systems.

Shade guides have become the standard for selecting shades by their visual qualities as seen by the human eye. However, shade guides are hardly suitable for industrial or scientific purposes, such as assuring uniform colour properties among different lots of materials or the research-centered shade measuring of teeth. Consequently, electronic shade matching devices, which perform reproducible quantitative shade measurements, are gaining in popularity. To date, these devices predominantly use the CIELAB L*, a*, b* colour co-ordinates (Fig. 2).


Fig. 2:

CIELAB L*, a*, b* colour co-ordinates. L* describes the lightness component of a colour: L*=0 means ‘absolutely black’ and L*=100 means ‘completely white’. The a* co-ordinate plots the colour on a red - green axis and the b* co-ordinate indicates the colour on a yellow - blue axis.

The L*, a*, b* sets of coordinates has proved to be a valuable system to describe colours. However, this system is not capable of identifying parameters such as opacity or transparency. Yet, these parameters affect the measurement of colour and should therefore not be neglected.

1.3 Optical properties of teeth

Teeth are characterized by exceptional optical properties, which by far transcend the qualities associated with colour. For instance, teeth have fluorescent properties. In addition, dentin is far more opaque and intensely coloured than enamel, whereas the enamel features additional opalescent qualities. While the components of colour can be measured and described, properties such as translucency, opacity and opalescence can hardly be determined. Colour measuring in the oral cavity appears to be rather difficult because the surrounding components and the reflections on the tooth surface have quite a considerable effect on the optical appearance of a tooth. Furthermore, extracted teeth, which are no longer in contact with saliva, look different from what they used to do in the oral cavity. It is no surprise that publications on the measuring of the optical properties of teeth are thin on the ground. A few of them are briefly discussed below.

0

10

20

30

40

50

60

70

80

90

L* a* b* T

Colour parameters

Val

ue

IncisalCentralCervical

Fig. 3:

In vivo colour and degrees of translucency of upper central incisors: The colours were measured by means of a Spectra Colorimeter. For this purpose, the palatal side of the teeth was draped in black cover. The level of translucency was determined on the basis of colour measurements in which the palatal side was alternatively covered with a black and a white piece of cloth.

Source: (Hasegawa et al, 2000)

A Japanese team of researchers measured the colour of anterior teeth with a colorimeter in randomly selected Japanese people (Hasegawa et al., 2000). By and large, the study reflects the evaluation of teeth as seen by the human eye (Fig. 3). From the incisal to the cervical region of teeth, the red and yellow components gradually increase. The translucency is much higher along incisal edges, which are predominantly composed of enamel, than at the


cervical sites. The pronounced shift towards red at the cervical margin may be attributed to the adjacent gingiva.

Another study measured the colour of extracted upper incisors. The following colour co-coordinates were measured along the central part of the teeth: L*, 70 ± 4: a*, -0.22 ± 1.4; b*, 18 ± 3 (ten Bosch and Coops, 1995). After removing the enamel, the colour of the remaining dentin was measured again. A high level of correlation was observed between the colour measurements of the entire tooth and the dentin core. From these measurements the authors concluded that tooth colour is mainly determined by the colour of dentin.

1.4 The Artemis system

An aesthetic restorative material should enable the dental professional to imitate the optical properties of natural teeth accurately. Consequently, manufacturers are required to supply dentin, enamel and characterization materials whose shades and levels of translucency are coordinated with each other. On their part, dentists have to use the best possible layering techniques to reproduce the shade, shape and translucency of teeth in such a way that they regain their original appearance. A system that is capable of satisfying all these requirements is therefore best developed in close cooperation between the manufacturer and expert dentists.

In the course of developing Artemis, the consistency and colour coordination of the individual components were checked repeatedly by selected external dentists and subsequently adjusted to customer requirements. The result is a system that embraces thirty materials. The table below provides an overview of all the shades and degrees of transparency available:

Shade Transparency

Dentin materials A2, A3, A3.5, A4 B3 C4 D2, D4 IVA5, IVA6

7 – 8 %

Enamel materials A1, A2, A3, A3.5, A4 B1, B2, B3, B4 C2 D2, D3

13 – 15 %

Bleach XL, L, M 10 – 20 % Effect materials White 6 % Blue, amber 21 – 26 % Clear 30 % Super Clear 50 %

Table 1: Artemis system of materials

Being able to rely on an appropriate range of materials represents the first step towards farbricating an aesthetically impeccable restoration. A technique guide has been prepared together with experienced dentists to support dental professionals in their efforts to satisfy the requirements of their patients. Using case presentations as a basis, this guide shows practitioners a route to attain results that meet exacting aesthetic demands.


2. Technical data

Standard – Composition (in weight %) Dentin Enamel Super Clear Dimethacrylates 22.7 23.2 24.2 Barium glass filler, silanized 50 67.4 75 Ytterbiumtrifluoride 15 1 - Mixed oxide, silanized 5 5 - Ba-Al-Fluoro silicate glass, silanized 5 1 - Highly dispersed silica, silanized 1 1 - Additives 0.9 1 0.5 Catalysts and Stabilizers 0.4 0.4 0.3 Pigments < 0.1 < 0.1 < 0.1

Physical properties In accordance with ISO 4049 - Polymer-based filling, restorative and luting materials

Flexural strength 135 135 135 MPa Modulus of elasticity 9000 9000 9000 MPa Water absorption 19.8 19.6 19.6 µg/mm³ Water solubility 1 1 1 µg/mm³ Radiopacity 350 200 200 % Al Depth of cure > 3 > 4 > 6 mm Compressive strength 260 260 260 MPa Vickers hardness HV 0.5/30 570 570 570 MPa Transparency 7 – 8 13 – 15 50 % Density 2.25 2.05 2.05 g/cm³


3. In vitro investigations

3.1 Colour, opacity and translucency

The table below lists the CIELAB colour co-ordinates as well as the degrees of opacity and transparency of the individual Artemis materials.

Shade L* a* b* CR (%) T ( % )

Dentin A2 77 4.5 21.8 79 7.9 Dentin A3 75 5.1 21.3 84 7.8

Dentin A3.5 72 5.8 23.8 83 7.5 Dentin A4 69 7.6 24.9 81 7.6 Dentin B3 74 5.3 24.4 78 7.9 Dentin C4 67 6.5 22.5 81 7.9 Dentin D2 74 3.3 18.2 84 7.5 Dentin D4 68 7.3 22.5 82 7.4

Dentin IVA5 66 8.2 24.3 82 7.5 Dentin IVA6 62 9.1 23.8 83 7.5 Enamel A1 76 1.0 13.3 57 14.2 Enamel A2 74 1.8 16.4 63 13.7 Enamel A3 74 2.7 20.4 61 13.7

Enamel A3.5 72 3.5 22.9 60 13.5 Enamel A4 68 6.2 25.7 61 13.8 Enamel B1 77 0.3 11.6 57 13.7 Enamel B2 76 1.5 22.3 62 13.2 Enamel B3 72 4.4 26.5 64 13.9 Enamel B4 71 5.5 27.0 61 13.8 Enamel C2 72 1.7 18.7 66 13.9 Enamel D2 72 2.3 16.9 60 14.2 Enamel D4 67 5.8 23.3 64 13.7

Enamel Bleach XL 82 -1.7 7.5 66 10.0 Enamel Bleach L 79 -1.8 7.7 53 15.0 Enamel Bleach M 77 -2.1 9.8 47 20.0

Effect Clear 74 -1.7 7.8 36 30.0 Effect Super Clear 72 -1.4 10.4 15 56.6

Effect White 88 -0.7 6.5 88 6.0 Effect Blue 66 -1.8 -5.3 53 21.1

Effect Amber 67 1.6 21.6 39 26.0

Table 2: CIELAB colour co-ordinates, levels of opacity (CR) and translucency (T) of the individual Artemis shades.

3.2 Filler composition

The filler composition plays an even more important role in highly aesthetic restorative materials than it does in universal composites. Not only does a highly aesthetic material have to fulfil particular requirements related to volume shrinkage, surface hardness, fracture resistance, flexural strength, flexural modulus, polishability, wear resistance and radiopacity, but the optical properties of its fillers and polymer matrix also need to be accurately coordinated with each other. A high level of coordination is vital to attain the shades and degrees of translucency required to achieve true-to-nature restorations.


As a consequence, particular attention was paid to the composition of the fillers in the course of developing Artemis. The scanning electron micrographs below show the surface of Artemis Enamel and Artemis Dentin after polishing.

Fig. 4: Scanning electron micrograph of Artemis Enamel and Dentin surfaces after they have been polished to a high gloss. The following fillers can be identified: white, ytterbium trifluoride; light grey, barium glass. The grey background represents the matrix.

Investigation: R&D Ivoclar Vivadent AG, Schaan, Liechtenstein

3.3 Fracture resistance of Artemis

The fracture mechanics describes the behaviour of a material when cracks are present in its surface. Such cracks may be accidentally created in the course of finishing and polishing the restoration or they may form during mastication due to fatigue. Generally, these types of defects have a weakening effect on the dental material The capability of a material to withstand crack propagation is called fracture toughness (K1c). The higher the K1c value is, the more capable is the material to withstand crack propagation. The chart below compares the K1c values of aesthetic composites with conventional materials.

0.00.20.40.60.81.01.21.41.61.82.0

Tetric

Artemis

Dentin

Tetric C

eram

Esthet-

X

Artemis

Enamel

Miris Ena

mel

Point 4

Heliom

olar

K1c

(MPa

·m1/

2 )

Fig. 5: Fracture toughness of Artemis Dentin and Enamel compared to other composites.



3.4 Wear - Willytec

The wear behaviour of restorative and prosthetic materials constitutes a vital parameter in the prospects of a restoration or prosthetic reconstruction. Wear processes affect the aesthetic appearance and masticatory function of dental restorations. Various types of wear mechanisms come into play in the oral environment; they often occur simultaneously: attrition (two-body wear), abrasion (three-body wear with the food bolus or tooth paste acting as the abrasive agent), erosion (chemical degradation) and fatigue/abfraction (chipping off due to crack formation).

Measuring the wear of dental materials in vivo involves lengthy, inaccurate procedures. Even if high-precision impression materials are utilized, the restorations need to be worn for at least 12 to 24 months until the actual wear exceeds the mean variation of measurements by a large enough margin to allow the rate of wear to be evaluated. For these reasons, dental materials are subjected to in vitro simulations of mastication processes to estimate their stability under clinical conditions.

Ivoclar Vivadent uses a Willytec chewing simulator to measure the wear resistance of restorative materials. Standardized antagonists made of Empress material are used to keep the data variance at a minimum. Plane test samples are subjected to 120,000 masticatory cycles, applying a force of 50N and a sliding movement of 0.7 mm. An abrasive medium is not used in this two-body wear testing method. The vertical substance loss and volume loss are measured by means of a 3D laser scanner.

0.0

0.2

0.4

0.6

0.8

1.0

Amalcap

Heliomolar

Heliomolar

HB

Artemis

Dentin

Human Enam

el

Artemis

Enamel

Point 4

Tetric

Ceram H

B

Renamel

Esthet-

X

Brillian

t Ena

mel

Herculite

Miris E

namel

InTen

-S

Tetric

Ceram

Filtek Z

250

Filtek Z

100

Vol

ume

loss

(mm

3 )

0

100

200

300

400

500

Verti

kal s

ubst

ance

loss

(µm

)

Fig 6: Volume loss and vertical substance loss of composite materials compared to amalgam and dentin. The results are ranked according to volume loss, starting with the lowest measurement.

A vertical loss of less than 200 µm is regarded as being low. A loss between 200 – 300 µm represents a moderate rate of wear. Experience gathered in the course of the clinical testing of InTen-S and Tetric Ceram have shown that wear in the range of 200 – 300 µm cannot be recognized in vivo by the human eye. In the above test, the wear behaviour of both Artemis Dentin and Artemis Enamel closely resembled that of natural enamel.



3.5 Wear - OHSU

The OHSU wear method, which was developed by Condon and Ferracane (Condon and Ferracane, 1996), has become one of the most frequently used test methods to determine the wear of dental materials in the oral environment.

The test samples were subjected to 100,000 chewing cycles with a slurry of polymethylmethacrylate powder and poppy seeds to determine the three-body wear of the materials in question.

01020304050607080

Filkek S

upreme B

ody

Artemis

Enamel

Filtek S

upreme Ena

mel

Artemis

Dentin

Point 4

Esthet-

XVen

us

Renamel

Miris

Vert

ical

loss

(µm

)

Abrasion

Attrition

Fig. 7: Abrasion and attrition in the OHSU chewing simulator

Investigation: Dr. Jack Ferracane, Oregon Health Science University, Portland, Oregon, USA

3.6 Marginal quality of Class V restorations

Investigations of marginal adaptation aim at evaluating in vitro the type of marginal quality as that which can be attained in clinical applications. For this purpose, extracted teeth are restored with the materials to be tested. Then, impressions of the samples are taken and the marginal quality is assessed on the basis of these impressions. The samples may also be subjected to thermocycling or cyclical mechanical loading to simulate masticatory forces.


0

20

40

60

80

100

Syntac/Artemis Excite/Artemis AdheSE/Artemis AdheSE/InTen-S AdheSE/TetricCeram

Perf

ect d

entin

mar

gin

(%)

before TC

after TC

0

20

40

60

80

100

Syntac/Artemis Excite/Artemis AdheSE/Artemis AdheSE/InTen-S AdheSE/TetricCeram

Perf

ect e

nam

el m

argi

n (%

)

before TCafter TC

Fig 8: Marginal quality of Artemis, InTen-S and Tetric Ceram restorations placed in conjunction with different Ivoclar Vivadent adhesives. Artificial Class V defects were restored, using Artemis and three different adhesives (Syntac, Excite or AdheSE). The results obtained with InTen-S and Tetric Ceram, used in conjunction with AdheSE, were used as a control. The preparation method of the defect ensured that both dentin and enamel were cut with a diamond bur. The results show that an excellent marginal quality was attained in both the dentin and enamel for each test group before thermocycling (TC). Thermocycling with 2000 cycles between 5 and 55 °C did not result in any significant deterioration of the marginal quality. Investigation: Dr. Uwe Blunck, Charité, Berlin, Germany

3.7 Marginal behaviour in Class IV restorations after masticatory loading

Aesthetic composites are employed for restorations in the visible anterior region in particular. Class IV cavities were restored with Artemis, using three different adhesive systems (Syntac, Excite and AdheSE) and the marginal quality of these restorations was evaluated. For this purpose, extensive cavities were prepared in extracted upper incisors, using 80 µm diamonds. In the process, approximately two thirds of the incisal edge were removed. The cervical preparation margin was located in the dentin below the amelo-dentinal junction. The


enamel margins were bevelled. The adhesives were applied according to the manufacturer’s instructions and, subsequently, Artemis was applied in increments. First, the dentin core was rebuilt. Then, the oral incisal was reconstructed and finally the buccal incisal was shaped. Each increment was light-cured with an Astralis 10 light unit for 40s immediately after having been placed. After the layering procedure had been completed, the restorations were polished. Six samples were prepared for each test group. The restorations were subjected to 1.2 mio. cycles at 49 N in the chewing simulator as well as to 3000 thermal cycles between 5 and 55 °C. Before and after masticatory loading, impressions of the samples were taken to produce epoxy replicas. A quantitative margin analysis was performed separately for the dentin and enamel margins, using a scanning electron microscope.

Fig. 9: Marginal quality of Artemis placed in conjunction with different Ivoclar Vivadent adhesives. The control data of EsthetX and Point 4 were measured by the same researcher in an identical set-up (Krejci and Stavridakis, 2001).

The results reveal that Artemis placed in conjunction with different Ivoclar Vivadent adhesives produces excellent marginal results. It is particularly surprising that only a slight decline in the marginal quality was detected after masticatory loading. All systems demonstrate favourable marginal results in the enamel, while a comparable degree of decline was observed in the enamel after masticatory loading.

Investigation: Prof. Dr. Ivo Krejci, University of Geneva, Switzerland

0

20

40

60

80

100

Con

tinuo

usm

argi

nin

den

tin(%

)

Prior to loading After loading

0

20

40

60

80

100

Artemis/

AdheS

E

Artemis/

Excite

Artemis/

Syntac

Estheti

X/P&B N

T

Point4/

Optibo

ndFL

Con

tinuo

usm

argi

nin

ena

mel

(%)


4. Clinical investigations Several clinical studies on Artemis were initiated a few years ago. In the meantime, the results of up to two years have become available .

4.1 Prof. Dr. Pier Nicola Mason, University of Padua, Italy

Experimental: A total of 62 Class III and IV cavities were restored with Artemis. Excite total-etch adhesive was used in 30 restorations, and AdheSE self-etch adhesive was used in the other 32 restorations.

Current status: The study was initiated in December 2002. The six-month evaluation was completed at the end of November 2004.

Results: After 6 months Artemis/AdheSE Artemis/Excite Marginal adaptation 100%A 100%A

Marginal discoloration 100%A 100%A

Anatomic form 100%A 100%A

Secondary caries 100%A 100%A

Shade adaptation 97%A, 3%B 100%A

Surface roughness 94%A, 6%B 87%A, 13%B

Postoperative sensitivity 100%A B 100%A

Retention 100%A 100%A

Conclusion: Loss of retention and marginal discoloration did not occur either in conjunction with AdheSE or Excite.

4.2 Prof. Dr. Marcos Vargas, College of Dentistry, University of Iowa, USA

Experimental: In this study, Class IV restorations, direct veneers and diastema closures were fabricated using Artemis and AdheSE as the bonding agent. Uncut enamel was etched with AdheSE before the restorations were placed.

Current status: Forty-seven restorations were placed in 28 patients. Twenty-five patients turned up at the recalls after six and twelve months. As a result, 44 restorations were assessed at these recalls.

Results: Artemis/AdheSE 6 months 12 months

Retention 98%A, 2%D 98%A, 2%D

Anatomic form 95%A, 5%B 98%A, 2%B

Marginal adaptation 64%A, 36%B 56%A, 44%B

Marginal discoloration 97%A, 3%B 90%A, 10%B

Shade adaptation 98%A, 2%B 99%A, 1%B

Secondary caries 100%A 100%A

Postoperative sensitivity 100%A 100%A


Conclusion: A single restoration became lose. Apart from this incident, unacceptable results were not found. This proves the excellent clinical performance of Artemis in restorations in the anterior region.

4.3 Prof. Dr. Gerard Kugel, Tufts University, Boston, USA

Experimental: Fifty Class V restorations were placed using an experimental variant of Artemis and AdheSE as the bonding agent.

Current status: All fifty restorations were inspected at baseline and after six months, while 42 restorations were available for inspection after 18 months.

Results: Artemis/AdheSE Baseline 6 months 18 months

Retention 100%A 98%A, 2%D 98%A, 2%D

Shade adaptation 100%A 100%A 100%A

Marginal quality 100%A 100%A 100%A

Marginal discoloration 98%A, 2%B 92%A, 6%B,

2%D 86%A, 9%B,

5%C

Anatomic form 100%A 100%A 100%A

Secondary caries 100%A 100%A 100%A

Postoperative sensitivity 100%A 100%A 100%A

Conclusion: Artemis, used in conjunction with AdheSE, produced excellent results during an observation period of 18 months. Only a single restoration had to be replaced due to loss of retention.

4.4 Dr. Arnd Peschke, Internal Clinic, R&D Ivoclar Vivadent, Schaan, Liechtenstein

Experimental: The purpose of this investigation was to evaluate the clinical performance of Artemis in conjunction with the proven Syntac adhesive and the AdheSE self-etch adhesive system in cavities of Classes I, II, III and V. All restorations were placed after isolation with a rubber dam.

Current status: In the meantime, these restorations have been in situ for 2 to 2.5 years.

Cavity class Syntac AdheSE I 5 5 II 15 14 III 14 13 V 8 8

Total: 42 40 Results: In view of the experience gathered thus far, the clinical performance of

Artemis can be rated as impeccable. The aesthetic integration of the material in terms of shade and translucency is excellent. Postoperative sensitivity did not occur in any of the patients treated.


4.5 Prof. Dr. Knut Merte, University Clinic Leipzig, Germany

Experimental: Forty-nine Artemis restorations were placed using AdheSE and 41 restorations were incorporated using Excite.

Current status: All restorations were placed between December 2002 and the end of February 2003. The 12-month recalls were completed in March 2004. Forty-seven restorations of the AdheSE group and 40 restorations of the Excite group were available for inspection.

Results: After 12 months Artemis/AdheSE Artemis/Excite Shade adaptation 74%A, 26%B 68%A, 32%B

Marginal discoloration 70%A, 30%B 75%A, 25%B

Marginal quality 62%A, 32%B, 4%C, 2%D 73%A, 27%B

Secondary caries 98%A, 2%C 98%A, 2%B

Anatomic form 96%A, 4%B 98%A, 2%B

Surface roughness 51%A, 49%B 78%A, 22%B

Postoperative sensitivity 100%A 100%A

Cumulative survival rate 94% 100%A

Conclusion: Since only shades A2 and A3 were available, it was not possible to achieve an optimal shade match. Only three restorations out of 90 were not acceptable. This result is proof of the favourable clinical performance of Artemis in restorations for the posterior region.

4.6 Prof. Dr. Joseph Dennison, University of Michigan, USA

Experimental: Fifty-three Class II Artemis restorations were placed in 30 patients using AdheSE as the adhesive system. Five of these restorations were placed in premolar and 48 in molar teeth.

Current status: Forty-eight restorations were available for inspection after 12 months and 40 restorations after 24 months.

Results: Artemis/AdheSE Baseline 12 months 24 months

Postoperative sensitivity 91%A, 9%B 94%A, 4%B, 2%D 93%A, 5%B, 2%D

Shade adaptation 87%A, 13%B 73%A, 17%B 58%A, 42%B

Marginal discoloration 100%A 88%A, 12%B 73%A, 27%B

Marginal adaptation 91%A, 9%B 50%A, 50%B 33%A, 67%B

Anatomic form 98%A, 2%B 67%A, 33%B 40%A, 60%B

Surface texture 100%A 96%A, 4%B 95%A, 5%B

Restoration fracture 100%A 96%A, 2%B, 2%D 94%A, 2%B, 4%D

Secondary caries 100%A 100%A 100%A

Survival rate 100%A 96%A, 4%D 92%A, 8%D


Conclusion: The restorations, which were placed as replacements for amalgam, were clearly visible because the surrounding tooth structure was discolored. The operators were satisfied with the clinical performance of Artemis; however, they said that sometimes they had slight difficulty in placing the restorations in the posterior region.

4.7 Summary

Artemis has produced excellent results in investigations involving anterior restorations and the clinicians commend this material highly for use in the anterior region. Artemis has also shown favourable clinical results in the posterior region. However, a few operators found it slightly difficult to apply the material in posterior restorations. This is reflected in the higher number of B-ratings for posterior restorations.

5. Toxicological evaluation

5.1 Introduction

Dentists tend to place very high requirements on aesthetic composite materials. When Artemis was developed, particular attention was paid to using types of raw material that have been tried-and-tested in dental materials in vivo for many years. Consequently, we can fall back on the experience gathered with proven dental composites and their ingredients to assess the toxicological properties of Artemis. Artemis contains the following fillers: barium glass, barium aluminium fluorosilicate glass, silicon dioxide and ytterbium trifluoride. Like Tetric and Tetric Ceram, the monomer matrix of Artemis is composed of Bis-GMA, urethane dimethacrylate and triethylene glycol dimethacrylate.

5.2 Toxicity of Artemis

Fillers composed of glass and silicon dioxide are chemically inert. In addition, the fillers are embedded in a resin matrix in the course of polymerization. Consequently, they do not represent a toxicological risk. The toxicity of the ytterbium trifluoride filler, which endows the Ivoclar Vivadent composites with their excellent radiopaque properties, was tested on rats. None of the rats died when exposed to the highest tested dose of 5000 mg/kg and pathological mutations of organs did not occur [1]. Furthermore, ytterbium trifluoride was tested for any radioactivity that may be present in addition to the naturally occurring radioactivity [2].

Tests showed that the LD50 level of both Bis-GMA and urethane dimethacrylate is higher than 5000 mg/kg [3]. The LD50 level of triethylene glycol dimethacrylate is 10,837 mg/kg. As Artemis comprises the same monomers as Tetric and Tetric Ceram, the toxicology data of these materials may be used to evaluate the toxicological risk of Artemis. The cytotoxic properties of polymerized Tetric were evaluated in an Agar overlay test using L929 mice cells. In this test, Tetric did not demonstrate a cytotoxic potential [4]. In view of the present data, it is safe to assume that Artemis, like Tetric and Tetric Ceram, does not involve any relevant toxicological risk.

5.3 Mutagenicity of Artemis

As Artemis contains the same monomers as Tetric and Tetric Ceram, the results obtained on the mutagenic properties of these two materials also apply to Artemis. Polymerized Tetric specimens were extracted at 37 °C in water or DMSO for 30 days. The extracts were examined using a Salmonella typhimurium reverse mutation assay (Ames Test). This test showed that Tetric is not mutagenic [5]. An umu-test on Tetric Ceram confirmed these results. This test was also conducted with Salmonella typhimurium [6] and the extracts of


Tetric Ceram were also negative in the Salmonella typhimurium reverse mutation assay [7]. In view of these results, we can conclude that Artemis does not have any mutagenic potential.

5.4 Irritation and sensitization

Like all light-curing dental materials, Artemis contains methacrylates. If uncured, methacrylates may have a slightly irritating effect. In addition, methacrylates may lead to sensitization and allergic reactions, such as contact dermatitis. The risk of allergies can be minimized by choosing a working technique that forestalls any direct or indirect skin contact.

5.5 Conclusion

Studies on the toxicology of dental materials that contain similar ingredients as Artemis show that, according to the current level of knowledge, Artemis does not pose a health risk to users or patients, with the exception of possible allergic reactions in predisposed individuals.

5.6 Literature on toxicology

[1] Acute Oral Toxicity (LD50) Study with Ytterbium-trifluoride, anhydrous in Rats. RCC Project 048881. July 1985.

[2] Certificate – Determination of radioactivity. RCC Project 045224. February 1985.

[3] Schmalz G (1998) The biocompatibility of non-amalgam dental filling materials. Eur. J. Oral. Sci. 106:696-706.

[4] Cytotoxicity test in vitro: Agar overlay assay. RCC Project 319926. March 1992.

[5] Salmonella typhimurium reverse mutation assay. CCR Project 314908, December 1992.

[6] Mutagenitätstest: Prüfung von Tetric®Ceram im umu-Test nach DIN 38 415-3. G. Leyhausen, Medizinische Universität Hannover, Interner Bericht. Dezember 1996.

[7] Salmonella Typhimurium Reverse Mutation Assay. CCR Project 563300. August 1996.

6. Literature Condon JR, Ferracane JL (1996). Evaluation of composite wear with a new multi-mode oral wear

simulator. Dent. Mater. 12:218-226.

Eisenmann DR (1998). Enamel structure. In: Oral Histology. Development, Structure and Function. AR Ten Cate editor. St. Louis: Mosby, pp. 218-235.

Fernandez CP, Chevitarese O (1991). The orientation and direction of rods in dental enamel. J. Prosthet. Dent. 65:793-800.

Garberoglio R, Brännström M (1976). Scanning electron microscopic investigation of human dentinal tubules. Arch Oral Biol 21:355-362.

Hasegawa A, Ikeda I, Kawaguchi S (2000). Color and translucency of in vivo natural central incisors. J. Prosthet. Dent. 83:418-423.

Krejci I, Stavridakis M (2001). Marginal adaptation of class IV composites before and after loading. J. Dent. Res. 80:590.

Schroeder HE (1991). Oral Structural Biology New York: Thieme.

ten Bosch JJ, Coops JC (1995). Tooth color and reflectance as related to light scattering and enamel hardness. J. Dent. Res. 74:374-380.

Torneck CD (1998). Dentin pulp complex. In: Oral Histology. Development, Structure and Function. AR Ten Cate editor. St. Louis: Mosby, pp. 150-196.

Scientific Documentation Artemis® Seite 19 von 19

This documentation contains a survey of internal and external scientific data (“Information”). The documentation and Information have been prepared exclusively for use in-house by Ivoclar Vivadent and for external Ivoclar Vivadent partners. They are not intended to be used for any other purpose. While we believe the Information is current, we have not reviewed all of the Information, and we cannot and do not guarantee its accuracy, truthfulness, or reliability. We will not be liable for use of or reliance on any of the Information, even if we have been advised to the contrary. In particular, use of the Information is at your sole risk. It is provided "as-is", "as available" and without any warranty express or implied, including (without limitation) of merchantability or fitness for a particular purpose. The Information has been provided without cost to you and in no event will we or anyone associated with us be liable to you or any other person for any incidental, direct, indirect, consequential, special, or punitive damages (including, but not limited to, damages for lost data, loss of use, or any cost to procure substitute information) arising out of your or another's use of or inability to use the Information even if we or our agents know of the possibility of such damages. Ivoclar Vivadent AG Research and Development Scientific Service Bendererstrasse 2 FL - 9494 Schaan Liechtenstein Content: Dr. Urs Lendenmann Edition: July 2005 Replaces Edition of: February 2003

scientific documentation...1.2 shade systems dental materials are predominantly described in terms...

Documents