Scientific Documentation Adhese Universal Page 2 of...

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Table of contents

1. Introduction 3

1.1 Mechanism of dental adhesion 3

1.2 Adhesive techniques 4

2. A brief History of Adhesives 5

3. Classification of Adhesives 6

3.1 Classification by generation 6

3.2 Classification by mechanism of adhesion / clinical steps 7

4. Universal Adhesives 8

5. Ivoclar Vivadent Adhesive Range 9

6. Adhese Universal 10

6.1 Indications 10

6.2 Mode of action 11

6.3 Advanced delivery via VivaPen 14

6.4 “Universality of Adhese Universal 16

7. Technical Data 17

8. In-Vitro Investigations 18

8.1 Adhesives and bond strength tests 18

8.2 Adhese Universal and direct restorations 19

8.3 Adhese Universal and core build up materials 29

8.4 Adhese Universal and indirect restorations 30

8.5 Adhese Universal – dentin penetration: bond and desensitisation 34

9. Clinical Investigations 36

10. Biocompatibility 38

10.1 Introduction 38

10.2 Cytotoxicity 38

10.3 Genotoxicity 38

10.4 Sensitisation and irritation 38 11. References 40

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1. Introduction Adhesive dentistry has undergone remarkable and constant progress over recent decades - and has undoubtedly co-revolutionised restorative dental practice.1

Dental adhesives have developed hand in hand with dental composites. Composite materials first became available in dentistry in the 1960s, 2 and initially were mainly used in the anterior region, where amalgam fillings were deemed unaesthetic. In the 1990s they began to substitute amalgam as a universal filling material and composite restorations heralded a new minimally invasive era in dentistry. The retentive aspect of amalgam fillings was no longer necessary as the hole to be filled, had only to be as large as the demineralised tissue to be removed. This “new” development in restorative dentistry was only possible due to the simultaneous development of clinically reliable enamel/dentin adhesives. The nature of these adhesives and composites has continued to change over time.

1.1 Mechanism of dental adhesion

Two basic types of adhesion are possible:

Mechanical: via the penetration of adhesive resin into the tooth surface

Chemical: via chemical bonding to the inorganic component (hydroxyapatite) or organic components (collagen) of the tooth structure

Irrespective of adhesive type, a combination of the above is usually responsible for bonding with all modern adhesives.

1.1.1 Substrate Adhesive systems must establish a bond to both the restoration and the dental hard tissue. Composite restoratives consist of a hydrophobic matrix in which different filler particles are embedded. Teeth are comprised of two very different substrates: enamel and dentin. Enamel is essentially 96% hydroxyapatite, crystalline calcium phosphate, and 4% organic material and water 3 whereas dentin consists of 70% hydroxyapatite, 20% collagen and 10% water.4 Enamel is thus an essentially dry substrate, whilst dentin is moist, though both can be considered essentially hydrophilic in comparison to restorative materials. Adhesives therefore need to possess both hydrophobic and hydrophilic properties in order to establish a bond to both tooth and restorative substrates.

1.1.2 Smear layer The smear layer refers to a layer of dental “debris” about one micron thick lying over the prepared sections of tooth after instrumentation. It may have a protective function as it lowers dentin permeability; however as it partly penetrates the dentin tubuli it can pose a challenge to effective bonding.1 With early composite materials, it was observed that bonding agents that removed the smear layer, achieved better retention rates in clinical trials than those that merely modified it.5,6 Removal of the smear layer appeared to be a prerequisite for adhesion to dentin, and remains a largely accepted concept. Studies found that if the smear layer was left in place, only about 5 MPa of bond could be achieved prior to cohesive fracture within the smear layer.7,8

This led to the establishment of the group of bonding materials referred to as “total-etch” and later on “etch-and-rinse” adhesives.

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Dentin should remain moist and slightly glossy in appearance, such that the collagen fibrils do not collapse (like cooked spaghetti) as this would make the surface less permeable to hydrophilic monomers in the adhesive and create a weak interface, potentially leading to a poor bond and postoperative sensitivity.

For this reason, plus the multi-step nature of the technique, total-etch adhesives are often referred to as technique-sensitive.14 They are however very well established and clinically successful.15, 16

1.2.2 Selective-Etch Technique This refers to the conventional etching technique whereby only the enamel edges of a preparation are etched with phosphoric acid and then rinsed. The dentin is then conditioned using an acidic primer step or an all-in-one self-etching adhesive. The smear layer is modified but not removed as surfaces are not rinsed after the primer application. This method can also be seen as an etch-and-rinse method for enamel only. This technique originally employed with total-etch adhesives (see Table 1), has enjoyed a resurgence in use with both self-etch adhesives and the new “universal” adhesives.

1.2.3 Self-Etch Technique Self-etch adhesives are intended for use without a separate etching step. Self-etch systems contain acidic monomers that prime/etch the enamel and dentin. In contrast to total-etch systems there is less danger of excessive demineralisation of the dentin as self-etch systems have a milder pH level. The potentially technique-sensitive step of drying the dentin to just the right degree after etching is also not required; thus the danger of collagen-fibre collapse can be excluded. Each of these factors should reduce the risk of postoperative complaints. As mentioned above, some dentists choose to acid-etch the enamel selectively prior to using self-etch adhesives.

The new universal adhesives are usually indicated for use with any one of the above etching techniques – depending on the clinical situation.

2. A brief History of Adhesives In order to understand the current situation with adhesive dentistry, it is important to look to the past and how and why the various generations of adhesives developed. The concept of bonding to enamel and dentin was first considered over 50 years ago by Buonocore.9

Extrapolating from industrial bonding techniques, he postulated that acids could be used as a surface treatment before the application of resins, and found that etching enamel with phosphoric acid increased the duration of adhesion under water. In 1963 he demonstrated further insight in discussing the differences of bonding to enamel vs. dentin.17 In the late 1960s, he suggested it was the formation of resin tags in the micro-porosities of etched enamel that were principally responsible for adhesion; with adhesion to dentin proving more elusive due to its composition, water content and the smear layer.

The first dental adhesives therefore only bonded resins to enamel, with little or no adhesion to dentin. Adhesives then evolved step by step with changes in chemistry, application, mechanism, technique and effectiveness – an evolution that accompanied the development of increasingly aesthetic dental materials, notably composite resins and ceramics.

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3. Classification of Adhesives Classifying adhesives into neat categories is nigh on impossible. Over the years, adhesives have been classified variably according to generation, method of etching, the number of bottles involved or the number of individual steps necessary for the entire bonding procedure. In addition to this, authors/dentists often define generations differently, they may or may not include etching in calculating the number of bottles or steps involved and some authors allocate specific adhesives to different groups e.g. the classification of a multi-step adhesive with a separate primer (traditionally viewed as an etch-and-rinse adhesive) as a self-etch adhesive. Comparative analysis is undoubtedly hindered by these not inconsiderable and inconsistent overlaps in attempts at classification and differences in interpretation. The following paragraphs and Table 1 attempt to clarify the situation.

3.1 Classification by generation

Dental adhesives can to a degree be categorised chronologically according to generation - a historical system of identification commonly used by adhesive manufacturers. The generation simply refers to when and in what order this type of adhesive was developed by the dental industry, ranging from 1st generation in the 1960s to modern 7th generation adhesives.

1st and 2nd generation bonding agents are no longer used, due mainly to failed attempts to bond with a loosely bound smear layer. They achieved poor bond strengths of 2-8 MPa 18 and failed to prevent marginal gaps.19 Manufacturers currently produce so-called 7th generation products, however 3rd, 4th, 5th and 6th generation adhesives remain popular and offer various advantages depending on the clinical situation and the clinician’s personal preferences and experience. The new “universal” adhesives can be applied either using the total-etch, selective-etch or self-etch technique. Thus they fall rather into a new side class of adhesives rather than a totally new generation. The approximate timescale and principle differences between generations are shown in Table 1:

Generation Developed Mechanism / Steps Description

1 1960s

No

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2-Step Total-etch/etch-and-rinse: combined primer and adhesive

6 Late 1990s

Sel

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7 2000 + Self-Etch/

1-Step

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Universal 2011 +

All-

Etc

h

Total/Self/Selective-Etch/ 1 or 2-Step

Total or selective etch procedure followed by universal adhesive or universal adhesive only in self-etch mode

Table 1: Classification overview of adhesives according to generation, mechanism of adhesion and number of clinical steps

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3.1.1 Generations of Ivoclar Vivadent adhesives The multi-step system Syntac can be seen as belonging to both the 3rd and 4th generation of adhesives as it can be used with the selective-etch technique (3rd generation) or the total-etch technique (4th generation). ExciTE F is a typical one bottle (or VivaPen) adhesive involving a separate total-etch step and belongs to the 5th generation. AdheSE as a two-step self-etch system belongs to the 6th generation and AdheSE One F a single component self-etching adhesive to the 7th generation. Adhese Universal belongs to the new universal class of adhesives that allows for all the etching techniques described in section 1.2.

3.2 Classification by mechanism of adhesion / clinical steps

Whilst the generational system of classification is helpful for looking at adhesives from a historical perspective, with regard to adhesives currently on the market (generations 3-7), it may be more meaningful to classify them according to how they work and how many working steps are involved.

Modern dental adhesives can be classified into two basic types: etch-and-rinse and self- etch adhesives. Although the etch-and-rinse term is often used synonymously for total-etch adhesives, theoretically it covers both total-etch and selective-etch adhesives (i.e. total-etch: both enamel and dentin are etched and rinsed; selective-etch: just the enamel is etched and rinsed). These systems can then be sub-categorised based on the number of clinical steps involved: e.g. multi-step, three-step and two-step etch-and-rinse systems and two-step and one-step self-etch systems.

The etch-and-rinse system is distinct in that it has a separate etch-and-rinse step prior to the priming and bonding steps. The three-step etch-and-rinse/total-etch system (using fourth-generation adhesives) follows the conventional “etch-rinse-prime-bond” approach. The two-step etch-and-rinse system (using fifth-generation adhesives, also known as one-bottle adhesives) combines the primer and the bonding agent into one application. The self-etch adhesive system eliminates the rinsing phase after etching by using non-rinse acidic monomers to etch and prime dentin simultaneously. The two-step self-etch system (involving sixth-generation adhesives) uses acidic monomers as self-etch primers in the initial step and an adhesive resin in the second step. The one-step self-etch system (using seventh generation adhesives, also known as all-in-one adhesives) combines the (self-etch) acidic primer with the adhesive resin in one application step. This allows for simultaneous infiltration of adhesive resin to the depth of demineralisation, which may reduce postoperative sensitivity. The universal adhesives differ in terms of their claimed universality (see section 4), however in general they too combine the acidic primer with the adhesive resin in one step, can be used with all etching techniques and are suitable for use with both direct and indirect restorations.

To provide an overview of adhesives from both a historical and current perspective, Table 1 attempts to combine both methods of classification.

Perception and trends in adhesive use In 2010, conventional bonding comprised approximately 45% of the German bonding market in terms of sales with self-etching accounting for the rest.20 In terms of actual adhesive use, a GfK dental market survey of 300 dentists in 2010, reported that an estimated 62% of the adhesive procedures carried out were conventional/etch-and-rinse with the remaining 38% reported as self-etch procedures.21 GfK figures from the first half of 2013 indicate that conventional bonding has fallen to approximately 43% of the market with self-etching (which includes universal adhesives) accounting for the rest.22

It is generally accepted that the more time given to adhesive technique the better the clinical results, and that phosphoric acid etching remains the most effective way of pre-treating enamel due to the consistently better marginal quality achieved with this method.23

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Due to differences in the ability of self-etch and total-etch adhesives in etching enamel and dentin, many dentists intuitively still prefer total-etch adhesives, notably if a major fraction of the bonding area is enamel e.g. aesthetically sensitive anterior restorations. Self-etch adhesives however have shown to provide superior and more predictable bond strengths to dentin and are, consequently, recommended for direct composite resin restorations, especially when predominantly supported by dentin.24 There has also been considerable recent discussion about the “resurrection” of selective-etching for self-etch adhesives. Frankenberger compared dentin and enamel bond values for self-etch adhesives used according to manufacturer instructions and again after an initial total-etch step. Whereas enamel values were shown to increase considerably the values on dentin tended to worsen. Selective-etching would therefore appear sensible when bonding to both enamel and dentin.23,25 According to Frankenberger, selective-etching always makes sense in combination with self-etch adhesives. 26

This apparent reluctance to forego phosphoric etching entirely has led to the next class of adhesives - universal adhesives which are not only less technique sensitive, but allow for the possibility of using the total or selective-etching technique.

4. Universal Adhesives Universal adhesives appeared on the market in 2011. This new (largely 1-step) adhesive category helps simplify the complexity surrounding the many types and categories of bonding procedures, offering products that can be used with all etch techniques, for direct and indirect bonding procedures and with light, dual and self-cure materials. The table below taken from The Dental Advisor 27 gives a current overview of the varying indications for five different “universal” adhesives

Product Company Total-Etch Technique

Self-Etch Technique

Dual-cure materials

without separate activator

Bonds to lithium

disilicate

without separate primer

Bonds to zirconia and

metal

without separate primer

ALL-BOND Universal

Bisco Dental Products

**

**

Peak Universal

Ultradent Products Inc.

Scotchbond Universal

3M ESPE

*

Optibond XTR

Kerr Corporation

Prime & Bond Elect

Dentsply Caulk

Table 2: A summary of indications for universal bonding agents on the market. Adapted from The Dental Advisor, March 2013 27

* Requires separate activator unless it is used with RelyX Ultimate Adhesive Resin Cement ** All-Bond Universal does bond to lithium disilicate and zirconia but the manufacturer recommends using a pure silane with

lithium disilicate and Z-Prime Plus with zirconia for optimum bond strengths.

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As table 2 indicates, it is important to note that the meaning of the term “universal” differs from manufacturer to manufacturer. Universal usually relates to one or more of the following issues:

compatibility with total, selective etch and self-etch techniques compatibility with direct and indirect bonding procedures ability to bond to different substrates ability to be used with dual-cure and self-cure materials (without the use of a separate

activator) use as a primer for silica-based and/or zirconia based and metallic restorations.

Universality is at times debateable. Although acceptable bond strengths were demonstrated to both enamel and dentin for the five universal adhesives noted in table 2 (in both total and self-etch modes) 27 - some products have drawbacks e.g. Scotchbond Universal/3M ESPE requires a separate activator when used for indirect restorations unless it is used with one particular cement - RelyX Ultimate Adhesive Resin Cement/3M ESPE. Prime & Bond Elect/Dentsply can be used with all etching techniques but is not alone compatible with dual cure materials. Optibond XTR/Kerr is not indicated for the total-etch technique.

Adhese Universal is indicated for use with the total-etch, self-etch techniques and with dual-cure materials without a separate activator. It is not however indicated as a separate primer for restorative substrates - as incorporating silane components into the adhesive has failed to render convincing in-vitro data. An external investigation by Lehmann and Kern at the University Clinic Schleswig-Holstein, Germany evaluated the adhesive bond achieved with “universal” adhesives to lithium disilicate ceramic - compared to a system using a dedicated primer. Four groups were compared: Monobond Plus & Multilink Automix vs. Scotchbond Universal & RelyX Ultimate/3M ESPE, Optibond XTR & NX 3/Kerr and All-Bond Universal & Duo-Link/Bisco. Although the initial bonding values were acceptable in all groups, the group using Monobond Plus indicated the highest values initially and these values also remained stable after 150 days’ water-storage and thermocycling. The All-Bond Universal group de-bonded after 30 days and the remaining groups exhibited very low bonding values of approximately 10 MPa. 28 As priming the indirect restoration represents a separate step anyway, the advantage of using the same product here is debateable. For optimal results with indirect restorations, the use of a dedicated ceramic / metal primer, such as Monobond Plus is strongly recommended.

5. Ivoclar Vivadent Adhesive Range Ivoclar Vivadent produces both total-etch and self-etch adhesives. The current range is depicted in table 3. There are valid pros and cons to both types of adhesive and of the multi-bottle/single bottle variants within these groups. Total-etch adhesives offer longer clinical experience, a more pronounced etch pattern in enamel and extensive removal of the smear layer. Self-etch adhesives on the other hand, may be less technique sensitive,29 reducing the danger of collagen collapse and can be applied in fewer steps. Adhese Universal aims to combine the advantages of both types of adhesive, offering dentists simplicity both in terms of application and the amount of practice-inventory required.

Total-Etch Adhesives Self-Etch Adhesives

Light-Cure Dual-Cure Light-Cure

Syntac Syntac AdheSE

ExciTE F ExciTE F DSC AdheSE One F

Universal Adhesives

Adhese Universal

Table 3: Ivoclar Vivadent adhesive range and associated category

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6.2 Mode of action

6.2.1 Bonding The breakthrough in dentin bonding came with the multi/three-step systems, which bridged the gap between the hydrophilic dentin and the hydrophobic resin-based filling material, via the sequential application of the components. In essence, the multi-component systems meant that each bonding issue could be dealt with in turn enabling the practitioner to achieve a transition between the hydrophilic dentin and hydrophobic composite. Syntac is a classic example of this 3rd/4th generation of adhesives. After etching and rinsing, the hydrophilic Syntac Primer is applied to the entire cavity (enamel and dentin) followed by the hydrophilic Syntac Adhesive and then a layer of the hydrophobic Heliobond. The table below illustrates the chronological advancement of Ivoclar Vivadent adhesives and the reduction in steps involved to achieve a bond between the restorative material and the tooth structure:

Working Step

Purpose of step Syntac (1990)

ExciTE (F) (1999)

AdheSE(2002)

AdheSE One (F) (2007)

Adhese Universal

(2014)

Enamel conditioning

Expose retentive etching pattern

Total Etch H3PO4

Total Etch H3PO4

AdheSEPrimer

AdheSE One F

Adhese Universal

Dentin conditioning

Modify smear layer and expose collagen and tubules, infiltration and hydrophilic wetting

Syntac Primer

Wetting

Infiltrate collagen with hydrophilic resin. Create transition between hydrophilic substrate and planned restoration via tag formation

Syntac Adhesive

ExciTE (F)

Bonding

Hydrophobic bonding agent to bond to restoration via co-polymerisation with restorative material

Heliobond AdheSE Bonding

Table 4: Bonding steps and how Ivoclar Vivadent adhesives work

Clearly adhesive development has aimed at providing dentists with products that are faster and easier to apply. Adhese Universal essentially belongs to a new class of adhesive rather than a new generation. In essence, it is also a one-bottle self-etch adhesive (1-step) which can also be used according to the total-etch or selective etching techniques (2-step) and for indirect bonding procedures.

Adhese Universal and universal adhesives in general, contain low levels of acidic monomer, and are therefore “mild-etching” adhesives. Adhese Universal has a pH of approximately 2.5 – 3.0. The Adhese Universal matrix is based on a combination of monomers of hydrophilic (hydroxyethyl methacrylate/HEMA), hydrophobic (decandiol dimethacrylate/D3MA) and intermediate (bis-GMA) nature. This combination of properties allows Adhese Universal to reliably bridge the gap between the hydrophilic tooth substrate and the hydrophobic resin restorative, under a variety of surface conditions. Table 5 details the monomer matrix of Adhese Universal.

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Monomer Name Type Purpose

MDP Methacryloyloxydecyl dihydrogen phosphate

Phosphoric methacrylate

Forms strong bond to apatite surfaces. Promotes adhesion to tooth surface by formation of non-soluble Ca2+ salts

MCAP Methacrylated carboxylic acid polymer

Carboxylic acid functional polymer reacts with and bonds to apatite. The presence of many carboxylic acid groups along a polymeric backbone/chain allows multiple bonds to the tooth surface.

HEMA Hydroxyethyl methacrylate

Hydrophilic mono-functional methacrylate

Promotes wetting of polar / inorganic and moist surfaces. Assists penetration of liquid filled dentinal tubuli.

Bis-GMA Bisphenol A glycidyl methacrylate

Hydrophilic / hydrophobic crosslinking dimethacrylate

Facilitates compatibility of hydrophilic HEMA and hydrophobic D3MA in the presence of water, thereby preventing phase separation of adhesive. Imparts high mechanical strength and resilience to adhesive layer.

D3MA Decandiol dimethacrylate

Hydrophobic crosslinking dimethacrylate

Enables the reaction of the adhesive with the less polar monomers of the filling or luting composite.

Table 5: Type and purpose of monomers contained in Adhese Universal

Table 6 describes the bonding mechanism of Adhese Universal in more detail i.e. how the different bonding steps/conditions are achieved by the balanced composition of specific components within the formulation. Adhese Universal is considered here when used alone i.e. according to the self-etch technique.

For clarity the traditional working/bonding “steps” as previously set out in table 4 are used, however, it should be made clear that with a one-step/one-liquid system, the steps are achieved simultaneously not consecutively.

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Scientific Documentation Adhese® Universal Page 13 of 42

Working Step Purpose of step Adhese Universal

Enamel conditioning

Formation of a stable bond via strongly bound monomer layer on enamel surface

Hydrophilic phosphate group of MDP facilitates mild acid demineralisation and formation of stable calcium salts and chemical bond to hydroxyapatite

Agitation of adhesive for 20s maximizes contact of acid monomers (MDP and MCAP) with enamel surface

Reliable wetting of apatite due to synergistic effect of MDP and MCAP promoting higher bond strengths to enamel

Precipitation of MDP as calcium salt provides stable bond to apatite and promotes marginal integrity

Dentin conditioning

Hybridisation and stabilisation of smear layer

Formation of a stable bond via strongly bound monomer layer on dentinal surface

Hydrophilic phosphate group of MDP facilitates mild acid demineralisation and formation of chemical bond with calcium and hydroxyapatite

Agitation of adhesive for 20s maximizes contact of acid monomers (MDP and MCAP) with dentin surface

Infiltration of dry and moist dentin facilitated by hydrophilicity of HEMA – and due to mild etching nature, dentin is not over-demineralised

Wetting Infiltrate collagen with hydrophilic resin.

Infiltration of hydrophilic surfaces facilitated by hydrophilic monomers

Bonding

Create compatibility and transition between hydrophilic tooth substrate and hydrophobic composite

Transition between hydrophilic tooth substrate and hydrophobic restorative aided by the hydrophilic/intermediate/hydrophobic monomer combination of HEMA, BisGMA and D3MA respectively

Table 6: How Adhese Universal components achieve a bond as a one-step universal adhesive

6.2.2 Desensitisation Dentin hypersensitivity is a common condition, notably after dental restorative work. It is generally agreed that hypersensitivity occurs due to fluid movements within the dentin tubuli in response to stimuli such as cold, warmth or osmotically active substances such as sugar.30

The water/ethanol solvents and the integrated micro-fillers used in Adhese Universal are designed to enhance penetration into the dentin tubuli to ensure the formation of a reliable dentin seal by a homogenous adhesive layer with defined resin tags. In addition, the acidic monomers contained in Adhese Universal trigger a coagulation of the proteins in the dentinal fluid - so contributing to the mechanical sealing of the tubuli by helping to prevent fluid movement and thus postoperative sensitivity associated with that movement. A combination of thixotropic silica and carboxylic acid functionalised polymer also facilitates the uniform film-formation of Adhese Universal. During the recommended 20 second scrubbing application, the adhesive flows over, penetrates and covers the dentine uniformly. Diffusion through the smear layer aids mechanical sealing and thus desensitisation. (See section 8.5 Adhese Universal – dentin penetration: bond and desensitisation).

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Scientific Documentation Adhese® Universal Page 14 of 42

6.2.3 Adhesive cementation of indirect restorations Adhesive layer thickness is an issue when seating indirect restorations. Adhese Universal is always “thinned out” with compressed air to form a thin coating – aided by the thixotropic silica filler. The adhesive layer is light-cured before seating indirect restorations – eliminating the need for an additional dual-cure activator (DCA). Curing Adhese Universal immobilises the acid monomers and allows good polymerisation at the adhesive-cement interface without a DCA (see section 8.4 for tests with indirect restorations).

The mild etching formulation also renders Adhese Universal compatible with the initiator systems of light and dual-curing luting composites and light, dual and self-curing core build up composites.

6.3 Advanced delivery via VivaPen

Adhese Universal is available in the unique VivaPen® for precision dispensing as well as quick and easy intraoral application for optimum efficiency with minimum waste. The VivaPen features an easy-to-use click mechanism and enables targeted, single-handed deployment of the adhesive exactly where it is needed. A few clicks are sufficient to saturate the brush tip of the snap-on cannula. The amount of adhesive left in the VivaPen can be checked via the fill-level-window at the end. Adhese Universal is also available in a bottle delivery form.

Fig. 4: Adhese Universal VivaPen with snap-on brush cannulas

The VivaPen is designed to keep solvent loss by evaporation to an absolute minimum. This is in contrast to adhesives dispensed from bottles where a higher degree of solvent loss is simply unavoidable. As such, the VivaPen delivery form helps to keep the liquid sealed ensuring maximal applications per ml and consistent adhesive viscosity. In a study by Berndt & Partner regarding the efficiency of the VivaPen and other adhesive delivery forms, it was found that the VivaPen delivered up to 190 single tooth applications per pen.

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Scientific Documentation Adhese® Universal Page 17 of 42

7. Technical Data Adhese Universal

Standard - Composition (in weight %)

Methacrylates 67.0

Water, Ethanol 25.0

Highly dispersed silicon dioxide 4.0

Initiators and Stabilisers 4.0

Physical properties: Shear bond strength

In combination with:

- direct restorative composites

- light-curing composite cements

- light-curing core build-up composites

Test method Specification Example value**

Dentin Enamel

MPa MPa

ISO 29022 ISO 29022

≥ 25* ≥ 17*

33.1 ± 3.921.5 ± 3.3

* 4 from 5 test pieces ** SE Modus in combination with Tetric EvoCeram (light-curing)

In combination with:

- self-curing core build-up composites

Test method Specification Example value***

Dentin Enamel

MPa MPa

ISO 29022 ISO 29022

≥ 25* ≥ 14*

28.0 ± 5.629.8 ± 3.7

* 4 from 5 test pieces *** TE Modus in combination with MultiCore Flow (self-curing)

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Scientific Documentation Adhese® Universal Page 26 of 42

Shear bond strength to enamel substrate. Shear bond strength to dentin substrate. M Irie, Okayama University Japan

and

Marginal sealability of modern self-etch adhesives in composite restorations. M Irie, J Tanaka, T Matsumoto, Y Maruo, G Nishigawa, S Minagi, D Watts*. Okayama University Japan, *University of Manchester UK. Abstract accepted: AADR Charlotte USA, March 2014

Irie investigated shear bond strengths to human enamel and dentin substrates when bonding the composite Clearfil AP-X/Kuraray with the following “universal” composites: Adhese Universal, Scotchbond Universal/3M ESPE, Prime & Bond Elect/Dentsply, OptiBond XTR/Kerr, All-Bond Universal/Bisco and BeautiBond Multi/Shofu. After application of the adhesives according to manufacturer instructions, a Teflon mould was clamped to the substrate surfaces and filled with the composite. Shear bond strength values were measured immediately after light-curing and after one day storage in water at 37°C. The table below shows the shear bond strength values after one day storage.

Fig. 16: Shear bond strengths of various “universal” adhesives when used with the self-etch and total-etch techniques. M Irie, Okayama University, December 2013

(Optibond XTR not indicated for total etch technique) Irie et al also investigated the percentage of perfect margins i.e. no marginal gap when bonding the composite Clearfil AP-X/Kuraray with various modern self-etch and “universal” adhesives: Prime&Bond Elect/Dentsply, Scotchbond Universal/3M ESPE, OptiBond XTR/Kerr, G-aenial Bond/GC, BeautiBond Multi/Shofu, Bond Force/Tokuyama and Clearfil SE Bond 2/Kuraray

Cylindrical Class I cavities (diameter 3.5 mm, depth 1.5 mm) were placed in premolars. A restorative procedure was performed according to manufacturer instructions. The restored tooth was polished immediately after light-curing and marginal gap formation was assessed using a microscope (x 400) and expressed as a percentage of the measured teeth (n=10 per group).

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8.4.2 ImImmediabondingtakes ptechniquimprovedentin s InfluencSchaan An inteimmediapetroleu Methodlight-cur(n=5). Tweeks iwas clewas rinsout usinrestorat Result

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Scientific Documentation Adhese® Universal Page 32 of 42

8.4.3 Film-thickness and accuracy of fit Investigation of film-layer thickness of Adhese Universal using white light interferometry. R&D Schaan May 2013

Adhesive layer thickness is an issue when seating indirect restorations. Adhese Universal is always “thinned out” with dispersed air (which is aided by the inclusion of thixotropic silica) and subsequently light cured before seating indirect restorations – eliminating the need for an additional dual-cure activator (DCA). Curing Adhese Universal immobilises the acid monomers and allows good polymerisation at the adhesive-cement interface without a DCA. As shown below, the cured adhesive exhibits a layer thickness of < 10µm on bovine dentin enabling the seating of even very tight-fitting indirect restorations.

Figure 22a represents a tooth surface (as seen from above) embedded in resin, which has been coated with Adhese Universal, dispersed with air and light cured. After curing, any unpolymerised material (inhibition layer) was rinsed away with ethanol. The film-thickness profile was calculated via the use of white light interferometry. This is a non-contact optical method for surface height measurement on 3-D structures with surface profiles varying between a few micrometers and a few centimeters. The pale circular ring around the outside of figure 22a shows where the adhesive rises in height due to the blowing action. Figure 22b depicts this profile graphically. At the very left the level is set at 0 where the tooth surface has no adhesive. Left and right the profile is also higher (graphically equivalent to the pale ring in figure 22a) representing how the layer was blown to the sides. The middle of the graph however (which represents the clinical situation) shows a consistently low film thickness of <10µm.

Fig. 22a-b Adhesive Universal layer on tooth surface sample viewed from above (left) and film-layer thickness profile (right). R&D Schaan, May 2013

Conclusion: The investigation shows the thin film-layer thickness of Adhese Universal consistent with providing for accuracy of fit with indirect restorations. The graph also emphasizes the importance of dispersing the adhesive with oil and moisture-free compressed air until a glossy immobile film layer results – as indicated in the instructions for use.

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Scientific Documentation Adhese® Universal Page 33 of 42

Marginal gap formation and accuracy of fit with indirect restorations. R&D Schaan, October 2013

The influence of Adhese Universal on accuracy of fit when used for bonding indirect restorations was investigated by three Ivoclar Vivadent dentists. Nine extracted, caries-free human molars of similar size (3 per dentist) were prepared with inlay cavities of the same size. Inlays were prepared using IPS e.max Press (LT), (spacer: Tru Fit Stumpflack/G. Taub Dental was used) and fitted to the cavities. With the non-adhesively-fixed inlay in each tooth, a mould and plaster die of each was made. This was used as a baseline model to quantify any changes in marginal gap after adhesive bonding. The 9 teeth were treated with Adhese Universal, according to the instructions for use and light-cured. Variolink II cement was applied to the pre-treated inlays and the inlays were placed and cured with Bluephase Style for 20 seconds in the cavities. Further moulds and plaster dies of the adhesively-bonded inlays were made for comparison. Both dies were scanned using an es1 scanner, compared and differences in the marginal gap recorded and assessed. As shown in table 8 none of the teeth exhibited an increase in marginal gap over 50 µm (related to the application of both the adhesive and the cement) which was set as the acceptance limit for not negatively affecting accuracy of fit. Inlay Dentist 1 Dentist 2 Dentist 3

1 45 µm 30 µm 40 µm

2 15 µm 30 µm 45 µm

3 10 µm 25 µm 15 µm

Table 8: Increase in marginal gap size after bonding IPS e.max Press inlays with Adhese Universal and Variolink II for different dentists/teeth. R&D Schaan, October 2013

There was no excessive increase in marginal gap size after bonding tests together with Variolink II i.e. no negative effect on accuracy of fit. Conclusion: Minimal marginal gap increase supports the thin film-building qualities of Adhese Universal and thus its suitability for use with indirect restorations.

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Scientific Documentation Adhese® Universal Page 34 of 42

8.5 Adhese Universal – dentin penetration: bond and desensitisation An ultra-morphological characterization of dentin using an experimental adhesive – Adhese Universal: Final Report. M. Lopes. University of Lisbon, Portugal. August 2013 Manuela Lopes, at the University of Lisbon, studied the ultra-morphological effects of Adhese Universal on dentin using electron microscopy.

Method: 56 extracted human molars (refrigerated in a solution of 0.5% chloramine for up to one month post-extraction) were used in this study. Teeth were left in distilled water at 37°C for 24 hours, then the occlusal enamel was removed with an Isomet 1000 diamond saw (Buehler Ltd) and 56 dentin discs with a thickness of 800 ± 200 µm were obtained from middle dentin by slow speed sectioning. A standard smear layer was created on the occlusal surface by wet sanding with 600-grit SiC sandpaper for 60 seconds. Adhese Universal was applied to the dentin surfaces and specimens were randomly divided into 4 equal (n=14) groups.

Group 1 Group 2 Group 3 Group 4

Self-Etch Total-Etch

Dry Wet Dry Wet

Dentin dried with compressed air for 5 s

Excess water blotted using moist cotton pellet

Phosphoric acid applied for 15 s and rinsed off for 10 s.

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pellet

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Table 9: Groupings of human teeth according to Self-Etch, Total-Etch and wet or dry techniques. M. Lopes, University of Lisbon, August 2013

After the application of Adhese Universal, a 1 mm thick layer of Tetric EvoFlow was applied to the treated dentin and light-cured for 40 seconds. The discs were then cross-sectioned into two identical halves. One half was examined with a scanning electron microscope (SEM) the other half was assigned to investigation with a transmission electron microscope (TEM) and nano-leakage – made observable by immersing the dentin specimens in silver nitrate.

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Results: (SEM) Both self-etch groups (dry and wet) exhibited a sealed acid-resistant resin-dentin inter-diffusion zone. Adhese Universal penetrated profusely into dentin tubuli up to 100 µm in all specimens analysed (see figure. 23a-b). The hybrid layer was 0.6 - 0.8 µm thick. In both total-etch groups (dry and wet) the hybrid layer was thicker at 3.5 - 5.0 µm, and densely infiltrated (see figure 24a-b). Resin tags were funnel shaped with peri-tubular triangular hybridisation characteristic of most total-etch systems.

(TEM) Both self-etch groups (dry and wet) showed heavy density of hydroxyapatite crystallites inside the hybrid area. In both total-etch groups (dry and wet) the dentin was demineralised to a depth of 3.5 - 5.0 µm, without morphological evidence of hydroxyapatite crystallites in the hybrid layer. The hybrid layer was very well-defined. The resin tags were filled to their entire extension. The least amount of nano-leakage (observable as dark spots of infiltrated silver nitrate) within the hybrid layer was obtained with the self-etch technique (dry and wet).

SELF-ETCH – dry SELF-ETCH - wet

Fig. 23 a-b: SEM of dentin tubuli after application of Adhese Universal using the self-etch technique under dry (left) and wet (right) conditions. M. Lopes, University of Lisbon, August 2013

TOTAL-ETCH – dry TOTAL ETCH - wet

Fig. 24 a-b: SEM of dentin tubuli after application of Adhese Universal using the total-etch technique under dry (left) and wet (right) conditions. M. Lopes, University of Lisbon, August 2013

Conclusion: The SEM photos show relatively uniform sealing/mechanical blockage of the dentin tubuli under all conditions – supporting the ability of Adhese Universal to form a strong bond to dentin whilst providing protection from hypersensitivity. More sealed tubuli are visible in figures 24a-b than figures 23a-b (irrespective of the magnification) due to the total etch technique having removed the smear layer. The similarity between dry and moist substrates supports the lack of technique sensitivity with Adhese Universal.

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9. Clinical Investigations Clinical trials remain the ultimate way to collect scientific evidence on the clinical effectiveness of an adhesive/restorative treatment.33 Currently baseline results from an internal clinical investigation are available. Recalls will be conducted at 6 months, 1 year, 2 years and 5 years. External clinical investigations are due to commence early 2014.

Baseline Report: Clinical observations with Adhese Universal in Class I and Class II cavities. R&D Clinic Schaan, Liechtenstein. December 2013

Introduction Adhese Universal was applied in the internal clinic at Ivoclar Vivadent. Baseline results are available. The main priority of this observation-study was to monitor Adhese Universal-bonded fillings using the etch & rinse (total-etch) technique in Class I and II cavities - as this technique represents the highest risk with regard to postoperative sensitivity.

Methods

40 etch & rinse i.e. total-etch-technique fillings using Adhese Universal are to be applied to vital teeth via four different internal dentists at Ivoclar Vivadent. 32 restorations have been carried out so far.

Adhesive: The enamel margins of the cavities were conditioned with Total Etch for 30 seconds and the dentin was conditioned for 15 seconds. The etch gel was removed with water and the cavity was dried until a white etch pattern was visible on the enamel. Starting with the enamel, Adhese Universal was then rubbed into the surfaces of the cavity for 20 seconds, dried with air and polymerised with Bluephase Style for 10 seconds. The light in the clinic was dimmed to its lowest level or set to orange-mode.

Composite: An optional layer of Tetric EvoFlow could be applied to the cavity floor which was polymerised separately. All fillings were then completed with Tetric EvoCeram Bulk Fill in layers with a maximum thickness of 4 mm. Each layer was cured for 10 seconds with Bluephase Style.

The baseline evaluation was carried out by the respective dentist, approximately 1 week after the placement of the filling. A clinical observation was carried out, an evaluation of aesthetic integration and marginal quality and patients were asked of their personal experience regarding post-operative sensitivity and occlusion. FDI evaluation criteria34 were used to rate the restorations i.e. α = clinically excellent, α2= clinically good, β=clinically satisfactory, γ=clinically unsatisfactory (but repairable) and δ= clinically poor (replacement necessary). Any problems with occlusion were checked and corrected if necessary.

Results

The results as relevant to the adhesive are presented here i.e. aspects such as the aesthetic ratings of the fillings are not discussed. Of the 32 fillings applied so far, 13 were Class I and 19 Class II fillings. The choice of delivery form i.e. VivaPen or bottle was left open to the clinician.

Application of Adhese Universal: Application via the VivaPen and brush cannula was seen as unproblematic, as was the use of the bottle delivery form. The viscosity of the material allowed rapid wetting of all required surfaces, a visible thin film was left even after blowing with a very strong stream of air. No pooling of material was observed. Light sensitivity proved unremarkable with no premature polymerisation of the material observed. The composites Tetric EvoFlow and Tetric EvoCeram Bulk Fill were easy to apply on top of the adhesive and exhibited good adaptation

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Postoperative Sensitivity: After one week all restorations were evaluated as α (100%) i.e. no hypersensitivity/normal vitality after testing by the dentist with cold spray and mechanical disturbance. Patients were also separately asked to give their own opinion regarding postoperative sensitivity within the first week. Thirty reported no hypersensitivity (α) and two patients reported initial sensitivity after placement, which had disappeared by the following day. In these two cases self-assessed postoperative sensitivity was rated as α2 i.e. minimal sensitivity for a limited time period with normal vitality.

Quality of restoration: 25 of 32 fillings were given the top rating α, 7 fillings were rated α2 due to whitish margins despite polishing – these irregularities affected a maximum of 25% of the circumference of the filling. The pictures below show one of the α-rated (after one week) restorations with Adhese Universal:

Fig.25a: Initial situation – insufficient amalgam filling in tooth 26 (mirror image)

Fig. 25b: Application of Adhese Universal

Fig. 25c: Situation after restoration with Adhese Universal and Tetric EvoCeram Bulk Fill. Fissures have been characterised and margins polished.

Fig. 25d: Baseline situation after approximately one week. Perfect (α) margins and clinically faultless performance.

Conclusion

In combination with a standard etch & rinse (total-etch) protocol, Adhese Universal exhibited excellent results in Class I and II cavities. It can be assumed from the baseline data that the adhesive is uncritical with regard to postoperative sensitivity. Application via the VivaPen was smooth and trouble-free.

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10. Biocompatibility

10.1 Introduction

Medical devices are subject to very strict requirements, which are designed to protect patients and operators from any potential biological risks. ISO 10993 “Biological evaluation of medical devices” defines how the biological safety of a medical device is to be evaluated. Furthermore, dental medical devices are subject to ISO 7405 “Preclinical evaluation of biocompatibility of medical devices used in dentistry”. The biocompatibility of Adhese Universal has been examined according to these standards.

10.2 Cytotoxicity

Cytotoxicity refers to the destructive action of a substance or mixture of substances on cells. The XTT assay is used to examine whether or not a substance causes cell death or inhibits cell proliferation in a cell culture. The XTT50 value refers to the concentration of a substance which reduces the cell number by half. The lower the XTT50 concentration of a substance, the more cytotoxic it is.

Uncured Adhese Universal was tested for cytotoxicity in vitro 35. As is to be expected on the basis of its monomer composition, uncured Adhese Universal exhibited cytotoxic potential in the XTT assay with an XTT50 value of 138.1µg/ml. When the adhesive is polymerised, the cytotoxic compounds (monomers) react and are immobilised; i.e. the cytotoxic effect of the uncured adhesive is limited in time. To reduce the risk of any cytotoxic effect on the pulp in very deep cavities, areas close to the pulp must be selectively coated with calcium hydroxide liner (e.g. ApexCal®); and subsequently covered with a pressure-resistant cement (e.g. a glass ionomer cement such as Vivaglass® Liner). Cytotoxicity is common to most dental adhesives in clinical use. Negative effects due to this cytotoxicity however, have not been observed so far. When applied according to the instructions of use, the cytotoxicity of Adhese Universal can be considered acceptable.

10.3 Genotoxicity

Genotoxicity refers to the capability of a substance or a mixture of substances to damage genetic material.

Adhese Universal has been examined regarding its potential gene changing properties via Ames mutagenicity tests 36. Adhese Universal did not induce gene mutations by base pair changes or frameshifts in the genome of the strains used. Adhese Universal is not considered genotoxic.

10.4 Sensitisation and irritation

Like all resin-based dental materials, Adhese Universal contains methacrylate and acrylate derivatives. Such materials may have an irritating effect and may cause sensitisation. This can lead to allergic contact dermatitis. Allergic reactions are extremely rare in patients but are increasingly observed in dental personnel, who handle uncured composite material on a daily basis.37-43. These reactions can be minimized by clean working conditions and avoiding contact of unpolymerised material with the skin. Commonly employed gloves, made of latex or vinyl, do not provide effective protection against sensitisation to such compounds.

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Conclusion

Having tested the toxicity and mutagenicity of Adhese Universal, the following conclusions can be drawn:

Uncured Adhese Universal is cytotoxic due to its monomer composition. After polymerisation, the monomers are immobilised within the polymer network, thus the cytotoxic effect is reduced shortly after application of the adhesive.

Adhese Universal, particularly in the uncured state may cause sensitisation to methacrylates. This is typical for all resin-based dental materials.

According to the data available Adhese Universal is not genotoxic. In summary, Adhese Universal is safe for use in humans if it is used according to the instructions given. Possible side effects, such as the sensitising property of methacrylates, occur infrequently in patients and the risk is negligible compared to the overall benefit of Adhese Universal.

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We take no responsibility for the accuracy, validity or reliability of information provided by third parties. We accept no liability regarding the use of the information, even if we have been advised to the contrary. Use of the information is entirely at your own risk. It is provided “as-is” or “as received” without any explicit or implicit warranty, including (without limitation) merchantability or fitness for a particular purpose, or regarding (without limitation) usability or suitability for a particular purpose.

The information is provided free of charge. Neither we, nor any party associated with us are liable for any incidental, direct, indirect, specific, special or punitive damages (including but not limited to lost data, loss of use, or any costs of procuring substitute information) arising from your or another’s use/non-use of the information, even if we or our representatives are informed of the possibility thereof. Ivoclar Vivadent AG Research and Development Scientific Services Bendererstrasse 2 FL - 9494 Schaan Liechtenstein Contents: Joanna-C. Todd / Dr Erik Braziulis Issued: January 2014