Monobond Etch&Prime

Scientific Documentation

Table of Content

1.

Introduction................................... .................................................................................. 2

1.1

The su cess of gl ss ceramic s ............................................................................... 2

1.2

The br nd Monob nd .............................................................................................. 3

1.3

Etching with hydrofluoric acid .................................................................................. 4

1.4

Monob nd Etch & Prime ......................................................................................... 5

1.5

The m chanism ..................... .................................................................................. 6

2.

echnical Data for Mo obond Etc & Prime .................................................................. 8

3.

aterials s ience and hysical inv estigations ................................................................ 9

3.1

Adhesi n to restor ative mater ials ............................................................................ 9

3.1.1

Tensile strength on various substrates ................................................................ 9

3.1.2

Tensile strength of various adhesives and primer on IPS e. ax CAD ........... 11

3.1.3

Shear bond strength of vari ous adhesives and primers on IP S e.max C D .... 12 12

3.1.4

Shear bond strength on IP e.max C D ........................................................... 13

3.1.5

Con lusion: ........................ ................................................................................ 14

3.2

onobond E tch & Prim versus hydrofluoric a cid ..................... 14

3.2.1

Scanning electr n microsc pe investi ation...................................................... 14

3.2.2

Mec anical pro erties (flex ural strength) ........................................................... 16

3.3

Tolera ce to cont mination ... ................................................................................ 17

3.4

User tolerance ....................... ................................................................................ 18

4.

5.

Etching effect of

iocompati ility............................. ................................................................................ 19

4.1

Introdu tion............................ ................................................................................ 19

4.2

Cytoto icity ............................ ................................................................................ 19

4.3

Genotoxicity........................... ................................................................................ 19

4.4

Skin irritation and skin damag e ............................................................................. 19

4.5

Sensiti ation .......................... ................................................................................ 20

4.6

Conclu ions: .......................... ................................................................................ 20

4.7

Toxicological data.................. ................................................................................ 20 eferences ................................... ................................................................................ 21

Scientif ic Docume tation Monobond Etc & Prime

Pag 1 of 22

1. Int roducti n 1.1 Th e succes of glass ceramics Glass eramics b came a s ccessful al ternative t amalgam or metal i lays and nlays in the posterior filling therapy si ce IPS Em press was launched i the 1990s . Long-ter clinical trials confirm the success rat [1,2,3] Thi s outcome was not a atter of c urse. Former glass cerami inlays, for example Dicor (De ntsply) sh wed a hi h numbe of fractur es after cement ing with gl ss ionom r cements [4]. With the implem ntation of an adhesi e luting proced re the s rvival of IPS Empr ss and ther glass ceramic brands h s been dramatically impro ed [5].

Fig. 1: Treatme t of teeth 6 and 17 amallgam

ith

Fi . 2: Treat ent of teet h 16 and 1 with gl ss cerami onlays

The adhesive luti g procedure is base on a co posite material and an adhesive which bonds to dentin and enam l. This c n be done in an e ch-and-rin e mode including phosphoric acid tching or with self-et ching adh sives. Th bond to the glass ceramic surface is achieve by etchin and silani zation. Glass ceramic can be etc hed by hydrofluoric acid forming a micro-retenti e etching pattern. The bulky lass is m ore susce tible by dissolution by the cid than the crystal p rts. A rough ceramic urface is o btained. In a s cond ste a chemi al bond i s formed by silanization. In g neral a f nctional methacrylate is us d with a trimethoxysil ane endgroup. These rocedure llows a perfect s aling of th dentin an enamel interface  a strong bond to the r storation  a high str ngth of the cement, which mi imizes tensile loads within the ceramic  structure Adhesi ely luted eramic inlays and o lays in the posterior region pr vide a number of advant ges to oth r restorative alternativ es, i.e. am lgam, glass ionomers or composites. Scientif ic Docume tation Monobond Etc & Prime

Pag 2 of 22

  

Ceramic is known as ioinert Ceramic is less prone to wear an discoloration Due to its stiffness nd its ha dness similar to en mel, cera ic shows a good adaptation to the rem ining tooth walls

1.2 Th e brand

onobond

The bonding of omposites reactiv agent is silane m dioxide surface (see fig.2). matrix during curing. Besid wettability of the hydrophili compo ite.

to glass eramic surfaces is chieved b y silanization. The thacrylate which for s a strong chemical bond to the silicon he remain ing methacrylate gro p reacts ith the c mposite s the che mical bon ing, the silanization also impr ves the ceramic surface for an easi r adaptati on of the organic

O HO H3C H2C

C

C

O H3 O

R

Si

O

Silane

O

OCH3

HO

O H3

ethacrylate

Si

Si O

Silicate surfac (schematic )

O H3C 2C

C

O

OH O R Si O

S O S O

Methacrylate silicate compound

Fig. 3:

chematic epresentation of the s ilanization eaction mechanism


Pag 3 of 22

Ivoclar Vivadent launched M nobond S as silanizi g product omposed of trimetho ypropyl methacrylate and solvent in 991. It pro ved its cli ical efficie cy in a nu mber of st dies [1] and su ported the success of glass cer amic resto ations in combination with Variolink II or Dual C ment. In 200 Monobon d Plus was launche by Ivocl r Vivaden . Monobo d Plus allows the priming and conditioning of different r storative ubstrates. It contains the silan plus a phosphoric acid methacrylate and a sul hide in one bottle. Its efficiency could be proved in several studies [6]

1.3 Et hing with hydrofluoric acid The combination f silanization and et hing of glass ceram c surfaces showed t e most effectiv bonding of luting c mposites to glass c ramics [7]. The appliication of diluted hydrofl oric acid f orms a retentive etch ing pattern by dissol ing silicon ions in th glassy state. ilicon has a high c emical af inity to fluoride ions. The form ed silicon fluoride derivati es are soluble and can be rapi ly washed off with w ter. Etchi g of glass ceramic with HF gel is an stablished method co mmonly carried out in the techni ian labora ory. But also dentists know the techni ue. Unfortunately hydr ofluoric acid is a very strong poi on [8] even in the di solute state. It is a weak acid and ca burn the skin. After penetrating it moves q ickly into d eeper tiss e layers and releases the freely dissociable flu oride anio . Fluoride is very to ic due to its high reactivi y. It reacts with cellul r calcium nd magnesium to for insoluble salts. This induces cellular deaths an necrosis. kin conta t with HF ( ven in dilu e solutions ) can caus painful burns t at heal very slowly. Latent dam ages can also be ob erved sin e the fluo ide ions penetrate through all layers of the epid ermis, der mis and e en the de eper subcutaneous tissues causing s vere dest uction, ne rosis and injuries to the underl aying bon due to decalci ication. The hi h toxic potential is t e reason why in so e countri s the app lication of ceramic etching gel is forbidden. A safer but also efficient allternative would be a reat benef it for the user.


Pag 4 of 22

1.4 Mo nobond

tch & Pri me

Mono ond Etch & Prime is a single bottle cer amic prim r which allows etching a nd silaniza ion of the glass cera mic surfac in one step. It contains a trimetho ypropyl m thacrylate for silanization and a ne polyfluoriide for th etching tep. The etching cr eates a roughness patter n which is less prono nced than with HF g l but as efficient for bond ing. The f llowing sil nization re action is similar as with onobond S or Monobond Plus. The effici ency of M nobond Etch Prime is proved by a number of intra- a d extramural bond strength tests (se e chapter ).

Fig. 4: EM photo of the etch pattern of IPS e.max Press after application of Monob nd Etch & Prim . R&D Ivo lar Vivade t AG, Schaan, FL


Pag 5 of 22

With Monobond Etch & Prime the pretr atment of glass ceramic surfac s for the dhesive luting i faster due to less application steps an less har ful due to the avoidance of hydrofl oric acid. lthough Monobond tch & Prime is corrosive its cyto toxicity sh wn in a XTT assay is with a XTT50 val e of 1970.1 g/ml les toxic than many of w ell-accepted dental products. The health risk for t e user is i an accepted level. Due to its milder eactivity there is no r isk of damage to sanitary ceram ic. A neutr alization step b fore disp sal is not necessa y. Monob nd Etch & Prime iis stable t room temper ture.

1.5 Th e mechan ism The ap lication of Monobond Etch & Pri e is linked to its reaction mecha ism: Monob nd Etch& Prime is a plied onto the luting urface wit a microbr ush and is rubbed for 20 s. Monobond Etch & Pri e remove saliva and silicon co tamination s.



Monob nd Etch & Prime rem ins on the surface for further 40 for suffici nt reaction.  

Ammonium polyfluori e reacts ith the cl an cerami surface t o achieve a rough etching pat ern Due to the increased surface a rea a kind of activation of the ceramic s rface is generated

Monob nd Etch & Prime is horoughly washed of f with water and then dried wit anothe 10 s.   

air for

The polyfluoride and t e reaction products with the ceramic are re oved The reaction between the silane nd the active glass ceramic start s A chemically bond thi layer of sil ane remai s.

The co position of Monobon Etch & Pr ime reflect its purpos (table 1). Purpos

Ingr dient

Etching

Am onium pol fluoride

Silaniz tion

Sila e system based o trimethoxypropyl met acrylate Solvents: alcohols and wat er

Handling

Visibilit Foo Colorant: Fast Green Table 1: Composition of Mon bond Etch & Prime


Pag 6 of 22

Fig. 5: Structure of Ammonium polyfluoride Ammonium polyfluoride reacts with the silicon in the glass ceramic without release of HF due to the high chemical affinity between silicon and fluoride. By 19F-NMR spectroscopy (see fig. 6) the absence of HF can be confirmed.

‐156.6

Ammoniu m polyfluorid

ppm

‐165.8 ppm

-120

-140

-160

HF

-180

-200

[ppm]

Fig. 6: 19F-NMR spectrum of ammonium polyfluoride and HF (D 20/EtOD). R&D Ivoclar Vivadent AG, Schaan, FL After the extraoral application the remaining liquid is thoroughly rinsed off. After drying a thin silane layer in molecular scale remains at the luting surface (see fig. 3), which reacts via the methacrylate group with the luting composite during curing. Scientific Documentation Monobond Etch & Prime

Page 7 of 22

2. Techni cal Data for Monobon d Etch & Prime Product category

Product

Monobon d Etch & Prime

Primer for silica glass ceramics

Function

Substance/Component

Etchant

Ammonium polyfluoride

Weight

15 - 25 Silane

Silane methacr ylate

Solvent

Alcoho l and water

Pigment

Colourant

1

Characteristics Bond strength

2

75 - 85

<1

Unit

MPa

Specification ≥

20

Example value

493

1

Physical properties ,

2

Tensile bond strength (24h), light-cured, with dual-curing resin-based dental luting material

3

IPS e.max CAD, Multilink Automix

Scientific Documentation Monobond Etch & Prime

Page 8 of 22

3. M terials cience nd phy ical inv stigati ns 3.1 Ad hesion to restorati e materi ls Monob nd Etch & Prime is a bonding ag ent and as such must promote a strong and durable bond b tween the restorative material (c eramic) and luting co posite. To confirm that this is the case, the bon ing perfor ance of Monobond tch & Prime has bee extensively tested in various material combinations and test conditions . Bondin strength is determi ed using arious test setups; often the s ear bond strength (SBS) and tensile bond strength ( TBS) are measure . In she ar bond strength measur ements, the load is applied para llel to the bonded su face. In te nsile bond strength measur ements, th load is applied perpe ndicular to the bonde surface. Tensile strength measureme ts should d emonstrat less scatt measur ements, a they are less depen dent on the surface bondin material is applied onto a p repared, f lat, retenti restorative material) accordiing to the instructions. Subse previously defined size is ad esively bo nded to th substrate then determined u ing a suitable univers al testing achine.

ring than s hear bond strength tructure o f the mate ial. The n-free su strate block (e.g. uently, a other blo k of a block. Th tensile st ength is

Since the results are highly dependent on the test setup an the test rocedure e.g. the diamet r of the s ecimens), the results of different test series can only be compared with each other to a limited extent [9, 10]. The ill stration b low show restorative materials.

a typical test setu for mea uring the tensile str ngth of

Fig. 7: est speci en for tensile strength testing

3.1.1

ensile str ength on v arious su strates R&D Ivoclar Vivadent G, Schaa , FL

The bo d strength of Monobond Etch & Prime on various ceramic substr tes was evaluated. Test specimens etched with ydrofluori acid and ilanized w th Monobo nd Plus w re used as refe ence. To conduct the measurements, cerami specimen s were fabricated usi ng lithium isilicate (IPS e.max CAD, IVAG), le cite (IPS Empress AD, IVAG , lithium etasilicate (Celtra, Scientif ic Docume tation Monobond Etc & Prime

Pag 9 of 22

Dentsply) and feldspar (Mark II, Vita) and conditioned either with 5% hydrofluoric acid gel (IPS Ceramic Etching Gel) and Monobond Plus according to the manufacturer's instructions or with Monobond Etch & Prime. Subsequently, the specimens were bonded to Multicore Flow cylinders using Variolink Esthetic (see Fig. 7: Test specimen for tensile strength testing. Whilst the reaction time required for hydrofluoric acid etching varied from material to material, Monobond Etch & Prime allowed all the ceramic samples to be conditioned using the same contact time (scrubbing for 20s; leaving to react for 40s). To determine the aging resistance of the adhesive bond, a number of specimens were artificially aged by subjecting them to thermocycling (10,000 cycles between 5 and 55°C). After thermocycling, the tensile bond strength was determined using a universal testing machine (Z010, Zwick-Roell). Zughaftung mit Variolink Esthetic 70 60 ] a50 P M [

HF/MBP 24h

g40 n u t f 30 a h g u Z20

HF/MBP 10kTC MB E&P 24h MB E&P 10kTC

10 0 e.max CAD Empress CAD

Celtra

Mark II

Fig. 8: Tensile bond strength on different ceramic materials: Monobond Etch & Prime (MB E&P) versus Monobond Plus (MBP) with hydrofluoric acid etching (HF), both in combination with Variolink Esthetic as the luting composite. The test specimens were examined after 24-h immersion in water or after 10,000 episodes of thermocycling between 5 and 55°C (10k TC).

Monobond Etch & Prime was also tested in combination with Multilink Automix on IPS e.max CAD and IPS Empress CAD samples. In this combination, Monobond Etch & Prime also showed tensile bond strength values comparable to the conventional combination of hydrofluoric acid etching plus Monobond Plus.


Page 10 of 22

Tensile Bond Strength wit h Multilink Aut omix 70 ] a60 P M [ h t 50 g n e40 r t S d n30 o B e l i 20 s n e T10

HF/MBP 24h HF/MBP 10kTC MBEP 24h MBEP 10kTC

0 e.max CAD

Empress CAD

Fig. 9: Tensile bond strength on different ceramic materials: Monobond Etch & Prime (MBEP) compared with Monobond Plus (MBP) and hydrofluoric acid etching (HF), both in combination with Multilink Automix as the luting composite. The test specimens were examined after 24-h immersion in water or after 10,000 thermocycles between 5 and 55°C (10k TC). Conclusion : Monobond Etch & Prime produces a similarly high aging-resistant adhesive

bond on various ceramic materials as Monobond Plus after hydrofluoric acid etching.

3.1.2

Tensile str ength of various adhesives and primers on IPS e.max CAD

R&D Ivoclar Vivadent AG, Schaan, FL Some manufacturers claim that their universal adhesives can generate a sufficiently strong bond to both the tooth structure and restorative material and are therefore suitable for being used as a bonding agent on ceramic materials after hydrofluoric acid etching. The bonding strength of various product combinations consisting of adhesive / primer and luting composite was examined in relation to the following products: Manufacturer 3M ESPE Kerr BISCO Ivoclar Vivadent

Primer / Adhesive HF Scotchbond Universal HF Optibond XTR HF Allbond Universal HF Monobond Plus no HF Monobond Etch & Prime

Luting composite RelyX Ultimate Nexus NX-3 Duolink Variolink Esthetic DC

Table 2 The following tensile bond strength results were measured on sandblasted titanium or sandblasted & anodized titanium samples after 24 hours and after 10k TC:


Page 11 of 22

Tensile Bond Strength on e.max CAD 60 initial

10k Thermocycles

50

]40 a P M [ h t30 g n e r t S20 d n o B e10 l i s n e T

0

Variolink Estethic Monobond Plus

Relyx Ultimate Scotchbond Universal

Nexus NX‐3 Otpibond XTR

Duolink Allbond Universal

Variolink Estethic Monobond Etch & Prime

Fig. 10: Tensile bond strength of various adhesives and primers on IPS e.max CAD * RU/SBU, DL/ABU: 1 debonding episode each (included as a value of 0 MPa in the mean value calculation) ** NX3/OBX: 2 debonding episodes each (with each episode being given 0 MPa in the mean value calculation)

Conclusion: The investigation has shown that Monobond Etch & Prime produces an

adhesive bond that is similarly strong and reliable as the bond established with Monobond Plus after hydrofluoric acid etching. By contrast, the universal adhesives resulted in a clearly weaker adhesive bond with spontaneous bond rupturing occurring in some samples in the course of thermocycling.

3.1.3

Shear bon d strengt h of vario us adhesives and primers on IPS e.max CAD

R&D Ivoclar Vivadent AG, Schaan, FL Similar to the tensile bond strength investigation described in Section 3.1.2, the shear bond strength was also evaluated in a comparison with other systems. The following adhesives / primers and luting composites were tested: Manufacturer 3M ESPE Kerr BISCO Ivoclar Vivadent

Primer / Adhesive HF Scotchbond Universal HF Optibond XTR HF Allbond Universal HF Monobond Plus no HF Monobond Etch & Prime

Luting composite RelyX Ultimate Nexus NX-3 Duolink Multilink Automix

Table 3


Page 12 of 22

She r Bon d Stre ngth o n IPS .max CAD 6 ] a P M [ ) h 4 2 ( S B S

SBS (24h, 37° )

SB (10kTC)

5 4 3 2 1 Monobond Etch Prime Multilin Automix

Monobond Plus

Optibond XTR

ultilink Automi

NX-3

AllBond Universall Scotchbond niversal Duolink RelyX Ultimate

Fig. 11: Shear bond strength n IPS e.max CAD: comparison of Monobon d Etch & P ime, Monob nd Plus (HF) and various univers al adhesiv s Conclu sion: The shear bon strength i nvestigation showed strengt investiga ion: the highest and most reliable bond Monob nd Plus and Monob nd Etch Prime. The adhesi adhesives - except for Scotchbond Universal – failed thermo ycling. 3.1.4

similar pi cture as th trengths ere achie e bonds f all the to withst and stres

tensile ed with niversal ing by

Shear bo n strength on IPS e. ax CAD M. Irie, Ok yama University, Jap n

The sh ar bond strength of by Prof . Irie at Okayama Uni test sp cimens a cording to directly compared with the s use diff erent meth ds.

onobond tch & Prime on IPS e.max CAD was also e amined ersity. Th bond strength value were det rmined on 3.6-mm ISO TR 11405: 200 [11, 12]. Hence, the results c nnot be ear bond trength values obtained in othe investigations that

Shear Bond trengt ] 50 a P M40 [ h t g n30 e r t S d20 n o B r 10 a e h S 0

MBEP MBP

30min

1d

Fig. 12: Shear bond strength alue of Mo nobond Et h & Prime (MBEP) an d Monobo d Plus (MBP) n IPS e.m x CAD. Scientif ic Docume tation Monobond Etc & Prime

Page 13 of 22

Also in this study onobond tch & Pri e and Mo obond Plu achieved comparati ely high bond strength val es on IPS e.max CA D both at he initial easureme nt after 30 minutes and aft r 24 hours.. 3.1.5

Conclusio

Tensile and shear bond str ngth inve tigations learly sho that ded icated pri ers are clearly better sui ed for pr viding an aging-res istant adh sive bond to glass ceramic materials than uni ersal adhesives.

3.2 Et hing effect of Monobond Et h & Prim e versus

ydrofluo ric acid

Monob nd Etch & Prime repl ces the c nventional two-step ceramic con ditioning p ocedure of etching with diluted hydrofl oric acid ( 1) and priming with M nobond Pl s (2) with singlestep pr cedure. In the process of cerami c etching, he microretentive surf ace increa es. The reactio time of h drofluoric cid has to be adapte to each c ramic to a chieve a p opitious surface structure. y contrast, the applic ation of M nobond Etch & Prime requires t e same reactio time for all ceramic aterials: sc rub for 20s and leave to react for 40s. 3.2.1

Scanning lectron m icroscope investigati on R&D Ivoclar Vivadent G, Schaa , FL

The et hing effec of Mono ond Etch & Prime and hydrofl oric acid as exami ed and compar ed by me ns of a canning e lectron microscope i vestigatio . To con uct the investigation, surf ce-ground flat cera ic samples made of lithium di ilicate (IP e.max CAD, IVAG), leu ite (IPS Empress C D, IVAG),, lithium metasilicate (Celtra, D ntsply), feldspar (Mark II, ita) were onditioned with IPS eramic Etching Gel o Monobon Etch & Prime ccording to the inst uctions for use and then rinse with wat r. In addi ion, the samples were rinsed with al ohol and leaned in an ultraso ic cleaner. Subsequently, the surfaces were analysed in a scanning el ctron micr scope (SEM). Table 4 lists the ceramic mat rials and a pplication processes used: C ramic IPS e..max CAD IPS Em press CAD eltra Mark II

IPS eramic Etching Gel 0s ith water 60s rinse ith water 30s rinse ith water 60s rinse ith water

Mono bond Etch

Prime

rinse

sc ub for 20s leave to react f r 40s rin e with water blow dry

Table 4


Page 14 of 22

Without conditioning

Monobond Etch & Prime (60s)

IPS Ceramic Etch ing Gel ((reaction time b/w 20 60s, depending o n material; acc. to IfU)

IPS e.max CAD

IPS Empres s CAD

Celtra

Mark II

Fig. 13: SEM images of glass-ceramic samples after conditioning with hydrofluoric acid or Monobond Etch & Prime Monobond Etch & Prime produced a clear etching pattern on all the ceramic materials investigated; the etching effect, however, was less pronounced than the etching effect of hydrofluoric acid. Although the etching effect of Monobond Etch & Prime is weaker than that of hydrofluoric acid, it is still strong enough to produce sufficient microretention for a reliable adhesive bond, as confirmed by the bond strength measurements (see Section 3.1)


Page 15 of 22

H

20

H

12 0s

Fig. 14: SEM ima es of IPS e.max CA surfaces fter varyin lengths o f contact time with 5% hydrofluoric acid (HF) and Monobon Etch & Prime (MBEP) The sc nning electron micro cope inve tigation cl arly shows that cera ic surfaces do not becom over-etch d even af er having been in contact with onobond Etch & Pri e for a prolonged length f time (120s). After a contact time of 120s, 5% hydrofl oric acid r esults in a substantially str nger etching effect o n the ceramic than it does after the recommended reactio time (20s). 3.2.2

Mechanica l properties (flexural strength) R&D Ivoclar Vivadent G, Schaa , FL

Etching may weaken the flex ral strengt of ceramic materials. For this re ason, the ffects of Monob nd Etch & Prime and hydrofluoric acid etching on the flexural str ength of IPS e.max CAD samples wer examined. The ce amic sam les were ither etche d with Ce amic Etchi g Gel for 20s or co ditioned with Monobond Et h & Prime for 60s. Un treated cer amic was used as refe rence.


Page 16 of 22

800

Flex ral Str ngth

700 600 ] a P M [

500 400 300 200 100 0 non-et hed

Mon bond Etch Prime

Hydro luoric Acid

Fig. 15: Flexural strength of untreated IP S e.max C D and after conditioni ng with Monobond Etch & Prime, hyd ofluoric acid or hydroflluoric acid nd Monob nd Etch & Prime

The fle ural stren th of the IPS e.max CAD samples was only minim lly affecte by the applica ion of Mo obond Etch & Prime and does not differ s gnificantly from the r ference samples. The pra tical effect of weaken ing the ce amic stren th by etch ing is min r; it has been r ported tha flexural s rength red uced by etching was reconstitut d when c mposite was ap lied [13].

3.3 To lerance to contami ation R&D Iv clar Vivad nt AG, Sc aan, FL Cerami c restorati ns often ecome co ntaminated with saliva during i traoral try ins and these ontaminati ons are not always completel removed afterward . In addition, the cerami surfaces may become conta inated with silicone material d ring the f it-check. Remain ing silicon residue i difficult t remove nd may i pair the a dhesive bond. It is therefo e importan that Monobond Etch & Prime establishes a reliable ad hesive bon even if contamination with saliva or ith a silico e-containi g material is present. To examine the t lerance t saliva co taminatio , IPS e.m x CAD te st specimens were contaminated with freshly collected hu an saliva and rinsed with wate before M nobond Etch & Prime as a plied. To exa ine the tolerance to ilicone resi due, the c ramic samples were rought int contact with Vi tual Extra Light Body impressio material for 7.5 minutes and t en the im ression material was rem ved. No ther meas ures were taken to lean the s amples before the applica ion of Mon bond Etch & Prime. Subsequently, the samples were conditi ned with Variolink Esthetic C.


onobond

tch & Pri e and bon ed with

Page 17 of 22

BS after Conta minati n 60 50 ] 40 a P M30 [ S B T 20

24h 10kTC

10 0 Saliva

Virtual

Fig. 16: Tensile b nd strengt of Monob ond Etch Prime / V riolink Est hetic on IPS e.max CAD samples afte contamin tion with s liva and Virtual Extra Light Body respectively The results show that Monob nd Etch & Prime pro uces an a hesive bo d that is tolerant of the contamination hat is likel to occur d uring clinic l procedur es in the d ntal practi e.

3.4 Us er toleran ce R&D Iv clar Vivad nt AG, Sc aan, FL To en ble a st eamlined working p rocedure during the placeme t of mul iple-unit restorations, exce ding the eaction tim e of Monobond Etch & Prime s hould not have an advers effect on the adhesive bond. Lik ewise, it s ould be possible to co ndition res orations some time in advance before they are in serted. Fo this reason, the tensiile bond str ength of cerami samples conditioned with Mo nobond E ch & Pri e was d termined after an extend d applicati n time (2 inutes) an d after 2 w eks of sto age. Protocol

T nsile bon stren th value [ MPa]

2-min te applicat ion time

3.0 ± 5.9

2-week stor ge of con itioned sp cs

6.0 ± 6.3

Sub trate

e. ax

Table 5: Tensile b nd strengt values as an indicat r of the us r toleranc of Monob nd Etch & Prime, applied in conj nction with Variolink sthetic DC As can be seen i n Table 5, accept nce criteria of 20 considered to be ufficiently weeks nd contact times dou

reliable te nsile bond strength values exce eding the required Pa were achieved. Monobond Etch & Prime is therefore olerant of surfaces c nditioned in advance and store for two led in leng th.


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4. Bi ocompa ibility 4.1 Int roduction Medicall devices re subject to very s trict requir ements, w ich are d esigned to protect patient and operators from any potentia l biological risks. ISO 0993 “Biol ogical eval ation of medicall devices” efines ho the biolo ical safety of a medi al device is to be evaluated. Further more, dental medical devices a re subject to ISO 7 05 “Precli nical evaluation of biocompatibility of medical devices used in dentistr ”. The biocompatibilit of Monob nd Etch & Prim has been examined ccording t these sta dards.

4.2 Cy totoxicity Cytotoxicity refers to the destructive acti n of a substance or ixture of s ubstances on cells. The XTT assay is used to examine whe her or not a substance causes c ell death o inhibits cell pro liferation in a cell cult re. The XT T50 value r efers to th concentra tion of a s bstance which r educes the cell number by half. The lower the XTT50 concentrati on of a su stance, the mo e cytotoxic it is. The cytotoxicity of Monobond Etch & Pri e was tested in vitro according to ISO 109 3-5 (1). Monob nd Etch & Prime is w ter soluble and only howed a c totoxic eff ct on the 929 cell line ex mined wh n applied in very hi h concent ations. Th calculate d XTT50 value was 1979.1 g/ml  Given that Monobond Et h & Prime is applied nly in smal l amounts t a time and the applicatio procedure is perform ed extraorally, the cyt toxic risk o f Monobon Etch & Prime i very low f r the patient and use .

4.3 Genotoxicit Genotoxicity refer to the ca ability of genetic material.

substanc or a mixture of sub tances to damage

Monob nd Etch & Prime has been exa ined regar ding its pot ntial gene damaging effect in a num er of mutagenicity te ts. Neithe the Ames assay no the mous e lymphoma assay (MLA) howed an gene damaging effec t for Mono ond Etch Prime (2, 3): On the basis of these r sults, it can be assu ed that Mo nobond Etch & Prime does not h ave any m tagenic potenti l.

4.4 Sk in irritation and ski n damage The irritation potential of Monobond Et h & Prim was measured usin g an EpiD rm skin model (4). To con uct the test, undiluted Monobon Etch & Pr me was di ectly appli d to the EpiDer model fo 60 minutes before th e irritation ffect was ssessed. he test sh wed an irritatio potential f or Monobo d Etch & rime. The corrosive effect of Mon bond Etch & Prime as exami ed in anot her epider al skin model (5). After a 3-minute application ti me, the corrosive effect of Mono bond Etch & Prime was lo ; after 60 inutes the corrosive e ffect had i creased. Monob nd Etch & Prime is designed to have an e ching effe t on cera ic surface . It may therefo e be expected that i has also an irritating and corr osive effec t on the skin. The results showed that a short c ntact time does not d mage the kin.


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Once t e etching rocedure as been co mpleted, onobond tch & Prim e is rinsed from the restoration. Theref ore, patien s are not t risk of b ing affected by the et ching effe t. Users are ma e aware of the mate ial's etchin g effect in he Instructions for Us e and notes on the packagiing. Furthe more, the tching effe ct of Monobond Etch Prime is f ar less severe than the etc ing effect of hydroflu ric acid, hich is wi ely used i ceramic tching pro edures. Given the widespr ad dental use of hyd ofluoric acid, it is ass med that sers have practice in handling corrosi e substan es.

4.5 Sensitizatio Monob nd Etch & Prime co tains met acrylate derivatives. Such mate rials may have an irritatin effect and cause se sitization, hich can lead to alle gic contact dermatitis. Allergic reactio s are extr mely rare in patients but are increasingly bserved i dental personnel, who handle uncur d composite material on a daily basis. The e reaction s can be minimized by clea working conditions and avoidin contact of the unpolymerized m terial with he skin. Comm nly emplo ed gloves, made of latex or vinyl, do n t provide effective p otection against sensitizati n to such ompounds .

4.6 Co nclusion : -

-

Monobond Etch & Pri e is slightl y cytotoxic. It is in the nature of onobond tch & Prime to have n etching effect because it is designed t etch glas -ceramic aterials. T e etching ompounds are rinsed off after completion of the extraoral appl ication procedure an therefore do not c me into contact wit the patient. Monobond Etch & P ime contai ns metha rylates, w ich may c ause sensitization; allergic reactions, however, are e tremely rare in patients. On the ba is of the information known to date, Monobond Etc h & Prime can be considered non-genot xic.

The results have shown that Monobond Etch & Prime is safe for use in umans if it is used according to the I structions for Use. It can be co cluded that the bene fits provided by the product exceed any potential risk.

4.7 To icologic l data (1) (2) (3) (4) (5)

Heppenheim er A. Cyto oxicity ass ay in vitro (XTT-Test). Harlan R port No. 1626302. 1 June 201 . Sokolowski . Salmon lla typhim rium and Escherichi coli reve se mutation assay Harlan Report No. 1626301. 10 Jul y 2014. ollny H-E. Cell mutation assay at the thymidine ki ase locus (TK+/-) in mouse lymphoma L 178Y cells Harlan Re port No. 1642302. 02 eptember 2014. Heppenheim er A. In vit o skin irrit tion test: uman skin model test Harlan Report No. 1 42303. 26 August 20 4. Heppenheim er A. In vitr o skin corr sion test: uman skin model test . Harlan Report No. 1 42304. 28 August 20 4.


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5. References [1] R. Frankenberger, M. Taschner, F. Garcia-Godoy, A. Petschelt, N. Krämer: Leucitreinforced glass ceramic inlays and onlays after 12 years; J. Adhes. Dent. 10, 393 (2008) [2] A. A. Galiatsatos, D. Bergou: Six-year clinical evaluation of ceramic inlays and onlays; Quintessence Int. 39, 407 (2008) [3] P. C. Güß, C. F. Selz, A. Voulgarakis, S. Stampf, C. F. Stappert: Prospective clinical study of press-ceramic overlap and full veneer restorations: 7-year results; Int. J. Prosthodont. 27,355 (2014) [4] R. Stenberg, L. Matsson: Clinical evaluation of glass ceramic inlays (Dicor); Acta Odontol. Scand. 51, 91 (1993) [5] A. Della Bona, J. R. Kelly: The clinical success of all-ceramic restorations; J. Am. Dent. Assoc. 139, 8S (2008) [6] A. Attia, M. Kern: Long-term resin bonding to zirconia ceramic with a new universal primer; J. Prosthet. Dent. 105, 319 (2011) [7] X. F. Meng, K. Yoshida, N. Gu: Chemical adhesion rather than mechanical retention enhances resin bond durability of a dental glass-ceramic with leucite crystallites; Biomed. Mater. 5, 044101 (2010) [8] M. Özkan, A. Allahbeickaraghi, M. Dündür: Possible hazardous effects of hydrofluoric acid and recommandations for treatment approach: a review; Clin. Oral. Invest. 16, 15 (2012) [9] S.D. Heintze, V. Rousson (2011). Pooling of dentin microtensile bond strength data improves clinical correlation. J Adhes Dent 13:107-10. [10] S.S .Scherrer, P.F. Cesar, M.V. Swain (2010). Direct comparison of the bond strength results of the different test methods: a critical literature review. Dent Mater 26:e78-93. [11] M. Irie, Y. Maruo, G. Nishigawa, K. Suzuki, D.C. Watts (2010). Physical properties of dual-cured luting-agents correlated to early no interfacial-gap incidence with composite inlay restorations. Dent Mater 26:608-15. [12] E.C Munksgaard, M. Irie, E. Asmussen (1985). Dentin-polymer bond promoted by Gluma and various resins. J Dent Res 64:1409-11. [13] L. Xiaoping, R. Dongfeng, N. Silikas; Dent. Mater. 30, e330 (2014)


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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 & Development Scientific Services Bendererstrasse 2 FL - 9494 Schaan Liechtenstein

Contents: Edition:

Dr. Thomas Völkel and Dr. Erik Braziulis March 2015


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Monobond Etch&Prime

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