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  • 1. Technical Product Profile RelyX™ Temp NE
  • 2. Table of contents 1. Preface..................................................................................1 2. Introduction...........................................................................2 2.1 History..................................................................................2 2.2 Motivation.............................................................................3 2.3 Indications............................................................................3 3. Chemical background..........................................................4 4. Product composition............................................................5 4.1 Product components.............................................................5 4.2 Constituents..........................................................................5 5. Test results...........................................................................6 5.1 Material properties................................................................6 5.2 Physico-technical data..........................................................6 5.2.1 Setting time........................................................................7 5.2.2 Film thickness....................................................................8 5.2.3. Compressive strength.....................................................10 5.2.4 Surface hardness.............................................................11 5.3 Effect of RelyX Temp NE on dentine adhesion...................11 5.4 Reliability of the adhesive strength.....................................13 5.5 Setting behaviour of RELYX(TM) TEMP NE.......................14 6. Conclusion..........................................................................15 7. Instructions.........................................................................16 8. Literature.............................................................................18 8.1 Literature on the product.....................................................18 8.2 General literature................................................................18 Clinical Research 04/1999
  • 3. 1. Preface RelyX Temp NE is a eugenol-free cement for the provisional attachment of temporary and permanent restorations. This may include crowns and bridges as well as inlays and onlays. Cements containing eugenol are capable of preventing composite material from curing. Therefore, if adhesive permanent bonding is planned prior use of a temporary cement containing eugenol is not recommended. RelyX Temp NE contains no eugenol and thus has universal applications because impairment of the permanent bond of the indirect restoration is eliminated. Good adhesion of the temporary restoration relegates the need for repeated recementations to the past. Additionally, RelyX Temp NE has also been improved so that temporary restorations can be easily removed when required. In comparison with other temporary luting cements, RelyX Temp NE is distinguished by an extremely thin film thickness. Thus optimum adaptation of the temporary restoration is faciliated and the crown and bridge materials, Protemp II and Protemp 3 Garant, now have an irreplaceable partner. Of course RelyX Temp NE is also compatible with other commercial crown and bridge materials, composite luting cements and core build-up materials. If an indirect restoration is luted on trial using RelyX Temp NE, this cement guarantees that the restoration you have produced with immense care fits properly. RelyX Temp NE, supplied as a paste-paste system in stand-up laminate tubes, allows simple dispensing, easy mixing and clean handling. Colour-coded caps prevent mix-ups and consequent cross contamination of the material, thus ensuring that simple and hygienic dispensing is possible until all the material is used up.
  • 4. 2. Introduction The provisional cementation of temporary and permanent restorations represent an important step in prosthetic treatment. Although the time they are required to last is limited, high demands are placed on temporary luting cements. Satisfactory mechanical properties and bond strengths between the tooth and restoration are important, as are easy removal, good handling properties and simple cleansing of both the temporary restoration and tooth afterwards. Protection of the pulp and periodontium are also prerequisites, especially in regard to the stresses on the masticatory apparatus after cavity preparation. Nevertheless, the temporary cement must be resistant to changing biological, physical and chemical influences in the oral cavity. 2.1 History Previous state-of-the-art temporary cements primarily consist of products containing zinc oxide OH mixed almost exclusively with eugenol. In numerous publications, a sedative effect on the pulp is OCH3 attributed to the eugenol which is used as a decisive reactant in the setting reaction. With the progress of dentistry towards adhesively cemented restorations, zinc oxide-eugenol cements (ZOE) have become disputed. Phenolic groups, such as those present in eugenol (see Figure 1) capture free radicals and thus inhibit polymerisation Figure 1: Eugenol of methacrylate monomers. For this reason, luting cements containing eugenol have been identified in numerous scientific articles as being incompatible with bonding systems and composite materials. Furthermore, reports such as those by H. Stark and P. Mojon et al. demonstrate that simple cleaning with pumice does not suffice to remove all the cement remnants from both metal surfaces and hard tooth substance.
  • 5. These findings have led to efforts to introduce appropriate eugenol-free zinc oxide materials alongside the ZOE cements which are already established on the market. Now, numerous eugenol-free temporary cements are available. These are described as compatible with composite materials. Nevertheless, a large part of this material group still has disadvantages such as reduced bonding of the temporary restoration or poor mechanical properties in comparison with ZOE cements. Due to the aforementioned compatibility problem of eugenol with compomers and composites, eugenol-free materials are still clinically recommended in adhesive luting technology. 2.2 Motivation As already described in the introduction, the demands placed on a temporary cement change when an adhesive luting technique is used in prosthetic and restorative treatment. The availability of a eugenol-free luting material is necessary in dentistry. With Protemp II/Protemp 3 Garant as temporary crown and bridge materials, and the RelyX cement family as luting materials, 3M ESPE has long made available to the practitioner a high-quality product range for indirect treatment of tooth defects. This range is now supplemented in accordance with the standards of modern dentistry with the eugenol-free temporary luting material RelyX Temp NE. 2.3 Indications RelyX Temp NE is a eugenol-free, self-curing cement for provisonal attachment of • temporary crowns, bridges, inlays and onlays • permanent crowns, bridges, inlays and onlays
  • 6. 3. Chemical background RelyX Temp NE is a Paste-Paste System as commonly used for temporary luting cements. The curing reaction of the cement is based on a chelation reaction between the acid functionality -COOH of a carboxylic acid from the catalyst paste with the metal cation Zn2+ from the base paste. At the same time this results in double coordinate bonding of the ligand -COOH to the central atom Zn 2+ with the formation of a cyclic compound. This reaction is depicted schematically in Figure 2: O O ZnO + Carboxylic Acid R C Zn C R + H2O O O Figure 2: Bonding reaction of RelyX Temp NE In addition, the resin used in the catalyst paste is functionalized with acid groups. These permit the formation of further chelate bonds, whereby the strength of the cured cement is increased. Apart from a ring-shaped coordination of the carboxylate groups to a central metal Zn2+ (see R Figure 2), they can also bond by cross-linkage C to two metal centres. Such a reaction is O O depicted graphically in Figure 3. Formation of a Zn Zn lattice structure becomes possible. Figure 3
  • 7. 4. Product composition 4.1 Product components RelyX Temp NE is a two-component cement for the temporary luting of tooth restorations. It is eugenol-free and cures chemically without the use of light. RelyX Temp NE is a paste-paste system which is supplied in stand-up laminate tubes. By the addition of RelyX Temp E modifier, the ultimate hardness of the cement can be reduced while the working time increases simultaneously. 4.2 Constituents The qualitative composition of RelyX Temp NE is listed in tables 1 and 2. RelyX Temp NE base paste: Zinc oxide Liquid paraffin Stabiliser Pigments Table 1: Composition of the base paste RelyX Temp NE catalyst paste: Resin Organic acids Inorganic Fillers Organic oils Table 2: Composition of the catalyst paste
  • 8. 5. Test results 5.1 Material properties As already described in the preceding chapters, the primary requirement for a modern temporary luting cement is that it must have no influence on the subsequent permanent cementation. Adhesive technology in particular formerly created problems in this respect. For this reason, it must be ensured that the polymerisation of composites is not impaired by the previous temporary restoration. From a physico-technical aspect, “film thickness” and “compressive strength” parameters play a major role in the analysis of temporary cements. A low film thickness guarantees optimum fitting of both the temporary work as well as the indirect restoration, which can also be fitted temporarily if required. A high compressive strength correlates with good bonding. Since the bonding of indirect work using zinc oxide cements is based primarily on retentive forces, the cement layer must be “broken open” when a crown, for example, is removed or lost. The force necessary to do this is substantially determined by the parameter of compressive strength. The practitioner also requires properties such as good removability of the temporary cement from the temporary restoration as well as from the preparation. Consistently reproducible bond strength, in combination with temporary crown and bridge materials, characterise the reliability of a cement. 5.2 Physico-technical data All the mechanical values listed here were determined in the Clinical Research Laboratory of 3M ESPE in accordance with ISO 3107 “Dental zinc oxide / eugenol cements and zinc oxide non-eugenol cements”. In addition, investigations were made in accordance with DIN 53456 ”Härteprüfung durch Eindruckversuch” (Hardness Test through Indentation Test).
  • 9. The physical characteristics of RelyX Temp NE are listed in Table 3. Parameter Value Standard Setting time 4:00 min. ISO 3107 Film thickness 3 ± 1µm ISO 3107 Compressive strength 11 ± 1 MPa ISO 3107 Surface hardness 27 ± 2 MPa DIN 53456 Table 3: Mechanical properties of RelyX Temp NE 5.2.1 Setting time The setting times for various temporary cements are within the standard limit and depicted graphically in Figure 4. Limit: 4-10 min 04:35 04:36 04:30 04:30 04:28 04:19 04:15 04:11 04:00 04:00 04:00 04:02 03:53 03:45 03:36 Figure 4: Setting time
  • 10. As for all chemical reactions, the setting time is dependent on the ambient temperature. The reaction rate is generally influenced by the following factors: • Change in the applied concentration of educts used • Change in the temperature When temperature changes occur, the kinetic energy of particles / reactants is affected and likewise their velocities. Higher temperatures increase the impact energy and therefore lead to a higher reaction rate. As a general rule of thumb: Each temperature increase of 10°C doubles the reaction rate Residual water and alcohol in the cavity as well as increased relative air humidity will accelerate setting. Low relative air humidity will delay setting, that is, for example, a relative air humidity of approx. 30 % will delay setting by half a minute. 5.2.2 Film thickness As illustrated in Figure 5, RelyX Temp NE is distinguished by an extremely low film thickness. In this way the optimum fit of the temporary restoration is just as effectively supported by RelyX Temp NE as is the temporary luting of a permanent indirect restoration.
  • 11. 3 Procem Procem 18 Provi Cem 9 Cavex IN- BETWEEN BETWEEN 18 Freegenol Freegenol 19 Provicol Provicol 6 Temp Bond NE Figure 5: Film thickness 4 Temp Bond 25 20 15 10 5 0 <25 µm Limit:
  • 12. 5.2.3. Compressive strength As already mentioned in the introduction, the physico-technical value of compressive strength correlates with the clinical parameter bond strength for zinc oxide based cements. An ideal luting material is therefore characterised as having a good bond strength which makes repeated recementing unnecessary. However, easy removability of temporary restoration work when needed must be ensured. Values from about 10 to14 MPa have proved to be especially successful in clinical practice (see Figure 6). 35 Limit: 30 < 35 MPa 25 20 15 13 13 11 10 7 5 4 5 3 0 Figure 6: Compressive strength
  • 13. 5.2.4 Surface hardness The surface hardness of various temporary cements is depicted graphically in Figure 7. MPa 40 36 35 30 27 25 20 20 16 15 14 15 12 10 5 0 Figure 7: Surface hardness 5.3 Effect of RelyX Temp NE on dentine adhesion The effect of temporary cements on the bond between dentine and adhesively bonded restorations is the subject of much discussion. The evaluation of a temporary cement is always accompanied by preclinical investigation of its influence on dentine adhesion. It was therefore an objective of the study to investigate dentine adhesion after application of RelyX Temp NE in comparison to a temporary cement classified as safe. To do this, the conical extrusion test (push-out-test) developed by R. Frankenberger was chosen (R. Frankenberger et al., 1997). The dentine adhesion of ceramic inlays is investigated in simulated cavities on human wisdom teeth after performance of the following working steps:
  • 14. • temporary cementing with RelyX Temp NE or Nogenol (GC: comparative substance) for 7 days • adhesive attachment using various materials (21 days immersion in distilled water and 24 hrs thermocycling at 5°/55°C) In the same way as the comparative product Nogenol, RelyX Temp NE demonstrated no negative influence on the dentine adhesion of ceramic inlays. Thus it is proven that the use of RelyX Temp NE for temporary attachment of tooth restorations has no inhibiting effect on the subsequent adhesive cementation. MPa 25,0 21,0 21,6 19,7 20,1 18,4 20,0 17,5 15,0 14,2 15,0 10,0 5,0 0,0 EC-P EC-N CB-P CB-N PA-P PA-N SV-P SV-N Figure 8: Results of the push-out-test of RelyX Temp NE and comparative materials (Dr. N. Krämer, Dr. R. Frankenberger, Prof. A. Petschelt, University of Erlangen, 1999). Legend: EBS-Multi + Compolute (EC), C&B Metabond (CB), Panavia 21 (PA), Syntac Classic + Variolink II (SV), Nogenol (N), RelyX™ Temp NE (P).
  • 15. 5.4 Reliability of the adhesive strength In addition to easy removability of excess material, one of the main requirements for the clinical success of a luting cement is reliable adhesion. The objective of this study carried out by C.-P. Ernst (University of Mainz) was therefore to investigate the reproducibility of retentive adhesion forces of different temporary luting materials (Temp Bond, Temp Bond NE and RelyX Temp NE) in combination with the temporary crown and bridge materials Luxatemp, Trim, Protemp Garant and Iso-Temp. In the following table, the determined bond strengths [N/cm2] and standard deviations [N/cm2] are given. Luxatemp Trim Protemp Garant Iso-Temp Temp Bond 24.7±18.2* 12.5±13.5 6.2±3.0* 15.8±8.8* Temp Bond NE 23.6±13.1* 10.2±9.0* 14.2±4.6* 29.5±19.9* RelyX™ Temp 34.1±18.1* 34.6±12.2* 13.3±5.6* 27.8±16.2* NE Table 4: Retentive bond strength (S. Schneider, C.-P. Ernst, E. Stender, B. Willershausen, University of Mainz, 1999). Legend: Statistical differences in the respective crown and bridge materials are in bold print; statistically significant differences in the application of temporary crown and bridge materials within a cement group are marked with an asterisk (*). Table 5 shows the relative deviations in percent, which may be interpreted as reproducibility of the retention. Luxatemp Trim Protemp Garant Iso-Temp Temp Bond 74 108 48 56 Temp Bond NE 56 88 32 67 RelyX™ Temp 53 35 42 58 NE Table 5: Relative deviations
  • 16. The lowest relative standard deviations are found for the adhesive bond of RelyX Temp NE in combination with various crown and bridge materials. In addition, the smallest relative deviations occur when using Protemp Garant with different temporary cements in contrast to the comparison groups. Both these findings demonstrate good reproducibility of adhesive forces when using these materials, i.e. a reliable result during application by the practitioner. 5.5 Setting behaviour of RELYX(TM) TEMP NE The setting time of dental materials is usually determined by viscosity change (e.g. by means of a curometer). The objective of the study presented here was to examine more precisely the setting of eugenol-free temporary cements. To do this, the compressive strength was determined relative to time. Particularly the compressive strength at an early point in time after attachment of the indirect work reflects the reliability of such a product. The results of this study, conducted by G. Rackelmann (3M ESPE) are summarised in the following table. TB PC NE FG NG PV PL 10 min 8.7 (0.8) 8.0 (0.6) 7.2 (1.2) 0.2 (0.1) 1.0 (0.2) 0.1 (0.1) 0.9 (0.1) 13 min 9.6 (0.7) 8.8 (0.9) 7.4 (1.2) 0.5 (0.1) 1.4 (0.2) 0.2 (0.1) 0.9 (0.1) 16 min 9.0 (0.8) 8.6 (0.8) 7.9 (0.9) 0.7 (0.2) 1.7 (0.1) 0.3 (0.1) 1.0 (0.2) 19 min 9.6 (0.9) 9.3 (0.8) 8.1 (1.1) 1.0 (0.2) 2.0 (0.3) 0.3 (0.1) 1.3 (0.2) 22 min 9.5 (1.0) 9.3 (0.9) 7.7 (0.8) 1.2 (0.2) 2.2 (0.2) 0.5 (0.1) 1.5 (0.2) 24 hrs 11.3 (0.8) 11.6 (1.0) 8.9 (0.4) 7.8 (0.3) 4.8 (0.3) 5.1 (0.2) 6.2 (0.5) Table 6: Compressive strengths (ISO 3107) relative to time [in MPa] Legend: Temp Bond (TB: serves as a eugenol-containing reference), RelyX™ Temp NE (PC), Temp Bond NE (NE), Freegenol (FG), Nogenol (NG), Provicem (PV; hand-mix version), Provicol (PL) The compressive strengths of Temp Bond and RelyX Temp NE are significantly higher than those of other materials. The values for compressive strength at an early point in time after cementation are significantly higher for RelyX Temp NE than for any other eugenol-free systems. Already directly after insertion of a temporary or indirect permanent restoration, RelyX Temp NE guarantees reliable results.
  • 17. 6. Conclusion RelyX Temp NE is a eugenol-free temporary luting cement for provisional attachment of both temporary as well as permanent • crowns and bridges • inlays and onlays RelyX Temp NE is particularly distinguished by • universal application • strong adhesion of temporary restorations • easy removability of excess temporary cement • easy removability of the temporary restorations • low film thickness and therefore optimum support of precision fitting temporary or indirect restorations • easy application due to an intelligent packaging concept RelyX Temp NE optimally supports the system approach and is therefore harmonised with the temporary crown and bridge materials Protemp II / Protemp 3 Garant as well as the RelyX cement family for definite cementation. Compatibility as with customary materials is assured.
  • 18. 7. Instructions RelyX Temp NE is a eugenol-free, self-curing cement for temporary attachment of tooth restorations. By the addition of RelyX Temp E modifier, the ultimate hardness of the cement can be reduced, for example, for easier removal of large bridges. RelyX Temp NE does not influence the polymerisation of restorative and luting materials made of composite, and is especially suited for patients with hypersensitivity to eugenol. Before cementation, the cavity surfaces should be cleaned with a water spray and dried. Residual water or alcohol in the cavity accelerates setting. For deep cavities, the usual pulp protection should be used for temporary cementation (e.g. Alkaliner). RelyX Temp NE is handled at 18 - 23°C/64 - 73°F ambient temperature and 45 - 55% relative humidity. Dispense equal-length strands of base paste and catalyst on a mixing pad. By the addition of RelyX Temp E modifier, the ultimate hardness of the cement can be reduced, while simultaneously the handling time is extended. Dispense the modifier at the same time up to a maximum of one strand length of base paste or catalyst. A greater quantity of catalyst increases the adhesive strength and extends the handling time. Thoroughly mix the pastes for 30 sec with a metal or plastic spatula, until a homogeneous consistency has been reached. Carefully close the tubes immediately after use. Do not exchange the two caps. Place a thin layer of cement on the surface of the restoration to be cemented and insert the restoration using slight pressure. In the following table, the handling times for RelyX Temp NE with and without the addition of RelyX Temp E Modifier are summarised:
  • 19. Working step Time without Time with maximum quantity of modifier [min:sec]* modifier [min:sec]* Mixing 0:30 0:30 Working from start of mix 2:00 2:30 Setting from start of mix 3:30 4:00 Table 7: Handling times; * at 23°C/73°F ambient temperature At ambient temperatures above 23°C/73°F and a relative humidity above 55%, setting is accelerated. "Flick off" excess with an instrument after the setting time has passed. Important. Never mix up the screw caps to prevent curing of the paste in the tube by cross contamination. For some people, sensitivity to a product cannot be ruled out. Should allergic reactions occur, cease using the product. In rare cases, particularly if the instructions are not heeded, pulpitic complaints are possible. Do not store the product at above 25°C/77°F. Do not use after the use by date has passed. The following table describes the types of pack available: Pack description Contents Item number Normal pack 36 g base paste 056660 16 g catalyst Single pack 13g Scutabond modifier 035113 Table 8: Types of packaging
  • 20. 8. Literature 8.1 Literature on the product N. Krämer, R. Frankenberger, A. Petschelt, Effekt eines neuen provisorischen Zements auf die Dentinhaftung, Arbeitsgemeinschaft für Grundlagenforschung, Mainz, 7./8.1.99, Abstractband V27. S. Schneider, C.-P. Ernst, E. Stender, B. Willershausen, Reliability of Retentive Strength of Different Temporary Cements, IADR, Vancouver, 1999, Abstract # 2991. G. Rackelmann, K.-P- Stefan, Comparison of the Setting Times of Provisional Eugenol-Free Luting Cements, IADR, Vancouver, 1999, Abstract # 985. 8.2 General literature R. Frankenberger, J. Sindel, N. Krämer, A. Petschelt, Dentinhaftung von Keramikinlays in simulierten Kavitäten, Dtsch. Zahnärztl. Z. 1998, 53, 507-512. R. Frankenberger, J. Sindel, N. Krämer, M. Pelka, A. Petschelt, A new Testing Design to determine Bond Strength to Dentin, J Dent Res 1997, 76, 416, Abstract # 3220. C. Holderegger, S.J. Paul, H. Lüthy, P. Schärer, Bond strength of one-bottle dentin bonding agents on human dentin, American Journal of Dentistry 1997, 10, 71-76. S.J. Paul, P. Schärer, Effect of provisional cements on the bond strength of various adhesive bonding systems on dentine, J. Oral Rehabilitation 1997, 24, 8-14. M. Bachmann, S.J. Paul, H. Lüthy, P. Schärer, Effect of cleaning dentine with soap and pumice on shear bond strength of dentine- bonding agents, J. Oral Rehabilitation 1997, 24, 433-438.
  • 21. A.M. Kielbassa, T. Attin, E. Hellwig, Diffusion Behavior of Eugenol from Zinc-Oxide-Eugenol Mixtures through Human and Bovine Dentin in Vitro, Operative Dentistry 1997, 22, 15-20. K.J. Anusavice, Dental Cements for Restorations and Pulp Protection, in: Phillips’ Science of Dental Materials, W.B. Saunders Company, Philadelphia, 10th edition, chapter 24, S. 525-554, 1996. K.J. Anusavice, Dental Cements for Bonding Applications, in: Phillips’ Science of Dental Materials, W.B. Saunders Company, Philadelphia, 10th edition, chapter 25, S. 555-581, 1996. M. Wichmann, A. Roßbach, G. Fust, Der Einfluß provisorischen Zementierens auf die Haftung definitiver Befestigungs- zemente an Dentin- und Metalloberflächen, Dtsch. Zahnärztl. Z. 1994, 49 (3), 245-249. S.N. White, Adhesive Cements and Cementation, CDA Journal 1993, 21 (6), 30-37. J.W. Farah, J.M. Powers (Eds.), Dental Cements, The Dental Advisor 1993, 10 (4), 1-8. A. M. Kielbassa, Zur Frage der Wirkung von Eugenol im Rahmen zahnerhaltender Maßnahmen, Endodontie 1993, 4, 285-299. S. Fujisawa, Y. Kadoma, Effect of phenolic compounds on the polymerization of methyl methacrylate, Dent. Mater. 1992, 8, 324-326. P. Mojon, E.B. Hawbolt, M.I. MacEntee, A Comparison of Two Methods for Removing Zinc Oxide-Eugenol Provisional Cement, Int. J. Prosthodont. 1992, 5, 78-84. H. Stark, Beeinflußt provisorisches Zementieren die Haftfestigkeit definitiv zementierter
  • 22. Kronen?, Dtsch. Zahnärztl. Z. 1991, 46 (11), 774-776. D.C. Smith, Dental Cements Current Status and Future Prospects, Dental Clinics of North America 1983, 6 (3), 763-791. G.M. Brauer, Zinkoxid-Eugenol als zahnärztlicher Werkstoff (Teil 1) Dtsch. Zahnärztl. Z. 1976, 31, 824-834. G.M. Brauer, Zinkoxid-Eugenol als zahnärztlicher Werkstoff (Teil 2) Dtsch. Zahnärztl. Z. 1976, 31, 890-894.