November 26, 2017
RelyX™ Ultimate is a dual-curing resin cement supplied in an automix syringe. It is used for the adhesive cementation of indirect restorations and available in various shades. RelyX™ Ultimate is used in combination with Scotchbond™ Universal Adhesive.
The adhesive can be used either as a “Total Etch” of “Self-Etch” procedure. The additional etching of the tooth structure with Scotchbond™ Universal Etchant increases the adhesive strength of the adhesive even further.
RelyX Ultimate contains bi-functional (meth)acrylate. The proportion of inorganic fillers is about 43 % by volume; the grain size (D 90%) is about 13 µm. The mixing ratio, based on volume, is 1 part base paste : 1 part catalyst.
These Instructions for Use must be kept for reference for the duration of product use. Please see the pertinent information for use for details on all of the products mentioned below.
Indications
Scotchbond Universal Etchant:
● Etching of enamel and dentin using the acid etching technique
RelyX Ultimate in combination with Scotchbond Universal as an adhesive for:
● Final cementation of all-ceramic, composite, or metal inlays, onlays, crowns and bridges. 2-3-unit Maryland bridges and 3-unit inlay/onlay bridges
● Final cementation of posts and screws
● Final cementation of all-ceramic, or composite veneers
● Final cementation of all-ceramic, composite, or metal restorations on implant abutments
Indications such as Maryland and inlay/onlay bridges (resin bonded bridges) demand especially high adhesive bond strength. Regardless of the manufacturer of the cement and restoration, these indications may be exposed to a higher risk of decementation. For Resin Nano Ceramic restorations (e.g. Lava™ Ultimate) it is important to maximize bond strength. For the detailed bonding procedure, please refer to the instructions for use of the restoration material.
Contraindications
Maryland and inlay/onlay bridges are contraindicated for patients with bruxism or periodontitis.
Precautionary Measures
For Patients and Dental Personnel
● Scotchbond Universal Adhesive: contact with eyes may cause severe eye damage. Wear eye protection to prevent injury. In case of contact with eyes, rinse immediately with plenty of water and seek medical advice.
● RelyX Ultimate base paste: contains sodium persulfate that may trigger an allergic reaction in certain individuals when inhaled. This product may not be appropriate for use in those individuals with known sensitivity to sulfites since a cross-reaction may occur with sodium persulfate.
● Scotchbond Universal Etchant: Contact with eyes or skin may cause burns. Wear suitable protective clothing, gloves, and eye/face protection. In case of contact, flush area with plenty of water and seek medical advice.
For Patients
● RelyX Ultimate and Scotchbond Universal Adhesive contain substances that may cause an allergic reaction by skin contact in certain individuals. Avoid use of this product in patients with known acrylate or perester allergies.
● If prolonged contact with oral tissue occurs, flush with large amounts of water. If allergic reaction occurs, seek medical attention as needed, remove the product if necessary, and discontinue future use.
For Dental Personnel
● RelyX Ultimate and Scotchbond Universal Adhesive contain substances that may cause an allergic reaction by skin contact in certain individuals. To reduce the risk of allergic response, minimize exposure to these materials. In particular, avoid exposure to uncured paste. If skin contact occurs, wash immediately with soap and water.
● The use of protective gloves and a no-touch technique is recommended. Acrylates may penetrate commonly used gloves. If RelyX Ultimate or Scotchbond Universal Adhesive contacts the glove, remove and discard the gloves. Wash your hands immediately with soap and water and re-glove.
● If allergic reaction occurs, seek medical attention as needed.
● Scotchbond Universal Adhesive is highly flammable. Avoid static electricity build-up. Keep away from heat, sparks, open flame, pilot lights, and other ignition sources.
Precautions during Processing
● Seat temporary restorations using a eugenol-free product (e.g., with RelyX™ Temp NE). The use of temporary cements containing eugenol can inhibit the polymerization process of RelyX Ultimate during the final cementing.
● Do not use hydrogen peroxide (H2O2) as the residues can adversely affect the adhesive strength and setting reaction of RelyX Ultimate.
● For the best possible bond, do not treat the surface of Zirconia, aluminum oxide, or metal restorations with phosphoric acid.
Pulp Protection
To avoid pulpal irritation, cover areas in close proximity to the pulp by applying small amounts of hard-setting calcium hydroxide material. To avoid bite increases during the cementing of the latter restoration, the pulp protection should be applied prior to taking an impression for the final restoration.
Tooth Preparation
Preparation of the Cavity/Tooth Stump
► Remove loose preparation debris by spraying with water.
► Clean the stump or the cavity thoroughly, rinse with a water spray, and lightly air dry in only 2-3 bursts of water-free and oil-free air, or use cotton pallets or similar materials to dry it off. Do not overdry.
The cavity should be just dry enough that the surface has a slightly glossy appearance. As is the case with any permanent cement, overdrying can lead to post-operative sensitivity.
Do not use substances such as desensitizers, disinfectants, astringents, dentin sealants, rinsing solutions containing EDTA, etc., after the final cleaning. Their residues may have a detrimental effect on the bonding strength and setting reaction of the adhesive.
Preparation of Root Canals
► Treat the root canal endodontically as usual (root canal filling with guttapercha and removal of the root canal filling, leaving 4 mm of guttapercha apically).
► Clean the root canal with a 2.5 % - 5.25 % solution of sodium hypochlorite (NaOCl).
► Rinse immediately with water, dry with paper tips, and continue with the application of the adhesive; see “Dosing and Applying Adhesive”.
The use of a rubber dam during the cementation of posts is recommended.
Preparation for Veneers
► Prepare and clean the tooth as is usual for veneers.
► Subsequently, it must be etched, as described under “Etching of the Tooth Structure”.
Preparation for Maryland and Inlay/Onlay Bridges
Abutment teeth must have an adequate enamel surface for bonding. They should be healthy or only slightly restored and the periodontal conditions should be good. It is the sole responsibility of the dentist to ensure proper selection of indication and technique. The guidelines of the relevant national professional associations must be observed for such indications.
► Prepare retentive elements such as cingular rests and/or approximal grooves.
► Subsequently, it must be etched, as described under “Etching of the Tooth Structure”.
► Use a rubber dam and keep the cavity free of any contamination during cementation.
Preparation for Chairside CAD/CAM Restorations
Please follow the instructions for use of the restoration material. For Lava Ultimate Resin Nano Ceramic restorations, please refer to the Lava Ultimate Instructions for Use.
Trial Fitting of the Restoration
► Remove the temporary restoration and thoroughly clean the tooth structure of any residue from the temporary cement.
► Make a trial insertion of the final restoration and check its fit, color, and contact points. Use RelyX™ Try-In Pate or similar material for this purpose.
If a low viscosity silicone is used for the trial fit, the silicone residue must then be removed completely, e.g. with alcohol.
For glass ceramic restorations, do not check the occlusion until the restoration has been cemented. Breakage could occur if done prior to being cemented in place.
Pre-treatment of Restorations
Avoid any contamination whatsoever of the surfaces to be treated during pre-treatment and until the final cementation.
Pre-treatment of Metal Restorations
Please follow the instructions for use of the restoration material. In the absence of deviating instructions, we recommend the following procedure.
► Blast the restoration surface to be luted with aluminum oxide ≤ 50 µm
► Clean the blasted surface with alcohol and dry it with water-free and oil-free air.
► Use the disposable applicator to apply Scotchbond Universal Adhesive to the entire surface to be luted and allow it to react for 20 sec.
During treatment, rewet the disposable applicator as required.
► Subsequently direct a gentle stream of air over the liquid for about 5 sec until it no longer moves and the solvent has evaporated completely.
For Maryland and inlay/onlay bridges, please refer to “Pre-treatment of Maryland and Inlay/Onlay bridges”.
Pre-treatment of Etchable Glass Ceramic Restorations
Please follow the instructions for use of the restoration material. In the absence of deviating instructions, we recommend the following procedure:
► Use hydrofluoric acid to etch the glass ceramic restoration surface to be luted.
► Rinse thoroughly with water for 15 seconds and dry with water-free and oil-free air.
► Use the disposable applicator to apply Scotchbond Universal Adhesive to the entire surface to be luted and allow it to react for 20 sec.
During treatment, rewet the disposable applicator as required.
► Subsequently direct a gentle stream of air over the liquid for about 5 sec until it no longer moves and the solvent has evaporated completely.
Alternatively, instead of Scotchbond Universal Adhesive any silane can be applied in accordance with its Instructions for Use after etching, e.g., RelyX™ Ceramic Primer: allow to react for 5 sec, then air dry completely so that the solvent evaporated completely.
Pre-treatment of Zirconia and Aluminum Oxide Ceramic Restorations
Please follow the instructions for use of the restoration material. In the absence of deviating instructions, we recommend the following procedure:
► Blast the restoration surface to be luted with aluminum oxide ≤ 50 µm
► Clean the blasted surface with alcohol and dry it with water-free and oil-free air.
► Use the disposable applicator to apply Scotchbond Universal Adhesive to the entire surface to be luted and allow it to react for 20 sec.
During treatment, rewet the disposable applicator as required.
► Subsequently direct a gentle stream of air over the liquid for about 5 sec until it no longer moves and the solvent has evaporated completely.
As an alternative, the restoration surface to be luted can be coated (silicated) with the micro-blasting device CoJet™ Prep and the blast-coating agent CoJet™ Sand from a distance of 2-10 mm and vertically to the surface for 15 sec, see instructions for use CoJet™ Prep and CoJet™ Sand. Then blow away any residues of the blasting agent with water-free and oil-free air. Use a disposable application to apply Scotchbond Universal Adhesive over the entire surface to be luted, rub in for 20 sec before blowing a gentle stream of air over the liquid for about 5 sec, or use a suitable silane in accordance with the instructions of use.
For Maryland and inlay/onlay bridges, please refer to “Pre-treatment of Maryland and Inlay/Onlay bridges”.
Pre-treatment of Composite and Resin Nano Ceramic (e.g. Lava Ultimate) Restorations
Please follow the instructions for use of the restoration material. In the absence of deviating instructions, we recommend the following procedure:
►Sandblast the composite restoration surface to be luted with aluminum oxide ≤ 50 µm (e.g. with Cojet Sand or Rocatec Soft) at two bar (30 psi) pressure until the entire bonding surface appears matt. Do not etch with HF or phosphoric acid.
► Clean the blasted surface with alcohol and dry it with water-free and oil-free air.
► Use a disposable applicator to apply Scotchbond Universal Adhesive over the entire surface to be luted, rub in for 20 sec before blowing a gentle stream of air over the liquid for about 5 sec. As an alternative, a suitable silane can be used in accordance with the instructions for use.
Pre-treatment of Glass Fiber-reinforced Posts
Please follow the instructions for use of the post to be used. In the absence of deviating instructions, we recommend the following procedure:
► Clean the post with alcohol and dry it with water-free and oil-free air.
► Use a disposable applicator to apply Scotchbond Universal Adhesive over the entire surface to be luted, rub in for 20 sec before blowing a gentle stream of air over the liquid for about 5 sec. As an alternative, a suitable silane can be used in accordance with the instructions for use.
Pre-treatment of Maryland and Inlay/Onlay Bridges
In the absence of deviating instructions, we recommend the following procedure for metal, Zirconia, and aluminum oxide surfaces:
► Coat (silicate) the restoration surface to be luted with the micro-blasting device CoJet Prep and the blast-coating agent CoJet Sand from a distance of 2-10 mm and vertically to be surface for 15 sec, see instructions for use for CoJet Prep and CoJet Sand.
► Blow away any residues of the blasting agent with water-free and oil-free air.
► Use a disposable applicator to apply Scotchbond Universal Adhesive over the entire surface to be luted, rub in for 20 sec before blowing a gentle stream of oir over the liquid for about 5 sec. As an alternative, a suitable silane can be used in accordance with the instructions for use.
For Maryland and inlay/onlay bridges made of etchable glass ceramics, please refer to “Pre-treatment of Etchable Glass Ceramic Restorations”.
Etching of the Tooth Structure (Optional, depending on material type and indication)
A clinically adequate adhesive bond is achieved by the application of RelyX Ultimate in combination with Scotchbond Universal Adhesive. However, selective etching of the enamel or the etching of the enamel and dentin (“Total Etch Procedure”) can produce higher adhesive values.
For veneers, Maryland and inlay/onlay bridges in general as well as for all Lava Ultimate restorations, higher adhesive strengths are necessary; therefore, etching is mandatory with these indications.
► The application of a rubber dam is recommended.
► Remove the Scotchbond Universal Etchant syringe from the foil pouch, unscrew the cap, and attach an Etchant Dispensing Tip.
► Apply the etching gel to the precise area of the enamel and/or dentin and allow to react for 15 sec. Rinse thoroughly for 15 sec with water, using a suction at the same time.
► Dry with water-free and oil-free air or with cotton pallets; do not overdry.
► Avoid any contamination of the etched surfaces. If contamination occurs, repeat the etching, rinsing, and drying.
► Continue immediately with the application of the adhesive.
► After etching, remove the Etchant Dispensing Tip from the syringe and replace the cap.
Dosing and Applying Adhesive
The dosing bottle cap has a thumb depression so that it can be opened to one side and closed again with one hand. The cap will remain open if the opening angle is ˃ 90°C.
► To open, take the bottle in your hand, place your thumb in the thumb depression, and push the cap to the side until it remains in the open position.
► Hold the bottle upside down in a vertical position and pour the required quantity of Scotchbond Universal Adhesive in a mixing well. Protect the adhesive in the mixing well from light.
► After use, carefully close the bottle again by applying pressure to the lever from above.
The cap tangibly snaps into place when pressed closed and a small, even gap between the cap and the bottle can be seen all the way around.
Application of the Adhesive
Avoid any contamination with blood, saliva, or sulcus fluid during application. A rubber dam is recommended to keep the treated area sufficiently dry.
► Use the disposable applicator to apply the adhesive to the entire tooth structure and rub it in for 20 sec. Avoid contact between the adhesive and the oral mucosa.
► If necessary, rewet the disposable applicator during treatment.
► Blow a gentle stream of air over the liquid for about 5 sec until it no longer moves and the solvent has evaporated completely. Remove any excess in the root canal with a paper tip and blow a gentle stream of air over it for 5 sec as well.
► When cementing indirect restorations or posts, Scotchbond Universal Adhesive is not light-cured, but it can optionally be polymerized for 10 sec using any commonly available light-curving device with a lightwave range of 400-500 nm.
Note: For maximum adhesion of Resin Nano Ceramic restorations (e.g. Lava Ultimate), light cure the adhesive for 10 seconds. For detailed bonding procedure, please refer to the instructions for use of the restoration material.
Times
The processing and setting times of RelyX Ultimate depend on the ambient and oral temperature. The times shown are based on conditions relevant for practice. As is the case with every composite cement, the setting of RelyX Ultimate cements slows down significantly at room temperature.
RelyX Ultimate is a dual-curing cement and therefore also sensitive to natural or artificial light. The working time is significantly reduced during application under operating lights.
Application of the Cement
When Using a New RelyX Ultimate Automix Syringe
► Remove the automix syringe with the required color from the foil pouch, note the removal date on the syringe label, and discard the foil pouch.
► Remove and discard the cap from the automix syringe; it must not be used to reclose the syringe because air bubbles could be introduced in this way.
► Check the syringe openings for blockage; remove any paste plugs.
► Squeeze out a small quantity of paste onto a block to equal the base paste and catalyst paste in the automix syringe. Discard the paste which has been squeezed out.
Before Every Application
► Remove and discard the mixing tip remaining on the automix syringe from the previous application.
► Attach one of the two types of mixing tips (“Standard” or “Wide”) and secure it by turning it to the right.
The mixing tip “Standard” is used without an Intraoral Tip for application in easily accessible areas.
The mixing tip “Wide” is used for the application with the Intraoral Tip or the Endo Tip. When using the missing tip “Wide”, always attach an Intraoral Tip or an Endo Tip.
► Squeeze out and discard a peppercorn-size quantity of RelyX Ultimate until an evenly mixed paste in a homogeneous color flows out of the tip.
The paste requires a certain amount of time to flow through the mixing tip. The flowthrough speed cannot be accelerated by increasing the pressure on the plunger.
As soon as the pressure on the plunger decreases, the material flow stops and the paste begins to set up. Do not use force to press out paste that has set as this could cause damage to the mixing tip and the automix syringe.
Application to Tooth or Restoration
Protect the working area from contamination with water, blood, salvia, and sulcal fluid during the application and setting phase.
► Wet the entire area of the cavity walls, the cavity floor, and, if necessary, the surface of the restoration to be cemented evenly with RelyX Ulitmate.
Keep the opening of the mixing tip “Standard” or of the Intraoral or Endo Tip immersed in the material during the entire application to prevent the inclusion of any air bubbles.
► Seat the restoration and stabilize long enough for the cement to fully set.
► Leave the used mixing tip on the automix syringe as a cap until the next application.
For veneers: owing to the relatively short processing time of RelyX Ultimate (dual curing begins after 2 min 30 sec), we recommend cementing a maximum of 2veneers at the same time.
Application in the Root Canal
Do not use Lentulo spirals to insert the cement in the root canal as this can excessively accelerate setting.
► Attach an Endo Tip to the mixing tip “Wide” for application in the root canal.
► Insert the Endo Tip as deeply as possible in the root canal and apply RelyX Ultimate, beginning apically. Keep the tip of the Endo Tip immersed in the cement and slowly move th Endo Tip upwards as the level of the paste rises.
Do not remove the Endo Tip from the cement until the root canal has been completely filled.
This so-called immersion filling should be carried out slowly and take at least 5 sec to minimize the inclusion of air bubbles.
► Place the post in the root canal filled with cement; apply moderate pressure to hold it in position. We recommend rotating the post slightly during insertion to avoid the inclusion of air bubbles.
Removal of Excess
Notes on oxygen inhibition: As is the case with all composite materials, RelyX Ultimate is subject to oxygen inhibition, i.e., the upper layer (about 50µm) which is in contact with atmospheric oxygen during the polymerization does not harden. Leaving sufficient excess permits the removal of the uncured layer during shaping/polishing without leaving behind a deficit.
Option 1 for best aesthetic results
► Remove the excess before polymerization, e.g., using a sponge pellet, white using a suitable instrument to hold the restoration in position.
► Cover the margins of the restoration with a glycerin gel to prevent oxygen inhibition.
► Immediately light-cure or wait for the self-curing to finish (see Polymerization and Shaping).
Option 2 for fast removal of excess
► Chip away cement excess after brief light curing (about 1-2 seconds using a commonly available polymerization device) or use a suitable instrument (e.g., scaler) to remove the cement excess during the self-curing (from 3 minutes after start of mixing in the “gel phase”). Larger volumes of excess are easier to remove.
If the excess is removed during the self-curing, a suitable instrument must be used to hold the restoration in position.
Polymerization and Shaping
► We recommend light-curing the cement through the restoration when doing ceramic and composite work. Select the exposure times appropriate for the number of surfaces (please refer to “Times”). Polymerize the cement through the post when using translucent posts. The exposure times depends on the translucency of the post being used; for RelyX Fiber Post, it is 40 sec.
► Shape any remaining uneven areas on the margins of restorations and polish the marginal area with diamond devices, aluminum oxide-coated discs (e.g., Sof-Lex™), and diamond polishing paste.
► Then check the occlusion.
After Shaping
► Carefully check the sulcus of the treated teeth and the surrounding areas; remove any cement residues still remaining. This is especially important when cementing to tiplant abutments.
Hygiene and Disinfection
► We recommend the use of commonly available hygienic protective covering to avoid any contamination of the RelyX Ultimate automix syringes during the treatment.
► Clean any contaminated RelyX Ultimate automix syringes, Scotchbond Universal Adhesive bottles, and Scotchbond Universal Etchant syringes with commonly used agents and disinfect them in accordance with the commonly used hygienic regulations.
Disposal
● Scotchbond Universal Etchant syringes must be completely emptied before being disposed of the recycling. Small amounts of Etching Gel can be disposed of with normal waste water when well diluted with water or when neutralized.
● Dispose of empty RelyX Ultimate Automix syringes and Scotchbond Universal Adhesive bottles with the normal household waste.
Notes
● RelyX Ultimate and Scotchbond Universal Adhesive can prematurely polymerize when exposed to natural or artificial lighting. Avoid intensive light exposure during application.
Storage and Stability
Store RelyX Ultimate in the foil pouch at 15°- 25°C/59° - 77°F. After removal from the oil pouch, use RelyX Ultimate within 6 months and before the lapse of the expiration date. Constantly high humidity influences the setting and must be avoided.
Store Scotchbond Universal Adhesive and Scotchbond Universal Etchant at 02°- 25°C/36° - 77°F.
Do not use after the expiration date.
Customer Information
No person is authorized to provide any information which deviates from the information provided in this instruction sheet.
Warranty
3M Deutschland GmbH warrants this product will be free from defects in material and manufacture. 3M Deutschland GmbH MAKES NO OTHER WARRANTIES, INCLUDING ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. User is responsible for determining the suitability of the product for user’s application. If this product is defective within the warranty period, your exclusive remedy and 3M Deutschland GmbH’s sole obligation shall be repair or replacement of the 3M Deutschland GmbH product.
Limitation of Liability
Except where prohibited by law, 3M Deutschland GmbH will not be liable for any loss or damage arising from this product, whether direct, indirect, special, incidental or consequential, regardless of the theory asserted, including warranty, contract, negligence, or strict liability.