MTA UNIVERSAL - DirectCaps- Mineral Trioxide Aggregate

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MT UNIVERSL - DirectCaps- Mineral Trioxide ggregate Technical Product Information Issued 05/2016

MT UNIVERSL - DirectCaps - Technical Product Information Table of Contents Product description.... 3 Features and Benefits.... 4 Indications.... 5 Consistency... 6 Overview physical properties... 7 Push-out bond strength... 8 Clinical studies pulp capping... 9 Competitive products... 10 ctivation of DirectCaps... 11 Literature... 12 page 2

MT UNIVERSL - DirectCaps - Technical Product Information PRODUCT DESCRIPTION MT UNIVERSL powder is consisting of very fine hydrophilic particles of se- veral mineral oxides. fter contact with MT UNIVERSL liquid it forms a gel that hardens to an impermeable barrier. During the setting phase release of calcium hydroxide takes place. MT UNIVERSL is suitable for the following indications: - repair of root perforations - root end filling (retrograde) - pulp capping - root end filling (orthograde) ccessories: application gun page 3

MT UNIVERSL - DirectCaps - Technical Product Information MT UNIVERSL Features and Benefits Features: biocompatible permanent cement high ph value excellent marginal adaptation thanks to bonding to dentine and very low solubility high radiopacity convenient mix and fixed proportions with capsule Benefits: real biological sealing bacteriostatic by release of calcium hydroxide excellent barrier against bacteria and fluids easy clinical documentation with radiographs very easy to use with excellent handling page 4

MT UNIVERSL - DirectCaps - Technical Product Information MT UNIVERSL - Indications MT UNIVERSL in DirectCaps gives a mixed cement with a consistency suitable for all indications given below. Repair of root Perforations Pulp capping Root end filling (orthograde) Root end filling (retrograde) page 5

after 1 min after 3 min after 1 min after 3 min after 1 min after 3 min MT UNIVERSL - DirectCaps - Technical Product Information MT UNIVERSL - Consistency The disc diameter is an indicator for the consistency of MT cements. defined portion of freshly mixed MT cement is placed on a glass plate and co- vered with a second glass plate. fter 1 minute (resp. after 3 minutes) from start of mixing a load of 5 kg is placed on the top plate. fter another 30 seconds, the load is removed and the disc diameter of the spreading specimen is determined by a ruler. [mm] Disc diameter of MT Cements 30 25 26 20 22 15 15 15 10 12 12 5 0 MT UNIVERSL DirectCaps Olident Pro Root MT (Dentsply) MT Gray (ngelus) High value for disc diameter means low viscosity. Low value for disc diameter means high viscosity. The photos below show the consistency of mixed MT UNIVERSL after extrusi- on from the capsule. page 6

MT UNIVERSL - DirectCaps - Technical Product Information MT UNIVERSL - Physical Data MT UNIVERSL DirectCaps (OLIDENT) Pro Root MT (Dentsply) MT Gray (ngelus) mixing ratio (powder/liquid by weight) - 4:1 1:1 mixing time [s] 30 60 30 working time [min] 2:00 2:00 1:10 material ready for next clinical step [min] acc. to IfU 5:00 4 hours 10:00 setting time acc. ISO 6876 [min] 17 12 4:30 disc diameter after 1min 22 26 15 disc diameter after 3min 15 12 12 consistency creamy soft creamy creamy color beige beige-grey grey compressive strength after 24h [MPa] 19 37 19 Radiopacity of MT UNIVERSL is about 250 % luminium. page 7

smear layer not removed smear layer removed smear layer not removed smear layer removed MT UNIVERSL - DirectCaps - Technical Product Information MT CEMENTS - Push-out bond strength Push-out bond strength* was tested on extracted human teeth with single canals. The prepared roots were sectioned at different levels (thickness of slices 2 mm). The force required to dislodge the MT cement from the root slice was measu- red with a Universal Testing Machine. MT UNIVERSL shows a push-out bond strength in the same range as Pro Root MT. fter removal of smear layer, push-out bond strength was significant- ly reduced. Push-out bond strength [MPa] [MPa] 8 7 6 7,64 7,54 6,47 6,58 5 4 3 2 1 0 MT UNIVERSL Olident Pro Root MT (Dentsply) *.M. EL-Ma aita,.j.e. Qualtrough, D.C. Watts, Dental Materials, 29 (2013) 797-803 page 8

MT UNIVERSL - DirectCaps - Technical Product Information MT CEMENTS - Clinical Studies Pulp Capping Independent clinical studies show that MT is more effective than calcium hydroxide to maintain the vitality of the pulp after direct pulp capping. fter treatment of 149 patients between 2001 and 2006, 108 of them (122 treated teeth) were available for follow up. successful outcome was recor- ded for 78% of teeth (54 of 69) in the MT group and for 60% of teeth (32 of 53) in the calcium hydroxide group. J. Mente, Mineral Trioxide ggregate or Calcium Hydroxide Direct Pulp Cap- ping: n nalysis of the Clinical Treatment Outcome Journal of Endodontics; 36(5), 806-813, May 2010 376 patients received a direct pulp cap with calcium hydroxide (n=181) or MT (n=195). fter 2 years follow up the failure was 31.5% for calcium hyd- roxide versus 19,7% for MT. T.J. Hilton, J.L. Ferracene and L. Manci, Comparison of CaOH with MT for Direct Pulp Capping: PBRN Randomized Clinical Trial Journal of Dental Research; 92 (1), 16S-22S, July 2013 page 9

MT UNIVERSL - DirectCaps - Technical Product Information MT UNIVERSL - Competitive Products Beside Pro Root MT (Dentsply) some other products for the same range of indications are listed below: Dentsply ngelus Isasan BioMT Maruchi valon Biomed Septodont Pro Root MT MT-NGELUS, MT-FILLPEX TECH BIOSELER (endo, apex, capping and root end) OrthoMT, RetroMT EndoCem MT MT Plus Biodentine For most of these materials the powder is pre-dosed, but normally these materials have to be mixed by hand on a glass plate. Disadvantages lost of material inhomogeneous mixture time-consuming labor-intensive (cleaning of glass plate and mixing device) EndoCemMT (Maruchi) and Biodentine (Septodent) offer a vial with a pre-dosed amount of powder. fter adding the liquid, the material is mixed in a mixing device. OLIDENT MT UNIVERSL is delivered in easy to mix DirectCaps. fter a mixing time of 30 seconds, the material is extruded from the DirectCap with an optimal consistency. page 10

MT UNIVERSL - DirectCaps - Technical Product Information Instruction for activating and mixing DirectCaps DirectCap before activation. For activation of the DirectCap press the plunger on a hard and plane surface to the end into the DirectCap. Insert the DirectCap into the DirectGun and click once to standardize. Note: The plunger must be at the same level as the bottom of the capsule. Insert the DirectCap into a mixer (or an amalgamator), close lid and mix immediately (about 4300 oscillations / min). Mixing time: 30 sec Remove the pin from the nozzle. If not, capsule can burst. Insert the DirectCap into the DirectGun. Pull the lever 2 times (2 clicks) to prime the DirectCap. Extrude the mixed material directly into the preparation. Unlock the gun (push button ) and remove the DirectCap. page 11

MT UNIVERSL - DirectCaps - Technical Product Information MT Cements - Literature D. Trohorsch, Mineral Trioxid ggregate - Ein endodontischer Reparaturzement ZWR - Das Deutsche Zahnärzteblatt 2012; 121 (5) Sonderdruck.M. EL-Ma aita,.j.e. Qualtrough, D.C. Watts, The effect of smear layer on push-out bond strength of root canal calcium silicate cements Dental Materials; 29 (2013) 797-803 M. Parirokh, M. Tarabinejad, Mineral Trioxide ggregate - Review rticle Part I Journal of Endodontics; 36(1), 16-27, January 2010 M. Parirokh, M. Tarabinejad, Mineral Trioxide ggregate - Review rticle Part II Journal of Endodontics; 36(2), 190-202, February 2010 M. Parirokh, M. Tarabinejad, Mineral Trioxide ggregate - Review rticle Part III Journal of Endodontics; 36(3), 400-413, March 2010 T. Damaschke, nwendung eines neuen bioaktiven Kalziumsilikat-Zements zur direkten Pulpenüberkappung ZWR - Das Deutsche Zahnärzteblatt 2012; 121 (7+8) J. Mente, Mineral Trioxide ggregate or Calcium Hydroxide Direct Pulp Capping: n nalysis of the Clinical Treatment Outcome Journal of Endodontics; 36(5), 806-813, May 2010 T.J. Hilton, J.L. Ferracene and L. Manci, Comparison of CaOH with MT for Direct Pulp Capping: PBRN Randomized Clinical Trial Journal of Dental Research; 92 (1), 16S-22S, July 2013 page 12

MT UNIVERSL - DirectCaps - Technical Product Information This presentation contains a survey of internal scientific product data. This product information has been prepared by OLIDENT research and evaluation labs. The information shows test results of random lots of presented materials tested under same conditions. Data were determined by best knowledge and effort. This presentation is only for your information, not for puplication purposes unless with OLIDENT s prior written approval. OLIDENT does not guarantee that data in this presentation are error-free and also cannot be held responsible for any injuries resulting from the use or handling of this product or this presentati- on. page 13