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  • 8/3/2019 Ketac Molar Sci Facts

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    A collection of

    scientific results

    KetacTM

    Glass Ionomer Restorative MaterialMolar

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    Table of Contents

    1 . . . . . . . . Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . page 3

    2 . . . . . . . . Clinical Studies on Ketac Molar . . . . . . . . . . . . . . . . . page 4 5

    2 . . . . . . . . Laboratory testing of Ketac Molar . . . . . . . . . . . . . . . page 6

    3 . . . . . . . . Antibacterial effect of Ketac Molar . . . . . . . . . . . . . . . page 7

    4 . . . . . . . . Hardness testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . page 8

    5 . . . . . . . . Strength testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . page 8

    6 . . . . . . . . Testing of color stability . . . . . . . . . . . . . . . . . . . . . . . . page 9

    7 . . . . . . . . Concluding remarks . . . . . . . . . . . . . . . . . . . . . . . . . . . page 10

    8 . . . . . . . . References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . page 11

    Ketac Molar

    2

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    Ketac Molar

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    Introduction

    Dear Dental Professional,

    Glass ionomers have been available to the profession for nearly a quarter of a

    century, and throughout this time 3M ESPE has continuously set new standards.

    Products such as Ketac Cem, Ketac Fil, Vitremer and Ketac Molar have

    each in turn broken new ground in the area of GIC development.

    Atraumatic Restorative Treatment (ART) is a low risk economical procedure

    and can often save a tooth from extraction. By manually excavating the caries

    and filling the cavity with glass ionomer you can conserve tooth tissue and

    reduce the chance for further decay.

    In 1997 3M ESPE launched Ketac Molar, a product that has proven its worth

    many thousand of times since then. Ketac Molar Easymix represents the latest

    contribution to the development of GIC. It has excellent compressive and

    flexural strength and thus is able to counteract occlusal loading, preventing

    restoration fracture.

    With its new granulated formula, Ketac Molar Easymix is also easier for you

    to handle:

    The improved wettability means it mixes faster and more easily.

    You can measure this pourable powder more exactly, for accurate, reproducible

    mixing results.

    The granulated powder produces less dust, improving hygiene in your

    workplace.

    Over time, Ketac Molar has attracted considerable scientific interest, and a wide

    range of studies have been published. In this brochure, you will find a review of

    the most important publications to date, along with answers to frequently asked

    questions about glass ionomer filling materials. Our goal is to keep you informed

    and help you to make up your own mind about Ketac Molar.

    Ros Randall, BChD, MPhil, PhDManager, Clinical Affairs

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    A number of reports on clinical evaluations have been published, particularly

    on use of Ketac Molar in the Atraumatic Restorative Treatment (ART) tech-

    nique. Holmgren et al [1] reported three-year data on an ART clinical study inChina. Two hundred sixty-seven ART Ketac Molar restorations in 197 children

    aged 12 to 13 years were evaluated, in particular for retention, secondary caries

    and anatomic form; 65% of these restorations had occlusal fissures sealed with

    Ketac Molar and these were also evaluated for retention and recurrent caries.

    The 'press finger' technique was used to place the restorations and sealants.

    The 3-year survival was 92% and 77% respectively for small and large Class I

    restorations, and 60% for Class II. The majority of failures were due to partialor complete loss of the restoration. The authors quoted Akerboom et al [2] in

    their comment that the failure rate for amalgam restorations in large Class I

    restorations might be expected to be higher than that seen in this study.

    None of the 174 sealed teeth developed caries in the first year. Fissure caries

    was found in one tooth at 2 years where sealant was missing, and three teeth

    with missing sealant developed caries at 3 years. At 3 years, 72% of the

    sealants were partially or completely retained. The authors commented thatthe 3-year survival rate was high and that the sealant retention rate seen in this

    study was higher than that usually reported for glass ionomer sealants. This

    suggests that the viscous glass ionomer, Ketac Molar performs well with the

    'press finger' technique for placement in the cavity and fissures.

    Ketac Molar

    Clinical Studies on Ketac Molar

    4

    Anatomic form (occlusal wear) scores at 3 years [1].

    Small Class I Large Class I Class II

    Alpha 93% 94% 89%

    Bravo 7% 6% 11%

    2-Years 3-Years1-Year

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    Ketac Molar

    Taifour et al [3] reported three-year results for ART Ketac Molar and Fuji IX

    (GC International Corp, Tokyo, Japan) restorations compared with convention-

    al amalgams in primary teeth. At baseline 482 ART glass ionomer restorationsand 353 minimal amalgam restorations were placed in 835 children aged 6 to 7

    years. At three years, 80% of the restorations were available for recall.

    The cumulative survival of ART single surface glass ionomer restorations at

    three years was 86%, and of conventional amalgam 80%. The three year cumu-

    lative survival of ART multiple surface restorations was 49%, and for amalgam

    43%. Secondary caries in single surface restorations was reported for 7% of

    ART and 14% of amalgams.

    The authors concluded that the ART approach using glass ionomer gave better

    results than the traditional use of amalgam in minimal cavities.

    Mickenautsch et al [4] placed 81 Ketac Molar and 82 Fuji IX restorations in

    one-surface cavities, including sealing the fissures, in permanent teeth in chil-

    dren of average age 10.5 years. The one-year survival rates were 94% for KetacMolar and 93% for Fuji IX; retention of sealant was 76% and 81% respective-

    ly. Mickenautsch et al [5] in an earlier paper showed how adoption of the ART

    approach by their clinics had significantly reduced both the number of teeth

    being extracted and the use of amalgam. In the year prior to their adoption of

    ART, of the 3346 teeth treated 48% were extractions, 55% of restorations were

    conventional glass ionomer and 28% were restored with amalgam. After intro-

    ducing the ART method, 8% fewer teeth were extracted, 98% of restorations

    were carried out using ART, and use of amalgam was virtually eliminated.They commented that the ART approach seemed to result in better patient

    acceptance of treatment. ART could be viewed as an acceptable alternative to

    amalgam restorations in childrens' teeth.

    Clinical Studies on Ketac Molar

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    % survival rates for ART materials at 3 years [3]

    Ketac Molar Fuji IX Amalgam

    Single surface

    restorations 87% 85% 80%

    Multiple surface

    restorations 48% 49% 43%

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    Ketac Molar

    Laboratory testing of Ketac Molar

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    Remineralizing effects of Ketac Molar

    Ketac Molar has been shown to inhibit demineralization of enamel in artificial

    caries studies [6]. Polarized light microscopy was used to measure the widthof inhibition zones created by various materials against acid attack on enamel.

    Ketac Molar gave demineralization-free zones of 25% compared with Fuji IX

    with 21%.

    The authors reported that the artificial demineralizing solution used, which had

    a pH of 4.7, caused a significant erosive surface loss of 51 microns for Fuji IX

    compared with 9 microns for Ketac Molar.Jang et al [7] evaluated the ability of glass ionomer materials to remineralize

    adjacent interproximal incipient caries lesions in vitro. Ketac Molar resulted in

    a 20% (sd=17) reduction in lesion area compared with Fuji IX at 15% (sd=8).

    Caries protective effects of Ketac Molar

    Microhardness measurements were used to test the protective effect of Ketac

    Molar and other glass ionomer restoratives placed in cavities in sound bovine

    enamel [8]. The sterilized tooth slabs with the test restorations were inserted

    into dentures worn by volunteers and were exposed to cariogenic conditions

    for 70 days. Compared to the resin composite control, Ketac Molar had a 69%

    caries protective effect, a statistically significant result.

    Chosen visual was not outcome

    of this study. Picture should

    only illustrate basic principles

    of study methodology.

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    Ketac Molar

    Antibacterial effect of Ketac Molar

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    Boeckh et al [9] reported on the antibacterial effect of Ketac Molar and other

    materials against Streptococcus mutans. The strongest antibacterial action was

    seen with zinc oxide/eugenol (ZOE), the control material. Ketac Molar alsoproduced significant inhibition of bacterial growth. The authors carried out a

    second test consisting of an eluate assay which was considered to more closely

    reflect the clinical situation. In the assay test only Ketac Molar and ZOE

    were able to inhibit bacterial growth, the other materials being tested allowing

    bacteria to proliferate.

    Growth Control

    Ariston pHc

    Tetric Ceram

    Photac-Fil

    Ketac Molar

    IRM

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    Ketac Molar

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    Other researchers have evaluated surface hardness of materials at various time

    frames and under different storage conditions. Peutzfeldt et al [10] measured

    Rockwell hardness and three-body wear (200,000 cycles) for a number ofmaterials.

    Ketac Molar and Z100 demonstrated the lowest amounts of wear in this study.

    Hardness testing

    Hardness and wear measurements [10]

    Hardness 3-Body wear

    Ketac Molar 38.2 (2.8) 37 (5)Fuji IX 35.5 (1.5) 49 (6)

    Fuji II LC 27.7 (1.6) 117 (21)

    Dyract 38.9 (1.5) 76 (2)

    Z100 62.6 (1.8) 15 (3)

    Compressive, diametral tensile and flexural strength measurements have been

    reported for Ketac Molar in comparison with various other materials. Ketac

    Molar consistently showed an increase in strength over time [11,12,13]. Thehigh powder to liquid ratio in Ketac Molar gives it high compressive strength

    [14]. The compressive strength obtained when the material is hand mixed,

    compared with mixing in a Capmix, is reduced by only 2% [15], the Rotomix

    tending to produce a stronger material. The authors commented that the high

    concentration of glass filler is responsible for the superior physical properties

    of Ketac Molar.

    In a study testing the strength of glass ionomers subjected to heat or ultrasonic

    application during the setting reaction, the materials showed increased com-

    pressive strength [16].

    Strength testing

    Compressive strength at 1 hour (sd) [15]

    Ketac Molar Fuji IX

    Standard cure 86 (11) MPa 83 (6) MPa

    23 CUltrasonic 118 (21) MPa 90 (15) MPa

    Heat 70 C 145 (12) MPa 117 (15) MPa

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    Ketac Molar

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    Lim et al [17] measured color stability for a number of glass ionomers stored

    in various solutions for up to 56 days. Ketac Molar showed no effect on storage

    in 75% ethanol, and some color change on storage in 10% hydrogen peroxide.Fuji IX was particularly damaged by hydrogen peroxide storage resulting in a

    large color change and extensive surface cracking.

    Testing of color stability

    Ketac Molar Easymix

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    The clinical studies in particular provide evidence of the effectiveness of Ketac

    Molar as a restorative. For the ART procedures good three-year data are reported

    in two separate studies [1,3], a further study reporting one-year results [4]. It isof value that Ketac Molar, a viscous glass ionomer, has been shown to perform

    well both as a restorative and a sealant when placed using the 'press finger

    technique' [1].

    The high powder to liquid ratio in Ketac Molar gives it excellent strength yet

    allows fluoride release and recharge to take place [10], enabling remineraliza-

    tion of the adjacent tooth substrate [6,7].

    The studies reviewed here are an endorsement of Ketac Molar in its intended

    clinical use.

    Ketac Molar

    Concluding remarks

    10

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    Ketac Molar

    [1] Holmgren CJ, Lo ECM, Hu DY, Wan HC. ART restorations and sealants placed

    in Chinese school children results after three years. Community Dent Oral

    Epidemiol 2000; 28: 314-320.[2] AkerboomHB, Advokaat JG, van Amerongen WE, Borgmeijer PJ. Long-term

    evaluation and re-restoration of amalgam restorations. Community Dent Oral

    Epidemiol 1993; 21: 45-48.

    [3] Taifour D, Frencken JE, Beiruti N, van't Hof MA, Truin GJ. Effectiveness of

    glass-ionomer (ART) and amalgam restorations in the deciduous dentition:

    Results after 3 years. Caries Res 2002; 36: 437-444.

    [4] Mickenautsch S, Kopsala J, Rudolph MJ, Ogunbodede EO. Clinical evaluation of

    the ART approach and materials in peri-urban farm schools of the Johannesburg

    area. S Africa Dent J 2000; 55: 364-368.

    [5] Mickenautsch S, Rudolph MJ, Ogunbodede EO, Frencken JE. The impact of the

    ART approach on the treatment profile in a mobile dental system (MDS) in South

    Africa. Int Dent J 1999; 49: 132-138.

    [6] Smales RJ, Gao W. In vitro caries inhibition at the enamel margins of glass

    ionomer restoratives developed for the ART approach. J Dent 2000; 28: 249-256.

    [7] Jang K-T, Garcia-Godoy F, Donly KJ, Segura A. Remineralizing effects of glass

    ionomer restorations on adjacent interproximal caries. J Dent Child 2001; 68:

    125-128.

    [8] Kotsanos N. An intraoral study of caries induced on enamel in contact with

    fluoride-releasing restioartive materials. Caries Res 2001; 35: 200-204.

    [9] Boeckh C, Schumacher E, Podbielshi A, Haller B. Antibacterial activity of

    restorative dental biomaterials in vitro. Caries Res 2002; 36: 101-107.

    [10] Peutzfeldt A, Garcia-Godoy F, Asmussen E. Surface hardness and wear of glass

    ionomers and compomers. Am J Dent 1997; 10: 15-17.[11] Khouw-Liu VHW, Anstice HM, Pearson GJ. An in vitro investigation of a

    poly(vinyl phosphonic acid) based cement with four conventional glass-ionomer

    cements. Part 1: Flexural strength and fluoride release. J Dent 1999; 27: 351-357.

    [12] Pereira LCG, Nunes MCP, Palma Dibb RG, Powers JM, Roulet J-F, Navarro MF.

    Mechanical properties and bond strength of glass ionomer cements. J Adhes Dent

    2002; 4: 73-80.

    [13] Piwowarczyk A, Ottl P, Lauer H-C, Buchler A. Laboratory strength of glass

    ionomer cement, compomers, and resin composites. J Prosthodont 2002; 11:

    86-91.

    [14] Xie D, Brantley WA, Culbertson BM, Wang G. Mechanical properties and

    microstructures of glass-ionomer cements. Dent Mater 2000; 16: 129-138.

    [15] Nomoto R, McCabe JF. Effect of mixing methods on the compressive strength

    of glass ionomer cements. J Dent 2001; 29: 205-210.

    [16] CJ, van Duinen RNB, Felizer AJ. Mechanical properties of glass ionomer cements

    affected by curing methods. Dent Mater 2004; 20: 45-50.[17] Lim B-S, Moon H-J, Baek K-W, Hahn S-H, Kim C-W. Color stability of glass-

    ionomers and polyacid-modified resin-based composites in various environmental

    solutions. Am J Dent 2001; 14; 241-246.

    References

    11

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    3M, ESPE, Ketac, Photacand Z100 are trademarksof 3M or 3M ESPE AG.Ariston and Tetric are regis-

    tered trademarks of IvoclarVivadent. IRM is a regis-tered trademark ofDentsply.

    3M 2004

    3M ESPE AG ESPE Platz82229 Seefeld GermanyE-Mail: [email protected]: http://www.3mespe.com