ketac molar sci facts
TRANSCRIPT
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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
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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
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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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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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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
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[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
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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