The Heliomolar Family: Heliomolar Heliomolar Flow Heliomolar HB
The Heliomolar Family: Heliomolar Heliomolar Flow Heliomolar HB
The Heliomolar Family: Heliomolar Heliomolar Flow Heliomolar HB
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Heliomolar
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Heliomolar Flow
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Heliomolar HB
Scientific Documentation
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Scientific Documentation Heliomolar Family Page 2 of 18
Table of Contents
1. Introduction........................................................................................................................ 3
1.1 Heliomolar...................................................................................................................................3
1.2 Heliomolar Flow .........................................................................................................................3
1.3 Heliomolar HB.............................................................................................................................3
5. Toxicology........................................................................................................................ 11
5.1 Acute oral toxicity ................................................................................................................... 11
5.2 Compatibility with the mucous membrane and local irritation of skin ............................. 11
5.3 Elution tests............................................................................................................................. 11
5.4 Ytterbium trifluoride................................................................................................................ 11
5.5 Sensitization ............................................................................................................................ 11
5.6 Mutagenic properties.............................................................................................................. 11
5.7 Literature on toxicology ......................................................................................................... 12
6. Literature .......................................................................................................................... 13
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1. Introduction
In the last few years, the growing call for invisible restorations and the search for alternative
materials to amalgam have led to an increase in the demand for composite materials. In
1984, Ivoclar Vivadent introduced Heliomolar, which has become one of the most widely
accepted dental composite materials. In 1994, CRA wrote that Heliomolar was being
successfully used all over the world since its introduction in 1984 and even eleven years after
its launch it continued to be one of the best composite materials. In April 1999, Heliomolar
Flow, a flowable version of Heliomolar, was introduced to cover all the requirements of
dentists in terms of indications and application procedures. Furthermore, in December 2000,
a condensible product variant called Heliomolar HB was launched, completing the range of
Heliomolar materials.
1.1 Heliomolar
Heliomolar falls into the category of inhomogeneous microfilled composites. In dentistry,
microfillers are materials whose filler particles are smaller than 1µm. Prepolymers may be
added to the microfilled composite to enhance its consistency and physical properties as well
as to increase its filler content. The prepolymers used in Heliomolar are microfilled pre-
polymerized composites that exhibit virtually the same properties as the matrix.
1.3 Heliomolar HB
Heliomolar HB is the latest member of the Heliomolar family. The adjunct HB stands for
Heavy Body. Heliomolar HB falls into the category of what are known as packable or
condensible composites. Ivoclar Vivadent offers Heliomolar in three different consistencies to
meet the varying requirements placed on the handling properties of composites. Heliomolar
HB is particularly suitable for direct restorations in the posterior region.
Two slight alterations of the original Heliomolar were required to obtain the heavy-body
consistency of Heliomolar HB. Firstly, the material was rendered less sticky by slightly
modifying the proportional composition of the monomer mixture, ie the portion of the
comparatively large copolymers was lowered while the portion of microfillers was slightly
raised. As a result, the viscosity of the material increased. Secondly, a rheology modifier in
the form of an organically modified compound silicate was added to the material. The
compound silicate, which contains surface linked, long chain organic groups, increases the
firmness of Heliomolar HB but does not compromise the material’s modelling properties.
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2. Technical Data
In accordance with: ISO 4049 – Polymer-based filling, restorative and luting materials
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3. Physical Studies
3.1 Abrasion
When Heliomolar was introduced, it set a new standard in terms of resistance to abrasion of
composite materials. In 1987, Tani et al published a study, in which Heliomolar’s high
resistance to abrasion was confirmed. Furthermore, in a study conducted by Leinfelder in
1991, Heliomolar was shown to be one of the materials that exhibited the lowest wear. The
experimental of this study included 400,000 cycles of repeated stress and PMMA pellets as
the abrasive. While the majority of the composite materials against which Heliomolar was
compared in 1987 and 1991 are no longer available, Heliomolar as well as Heliomolar Flow
and Heliomolar HB, the two new Heliomolar versions, still rank among the leading
composites in terms of resistance to abrasion (Sorensen 2000, Report on file).
12 60
10 50
Abrasion (µm3x10-3)
8 40
Abrasion (µm)
6 30
4 20
2 10
0 0
Clearfil Estilux Ful-fil Lite Fil P Occlusin P-10 P-30 Photo Heliomolar Adaptic-2 Bis-Fil Clearfil Herculite Occlusin P-10 P-30 P-50 Heliomolar
Posterior Posterior Clearfil A Posterior
60
40
studies: The results of Tani and Leinfelder are taken
Verlust (µm)
0
Filtek Z- Herculite Prodigy Pyramid Solitaire Surefil Heliomolar Heliomolar Heliomolar
250 Flow HB
Abrasion Attrition
Sorensen (2000)
∆Y ∆S ∆K ∆CR
Heliomolar -1.6 -0.02 0.021 0.003
Herculite -1.9 0.13 0.043 0.070
P-30 -9.3 0.07 0.017 0.068
Bis-Fil II -2.3 0.04 0.039 0.021
Estilux Posterior 4.8 0.32 -0.006 0.122
Distalite 1.6 0.03 -0.14 0.006
Optical stability of Heliomolar
∆Y = Change in the degree of transmission ∆S = Change in light scattering
∆K = Change in the absorption coefficient ∆CR = Change in opacity
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12
10
8
[µg/cm²]
0
0 100 200 300 400
Zeit [Tage]
5
Depth of dye penetration:
Anzahl Restaurationen
3
0 = no dye penetration
1 = dye penetration into the upper half of the restoration
2
2 = dye penetration into the lower half of the restoration
1 3 = dye penetration down to the cavity floor
0
0 1 2 3
Grad der Farbstoffpenetration
Heliomolar Gold
4. Clinical Studies
4.1 Heliomolar
Heliomolar was launched in 1984. Since then, several three- and five-year studies on the
material have been accomplished.
3-year studies
Knibbs and Smart (1992) conducted a comparative three-year study with Heliomolar and
amalgam. Fifty-two fillings of each material were placed and monitored in terms of marginal
adaptation, surface quality, anatomical shape, and proximal antagonist contact. No
significant difference in the performance of Heliomolar and amalgam was found; both
materials produced favourable clinical results.
Lundin et al (1990) monitored the clinical performance of six different dental composites over
three years. The materials, which were placed in Class II cavities, showed very low failure
rates. Heliomolar demonstrated the lowest abrasion of all six materials
Taylor et al (1994) summarized the data of ten clinical three-year studies on the wear of
restorative materials. Heliomolar ranked second among the 28 composites examined.
In a clinical three-year study conducted by CRA in the US, Heliomolar produced the best
results among the 21 restorations investigated. The following aspects were monitored:
abrasion, marginal adaptation, surface quality, antagonist abrasion, resistance to fracture
and shade adaptation.
Clinical Research Associates Newsletter, Volume 18, Issue 5 May 1994: Comparative
performance of 21 class 2 materials at 3 years
5-year studies
In a clinical study conducted by Leinfelder (Mazer and Leinfelder, 1992), 68 Class I and II
restorations were placed using Heliomolar. The mean abrasion was as low as 7.7 µm/year..
According to Leinfelder, the Heliomolar restorations were characterized by a high degree of
shade stability, surface smoothness, resistance to abrasion and acceptance by patients
throughout the five years. During the first two years, none of the restorations demonstrated
secondary caries. Only two restorations showed signs of incipient secondary caries.
Leinfelder attributes the low rate of secondary caries to the fact that Heliomolar releases
fluoride ions.
The authors compared the data on abrasion and secondary caries with the corresponding
data of other materials. Heliomolar restorations demonstrated the lowest abrasion and were
the least prone to developing secondary caries (Mazer and Leinfelder, 1992).
Setcos and Phillips (1995) compared Heliomolar and amalgam in a clinical study on Class I
and II restorations. The observation period was five years and the following aspects were
monitored: shade stability, marginal discoloration, anatomic shape, marginal integrity,
secondary caries, abrasion and sensitivity to temperature. The results prove the favourable
clinical performance of Heliomolar.
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A CRA Newsletters (1989) summarized the results of clinical trials conducted on 21 different
dental composites placed in Class II cavities. In the trials, which lasted between two to five
years, the following aspects were monitored: marginal adaptation, proximal contact areas,
postoperative sensitivity, secondary caries, surface quality, discoloration and shade. The
Heliomolar restorations were attested favourable ratings with regard to all of these aspects.
Moreover, Heliomolar demonstrated the lowest abrasion of all the materials tested.
If the results of the 3- and 5-year studies are all added up and a loss analysis according to
Kaplan-Meier is conducted, very high survival rates are observed.
4.2 Heliomolar HB
Clinical studies to examine Heliomolar HB have been initiated. The 12-month results are
available.
Head of study: Dr Jim R Dunn, D Carlos Munoz
Loma Linda University, California, USA
Objective: Examine the clinical performance of Heliomolar HB
Experimental: Fifty Class II cavities were placed in a total of 32 patients, using
Heliomolar HB and Excite dentin adhesive. Heliomolar HB was applied
in increments. The restorations were examined after six and twelve
months. The next follow-up evaluation is due to be conducted 24
months after placement.
Results: Heliomolar HB
Criteria 1 months 6 months 12 months
Restorations evaluated 44 48 43
Marginal adaptation 100% A 100% A 88% A
Interproximal anatomical shape 98% A 100% A 95% A
Post-operative sensitivity 90% A 96% A 91% A
Secondary caries 100% A 100% A 100% A
Marginal discoloration 96% A 98% A 88% A
Proximal contact areas 86% A 96% A 91% A
Surface polish 100% A 100% A 100% A
Retention 100 % 100% 98% A
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Results: Heliomolar HB
Criteria Baseline 6 months 12 months
Marginal integrity 100% A 100% A 87% A, 13% B
Discoloration 100% A 100% A 100% A
Secondary caries 100% A 100% A 100% A
Surface quality 100% A 100% A 100% A
Anatomical shape 100% A 100% A 100% A
Post-operative sensitivity 97% A, 3% B 97% A, 3% B 91% A, 9% B
Retention 100% A 100% A 100% A
5. Toxicology
Heliomolar is applied directly into the cavity. The resin is light-cured in the oral cavity.
The following toxicological risks had to be investigated:
y Acute oral risk: patients may accidentally swallow the portion of uncured Heliomolar
placed in the cavity
y Local incompatibility with surrounding tissue that comes into contact with the material
y Possible sensitizing reactions
y Peroral long-term risk by eluted low-molecular components
y Mutagenic potential of eluted low-molecular components
5.2 Compatibility with the mucous membrane and local irritation of skin
A primary irritation index of 0.3 was measured in the mucuous membrane. On the basis of
this result, the material may be regarded as having a minimally irritating effect in an uncured
state [4]. The skin irritation index was also 0.3, indicating a minimal primary irritation effect on
skin [5].
5.5 Sensitization
Uncured Heliomolar was subjected to a sensitization (maximization) test in guinea pigs. In
this rigorous test [9], slight irritation occurred. However, it may be assumed that the cured
material has no sensitizing effect.
Conclusion:
On the basis of the data on hand, an acute or chronic risk for patients is not indicated,
if Heliomolar is used properly.
The results of the clinical studies and the general toxicological data on composite
materials support the above conclusion.
The chemistry of Heliomolar Flow and Heliomolar HB are similar to that of Heliomolar.
The monomer content and the filler composition have only been slightly changed to
modify the consistency of the materials.
Thus, the toxicological data on Heliomolar also apply to Heliomolar Flow and
Heliomolar HB.
6. Literature
Arend J, van der Zee Y
Fluoride uptake in bovine enamel and dentin Ludin SA, Andersson B, Koch G, Rasmusson CG
from fluoride-releasing composite resin Class II composite resin restorations: A three
Quitessence International 21 (1990) 541-544 year clinical study of six different posterior
composites
Arends J, Ruben J Swed Dent J 14 (1990) 104-115
Fluoride release from a composite
Quitessence International 19 (1988) 513-514 Mazer R, Leinfelder K
Evaluating a microfill posterior composite resin
Clinical Research Associates - a five year study
Comparative performance of 21 class 2 J Am Dent Assoc 123 (1992) 33-38
materials at 3 years
Clinical Research Associates Newsletter, Volume Powers JM, Bakus ER, Goldberg AJ
18, Issue 5 May 1994 In vitro color changes of posterior composites
Dent Mater 4 (1988) 151-154
Clinical Research Associates
Restorative resins, new products, one year Setcos JC
clinical performance Heliomolar radiopaque als Amalgamersatz?
Clinical Research Associates Newsletter, Volume Phillip J 12 (1995) 93-95
18, Issue 11 November 1994
Staehle HJ, Ackermann J
Feilzer AJ, De Gee AJ, Davidson CL Experimentelle Untersuchungen über die
Curing contraction of composites and glass- Dichtigkeit von okklusalen Kompositfüllungen
ionomer cements im Vergleich zu okklusalen Metallinlays
J Prosthetic Dent 59 (1988) 297-300 ZWR 100 (1991) 648-653
Bouschlicher MR, Cobb DS, Boyer DB A clinical trial of four light curing posterior
Radiopacity of compomers, flowable and composite resins: 9-month report
conventional resin composites for posterior Quintessence Int 20 (1989) 641-652
restorations
Oper Dent 24 (1999) 20-25 Dietschi D, Holz J
Klinische Untersuchung von vier lichthärtenden
Bryant RW, Hodge KLV Kompositmaterialien für den Seitenzahnbereich
A clinical evaluation of posterior composite resin - Ergebnisse nach zwei Jahren (1)
restorations Quintessenz 42 (1991) 743-751
Aust Dent J 39 (1994) 77-81
Dietschi D, Magne P, Holz J
Bryant RW, Marzbani N, Hodge KLV Recent trends in esthetic restorations for
Occlusal margin defects around different types of posterior teeth
composite resin restorations in posterior teeth Quintessence Int 25 (1994) 659-677
Oper Dent 17 (1992) 215-221
Dijkman GEHM, Arends J
Castline JM, TU SJ Secondary Caries in situ around Fluoride-
Measured light intensities at simulated dentin/ Releasing Light-Curing Composites: A
composite bonding interfaces Quantitative Model Investigation on Four
J Dent Res 79 (2000) 280 Materials
Caries Res 26 (1992) 351-357
Christensen GJ
Restorative Dentistry: An update for Dijkman GEHM, De Vries J, Lodding A, Arends J
Practitioners, Educators, Examining Boards Long-term fluoride release of visible ligth-
J Am Dent Assoc 126 (1995) 1165-1168 activated composites in vitro: a correlation with
in situ demineralisation data
Christensen GJ, Christensen RP Caries Res 27 (1993) 117-123
A new technique for the restoration of worn
anterior teeth - 1995 Donly K, Gomez C
J Am Dent Assoc 126 (1995) 1543-1546 In vitro demineralization-remineralization of
enamel caries at restoration margins utilizing
Chung K fluoride-releasing composite resin
Effects of finishing and polishing procedures on Quintessence Int 25 (1994) 355-358
surface texture of resin composites
Dent Mater 10 (1994) 325-330 Fallo GJ, Wakefield CW
Effects of uncontrolled outdoor storage on the
Condon JR, Ferracane JL polymerization, manipulation, and appearance
Assessing the effect of composite formulation on of visible light-cured composite resin and resin-
polymerization stress modified glass ionomer materials
J Am Dent Assoc 131 (2000) 497-503 Military Medicine 161 (1996) 290-293
The effect of thermal cycling on the fracture Comparison of two- and three-body wear of
toughness of seven composite restorative glass-ionomers and composites
materials Eur J Oral Sci 104 (1996) 132-137
Dent Mater 5 (1989) 23-26
Pelka M, Frankenberger R, Sindlinger R, Petschelt A
Margolis HC, Moreno EC, Murphy BJ Verschleißsimulation natürlicher
Effect of low levels of fluoride in solution on Zahnhartsubstanzen im abrasiven Kontakt
enamel demineralization in vitro Dtsch Zahnärztl Z 53 (1998) 61-64
J Dent Res 65 (1986) 23-29
Pilo R, Brosh T, Lugassy H, Baharav H, Helft M
Mazer R, Leinfelder K The effect of irradiation time on the shear
Evaluating a microfill posterior composite resin - strength of composites
a five year study Dent Mater 10 (1994) 338-342
J Am Dent Assoc 123 (1992) 33-38
Powers JM, Bakus ER, Goldberg AJ
Mazer R, Leinfelder K, Russell CM In vitro color changes of posterior composites
Degradation of microfilled posterior composite Dent Mater 4 (1988) 151-154
Dent Mater 8 (1992) 185-189
Powers JM, McDowell GC, Lang BR
Milosevic A In vivo wear. Part II: Wear and abrasion of
The influence of surface finish and in-vitro composite restorative materials
pellicle on contact-angle measurement and J Prosthet Dent 60 (1988) 242-249
surface morphology of three commercially
available composite restoratives Prati C
J Oral Rehab 19 (1992) 85-97 Early marginal microleakage in class II resin
composite restorations
Momoi Y, McCabe JF Dent Mater 5 (1989) 392-398
Hygroscopic expansion of resin based
composites during 6 months of water storage Rasmusson CG, Lundin SA
Br Dent J 176 (1994) 91-96 Class II restorations in six different posterior
composite resins: Five-year results.
Mount GJ Swed Dent J 19 (1995) 173-182
The tensile strength of the union between
various glass ionomer cements and various Rees JS, Jacobsen PH
composite resins The polymerization shrinkage of composite
Aust Dent J 34 (1989) 136-146 resins
Dent Mater 5 (1989) 41-44
Munksgaard EC, Nolte J, Kristensen K
Adherence of chewing gum to dental restorative Reich E, Schmalz G, Federlin M
materials Randspaltverhalten von Keramik- und
Am J Dent 8 (1995) 137-139 Kompositinlays in vitro
Dtsch Zahnärztl Z 45 (1990) 656-660
NaBadalung DP, Nicholls JI, Brudvik JS
Frictional resistance of removable partial Reinhardt KJ
dentures with retrofitted resin composite guide Der Einfluss der Lichtquelle auf die
planes Randständigkeit von Kompositfüllungen
Int J Prosthodont 10 (1997) 116-122 Dtsch Zahnärztl Z 46 ( 1991) 132-134
Palenik CJ, Setcos JC Retief DH, Mandras RS, Russell CM, Denys FR
Antimicrobial abilities of various dentine bonding Evaluation of the Syntac bonding system
agents and restorative materials Am J Dent 6 (1993) 17-21
J Dent 24 (1996) 289-295
Retief H, Mandras R, Russell CM
Papagiannoulis L, Tzoutzas J, Eliades G Shear bond strength required to prevent
Effect of topical fluoride agents on the microleakage at the dentin/restoration interface
morphologic characteristics and composition of Am J Dent 7 (1994) 43-46
resin composite restorative materials
J Prosthet Dent 77 (1997) 405-413 Rzanny A, Göbel R, Welker D
Quasistatische Prüfungen an 21 Füllungs- und
Pelka M, Ebert J, Schneider H, Krämer N, Petschelt Verblendkomposits
A ZWR 104 (1995) 698-703
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Rzanny A, Welker D
Biegefestigkeitsprüfungen an Komposits im Taylor DF, Bayne SC, Leinfelder KF, Davis S, Koch
methodischen Vergleich GG
Quintessenz Zahntech 19 (1993) 1467-1473 Pooling of long term clinical data for posterior
composites
Sakaguchi RL, Peters MC, Nelson SR, Douglas WH, Am J Dent 7 (1994) 167-174
Poort HW
Effects of polymerization contraction in Tjan AHL, Chan CA
composite restorations The polishability of posterior composites
J Dent 20 (1992) 178-182 J Prosthet Dent 61 (1989) 138-146
Shinkai K, Suzuki S, Leinfelder K, Katoh Y Wassel RW, McCabe JF, Walls AWG
How heat treatment and thermal cycling affect A two-body friction wear test
wear of composite resin inlays J Dent Res 73 (1994) 1546-1553
J Am Dent Assoc 125 (1994) 1467-1472
Wassel RW, McCabe JF, Walls AWG
Sjörgen G, Hdlund SO, Jonsson C Subsurface deformation associated with
A 3-year follow-up study of preformed beta- hardness measurements of composites
quartz glass-ceramic insert restorations Dent Mater 8 (1992) 218-223
Quintessence Int 31 (2000) 25-31
Wassell RW, McCabe JF, Walls AW
Staehle HJ, Ackermann J Wear characteristics in a two-body wear test
Experimentelle Untersuchungen über die Dent Mater 10 (1994) 269-274
Dichtigkeit von okklusalen Kompositfullungen im
Vergleich zu okklusalen Metallinlays Watts DC, Cash AJ
ZWR 100 (1991) 648-653 Analysis of optical transmission by 400-500 nm
visible ligth into aesthetic dental biomaterials
Steinmetz MJ, Pruhs RJ, Brooks JC, Dhuru VB, Post J Dent 22 (1994) 112-117
AC
Rechargeability of fluoride releasing pit and Willems G, Lambrechts P, Braem M, Celis JP,
fissure sealants and restorative composites Vanherle G
Am J Dent 10 (1997) 36-40 A classification of dental composites according
to their morphological and mechanical
Suliman AA, Boyer DB, Lakes RS characteristics
Cups movement in premolars resulting from Dent Mater 8 (1992) 310-319
composite polymerization shrinkage
Dent Mater 9 (1993) 6-10 Willems G, Lambrechts P, Braem MJA, Vuylsteke-
Wauters M, Vanherle G
Suliman AA, Boyer DB, Lakes RS The surface roughness of enamel-to enamel
Interferometric measurements of cusp areas compared with the intrinsic roughness of
deformation of teeth restored with composites dental composites
J Dent Res 72 (1993) 1532-1536 J Dent Res 70 (1991) 1299-1305
J Dent Res 79(2000) 284 Frei modellierte Brücken mit Heliomolar - Ein
Fallbericht
Zeppenfeld W Phillip J 12 (1995) 105-107
Publications on Heliomolar HB
Dunn JR, Munoz CA, Bernal G, Torres J, Wilson A
Clinical evalutation of Heliomolar HB for Heintze SD, Cavalleri A, Vogel K, Sele J
posterior restorations Microleakage of composite class II restorations
J Dent Res 80 (2001) 91 in vitro
J Dent Res 80 (2001) 589
Lowe E
Heavy duty tips and tricks for using Heliomolar Jackson RD
HB Replacing failed amalgam fillings using
Dental Town Magazine 0 (2001) 14-15 Heliomolar HB direct adhesive resin
Dental Products Report 3 (2001) 70
Neme AL, Pink FE, Aksu MN, Maxson BB, Kashani
N
In-vitro microleakage in class II packable resin
composite restorations
J Dent Res 80 (2001) 105
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