Professional Documents
Culture Documents
discussions, stats, and author profiles for this publication at: https://www.researchgate.net/publication/7222969
CITATIONS READS
20 54
4 authors, including:
Roland Frankenberger
Philipps University of Marburg
371 PUBLICATIONS 4,717 CITATIONS
SEE PROFILE
All content following this page was uploaded by Franklin Garcia-Godoy on 12 October 2015.
The user has requested enhancement of the downloaded file. All in-text references underlined in blue are added to the original document
and are linked to publications on ResearchGate, letting you access and read them immediately.
_______________________________________________________________________________________________________________________________________________________________
Research Article
_______________________________________________________________________________________________________________________________________________________________
ABSTRACT: Purpose: To clinically evaluate two polyacid-modified resin composites (Hytac and Dyract AP) for the
restoration of posterior teeth over a 4-year period and to investigate accessible margins by light microscopy. Methods:
In a controlled prospective clinical study, 71 cavities (21 occlusal, 41 MO/OD, 9 MOD) in 30 patients were restored
with compomers by three dentists. Thirty-eight restorations were placed with the combination OSB/Hytac, the same
patients received 33 restorations with Prime&Bond 2.1/Dyract AP. Enamel margins of the cavities were etched with
phosphoric acid. At baseline, after 12, 24, and 48 months, the restorations were examined by two independent
investigators according to modified USPHS-criteria. Focusing on the 40 restorations available at all recalls, a semi-
quantitative margin analysis was carried out at each recall using replicas and light microscopy at x130 magnification.
Results: Twenty restorations were not investigated at the 4-year recall (drop-out). After 48 months, 11 restorations
(Hytac: n=8, Dyract AP: n=3) had to be replaced due to tooth fracture (n=4), gap formation (n=5), and adhesive failure
(n=2). Forty restorations were still in function after 4 years (overall failure rate 16%; Hytac: 21%; Dyract: 9%).
Between the recalls, statistically significant differences were detected for the criteria marginal integrity (Alpha dropping
from 76% at baseline to 32% after 4 years), restoration integrity (Alpha ratings at baseline 99% vs. 40% after 4 years),
and occlusion (100% vs. 24%). For the criteria surface roughness (from the 6-month recall) and anatomical shape (after
4 years), a significant difference between the materials was evident in favor of Dyract AP. Except gap-free margins, the
predominant criterion in the microscopic analysis at baseline was marginal overhang (24%) and 30% negative step
formation after 4 years. (Am J Dent 2006;19: 61-66).
CLINICAL SIGNIFICANCE: Dyract AP achieved a 91% success rate after 4 years when enamel margins were etched.
Facing a 21% failure rate after 4 years of clinical service, the compomer material Hytac did not fulfill the ADA criteria
for direct posterior restorative materials.
: Prof. Dr. Norbert Krmer, Glueckstrasse 11, D-91054 Erlangen, Germany. E- : kraemer@dent.uni-erlangen.de
Table 1. Pooled results for both restorative materials under clinical observation.
_______________________________________________________________________________________________________________________________________________________________________________________________________________
Criterion Baseline (n = 71) 6 Months (n = 69) 12 Months (n = 63) 24 Months (n = 54) 48 Months (n = 47)
Alpha Bravo Charlie Alpha Bravo Charlie Alpha Bravo Charlie Delta Alpha Bravo Charlie Alpha Bravo Charlie
in % in % in % in % in %
_______________________________________________________________________________________________________________________________________________________________________________________________________________
Surface roughness 97 3 - 81 19 - 54 46 - - 56 44 - 62 38 -
Color match 99 1 - 97 3 - 91 9 - - 85 15 - 89 11 -
Anatomical shape 90 10 - 94 6 - 95 5 - - 92 8 - 49 51 -
Marginal integrity 76 24 - 77 23 - 71 27 2 - 37 57 6 32 62 6
Integrity tooth 92 8 - 91 9 - 90 8 - 2 92 6 2 72 28 -
Integrity restoration 99 1 - 88 12 - 84 16 - - 82 18 - 40 60 -
Occlusion 100 - - 100 - - 100 - - - 98 2 - 24 70 6
Proximal contact 89 11 - 89 11 - 81 19 - - 89 11 - 78 19 3
Hypersensitivity 99 1 - 96 4 - 100 - - - 98 2 - 96 4 -
_______________________________________________________________________________________________________________________________________________________________________________________________________________
Criterion Baseline (n = 38) 6 Months (n = 36) 12 Months (n = 32) 24 Months (n = 28) 48 Months (n = 26)
Alpha Bravo Charlie Alpha Bravo Charlie Alpha Bravo Charlie Delta Alpha Bravo Charlie Alpha Bravo Charlie
in % in % in % in % in %
_______________________________________________________________________________________________________________________________________________________________________________________________________________
Surface roughness 97 3 - 63 36 - 22 78 - - 21 79 - 31 69 -
Color matching 100 - - 97 3 - 91 9 - - 79 21 - 92 8 -
Anatomical shape 90 10 - 94 6 - 97 3 - - 89 11 - 35 65 -
Marginal integrity 79 21 - 83 17 - 69 31 2 - 39 50 11 23 69 8
Integrity tooth 90 10 - 86 14 - 84 13 - 3 89 11 - 73 27 -
Integrity restoration 97 3 - 92 8 - 87 13 - - 75 25 - 27 73 -
Occlusion 100 - - 100 - - 100 - - - 100 - - 34 58 8
Proximal contact 84 16 - 91 9 - 82 18 - - 80 20 - 80 15 5
Hypersensitivity 97 3 - 92 8 - 100 - - - 96 4 - 96 4 -
_______________________________________________________________________________________________________________________________________________________________________________________________________________
Criterion Baseline (n = 33) 6 Months (n = 33) 12 Months (n = 31) 24 Months (n = 26) 48 Months (n = 21)
Alpha Bravo Charlie Alpha Bravo Charlie Alpha Bravo Charlie Delta Alpha Bravo Charlie Alpha Bravo Charlie
in % in % in % in % in %
_______________________________________________________________________________________________________________________________________________________________________________________________________________
Materials and Methods involving five appointments: The baseline investigation, 6-, 12-,
24-, and 48-month recalls.
Patient selection - Patients were selected for this study
Seventy one cavities in 30 patients (8 male, 22 female; aged
according to the following criteria:
18-60 years, average 32 years) were restored with polyacid-
; Absence of pain relating to the restored tooth; modified resin composite materials during the period of Feb-
; No pathologic periodontal or pulpal diagnosis; ruary through November 1998 (restorations with one surface:
; No cusp reconstruction required; and n=21; two surfaces: n=41; three surfaces: n=9). Seventeen of
; No known allergic reaction against any components of the the restorations were located in maxillary molars (~24%), 28 in
used materials. maxillary bicuspids (~39%), 12 in mandibular molars (~17%),
and 12 restorations were placed in mandibular premolars (~17
The patients were treated in the Department of Operative %). Local anesthesia (Ultracain DSa) was applied in all cases.
Dentistry and Periodontology, University of Erlangen- Thirty eight restorations were placed using Hytac bonded
Nuremberg (n=17) and in a private practice (n=13) by two with OSB.b Thirty-three restorations were made of Dyract AP
different clinicians having experience with direct posterior bonded with Prime&Bond 2.1.c
adhesive restorations. All treatment steps from the preparation to the polish were
Patients were required to sign a consent form indicating that performed by use of magnifying glasses providing 2.3-fold
the adhesive system and the dental restorative were recently magnification.d
developed and that no long-term experience was available at
baseline of the investigation. The clinical study was conducted Preparation - The cavities were prepared under pre-wedging
according to EN 540 (clinical investigation of medical devices with wooden wedges (Sycamore interdental wedgese) accord-
for human subjects according to the European Committee for ing to minimally invasive preparation rules, therefore pre-
Standardization). The patients agreed to a 4-year recall system ventive extension was avoided. The margins were not beveled
American Journal of Dentistry, Vol. 19, No. 1, February, 2006
Compomers after 4 years 63
Baseline (n=40) 6 Months (n=40) 12 Months (n=40) 24 Months (n=40) 48 Months (n=40)
Length (m) 11.7 x 103 11.6 x 103 11.5 x 103 12.9 x 103 12.0 x 103
Criterion Percentage of entire evaluable margin length (SD)
_______________________________________________________________________________________________________________________________________________________________________________________________________________
Perfect margin 62.6 (20.5) 74.5 (18.2) 80.0 (13.9) 53.9 (24.0) 59.1 (26.5)
Negative step formation 3.1 (4.8) 6.4 (8.4) 8.3 (8.6) 32.6 (25.4) 29.8 (24.8)
Gap formation 3.6 (1.4) 1.5 (3.4) 1.3 (3.2) 2.9 (7.6) 6.4 (17.1)
Overhang 24.3 (19.8) 12.7 (16.1) 6.9 (9.0) 2.5 (1.5) 8.0 (4.1)
Positive step formation 6.4 (2.2) 1.7 (4.9) 1.2 (3.9) 6.2 (14.5) 4.3 (8.5)
Artifact 8.9 (9.9) 3.1 (4.6) 2.3 (3.1) 1.4 (5.6) 6.6 (4.0)
_______________________________________________________________________________________________________________________________________________________________________________________________________________
Fig. 3. Survival rates for both materials under investigation according to the algorithm of Kaplan/Meier.
The authors decided to selectively etch the enamel margins based composites.7,24 This laboratory generated fact can be
instead of total etching to avoid rather complicated wet bonding confirmed facing the in vivo data of the present study, at least
procedures as described even later in the literature, facing the for the compomer material Hytac.
enormous technique sensitivity of these materials, above all The additionally performed margin analysis using a light
when acetone is the solvent of choice like in both adhesives microscope at x130 magnification delivers only a confirmation
used in the present study.22,23 of facts emerging from the clinical investigation.21 Microscopic
Regarding the clinical results, it is obvious that the higher investigations in vivo are always compromised due to the fact
surface roughness of Hytac in comparison to Dyract led to that the important proximal parts of the restorations cannot be
clinically detectable rougher restoration surfaces over the whole reproduced sufficiently and marginal gaps could theoretically
observation period.6 The reason for that observation lays in be obstructed by plaque, because no separate etching to clean
different filler sizes when Hytac and Dyract AP are compared.6 the margins could be carried out.20 Therefore, the margin
This was already significantly different at the 6-month analysis is at least a useful additional tool for the whole investi-
evaluation. A later sign of different filler concepts is evidently gation, but is not able to replace any clinical evaluation of
the loss of anatomical shape due to occlusal and proximal wear restorative materials after a certain time of clinical service.
between the 2-year and the 4-year recalls. This observation was Altogether, the present results indicated that it cannot be
significantly clearer for the Hytac restorations. Also the Dyract assumed that compomers per se can clinically work equally
AP restorations lost anatomical shape over time; however, this well as resin-based composites,1 even when the bonding
did not lead to Charlie ratings like for Hytac. protocol is similar. At least for Hytac, it was concluded that the
The clinical performance of Hytac compomer was not ADA requirements i.e. 90% success after 4 years was not
favorable. Even when treating the material as a resin-based fulfilled.26 Hytac is no longer in the market since January 2003.
composite. i.e. with phosphoric acid etching of the enamel mar-
a. Aventis, Frankfurt/Main, Germany.
gins, a failure rate of 21% after 4 years was observed. This b. 3M ESPE AG, Seefeld, Germany.
observed failure rate is only slightly better than comparable c. De Trey/Dentsply, Konstanz, Germany.
studies applying Dyract AP13 or Hytac24 without enamel etch- d. Jenoptik, Jena, Germany.
e. Kerr Hawe-Neos, Bioggio, Switzerland.
ing. It is interesting that only 28% of all observed failures were f. Komet Corp., Lemgo, Germany.
attributed to marginal gap formation. However, in another g. Nikon, Tokyo, Japan.
study without enamel etching, more than 80% of the failures h. Agfa Gevaert, Leverkusen, Germany.
were due to severe gap formation.24 Different recall protocols i. Hu-Friedy, Leimen, Germany.
j. 3M ESPE, St. Paul, MN, USA.
(number of investigators, modifications of USPHS criteria, k. GC Europe, Leuven, Belgium.
including Charlie and Delta into the survival algorithm, and l. YDM Yamamura, Tokyo, Japan.
finally the presence of an additional marginal analysis) tend to m. Colgate-Palmolive, Hamburg, Germany.
n. Ivoclar-Vivadent, Schaan, Principality of Liechtenstein.
complicate comparisons with other clinical studies reported in o. Sony, Cologne, Germany.
the literature. p. Matrox Meteor RGB, AVT Horn, Aalen, Germany.
An important point emerging from the clinical results is the q. Balzers SCD 40, Balzers, Principality of Liechtenstein.
r. Akashi, Tokyo, Japan.
wear behavior of the materials under investigation, above all of s. SPSS inc, Chicago, IL, USA.
Hytac. Betwen the 2- and 4-year recalls, a clear deterioration of
anatomical shape of the restorations was evident, leading to Acknowledgements - This study was supported by materials and a grant from
Charlie ratings due to missing occlusal and proximal contact 3M ESPE AG (Seefeld, Germany). The authors are grateful to Mrs. Gudrun
Amberger for the helpful assistance during the SEM processing.
points. It is known from several in vitro wear analyses that
compomer materials provide less abrasion resistance than resin- Dr. Krmer and Dr. Frankenberger are Associate Professors, Department of
American Journal of Dentistry, Vol. 19, No. 1, February, 2006
66 Krmer et al
Operative Dentistry and Periodontology, University of Erlangen-Nuremberg, 12. Gross LC, Griffen AL, Casamassimo PS. Compomers as Class II
Erlangen, Germany; Dr. Garca-Godoy is Professor and Associate Dean for restorations in primary molars. Pediatr Dent 2001;3:24-27.
Research, College of Dental Medicine, Nova Southeastern University, Fort 13. Cehreli ZC, Altay N. Three-year clinical evaluation of a polyacid-modified
Lauderdale, Florida, USA; Dr. Reinelt is in private practice in Nuremberg, resin composite in minimally invasive occlusal cavities. J Dent
Germany. 2000;28:117-122.
14. Rosa BT, Perdigo J. Bond strengths of nonrinsing adhesives. Quintessence
References Int 2000;31:353-358.
1. Busato AL, Loguercio AD, Reis A, de Oliveira Carrilho MR. Clinical 15. Tate WH, You C, Powers JM. Bond strength of compomers to human
evaluation of posterior composite restorations: 6-year results. Am J Dent enamel. Oper Dent 2000;5:283-291.
2001;14:304-308. 16. Frankenberger R, Perdigo J, Rosa BT, Lopes M. No-bottle vs. multi-bottle
2. Wilson NH, Cowan AJ, Unterbrink G, Wilson MA, Crisp RJ. A clinical adhesives. A microtensile and morphological study. Dent Mater 2001;
evaluation of Class II composites placed using a decoupling technique. J 17:373-380.
Adhes Dent 2000;2:319-329. 17. Ryge G, Cvar JF. Criteria for the clinical evaluation of dental restorative
3. Marks LA, Weerheijm KL, van Amerongen WE, Groen HG, Martens LC. materials. United States Dental Health Center, US Government Printing
Dyract versus Tytin Class II restorations in primary molars: 36 months Office, San Francisco 1971, Pub. 7902244.
evaluation. Caries Res 1999;33:387-392. 18. Ryge G, Snyder M. Evaluating the clinical quality of restorations. J Am
4. Khler B, Rasmusson C-G, dman P. A five-year clinical evaluation of Dent Assoc 1973;87:369-377.
class II composite resin restorations. J Dent 2000;28:111-116. 19. Ryge G, Jendresen MD, Glantz PO, Mjr I. Standardization of clinical
5. Krejci I, Besek M, Lutz F. Clinical and SEM study of Tetric resin composite investigators for studies of restorative materials. Swed Dent J 1981;5:235-239.
in posterior teeth: 12-months results. Am J Dent 1994;7:325-331. 20. Roulet JF. Marginal integrity: Clinical significance. J Dent 1994;22:S9-12.
6. el-Kalla IH, Garca-Godoy F. Mechanical properties of compomer 21. Braun A-R, Frankenberger R, Krmer N. Clinical performance and margin
restorative materials. Oper Dent 1999;24: 2-8. analysis of Ariston pHc versus Solitaire as posterior restorations after one
7. Latta MA, Barkmeier WW, Wilwerding TM, Blake SM. Localized wear of year. Clin Oral Investig 2001;5:139-147.
compomer restorative materials. Am J Dent 2001;14:238-240. 22. Perdigo J, Frankenberger R. Effect of solvent and re-wetting time on
8. Vercruysse CW, De Maeyer EA, Verbeeck RM. Fluoride release of dentin adhesion. Quintessence Int 2001;32:385-390.
polyacid-modified composite resins with and without bonding agents. Dent 23. Kanca J. Resin bonding to wet substrate. I. Bonding to dentin. Quintessence
Mater 2001;17:354-358. Int 1992;23:39-41.
9. Peutzfeldt A. Compomers and glass ionomers: Bond strength to dentin and 24. Huth KC, Manhart J, Selbertinger A, Paschos E, Kaaden C, Kunzelmann KH,
mechanical properties. Am J Dent 1996;9:259-263. Hickel R. 4-year clinical performance and survival analysis of Class I and II
10. Barnes D, Blank L, Thompson V, Holston AM, Gingell JC. A 5- and 8- compomer restorations in permanent teeth. Am J Dent 2004;17:51-55.
year clinical evaluation of a posterior composite resin. Quintessence Int 25. Krmer N, Pelka M, Kautetzky P, Sindel J, Petschelt A. Wear resistance of
1991;22:143-151. compomers and packable glass ionomer cements. Dtsch Zahnrztl Z
11. Roeters JJ, Frankenmolen F, Burgersdijk RC, Peters TC. Clinical 1997;52:186-189. (In German).
evaluation of Dyract in primary molars: 3-year results. Am J Dent 26. ADA American Dental Association Council on Scientific Affairs.
1998;11:143-148. Acceptance Program Guidelines Restorative Materials, March 1996.