Ten-year outcome of three-unit fixed dental prostheses made from monolithic lithium disilicate ceramic Matthias Kern, Martin

Sasse and Stefan Wolfart JADA 2012;143(3):234-240 The following resources related to this article are available online at jada.ada.org ( this information is current as of November 19, 2012):
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Ten-year outcome of three-unit fixed dental prostheses made from monolithic lithium disilicate ceramic
Matthias Kern, Dr med dent, PhD; Martin Sasse, Dr med dent; Stefan Wolfart, Dr med dent, PhD

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espite the increasing use of all-ceramic materials in prosthodontics, systematic reviews from the last five years have revealed a lack of longterm clinical data (data for a period of 10 and more years) for all-ceramic fixed dental prostheses (FDPs).1-6 All-ceramic materials used for FDP fabrication are either oxide ceramics (zirconia or alumina based), which require esthetic veneering with silica-based ceramics, or lithium disilicate ceramics, which can be used in a monolithic form owing to their broad range of optical properties (that is, a variety of available translucencies and shades).1-6 Lithium disilicate is a unique glassceramic material, in which small needle-shaped crystals compress the surrounding glass matrix during cooling; this process counteracts tensile stresses before crack propagation starts and results in relatively high flexural strength (350400 megapascals).7 The first lithium disilicate ceramic (IPS Empress 2, Ivoclar Vivadent, Schaan, Liechtenstein) still was used with veneering ceramic but was not designed to be used in its monolithic form. The results of studies showed it to have an excellent clinical outcome in posterior and anterior crowns across five8 and 109 years, but within five

AB STRACT

CON
T

Background. The authors conducted a prospective study to evaluate the long-term outcome of crown-retained fixed dental prostheses (FDPs) made from monolithic lithium disilicate A 1 RT ceramic (IPS e.max Press, Ivoclar Vivadent, I C LE Schaan, Liechtenstein). Methods. Faculty dentists at the Department of Prosthodontics, Propaedeutics and Dental Materials, School of Dentistry, ChristianAlbrechts University at Kiel, Germany, placed 36 three-unit FDPs in 28 patients to replace six anterior and 30 posterior teeth. The proximal connector size (height and width) was 4 3 millimeters for anterior FDPs and 4 4 mm for posterior FDPs. FDPs were cemented either conventionally with glass ionomer cement (n = 19) or adhesively with resin-based composite (n = 17). Patients made annual recall visits. Results. The mean (standard deviation) observation period was 121 (12.8) months. FDPs survival rate (survival being defined as remaining in place either with or without complications) was 100 percent after five years and 87.9 percent after 10 years, and their success rate (success being defined as remaining unchanged and free of complications) was 91.1 percent after five years and 69.8 percent after 10 years. The cementation method did not affect the outcome. Conclusion. Three-unit FDPs made from monolithic lithium disilicate ceramic showed five- and 10-year survival and success rates that were similar to those of conventional metal-ceramic FDPs. Clinical Implications. If the manufacturers recommendations are followed, three-unit FDPs made from monolithic lithium disilicate ceramic may be a safe alternative to metal-ceramic FDPs regardless of the cementation method used. Key Words. All-ceramic system; survival rate; clinical outcome; fixed dental prostheses; ceramic fracture. JADA 2012;143(3):234-240.
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Dr. Kern is a professor and the chair, Department of Prosthodontics, Propaedeutics and Dental Materials, School of Dentistry, Christian-Albrechts University at Kiel, Arnold-Heller-Strasse 16, 24105 Kiel, Germany, e-mail mkern@proth.uni-kiel.de. Address reprint requests to Dr. Kern. Dr. Sasse is an assistant professor, Department of Prosthodontics, Propaedeutics and Dental Materials, School of Dentistry, Christian-Albrechts University at Kiel, Germany. Dr. Wolfart is a professor and the chair, Department of Prosthodontics and Dental Materials, Medical Faculty, RWTH Aachen University, Germany.

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years of clinical service, investigators reported a fracture rate of 30 percent when used for the replacement of anterior teeth and first premolars.8 The second generation of lithium disilicate ceramic (IPS e.max Press, Ivoclar Vivadent) has smaller and more homogeneous crystals and improved physical properties (flexural strength and fracture toughness about 10 percent higher) than its predecessor.10 Therefore, it seemed of particular interest as to whether or not the higher strength of IPS e.max Press in comparison with IPS Empress 2 translates into improvement of in vivo stability of three-unit FPDs. So far, researchers have reported, IPS e.max Press has been used successfully for monolithic FDPs even in the posterior area for as long as eight years.11 However, taking longterm outcome as a measure, it still is questionable whether all-ceramic FDPs can compete with metal-ceramic FDPs, for which systematic reviews showed 10-year survival rates of 87.0 to 89.2 percent.12,13 Therefore, our purpose in this article is to present results of a prospective study yielding the first 10-year outcome data regarding threeunit all-ceramic FDPs fabricated from a monolithic lithium disilicate ceramic (IPS e.max Press) and to compare those findings with outcome data regarding metal-ceramic FDPs as revealed by systematic reviews.
METHODS

The study protocol was approved by the ethics committee of the Christian-Albrechts University at Kiel, Germany, in 1999, and all study participants provided informed consent. Our research team11,14 has published detailed descriptions of patient selection, study design, prosthodontic procedures and the outcome across a mean observation time of 86 months. In short, faculty dentists of the Department of Prosthodontics, Propaedeutics and Dental Materials, ChristianAlbrechts University at Kiel, inserted 36 threeunit FDPs made from monolithic lithium disilicate ceramic (IPS e.max Press, Ivoclar Vivadent) without any cantilever pontics in 28 patients with a mean (standard deviation) age of 47.5 (11.6) years (17 women, 11 men). Two of the authors (M.K., S.W.) supervised the process closely. We included patients with missing single teeth if the edentulous space was equal to or smaller than the width of a molar. We required that the abutment teeth be vital, that the bone level of the abutment teeth correspond to at least two-thirds of the root length and that the abutment teeth display no signs of active perio-

dontal disease. We required that oral hygiene be good and caries activity low. We accepted a maximum tooth mobility level of Grade I according to the scale described by Nyman and Lindhe.15 We excluded from the study patients who had probing depths of greater than 4 mm, vertical bone pockets around the abutment teeth, bruxism or a medical or psychological history conspicuous for disease. Although the manufacturer recommends the use of lithium disilicate ceramic only for the replacement of anterior teeth and premolars, in this study, we included the replacement of molars to test the suitability of the ceramic as monolithic FDP material in the high-stress posterior area. The departments dental technicians fabricated FDPs by using the lost-wax technique, whereby they waxed the FDPs to their final shape and invested them in a special flask with a special type of phosphate-bonded investment material (IPS PressVest Speed, Ivoclar Vivadent). They plastified the desired shade of a ceramic ingot at 920C and pressed it under vacuum into the mold of the investment using a press furnace (Programat EP600, Ivoclar Vivadent). They pressed each FDP in one monolithic piece with no additional veneering. They individualized the shade of each FDP by using universal intensive stains (Universal Stains Kit, Ivoclar Vivadent). Twenty-four FDPs replaced molars, six FDPs replaced premolars and six FDPs replaced anterior teeth, respectively. The minimal occlusal thickness of the abutment crowns was 1.5 millimeters, and the proximal connector dimensions (height width) were at least 4 3 mm for anterior FDPs and 4 4 mm for posterior FDPs, as recommended by the manufacturer. If the finishing line was more than 0.5 mm subgingival as judged by use of dental loupes with 4 magnification (19), we cemented FDPs with glass ionomer cement (Ketac-Cem, 3M ESPE, St. Paul, Minn.) according to the manufacturers instructions; if the finishing line was less than 0.5 mm subgingival by use of dental loupes with 4 magnification (17), we cemented FDPs adhesively. In both groups, we etched the ceramic luting surfaces with 5 percent hydrofluoric acid for 20 seconds (IPS Ceramic Etching Gel, Ivoclar Vivadent) before cementation. However, in the adhesive cementation group, we additionally silanated the ceramic luting surfaces (Monobond S, Ivoclar Vivadent) and luted them with dentin adhesive
ABBREVIATION KEY. FDP: Fixed dental prosthesis.
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Descriptive analysis of the failures and complications of fixed dental prostheses made from lithium disilicate ceramic (N = 36).
NO.* PARTICIPANT Sex 1 2 3 4 Male Female Female Male Age in Years 43 41 61 38 REPLACED TOOTH CEMENTATION MODE TIME OF EVENT 79 82 116 70 EVENT MODE# TYPE OF FAILURE OR COMPLICATION Technical, complete Technical, complete Technical, complete Technical, partial LENGTH OF SURVIVAL (MONTHS) Lost at time of event Lost at time of event Lost at time of event 121

30 19 13 10

Adhesive Adhesive Conventional Adhesive

Mesial fracture of tooth no. 31 Crown fracture of tooth no. 18 (Figure 3) Crown fracture of tooth no. 14 (Figure 4) Chipping on tooth no. 11 (incisal) within additionally used veneering ceramic; size of the chip: 0.5 millimeter (height), 1 mm (width), 0.5 mm (thickness); repair: polishing Chipping on tooth no. 9 (pontic area) within additionally used veneering ceramic; size: 2 mm (height), 3 mm (width), 0.5 mm (thickness); repair: composite material Recementation Recementation Minor chipping on teeth nos. 2, 3 and 4 (on the palatal cusps); repair: polishing Minor chipping on teeth nos. 13, 14 and 15 (on the palatal cusps); repair: polishing Minor chipping on teeth nos. 5 and 6 (on incisal/occlusal surfaces) (Figure 5); repair: polishing Recementation Small crack within the ceramic of tooth no. 16 after endodontic treatment Teeth nos. 5 and 7 were extracted owing to periodontal reasons Tooth no. 15 required endodontic treatment Tooth no. 3 required endodontic treatment

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Female

34

Conventional

38

Technical, partial

128

6 7 8

Male Male Female

25 44 57

19 3 3

Conventional Conventional Adhesive

64 81 125

Technical, partial Technical, partial Technical, partial

130 128 125

Female

57

14

Adhesive

125

Technical, partial

125

10

Female

48

Adhesive

124

Technical, partial

124

11 12

Male Female

33 43

14 4

Adhesive Adhesive

124 133

Technical, partial Technical, partial

124 133

13

Female

50

Adhesive

91

Biological, complete Biological, partial Biological, partial

Lost at time of event 123 133

14 15 * #

Female Female

45 43

14 4

Conventional Adhesive

14 9

Each eventfailure or technical or biological complicationwas numbered for purposes of identification. At time of cementation. Number according to the Universal/National tooth numbering system. Conventional: Conventional cementation (glass ionomer cement). Adhesive: Adhesive cementation. In number of months since cementation. Event mode and number of affected tooth or pontic (according to the Universal/National tooth numbering system).

and bonding resin (Syntac Classic and Variolink II, respectively, both Ivoclar Vivadent) after placing retraction cords (Ultrapak, Size 0, Ultradent, South Jordan, Utah). We conducted a
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baseline evaluation of the restorations one to three weeks after insertion; we performed follow-up recalls after six and 12 months and then annually.

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SURVIVAL RATE (PERCENTAGE)

100 90 80 70
Failures due to ceramic fractures

60 50 0 20 40

All failures

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60

80

100

120

OBSERVATION TIME (MONTHS)

Figure 1. Survival of crown-retained fixed dental prostheses composed of monolithic lithium disilicate ceramic in terms of losses due to catastrophic ceramic fractures and in terms of all losses (according to Kaplan-Meier analysis).

We calculated cumulative survival and success rates according to Kaplan-Meier analyses.16 For the survival rate, we considered technical failures caused by catastrophic fractures of the FDPs and losses due to biological reasons to be separate criteria. We defined a successful FDP as one that remained unchanged and free of complications. For the success rate calculation, we differentiated between ceramic-related technical complications (ceramic fractures and chipping) and other technical and biological complications (such as loss of FDP retention or need for endodontic treatment). We calculated data from the cementation date to either the end of the latest follow-up visit (March 2011) or to the latest date of known status for patients who were deceased or who dropped out of the study. We used the log-rank test for statistical comparison of cementation groups at a 95 percent confidence level.
RESULTS

Of the original 28 patients, two patients with three FDPs died during the observation period. Until the time of death, these FDPs were successful; thus, we defined the patients as having dropped out of the study. All other patients attended the annual recall sessions. We were able to perform the five-year recall for 33 FDPs (all in the living patients), the eight-year recall

for 30 FDPs and the 10-year recall for 29 FDPs. The mean (SD) observation time of the FDPs was 121 (12.8) months (range, 79 to 133 months). Overall, four failures (three technical and one biological) and 11 additional complications (nine technical and two biological) occurred in 15 FDPs (Table). Figures 1 and 2 show the rates of survival and success, respectively, according to KaplanMeier analyses. The survival rate was 100.0 percent after five years and 90.8 percent (95 percent confidence interval [CI], 76.3-96.8) after 10 years if we considered only losses caused by catastrophic ceramic fractures (which amounted to three). The 10-year survival rate dropped to 87.9 percent (95 percent CI, 73.0-95.1 percent) if we took into account all losses (which amounted to four). The success rate regarding catastrophic ceramic fractures and chipping that did not affect FDP function was 94.0 percent (95 percent CI, 85.0-99.4 percent) after five years and 84.7 percent (95 percent CI, 69.0-93.3 percent) after 10 years. Figures 3 through 5 (page 239) depict clinical examples of catastrophic ceramic fractures and chipping. The success rate dropped to 91.1 percent (95 percent CI, 76.996.9 percent) after five years and to 69.8 percent (95 percent CI, 53.2-82.5 percent) after 10 years if we considered all technical and biological complications. Differences between cementation
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SUCCESS RATE (PERCENTAGE)

100 90 80 70 60 50
Complications due to ceramic fractures/chipping All complications

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20

40

60

80

100

120

OBSERVATION TIME (MONTHS)

Figure 2. Success of crown-retained fixed dental prostheses made from monolithic lithium disilicate ceramic regarding complications due to ceramic fractures and chipping and regarding all complications (according to Kaplan-Meier analysis).

groups were not significant for any comparison (P > .05, log-rank test).
DISCUSSION

For the monolithic lithium disilicate FDPs in this study, the calculated survival rate was 100.0 percent after five years and dropped to 90.8 percent (when considering only catastrophic ceramic fractures) and 87.9 percent (when considering catastrophic ceramic fractures and biological failures) after 10 years. This clinical outcome is considerably better than that in a five-year report by Marquardt and Strub8 involving the use of the predecessor material IPS Empress 2; the investigators reported a 30 percent failure rate for anterior and premolar FDPs. This difference might be explained in part by the improvement of material properties10 and by design differences between the FDPs placed in the two studies. Although in our study we fabricated IPS e.max Press FDPs as monolithic constructions, strictly following the manufacturers recommended dimensions, Marquardt and Strub8 used IPS Empress 2 FDPs as veneered (bilayered) constructions and did not always follow the recommended dimensions. The outcome difference suggests that exact adherence to the recommended dimensions is crucial for all-ceramic FDPs made from lithium disilicate ceramic.
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The results of a 2010 systematic review of research regarding zirconia ceramic FDPs revealed a 94.3 percent survival rate after five years, although a survival rate after 10 years could not be calculated because of lack of published studies.3 So in our study, FDPs made of the current version of pressable lithium disilicate glass-ceramic showed better five-year survival and success rates than did FDPs made from other all-ceramic materials, including zirconia ceramic, as shown by systematic reviews published thus far.1-6 To our best knowledge as we wrote this article, no other long-term studies had been published that involved a 10-year observation period of all-ceramic FDPs; therefore, our data can be compared with those of other studies on all-ceramic FDPs to only a limited extent. However, authors of systematic reviews regarding the outcome of three-unit metal-ceramic FDPs calculated 10-year survival rates ranging from 87.0 to 89.2 percent,7,8 which compares well with the 87.8 percent survival rate of monolithic lithium disilicate FDPs in our study. However, we should note that all catastrophic fractures in our study occurred in FDPs replacing molars, which is an indication not recommended by the manufacturer of the lithium disilicate ceramic. In the indication recommended by the manufacturerreplacement of premolars and anterior

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Figure 3. Catastrophic fracture of a monolithic lithium disilicate (IPS e.max Press, Ivoclar Vivadent, Schaan, Liechtenstein) ceramic crown-retained fixed dental prosthesis after 82 months.

Figure 4. Catastrophic fracture of a monolithic lithium disilicate (IPS e.max Press, Ivoclar Vivadent, Schaan, Liechtenstein) ceramic crown-retained fixed dental prosthesis after 116 months.

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Figure 5. Minor chipping on a monolithic lithium disilicate (IPS e.max Press, Ivoclar Vivadent, Schaan, Liechtenstein) ceramic crown-retained fixed dental prosthesis after 124 months.

well with the 84.5 percent (95 percent CI, 72.391.5) calculated success rate of metal-ceramic FDPs after five years demonstrated in a systematic review.13 However, we should note that catastrophic ceramic fractures in our study occurred only after almost eight years in function and only in molars. This suggests that in high-stress applications such molar replacement, fatigue plays a role. Also, the majority of chips occurred on posterior teeth with time, and this also suggests that slow crack growth in the ceramic plays a role in this type of failure. Realistically, the clinician must assume that additional fractures will occur as time goes by. It will be of great interest whether the expected failures of lithium disilicate ceramic FDPs will exceed those experienced with metal-ceramic FDPs.
CONCLUSIONS

teethno catastrophic fractures occurred in our study during the observation time of 10 years. The rate of ceramic chipping (3.0 percent after five years and 6.1 percent after 10 years) was similar to that in metal-ceramic FDPs (3 percent after three to five years) but considerably smaller than has been reported for allceramic FDPs (10 percent after three years and 13.6-16 percent after five years).1,4 The favorable outcome in terms of reduced chipping of allceramic FDPs in our study might be related to their monolithic fabrication (our dental technicians applied additional veneering ceramic only in exceptional cases). This outcome also compares well with that of a 2010 laboratory study in which investigators found monolithic lithium disilicate ceramic crowns to have a ceramic fracture resistance better than that of veneered zirconia ceramic crowns.17 The total success rate (FDPs that remained unchanged and remained free of complications) in our study was 91.1 percent after five years and 69.8 percent after 10 years. Again, this compares

Three-unit FDPs composed of monolithic lithium disilicate ceramic had five- and 10-year survival and success rates similar to those of conventional metal-ceramic FDPs. All catastrophic fractures occurred in FDPs replacing molars, which suggests that lithium disilicate ceramic can be used most safely for the replacement of anterior teeth and premolarswhich is the manufacturers recommended indication.
Disclosure. Drs. Kern and Wolfart have received honoraria for lectures at continuing education meetings from Ivoclar Vivadent, Schaan, Liechtenstein, and various other dental manufacturers but which materials were not involved in the current study. This study was supported by Ivoclar Vivadent, Schaan, Liechtenstein. After the authors submitted this article to The Journal of the American Dental Association, the following report of a study involving 10-year data regarding all-ceramic fixed dental prostheses (FDPs) made from veneered zirconia was published: Sax C, Hmmerle CHF, Sailer I. 10-year clinical outcomes of fixed dental prostheses with zirconia frameworks. Int J Comput Dent 2011;14(3): 183-202. Because of the timing of publication, the authors were unable to cite and discuss the work by Sax and colleagues in this

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8. Marquardt P, Strub JR. Survival rates of IPS empress 2 allceramic crowns and fixed partial dentures: results of a 5-year prospective clinical study. Quintessence Int 2006;37(4):253-259. 9. Valenti M, Valenti A. Retrospective survival analysis of 261 lithium disilicate crowns in a private general practice. Quintessence Int 2009;40(7):573-579. 10. Tysowsky GW. The science behind lithium disilicate: a metalfree alternative. Dent Today 2009;28(3):112-113. 11. Wolfart S, Eschbach S, Scherrer S, Kern M. Clinical outcome of three-unit lithium-disilicate glass-ceramic fixed dental prostheses: up to 8 years results. Dent Mater 2009;25(9):e63-e71. 12. Scurria MS, Bader JD, Shugars DA. Meta-analysis of fixed partial denture survival: prostheses and abutments. J Prosthet Dent 1998;79(4):459-464. 13. Pjetursson BE, Brgger U, Lang NP, Zwahlen M. Comparison of survival and complication rates of tooth-supported fixed dental prostheses (FDPs) and implant-supported FDPs and single crowns (SCs). Clin Oral Implants Res 2007;18(suppl 3):97-113. 14. Wolfart S, Bohlsen F, Wegner SM, Kern M. A preliminary prospective evaluation of all-ceramic crown-retained and inlayretained fixed partial dentures. Int J Prosthodont 2005;18(6):497-505. 15. Nyman S, Lindhe J. Examination of patients with periodontal disease. In: Lindhe J, T Karring, NP Lang, eds. Clinical Periodontology and Implant Dentistry. Oxford, England: Blackwell Munksgaard; 2003:409-425. 16. Kaplan EL, Meier P. Nonparametric estimation from incomplete observations. J Am Statist Assoc 1958;53(282):457-481. 17. Guess PC, Zavanelli RA, Silva NR, Bonfante EA, Coelho PG, Thompson VP. Monolithic CAD/CAM lithium disilicate versus veneered Y-TZP crowns: comparison of failure modes and reliability after fatigue. Int J Prosthodont 2010;23(5):434-442.

JADA article. However, for the record, Sax and colleagues reported a 10-year survival rate of 67 percent for zirconia ceramic FDPs. The authors appreciate the kind cooperation of the participating dentists and patients of the Department of Prosthodontics, Propaedeutics and Dental Materials, Christian-Albrechts University at Kiel, Germany, as well as the contributions of department dental technicians Britta Schlueter and Raphael Gerhardt. 1. Sailer I, Pjetursson BE, Zwahlen M, Hmmerle CHF. A systematic review of the survival and complication rates of all-ceramic and metal-ceramic reconstructions after an observation period of at least 3 years, part II: fixed dental prostheses (published correction appears in Clin Oral Implants Res 2008;19[3]:326-328). Clin Oral Implants Res 2007;18(suppl 3):86-96. 2. Denry I, Kelly JR. State of the art of zirconia for dental applications. Dent Mater 2008;24(3):299-307. 3. Schley JS, Heussen N, Reich S, Fischer J, Haselhuhn K, Wolfart S. Survival probability of zirconia-based fixed dental prostheses up to 5 yr: a systematic review of the literature. Eur J Oral Sci 2010; 118(5):443-450. 4. Heintze SD, Rousson V. Survival of zirconia- and metal-supported fixed dental prostheses: a systematic review. Int J Prosthodont 2010;23(6):493-502. 5. Komine F, Blatz MB, Matsumura H. Current status of zirconiabased fixed restorations. J Oral Sci 2010;52(4):531-539. 6. Al-Amleh B, Lyons K, Swain M. Clinical trials in zirconia: a systematic review. J Oral Rehabil 2010;37(8):641-652. 7. Hland W, Schweiger M, Frank M, Rheinberger V. A comparison of the microstructure and properties of the IPS Empress 2 and the IPS Empress glass-ceramics. J Biomed Mater Res 2000;53(4):297-303.

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