Long Term Results of A Randomized Clinical Trial o
Long Term Results of A Randomized Clinical Trial o
Long Term Results of A Randomized Clinical Trial o
a
Assistant professor, Department of Dental Medicine, Karolinska Institutet, Huddinge, Sweden; and Specialist in Dental Prosthetics, Department of Prosthetic Dentistry,
Folktandvården Eastmaninstitutet, Stockholm, Sweden.
b
Professor and Head, Specialist in Dental Prosthetics, Division of Oral Diagnosis and Rehabilitation, Department of Dental Medicine, Karolinska Institutet, Huddinge,
Sweden; and Professor, Scandinavian Centre for Orofacial Neuroscience (SCON), Huddinge, Sweden.
c
Professor and Head, Section of Orofacial Pain and Jaw Function, Department of Dentistry and Oral Health, Aarhus university, Aarhus, Denmark; and Professor, Faculty of
Odontology, Malmö University, Malmö, Sweden; and Professor, Scandinavian Centre for Orofacial Neuroscience (SCON), Huddinge, Sweden.
d
Associate professor, Department of Dental Medicine, Karolinska Institutet, Huddinge, Sweden; and Specialist in Dental Prosthetics, Department of Prosthetic Dentistry,
Folktandvården Eastmaninstitutet, Stockholm, Sweden.
Table 1. Sex, age, number of maxillary and mandibular teeth, number of restorations, necessary adjustments were performed on
maxillary and mandibular teeth with tooth wear >grade 2 in study the interim restorations before the definitive restorations
population and 2 participant groups who received lithium disilicate (LD) were made. For most participants, a second visit was
and translucent zirconia (TZ)
required to refine the preparations. Impressions of the
Participants Participants
Total With LD With TZ prepared teeth were made in polyether materials (Per-
Number of participants 64 32 32 madyne Garant 2 and Impregum Penta; 3M ESPE), and
Sex all the crowns were fabricated at the same dental labo-
Number of women 19 ±29.7% 10 ±31.2% 9 ±28.1% ratory by 5 dental laboratory technicians. The color for
Number of men 45 ±70.3% 22 ±68.8% 23 ±71.9% the restorations was selected in consultation with the
Age (y) 44.8 ±9.1, 25-63 43.0 ±8.6, 25-62 46.6 ±9.6, 29-63 dental laboratory technicians. However, an indication of
Number of teeth the ceramic material to be used was avoided, since the
Maxillary 858 429 429 participants were blinded in this respect.
13.4 ±0.9, 10-14 13.4 ±1.0, 10-14 !3.4 ±0.9, 11-14
The crowns were clinically evaluated for occlusion and
Mandibular 868 438 430
13.6 ±0.8, 10-14 13.7 ±0.5, 12-14 13.4 ±1.0, 10-14 articulation, minor corrections were made chairside, and
Number of teeth a new occlusal registration was obtained before returning
with tooth wear >grade 2 the crowns to the dental laboratory for characterization
Maxillary 627 318 309
9.8 ±2.8, 4-14 9.9 ±2.7, 4-14 9.7 ±2.9, 4-14
and the application of a ceramic glaze. Although the
Mandibular 462 214 248 majority of the 351 TZ crowns were monolithic,
7.2 ±4.1, 0-14 6.7 ±4.1, 0-14 7.8 ±4.2, 0-14 approximately 85 had a 0.3-mm to 0.8-mm facial veneer
Mean ±standard deviation, range. for improved esthetics. The intaglio surfaces of the LD
crowns were etched with 4.5% hydrofluoric acid (IPS
either more chemical or mechanical risk factors, it was Ceramic Etching Gel; Ivoclar Vivadent AG) for 20 sec-
decided post hoc to present the results both for the 2 onds, and the TZ crowns were airborne-particle abraded
different risk factors26,27 and for the 2 different ceramics. As with 110-mm aluminum oxide at 0.2 MPa for 10 seconds.
illustrated in Table 2, the 11 participants who did not The ceramic crowns were cemented with 10-
belong to either of these clusters (3 participants excluded methacryloyloxydecyl dihydrogen phosphateebased
from clustering because of incomplete data and 7 who did self-etching adhesive cement (Panavia F2.0; Kuraray
not participate in the previous studies) were allocated ac- Noritake Dental Inc), and the same cementation protocol
cording to the most significant factors in the cluster anal- was used for both LD and TZ crowns. Static and dynamic
ysis in combination with the most significant clinical occlusion were evaluated, and approximately 10 crowns
features of the mechanical cluster. were adjusted and repolished with ceramic silicone pol-
Preprosthetic treatment, including crown lengthening ishers (DIAPOL RA; EVE Ernst Vetter GmbH). To
and endodontic and orthodontic treatments, was per- accommodate the involvement of participants in other
formed when indicated. As a standard procedure, each studies, as well as to maintain blinding, 58 participants
participant’s diagnostic casts were mounted in centric were treated by 1 prosthodontist (W.H.) and the
relation in a semiadjustable articulator, and a diagnostic remaining 4 by 2 calibrated dentists. Baseline and follow-
waxing fabricated to attain the prescribed occlusal and up examinations were performed between August 2013
esthetic goals. The vertical dimension was increased only and December 2019. The clinical performance and suc-
when needed to create sufficient space for the restora- cess rate of the crowns were assessed in accordance with
tions. In participants with localized tooth wear, space for the modified United States Public Health Service
the restorations was created by using the Dahl concept29 (USPHS) criteria30 (Table 3) by an independent blinded
with interim appliances and/or adjustment of antagonist examiner (J.-I.S.) using a dental mirror and explorer (LM
teeth (enameloplasty). 17-23 SI; LM-Dental) at baseline and on average 14, 31,
During preparation, removal of tooth tissue was 39, 54, and 65 months after insertion of the crowns.
minimal, and a chamfer finish line of at least 1 mm wide Absolute failure, defined as clinically unacceptable
and a 4.0-mm preparation height were ensured. While loss of a crown which required replacement of the
attempts were made to maintain a consistent material restoration, was used for the survival rate. Relative fail-
thickness of at least 1 mm, the dental laboratory tech- ures, defined as endodontic complications, minimal
nician was authorized to reduce this to 0.6 mm in ceramic fractures which were clinically acceptable, and/or
localized areas in some crowns. Laboratory fabricated adhesion loss of a restoration that could be successfully
polymethyl methacrylate interim restorations (SR Ivoc- recemented, were included in the success rate. The
ron; Ivoclar Vivadent AG) were placed after tooth prep- modified USPHS criteria were tabulated with a statistical
aration and used to identify the ideal proportions of tooth software program (IBM SPSS Statistics, v22; IBM Corp)
height and width, as well as to allow feedback from the and a spreadsheet (Excel 2016; Microsoft Corp). The Chi
participants. To avoid major corrections of the definitive square test was used to compare the USPHS criteria
Randomized (n=64)
Allocation
Allocated to intervention LD (n=32) Allocated to intervention TZ (n=32)
Follow-Up
Analysis
Figure 1. Study flow chart. LD, lithium disilicate (IPS e. maxddPress; Ivoclar Vivadent AG); TZ, translucent zirconia (BruxZir; Glidewell Laboratories).
regarding the 2 crown types and the 2 different etiology after mean follow-up periods of 14, 31, 39, 54, and 65
clusters (a=.05). months. At present, all participants are still enrolled in the
study, and most of them attended the first recall (12-24
months). Since the crowns were inserted over a period of
RESULTS
more than 5 years, some restorations have not yet received
Among the 64 participants shown in Table 1, 2 women the second, third, fourth, and fifth recalls. In addition, some
assigned to the TZ group were excluded, giving a final participants could not attend the follow-up visits as
number of 62 (LD group=32, TZ group=30) (Fig. 1). The scheduled and showed up later. After observation for up to 6
first was excluded because her small-sized mandibular years, the survival rate for both types of crowns was 99.7%.
incisors did not permit facial porcelain veneering of TZ One LD crown lost retention after 1 year (this tooth received
and she received LD crowns instead. The second was a new crown), and 1 TZ crown was associated with tooth
excluded because of her high esthetic demands. The total fracture at the cemento-enamel junction after 3 years. The
number of maxillary and mandibular crowns inserted was success rates were 98.6% for LD and 99.1% for TZ. The
713 (LD=362, TZ=351), and the distribution of these failure experienced by 3 participants in each group was
crowns is shown in Figure 2. While the total number of because of the development of apical lesions, minimal
anterior crowns including the central incisors, lateral in- ceramic fractures, or loss of crown adhesion requiring
cisors, and canines was 342 crowns (maxillary=295, rebonding. At baseline, the color match with the LD crowns
mandibular=47), the number of posterior crowns (84.8% Alfa, 15.2% Bravo) was significantly better than with
including premolars and molars was 371 crowns (maxil- the TZ crowns, including those with facial veneers (36.5%
lary=197, mandibular=174). Figure 3 shows a represen- Alfa, 63.5% Bravo) (P<.001). Secondary caries and cracks
tative participant who received LD crowns, and Figure 4 did not occur.
shows a participant with TZ crowns. Table 5 depicts the same evaluation of crowns at the
Table 4 documents the restorations performed and same follow-up periods with respect to the chemical and
clinical evaluation of the 2 types of ceramic crowns ac- mechanical clusters. After observation for up to 6 years,
cording to the modified USPHS criteria shown in Table 3 the survival rate for the chemical cluster was 99.8% (1
Table 2. Cut-off criteria used to determine cluster membership for 11 Table 3. Modified United States Public Health Service criteria for clinical
participants not clustered in previous study evaluation of restorations
Participants Cluster Characteristics Rating Criteria
ID Criteria 1 Criteria 2 Criteria 3 Criteria 4 Membership Secondary Alfa No evidence of caries at the margin of the
1 d d d d C caries restoration
2 X d d d M Bravo Caries evident at the margin of the
3 X d d d M restoration
35
30
Number of Teeth Restored
25
20
15
10
0
17 16 15 14 13 12 11 21 22 23 24 25 26 27
47 46 45 44 43 42 41 31 32 33 34 35 36 37
0
Number of Teeth Restored
10
15
20
25
TZ LD
Figure 2. Distribution of delivered maxillary and mandibular crowns in study population. LD, lithium disilicate (IPS e. max-Press; Ivoclar Vivadent AG);
TZ, translucent zirconia (BruxZir; Glidewell Laboratories).
of a conventional opaque zirconia and 3 times more than involving shorter follow-up of direct composite resin
veneering material.19,31 The flexural strength of TZ is restorations in participants with tooth wear with different
claimed to be two-thirds greater than that of LD and its etiologies.33
fracture resistance is also higher than that of both LD and The differences at baseline between the crowns in the
porcelain-veneered restorations.32 In the present ran- 2 clusters with respect to marginal adaptation and
domized clinical trial, confounding bias was minimized anatomic form may reflect the fact that the crowns in the
by the knowledge of the presumed chemical and me- mechanical cluster were fabricated according to the rec-
chanical risk factors for the participants.26,27 The present ommendations of Beyron, a Swedish prosthodontist, as
results demonstrated that patients with extensive tooth relatively bulky with wide occluding surfaces. Such a
wear may be treated with adhesively luted high-strength design may result in an axial load, both during occlusion
ceramic crowns, regardless of the etiology of the wear. and sliding movements.34 Although it is possible that the
The 11 participants who were classified based on cut-off assessor’s preference for the Beyron criteria may have
criteria did not have significant influence on the results influenced the evaluation, the lack of any other difference
either. Similar results were reported from a study between the 2 ceramic materials (Table 4) indicates that
Figure 3. Representative participant: 52-year-old woman with previous history of gastric reflux and acidic diet consumption including 1 liter of
carbonated drinks per day under 17 years. She had extensive tooth wear in majority of maxillary teeth and mandibular posterior teeth (A.1-4). Her
mandibular anterior teeth bleached with 10 % carbamide peroxide before prosthetic restoration. She received monolithic lithium disilicate crowns on
teeth starting from right maxillary second molar to left first premolar; left maxillary second molar; left mandibular second molar; teeth from right
mandibular second premolar to second molar as well as a metal-ceramic fixed partial denture between left mandibular first molar and first premolar
(B.1-4) (69 months after delivery).
Figure 4. Representative participant: 63-year-old man with history of hypertension, stroke, and gastric reflux. He was medicated with antihypertensive
and anticoagulant medications in addition to proton pump inhibitors. He had generalized extensive tooth wear, history of continually failed and
discolored composite resin restorations, as well as food impaction (A.1-4). His composite resin restorations required continuous repair and constant
review which provoked increased long-term costs. He received monolithic translucent zirconia crowns on maxillary and mandibular teeth from left
second molars to right second molars (B.1-4) (63 months after delivery).
this was not a major source of bias. Moreover, the To avoid the evaluation bias associated with other
excellent survival rate achieved here might be, at least in studies on this topic, both the examiner and participants
part, because the participants had a sufficient number of were blinded to the type of the ceramic material used. It
occluding pairs of teeth and/or restorations, which pro- would have been preferable to have 2 independent ex-
vided an even distribution of forces and occlusal har- aminers, but the large number of participants and res-
mony. The participants were also provided with torations made this impractical. Furthermore, owing to
additional prosthetic restorations other than the ceramic the differences in the position of the worn teeth within
crowns presented in Tables 4 and 5. Nevertheless, in the dental arch, the type of the occlusal relationship, and
order to assess the role of occlusion, the number of the quality of the remaining tooth tissue, standardization
occlusal contacts and other occlusal parameters should be difficulties were encountered.
considered in dental indices used for assessment of the Esthetic concerns appear to be the most common
long-term success of different prosthetic materials and complaint for individuals exhibiting tooth wear from the
restoration designs. reasons given by the current participants, as well as
Table 4. Modified United States Public Health Service criteria and clinical evaluation of 2 types of ceramic crowns after mean follow-up period of 14, 31,
39, 54, and 65 months
LD, lithium disilicate (IPS e. max-Press; Ivoclar Vivadent AG), TZ, Translucent zirconia (BruxZir; Glidewell Laboratories). Number of participants and crowns.
those in other studies.35,36 In the current study, all par- teeth. This probably affected the examiner assessment
ticipants had the opportunity to discuss and select a and current results of the USPHS criteria regarding the
shade, often choosing a lighter shade than their own color match. Moreover, in a recent in vitro comparison of
Table 5. Modified United States Public Health Service criteria and clinical evaluation of ceramic crowns in chemical and mechanical clusters after mean
follow-up periods of 14, 31, 39, 54, and 65 months
Recall Time (mo)
Min-Max 12-24 25-36 37-48 49-60 61-72
Mean Baseline 14 31 39 54 65
No. of participants 62 59 23 25 20 9
Total no. of crowns 713 683 277 292 234 87
C=421 C=391 C=179 C=177 C=148 C=87
M=292 M=292 M=98 M=115 M=86 M=0
USPHS-criteria
Secondary caries
Alfa d d d d d d d d d d d d
Bravo d d d d d d d d d d d d
Marginal adaptation
Alfa 413 277 378 283 177 95 171 113 146 77 82 d
(98.1%) (94.9%) (96.7%) (96.9%) (98.9%) (96.9%) (96.6%) (98.3%) (98.6%) (89.5%) (94.3%)
Bravo 8 (1.9%) 15 (5.1%) 13 (3.3%) 9 (3.1%) 2 (1.1%) 3 (3.1%) 6 (3.4%) 2 (1.7%) 2 (1.4%) 9 (10.5%) 5 (5.7%) d
Charlie d d d d d d d d d d d d
Marginal discoloration
Alfa 421 292 384 265 164 97 170 112 147 73 74 d
(100%) (100%) (98.2%) (90.8%) (91.6%) (99.0%) (96.0%) (97.4%) (99.3%) (84.9%) (85.1%)
Bravo d d 7 (1.8%) 27 (9.2%) 15 (8.4%) 1 (1.0%) 7 (4.0%) 3 (2.6%) 1 (1.0%) 13 13 d
(15.1%) (14.9%)
Charlie d d d d d d d d d d d d
Color match
Alfa 269 166 230 173 102 43 90 (50.8%) 78 (67.8%) 90 (60.8%) 43 (50%) 67 d
(63.9%) (56.8%) (58.8%) (59.2%) (57.0%) (43.9%) (77.0%)
Bravo 152 126 161 119 77 (43.0%) 55 87 (49.2%) 37 (32.2%) 58 (39.2%) 43 (50%) 20 d
(36.1%) (43.2%) (41.2%) (40.8%) (56.1%) (23.0%)
Charlie d d d d d d d d d d d d
Anatomic form
Alfa 385 166 327 279 165 98 158 103 123 85 76 d
(91.4%) (56.8%) (83.6%) (95.5%) (92.2%) (100%) (89.3%) (89.6%) (83.1%) (98.8%) (87.4%)
Bravo 36 (8.6%) 126 64 (16.4%) 13 (4.5%) 14 (7.8%) 0 (0%) 19 (10.7%) 12 (10.4%) 25 (16.9%) 1 (1.2%) 11 d
(43.2%) (12.6%)
Charlie d d d d d d d d d d d d
Endodontic complications
Apical lesion d d 2 (0.5%) d 2 (1.1%) d d d d d d d
Percusion +ve d d d d d d d d d d d d
Crack
None d d d d d d d d d d d d
Minimal/acceptable d d d d d d d d d d d d
Large/unacceptable d d d d d d d d d d d d
Fracture of the crown
None d d d d d d d d d d d d
Minimal/acceptable d d d d d 1 (1.0%) 1 (0.6%) d d d d d
Large/unacceptable d d d d d d d d d d d d
Retention of the crown
Bonded d d d d d d d d d d d d
Rebonded d d d d d d 1 (0.6%) d 1 (0.7%) d d d
Lost d d d d 1 (0.6%) d d d d d d d
Fracture of the tooth
None d d d d d d d d d d d d
At or above cemento-enamel d d d d d d d 1 (0.9%) d d d d
junction
1-mm-thick restorations, LD was found to be signifi- contemporary high-strength ceramics and the assess-
cantly more translucent than 5 types of monolithic zir- ment of participant satisfaction with appearance and the
conias.37 Future studies on individuals with tooth wear impact of the prosthetic treatment on the quality of life
regarding the clinical performance of other are indicated.
CONCLUSIONS 19. Denry I, Kelly JR. State of the art of zirconia for dental applications. Dent
Mater 2008;24:299-307.
Based on the findings of this randomized clinical trial, the 20. Zhang F, Inokoshi M, Batuk M, Hadermann J, Naert I, Van Meerbeek B, et al.
Strength, toughness and aging stability of highly-translucent Y-TZP ceramics
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275-84.
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