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Abstract
Patients’ esthetic expectations are increasing, and the options of the prosthetic pathways are currently evolving. The objective of this
randomized multicenter clinical trial was to assess and compare the esthetic outcome and clinical performance of anterior maxillary
all-ceramic implant crowns (ICs) based either on prefabricated zirconia abutments veneered with pressed ceramics or on CAD/CAM
zirconia abutments veneered with hand buildup technique. The null hypothesis was that there is no statistically significant difference
between the 2 groups. Forty implants were inserted in sites 14 to 24 (FDI) in 40 patients in 2 centers, the Universities of Bern and
Geneva, Switzerland. After final impression, 20 patients were randomized into group A, restored with a 1-piece screw-retained single
crown made of a prefabricated zirconia abutment with pressed ceramic as the veneering material using the cut-back technique, or group
B using an individualized CAD/CAM zirconia abutment (CARES abutment; Institut Straumann AG) with a hand buildup technique. At
baseline, 6 mo, and 1 y clinical, esthetic and radiographic parameters were assessed. Group A exhibited 1 dropout patient and 1 failure,
resulting in a survival rate of 94.7% after 1 y, in comparison to 100% for group B. No other complications occurred. Clinical parameters
presented stable and healthy peri-implant soft tissues. Overall, no or only minimal crestal bone changes were observed with a mean
DIB (distance from the implant shoulder to the first bone-to-implant contact) of −0.15 mm (group A) and 0.12 mm (group B) at 1 y.
There were no significant differences at baseline, 6 mo, and 1 y for DIB values between the 2 groups. Pink esthetic score (PES) and white
esthetic score (WES) values at all 3 examinations indicated stability over time for both groups and pleasing esthetic outcomes. Both
implant-supported prosthetic pathways represent a valuable treatment option for the restoration of single ICs in the anterior maxilla
(ClinicalTrials.gov NCT02905838).
Keywords: esthetic dentistry, clinical studies/trials, fixed and removable prosthodontics, implant dentistry/implantology, oral implants/
implantology, prosthetic dentistry/prosthodontics
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Prefabricated or customized zirconium dioxide abutments Bern (approval no. 061/10). The informed consent document
are available. To use a standardized abutment, the implant has was written in accordance with the “Declaration of Helsinki.”
to be placed in a preferably ideal prosthetic position. The indi-
cation to use standard abutments is limited, depending on the
position of the implant in the vertical dimension. If the implant Screening and Eligibility Criteria
is placed too deep, it cannot be used, especially not for screw- The subjects were evaluated for initial study eligibility during
retained reconstructions, as it does not provide enough support the screening visit.
for the veneering ceramic. According to the manufacturer, a
maximum of 2 mm directly veneered ceramic should be used on Inclusion criteria. All of the following criteria had to be met for
top of the prefabricated abutment when using screw retention. inclusion in the study:
Individualization of an implant abutment is advantageous.
The abutment can be designed via a wax-up exactly matching 1. Subjects must have voluntarily signed the informed
the ideal support for the final crown for screw-retained crowns consent form before any study-related action
or individualization of the final marginal finish line for 2. Males and females aged at least 18 y
cemented crowns. Also, the profile of the mucosa at the emer- 3. Single-tooth gaps in the anterior maxilla position 14 to
gence of the crown in the transition zone can be individualized 24 (FDI)
according to the achieved result during the provisional phase 4. Successfully osseointegrated single-tooth implant inserted
(Buser, Chappuis, Bornstein, et al. 2013). at least 16 wk after tooth extraction
The purpose of this randomized prospective multicenter 5. Full mouth plaque index (PI) according to O’Leary ≤25%
clinical trial was to compare the overall clinical performance 6. Implant axis compatible with transocclusal screw
during 1 y—including the esthetic outcome—between indi- retention (screw access palatal of incisal edges)
vidualized CAD/CAM abutments veneered with a hand
buildup technique and prefabricated zirconium dioxide abut- Exclusion criteria. If any of the following criteria were met, the
ments veneered with pressed ceramics to restore implants subject had to be excluded from the study.
inserted in single-tooth gaps in the anterior maxilla.
Surgical exclusion criteria
Materials and Methods 1. Systemic disease that would interfere with dental
implant therapy
Patient Cohort and Clinical Procedures 2. Any contraindications for oral surgical procedures
Forty subjects were recruited from 2 centers, the Universities 3. History of local irradiation therapy
of Bern (20 patients) and Geneva (20 patients), Switzerland. 4. Patients who smoked >10 cigarettes per day or tobacco
The recruitment period ran from August 2009 to August 2012. equivalents or chewed tobacco
Sample size was calculated according to previously published 5. Subjects who had undergone administration of any
investigations with similar indication. No data on the primary investigational device within 30 d of enrollment in the
endpoint were available as a basis for a power calculation. study
Participants were recruited from the same patient population 6. Conditions or circumstances, in the opinion of the
that had previously received dental implant treatment and a investigator, that would prevent completion of study
screw-retained implant-supported provisional restoration for participation or interfere with analysis of study results,
soft tissue conditioning using the dynamic compression tech- such as history of noncompliance
nique (Buser, Chappuis, Bornstein, et al. 2013). All patients 7. Physical or mental handicaps that would interfere with
had received a dental implant (Bone Level Implant 4.1-mm the ability to perform adequate oral hygiene
diameter, length 8 or 10 or 12 mm; Institut Straumann AG) 8. Pregnant or breastfeeding women
with the use of contour augmentation (Buser, Chappuis,
Bornstein, et al. 2013; Buser, Chappuis, Kuchler, et al. 2013) in Dental exclusion criteria
a single edentulous space with one missing maxillary anterior 9. Existing implants in the adjacent position
tooth in sites 14 to 24 (FDI). After the provisional phase and 10. Removable dentures or unrestored tooth gaps in the
final impression, 1-piece screw-retained single crowns were opposing dentition
fabricated using 2 different zirconium dioxide abutments and 2 11. Patients with inadequate oral hygiene or unmotivated
different veneering ceramic techniques. The patients were ran- for adequate home care
domly assigned to either group A or B by the use of a sealed 12. Probing pocket depth of ≥4 mm on one of the teeth
envelope, which had been prepared by an independent person. immediately adjacent to the dental implant site
Each study center had a separate randomization schedule to 13. Lack of primary stability of the implant
ensure that treatments were balanced between centers. Ethical 14. Inappropriate implant position for the prosthetic require-
approval was provided by the Ethics Committee of the State of ments
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15. Major simultaneous augmentation procedures buccal side only), the following clinical parameters were eval-
16. Insufficient stability of the implant uated at baseline and 6 mo and 12 mo after baseline:
Prosthetic exclusion criteria •• Modified pink esthetic score (mod PES) (Fürhauser et al.
17. Screw access position located too close to the planned 2005; Belser et al. 2009)
incisal edge •• WES (Belser et al. 2009)
18. Need of angled abutment due to prosthetic malposition •• Presence/absence of plaque (mod PI): will be evaluated
of the implant according to criteria of the PI (Silness and Loe 1964)
19. Height of the abutment is <65% of the height of the adapted for oral implants (Mombelli et al. 1987)
complete restoration •• Pocket probing depth (PPD)
20. Severe bruxing or clenching habits •• Modified Sulcus Bleeding Index (mSBI) (Lang et al. 1986)
•• KM in mm
Laboratory Procedures Evaluation of presence of technical/mechanical complications
Group A. Implant-supported single crown was fabricated using and failures. The presence/absence of technical/mechanical
a prefabricated stock abutment made of yttrium oxide partially complications had to be recorded. A prosthetic failure was
stabilized tetragonal zirconia polycrystalline (Y-TZP) (Ana- defined as an event leading to the loss of the reconstruction and
tomic IPS e.max Abutment, straight, color M1; Ivoclar) and the need to renew the entire implant-supported crown or the
pressed ceramic (fluorapatite glass-ceramic, IPS e.max Zir- explantation/loss of the implant and therefore also the loss of
Press; Ivoclar) using the cut-back technique and hand veneered the implant-supported restoration.
with a thin layer of fluorapatite veneering ceramic (fluorapatite
veneering ceramic, IPS e.max Ceram; Ivoclar). Implant success and survival rate. Implant success and survival
was assessed at the screening visit, baseline, and 6 mo and 12
Group B. Implant-supported single crown was fabricated using mo after baseline. A surviving implant was defined as an
an individualized CAD/CAM abutment made of Y-TZP implant in place at the time of follow-up. Implants were graded
(CARES Abutment; Institut Straumann AG) and hand buildup as a success according to the success criteria published by
veneering ceramic technique (fluorapatite veneering ceramic, Buser et al. (1991) and Albrektsson et al. (1986), which are
IPS e.max Ceram; Ivoclar). defined as follows:
All implant-supported crowns were fabricated in the same
dental laboratory by the same dental technician (Dominique •• Absence of persisting subjective discomfort such as
Vinci, Geneva, Switzerland). The implants were placed by pain, foreign body perception, and/or dysesthesia (pain-
experienced oral surgeons in a prosthetic ideal position. ful sensation)
•• Absence of a recurrent peri-implant infection with sup-
puration (where an infection is termed recurrent if it is
Insertion of the All-Ceramic Crowns observed at 2 or more follow-up visits after treatment
The final all-ceramic crowns were inserted by experienced with systemic antibiotics)
prosthodontists 4 to 6 mo after surgical placement of the •• Absence of implant mobility on manual palpation
implants and torqued to 35 Ncm. Occlusion was evaluated in •• Absence of any continuous peri-implant radiolucency
static and dynamic movements following the mutually protec-
tive occlusion concept (Kim et al. 2005). Oral hygiene instruc- Cast analysis. Dental impressions were taken at the baseline,
tions and motivation were given in detail to all patients included. 6-mo, and 12-mo follow-up visits to produce stone casts of the
maxilla. The casts were photographed with a standardized tech-
nique, including a millimeter grid as a reference in the picture.
Follow-up Examinations With these photographs, the length of the mid-facial height of
Patients were seen at baseline, 6 mo, and 12 mo, and the clini- the implant crown (IC) and the corresponding height of the con-
cal and radiographic parameters were assessed by the same tralateral tooth crown (TC) were both measured to identify
examiners. Baseline was defined 1 wk after insertion of the changes in crown height, indicating an absence or presence of
final all-ceramic implant-supported crown. Primary outcome mucosal recession. This cast analysis technique has been previ-
was pink esthetic score/white esthetic score (PES/WES) ously used in clinical studies (Buser et al. 2009; Buser, Chap-
esthetic index; secondary outcomes were radiographic findings puis, Bornstein, et al. 2013).
(crestal bone-level changes [DIB]), cast analysis, implant suc-
cess and survival, mechanical complications, and survival of Esthetic parameters. The modPES and WES assessments at
implant-supported prosthesis and clinical parameters. the baseline, 6-mo, and 12-mo follow-up examinations were
completed by 2 experienced prosthodontists, one of whom has
Clinical peri-implant measurements. At 4 sites per implant used this index previously in 2 published clinical studies. The
(mesial/distal/buccal/oral; except keratinized mucosa [KM]: examiners were blinded regarding the group allocation.
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Table 1. Overview of Failure, Complication, Survival, and Success Clinical Findings
Rates after 1 y Comparing Prefabricated Abutments versus Individualized
CAD/CAM Abutments and Individual Tooth Positions of Evaluated Overall, patients exhibited good oral hygiene, documented by
Implant Crowns.
a mean mPI of 0.15 (group A) and 0.14 (group B) at 1 y (Table
Prefabricated CAD/CAM 2). The peri-implant soft tissues appeared healthy overall as
Abutment Abutment documented by a low mean mSBI of 0.21 (group A) and 0.18
Enrolled, n 20 20 (group B) at the 1-y examination (Table 2). The mean PDs at 1
Underexposure, n 19 20 y were 3.04 and 3.08, respectively. All implants showed a KM
Dropout, n 1 0 on the facial aspect with a mean KM of more than 3.6 mm.
Failure, n 1 0 ANOVA concluded no statistical significant effect within
Complications, n 0 0 the groups or centers at the 3 time points.
Survival, % 94.7 100
Success, % 94.7 100
Tooth position maxilla (FDI 14-24), n Radiographic Findings
1. Quadrant first premolar (14) 0 0
1. Quadrant canine (13) 0 1 Detailed results are shown in the Figure. For the radiographic
1. Quadrant lateral incisor (12) 2 1 parameters, there was no significant difference between the 2
1. Quadrant central incisor (11) 7 9 centers. Overall, no or only minimal crestal bone loss was
2. Quadrant central incisor (21) 8 6 observed with a mean DIB of −0.15 mm (group A) and 0.12
2. Quadrant lateral incisor (22) 0 2 mm (group B) at 1 y (range, –2.3 to 3.2 mm). There were no
2. Quadrant canine (23) 1 0
significant differences at baseline, 6 mo, and 1 y for DIB val-
2. Quadrant first premolar (24) 1 1
ues between the 2 groups. Over the observation periods, the
DIB values showed no significant changes for both groups cal-
culated by ANOVA.
Radiographic parameters. Standardized periapical radiographs
were obtained at baseline, 6 mo, and 12 mo. The distance from
the implant shoulder to the first bone-to-implant contact (DIB)
Esthetic Outcomes
was measured (mm) at the mesial and distal aspect of the Detailed results are given in Table 3. The esthetic outcomes
implants (Weber et al. 1992) by 1 experienced clinician. The were pleasing overall throughout the study period. The PES
change in crestal bone height in relation to the reference points and WES values at all 3 examinations also indicated stability
on the implant over the observation time was calculated. over time for both groups. At the 1-y examination, the analysis
revealed mean PES values of 7 (group A) and 7.65 (group B).
Statistical analysis. First, the data were analyzed descriptively by The WES exhibited values of 8.28 (group A) and 8.50 (group
computing means and standard deviations for all factors and lev- B). No discoloration of the peri-implant mucosa was visible.
els of interest. Then, differences between the 2 groups and the 2 ANOVA showed that there were no statistically significant
centers (Bern and Geneva) were analyzed performing a 2-way changes over the observation periods.
analysis of variance (ANOVA) for repeated measures among 3
time points. Because of sample size considerations, the chosen
ANOVA was a nonparametric one according to Brunner and
Cast Analysis
Langer. The P values of all main effects and interactions were Detailed results are shown in Table 4. Focusing on outcomes of
corrected for multiple testing using Holm’s method. IC, no statistically significant effect of group or center was
In case of a significant effect, post hoc tests were then done per- found over the observation periods.
forming Wilcoxon-Mann-Whitney tests without correction for mul- Regarding the outcomes of TC, interactions between the 2
tiple testing due to the explorative nature of this further analysis. centers and groups were significant (P = 0.04), and therefore
The level of significance was set to 0.05. All calculations pairwise comparisons between every pair of combinations of
were done with R, version 3.3.1 (The R Project for Statistical the 2 centers and 2 groups were performed using post hoc tests
Computing; www.r-project.org). (Wilcoxon-Mann-Whitney tests). Within group A, the center
effect was statistically significant (P = 0.01). Center effect was
Results also statistically significant between group B (P = 0.03) com-
paring Geneva and Bern. Within the center Geneva, there was a
Clinical Performance significant difference between groups A and B (P = 0.01).
One patient in the patient pool from the University of Geneva
was lost even before completion of the treatment and therefore Discussion
was considered a dropout. Therefore, 1 dropout patient and 1
failure (fracture of the ceramic crown) resulted in a survival Due to its better mechanical properties, Y-TZP has overtaken
rate of 94.7% for group A, whereas the survival rate for group alumina as the preferred ceramic abutment material (Manicone
B was 100% (Table 1). No complications occurred during the et al. 2007; Zarone et al. 2011). It has high flexural strength
entire observation time (Table 1). An overview of the individ- values and fracture toughness, with the advantage of being
ual tooth positions (FDI) of the ICs are listed in Table 1. able to initiate a unique phase transformation toughening
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Table 2. Overview of Clinical Parameters of the Implants (Mean ± Standard Deviation) up to a Follow-up of 1 y Comparing Prefabricated Stock
Abutment versus Individualized CAD/CAM Abutment.
Baseline PA: 0.14 ± 0.24 PA: 0.18 ± 0.20 PA: 3.05 ± 0.60 PA: 3.84 ± 1.49
IA: 0.10 ± 0.29 IA: 0.08 ± 0.20 IA: 2.64 ± 0.53 IA: 4.10 ± 1.15
6 mo PA: 0.89 ± 1.04 PA: 0.13 ± 0.20 PA: 3.07 ± 0.99 PA: 3.47 ± 1.26
IA: 0.62 ± 0.26 IA: 0.10 ± 0.17 IA: 2.92 ± 0.26 IA: 4.22 ± 1.13
1y PA: 0.15 ± 0.23 PA: 0.21 ± 0.23 PA: 3.04 ± 0.89 PA: 3.67 ± 1.27
IA: 0.14 ± 0.21 IA: 0.18 ± 0.24 IA: 3.08 ± 0.57 IA: 4.35 ± 1.28
IA, individualized CAD/CAM abutment; KM, keratinized mucosa; mPI, modified plaque index; mSBI, modified sulcus bleeding index; PA, prefabricated
abutment; PPD, probing depth.
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Table 3. Mean PES and WES Values and Total PES/WES of the Implant-Supported Single Crowns at the 3 Time Points Analyzed (Mean Value)
Comparing PA versus IA.
PES
Baseline
PA 1.53 1.26 1.47 1.26 1.05 6.53a
IA 1.65 1.30 1.80 1.65 1.35 7.75a
6 mo
PA 1.47 1.29 1.47 1.47 1.24 6.94
IA 1.67 1.33 1.78 1.61 1.22 7.67
1y
PA 1.61 1.22 1.44 1.44 1.28 7.00
IA 1.65 1.30 1.75 1.60 1.30 7.65
WES
Tooth Volume/
Time Point Tooth Form Outline Color Surface Texture Translucency Mean WES
Baseline
PA 1.63 1.47 1.47 1.84 1.84 8.26
IA 1.70 1.70 1.45 1.80 1.85 8.50
6 mo
PA 1.59 1.53 1.53 1.71 1.88 8.24
IA 1.72 1.72 1.50 1.72 1.78 8.44
1y
PA 1.67 1.50 1.50 1.72 1.89 8.28
IA 1.70 1.60 1.55 1.80 1.85 8.50
Baseline
PA 14.79
IA 16.25
6 mo
PA 15.18
IA 16.11
1y
PA 15.28
IA 16.15
IA, individualized CAD/CAM abutment; PA, prefabricated abutment; PES, pink esthetic score; WES, white esthetic score.
Table 4. Results of the Cast Analysis Measuring the Length of the IC and Contralateral TC (mm; Mean ± SD) at Baseline, 6 mo, and 1 y Comparing
PA versus IA.
Exam n IC TC ΔIC–TC
Baseline PA: 20 PA: 10.09 ± 1.11 PA: 9.43 ± 1.34 PA: 0.66 ± 0.61
IA: 20 IA: 10.30 ± 1.60 IA: 9.94 ± 1.55 IA: 0.36 ± 0.61
6 mo PA: 20 PA: 10.09 ± 1.17 PA: 9.53 ± 1.24 PA: 0.56 ± 0.42
IA: 20 IA: 10.26 ± 1.77 IA: 9.91 ± 1.65 IA: 0.35 ± 0.60
1y PA: 20 PA: 10.21 ± 0.98 PA: 9.68 ± 1.25 PA: 0.53 ± 0.58
IA: 20 IA: 10.39 ± 1.43 IA: 10.08 ± 1.32 IA: 0.31 ± 0.64
IA, individualized CAD/CAM abutment; IC, implant crown; PA, prefabricated abutment; TC, tooth crown.
Besides the survival rates being similar in both groups, also the most reproducible esthetic index, which is not influenced
the esthetic scores were not statistically different, and the clini- by different observers and therefore recommended for clinical
cal parameters and cast analysis did not show any differences. use (Tettamanti et al. 2016). The present PES/WES results can
PES/WES index (Fürhauser et al. 2005; Gehrke et al. 2008; be compared (Table 4) with published data from a study by
Belser et al. 2009) was used in the present investigation, as it is Buser et al. (2011) reevaluating 20 implant-supported single
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0.12 mm in group B) at 1 y (Figure). Again, these results are 82(3):342–349.
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comparable with the study by Buser et al. (2011), presenting a single-implant restorations. Int J Prosthodont. 20(5):489–493.
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Author Contributions sion, vascular endothelial growth factor expression, and proliferative activ-
J.G. Wittneben, contributed to conception, design, and data analysis, ity in peri-implant soft tissues around titanium and zirconium oxide healing
caps. J Periodontol. 77(1):73–80.
drafted and critically revised the manuscript; J. Gavric, contributed Ekfeldt A, Furst B, Carlsson GE. 2011. Zirconia abutments for single-tooth
to conception, design, and data analysis, critically revised the manu- implant restorations: a retrospective and clinical follow-up study. Clin Oral
script; U.C. Belser, T. Joda, U. Brägger, contributed to conception Implants Res. 22(11):1308–1314.
Fürhauser R, Florescu D, Benesch T, Haas R, Mailath G, Watzek G. 2005.
and design, critically revised the manuscript; M.M. Bornstein, I. Evaluation of soft tissue around single-tooth implant crowns: the pink
Sailer, contributed to data analysis, critically revised the manuscript; esthetic score. Clin Oral Implants Res. 16(6):639–644.
V. Chappuis, contributed to the conception, design, and data analy- Gehrke P, Lobert M, Dhom G. 2008. Reproducibility of the pink esthetic
score—rating soft tissue esthetics around single-implant restorations with
sis, critically revised the manuscript. All authors gave final approval regard to dental observer specialization. J Esthet Restor Dent. 20(6):375–
and agree to be accountable for all aspects of the work. 384; discussion 385.
Guess PC, Att W, Strub JR. 2012. Zirconia in fixed implant prosthodontics.
Clin Implant Dent Relat Res. 14(5):633–645.
Acknowledgments Hisbergues M, Vendeville S, Vendeville P. 2009. Zirconia: established facts
Institut Straumann AG has provided material (implant prosthetic and perspectives for a biomaterial in dental implantology. J Biomed Mater
Res B Appl Biomater. 88(2):519–529.
components) and financial support for the included patient treat- Hosseini M, Worsaae N, Schiodt M, Gotfredsen K. 2013. A 3-year prospec-
ment for this study. The authors are grateful to Gabriel Fischer (sig- tive study of implant-supported, single-tooth restorations of all-ceramic and
nificantis GmbH) for his assistance regarding the statistical analysis. metal-ceramic materials in patients with tooth agenesis. Clin Oral Implants
The authors declare no potential conflicts of interest with respect to Res. 24(10):1078–1087.
Ishikawa-Nagai S, Da Silva JD, Weber HP, Park SE. 2007. Optical phenom-
the authorship and/or publication of this article. enon of peri-implant soft tissue. Part II. Preferred implant neck color to
improve soft tissue esthetics. Clin Oral Implants Res. 18(5):575–580.
Jung RE, Sailer I, Hammerle CH, Attin T, Schmidlin P. 2007. In vitro color
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