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CLINICAL SCIENCE

Clinical efcacy of polyvinyl siloxane impression materials


using the one-step two-viscosity impression technique
Sami Dogan, DDS,a E. Ricardo Schwedhelm, DDS, MSD,b Harald Heindl, MDT,c Lloyd Mancl, PhD,d and
Ariel J. Raigrodski, DMD, MSe
The goal of making denitive
impressions is to provide accurate information for indirect
restorations. Polyvinyl siloxane
(PVS) impression materials
have become one of the most
widely used in restorative
dentistry for indirect restorations such as crowns, xed
dental prostheses, veneers,
inlays,
onlays,
implantsupported restorations, and
removable partial and complete dentures.1,2
Newer PVS impression materials have been designed to
provide optimal material properties to enhance precision and
minimize clinical challenges
such as voids, bubbles, pulls,
and tears.3-5 The rheological or
ow characteristics of newer
PVS impression materials have
improved their handling properties and adaptation to soft and
hard tissues.6-8
Factors that inuence the
accuracy of an impression include proper material handling,

ABSTRACT
Statement of problem. Impression making is a challenging clinical procedure for both patients and
dentists.
Purpose. The purpose of this clinical study was to compare a recently introduced fast-setting
polyvinyl siloxane (PVS) impression material with heavy body/light body (HB/LB) combination
(Imprint 4; 3M ESPE) (experimental group) with a conventional PVS impression material with HB/
LB combination (Imprint 3; 3M ESPE) (control group), using the 1-step 2-viscosity impression
technique.
Material and methods. Two denitive impressions (1 of each material combination) were made of
20 crown preparations from 20 participants. The quality of impressions was rated by 3 evaluators
(clinical evaluator, clinical operator, and dental technician) and by the patients for the level of
comfort and taste of the impression materials. The order in which the 2 impressions were made
with each material combination was randomized for each crown preparation. A paired t test for
paired means and McNemar test for paired proportions were used for statistical comparisons
(a=.05).
Results. Participants rated the comfort of the impression making with the experimental group
signicantly higher than that with the control group (P=.001). No signicant differences were found
in participants rating for the taste of the impression materials (P=.46). The viscosity for tray material
was rated as signicantly better for the control group by the clinical operator (P=.004). The readability of the impression and visibility around the nish line were rated as signicantly better for the
experimental group than for the control group (P<.001). Except for the ease of removal of the stone
(RS), the ratings for the 2 groups by the dental technician were similar. The ease of RS was rated as
signicantly better for the experimental group (P<.001). Eleven dies from the control and 9 from the
experimental group were selected for fabrication of the denitive crowns (P=.65).
Conclusion. Within the limitations of this clinical study, no signicant differences were found
in the overall clinical performance of the experimental and the control groups. Impressions
made with both materials were clinically acceptable. Participants rated the comfort provided by
the experimental group signicantly better than that of the control group. (J Prosthet Dent
2015;-:---)

Supported by a research grant from 3M ESPE.


a
Assistant Professor, Department of Restorative Dentistry, School of Dentistry, University of Washington, Seattle, Wash.
b
Clinical Associate Professor, Department of Restorative Dentistry, School of Dentistry, University of Washington, Seattle, Wash.
c
Master Dental Technician, Aesthetic Dental Creations, Mill Creek, Wash.
d
Research Associate Professor, Department of Oral Health Sciences, School of Dentistry, University of Washington, Seattle, Wash.
e
Professor, Department of Restorative Dentistry, School of Dentistry, School of Dentistry, University of Washington, Seattle, Wash.

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Clinical Implications
Both fast-setting (experimental group) and
conventional-setting (control group) PVS impression
materials may be used with high success for single
crowns. Fast-setting impression materials may be
preferred for a limited number of crowns over
conventional-setting materials for improved patient
comfort.

9,10

clinicians experience and skill,


and preference for
impression materials,11 impression technique,12,13 working
time,14 number of units to be impressed, and patient
compliance. Furthermore, nish-line placement as related to the free gingival margin (sub-, equi-, or
supragingival nish lines),2,15,16 gingival health and soft
tissue management,17,18 moisture control,16,19,20 and
tray selection21-24 are all paramount for making a predictable and accurate denitive impression.
With the evolution of computer-assisted design/
computer-assisted manufacturing (CAD/CAM) systems,
digital impressions are becoming more widely available
because of their efciency and patient acceptance.25,26
However, the use of traditional impressions will remain
the gold standard until digital impression-making becomes a more common and cost effective procedure.
The new fast-setting PVS impression materials offer
shorter chair time during impression making than
conventional-setting PVS impression materials. However, whether the new fast-setting PVS impression materials are as accurate as the conventional-setting PVS
impression materials should be assessed.
Impression materials have been studied clinically
through the subjective evaluation of denitive impressions and the resulting denitive casts. However, the
number of clinical studies evaluating the success of
impression making is limited.9-11 In addition, none of the
studies evaluated patient comfort or taste during the
impression-making procedure. The purpose of this clinical study was to evaluate and compare 2 PVS impression
materials and their corresponding denitive casts by
using the 1-step 2-viscosity impression technique.2 The
null hypotheses of this study were that no differences in
clinical outcomes would be found by the patient or for
the quality of the denitive impressions and denitive
casts evaluated by the clinical evaluator, clinical operator,
and dental technician.
MATERIAL AND METHODS
Twenty participants between 34 and 78 years of age
(mean [SD] 56.7 [11.8] years of age) were assigned
to the study after they had given informed consent,
as approved by the University of Washington Human
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Figure 1. Denitive impressions made with Imprint 4 (experimental


group), rated as alpha.

Figure 2. Denitive impressions made with Imprint 3 (control group),


rated as alpha.
Table 1. Impression materials evaluated
Brand
Imprint 4 Penta
Heavy

Material Type

Lot No.

Heavy-bodied consistency, fast-setting

511512

Imprint 4 Light

Light-bodied consistency, fast-setting

511295

Imprint 3 Penta
Heavy

Heavy-bodied consistency, conventional-setting

500728

Imprint 3 Light

Light-bodied consistency, conventional-setting

501772

All materials were obtained from 3M ESPE.

Subjects Division. They were selected from patients


treated at the predoctoral restorative clinic at the University of Washington School of Dentistry. Patients 18
years of age and older needing a single metal ceramic
crown, either in the maxillary or mandibular arch, were
recruited. Those with a history of adverse reactions to
impression materials, impressions for implant-supported
restorations, tooth preparation with nish lines located
100% supragingivally or located 2.0 mm below the free
gingival margins or those who refused to give informed
consent were excluded from the study.
Two master impressions were made for each participant, using a recently introduced fast-setting impression
material (Imprint 4; 3M ESPE), dened in this study as
the fast-setting experimental group (fast set) (Fig. 1), and
a conventional-setting impression material (Imprint 3;
3M ESPE), dened as the control group (conventional
set) (Fig. 2). A total of 40 denitive impressions were
made in a randomized manner using a randomization list
(S-PLUS statistical software; Insightful Corp). Impression
materials used are listed in Table 1.
Dogan et al

2015

Impression-making and evaluation procedures were


performed by 2 prosthodontists (S.D., the clinical operator, and E.R.S., an evaluator), following a standardized
protocol. Oral hygiene, location of the nish line, and
occurrence of bleeding were documented by the clinical
operator before impression-making.
Impressions were made in the conventional manner
with rigid, disposable stock impression trays (Position
Tray; 3M ESPE). Tray adhesive (PVS Tray Adhesive; 3M
ESPE) was applied and allowed to dry for 15 minutes according to the manufacturers instructions. The doublecord technique19,20 with a dry nonimpregnated small
diameter cord followed by a cord with a larger diameter
(Ultrapack; Ultradent Corp) was used according to the
clinicians preference. The second cord was impregnated
with aluminum chloride hemostatic agent (Viscostat clear;
Ultradent Corp). The abutment tooth was rinsed with
water to eliminate any contamination of the impression
material by the hemostatic agent and to reduce epithelial
tears during removal of the impregnated large-diameter
cord. Once that cord was removed, the tooth was dried.
The nonimpregnated, smaller diameter cord was left in the
sulcus during the impression-making procedure. All heavy
body (HB) impression materials were mixed using an
automatic mixing unit (Pentamix 3; 3M ESPE), and light
body (LB) impression materials were syringed around the
prepared tooth with single-use intraoral syringes (Imprint
3 Intra-oral Syringe; 3M ESPE). Once the tray was lled
with the HB material, LB material was added on top of the
HB, and the tray was inserted into the participants mouth
for 2 minutes for the experimental group and 5 minutes for
the control group according to the manufacturers instructions. A minimum of 5 minutes was required between
impressions to allow adequate time for cord placement and
adequate preparation for making the second impression.
Participants were asked to rate the level of comfort
they experienced during the impression-making procedure and to rate the acceptability of the taste of the
impression material by using a numerical rating scale of 1
to 10 (where 1=excellent, 5=acceptable, 10=poor).
Impression materials were rated in terms of viscosity,
owability, and adhesion to the tray by the clinical
operator using a visual analog rating scale of 1 to 10
(1=excellent, 5=acceptable, 10=poor). Impressions were
visually inspected and assessed by the clinical evaluator
for each procedure, according to a rating scale for the
readability of the abutment teeth and the presence of
voids, bubbles, and tears (Table 2).
Impressions rated by the clinical evaluator as alpha
(no defects) or bravo (small defects which did not affect
nish line) were sent to the dental technician (H.H.) for
the assessment of the impression and pouring and
assessment of the denitive casts. Questions concerning
overall assessment, handling properties, and quality of
the impression material were answered by the dental
Dogan et al

Table 2. Rating criteria for overall evaluation of impression by clinical


evaluator
1. Overall evaluation (alpha to delta score)
Alpha: No defects. Impression is usable.
Bravo: Small defects such as tears, voids, bubbles, which do not affect nish
line or prevent use of impressions. Impression is usable.
Charlie: Good reproduction of preparation nish line. Other defects require
impression to be remade.
Delta: Defects at preparation nish line. Impression needs to be remade.
2. Tears (number and location) ________________.
3. Voids (number and location) ________________.
4. Bubbles (number and location) ________________.

Table 3. Quality rating criteria of denitive casts by dental technician


Ease of wetting of impression by stone
Ease of removal from stone cast
Tear resistance upon removal from cast
Adhesion of light body to heavy body
Potential of multiple pouring as related to presence of tears after removal of cast
from impression
Visibility of full 360-degree nish line on cast
Visibility of air bubbles in cast, especially nish line
Overall satisfaction

Figure 3. Denitive cast.

technician by using a 1 to 10 numerical rating scale


(1=excellent, 5=acceptable, 10=poor) before the impression was poured with Type IV stone (GC Fujirock EP; GC
America) (Table 3).
A quality rating of the denitive cast was made by the
dental technician using the same numerical rating scale
(1=excellent, 5=acceptable, 10=poor). Stone casts were
sent to the clinical evaluator, who was blinded to the
material, for selection of the denitive cast for fabricating
the denitive restoration. Only the denitive cast judged
to be the best by the dental technician and the blinded
clinical evaluator was used to make the denitive crown
(Fig. 3). In case of a disagreement between the technicians and clinical evaluators selection, a consensus
evaluation was made for the denitive cast selection.
The overall score of each impression material (rated
from alpha to delta) was described by the frequency and
percentage for each material. Quantitative measurements
and numerical ratings of the 2 impression materials were
compared using a paired t test, and comparisons were
conrmed with a Sign test.27 In addition, 95% condence
intervals (CI) were reported for the differences between
impression averages. Comparisons between the 2
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Table 4. Comparison of participant rating of comfort and taste between


impression materials
Characteristic N

Experimental
Control
Difference
Mean (SD) Mean (SD) Mean (SD)

Comfort

20

3.1 (1.9)

5.0 (2.5)

Taste

20

3.3 (1.8)

2.9 (1.7)

-1.9 (3.0)
0.4 (2.1)

Pa

Issue

Table 5. Comparison of operators ratings of viscosity, readability, and


visibility between impression materials

95% CI

Characteristic N

Experimental Control
Difference
Mean (SD) Mean (SD) Mean (SD)

Pa

95% CI

.004

0.1-0.7

.001 -3.3 to -0.5

Viscosity

20

1.7 (0.5)

1.2 (0.4)

.46

Readability

20

1.0 (0.0)

1.7 (0.5)

-0.7 (0.5)

<.001 -0.9 to 0.4

Visibility

20

1.0 (0.0)

1.5 (0.5)

-0.5 (0.5)

<.001 -0.7 to -0.3

-0.6 to 1.3

Paired t test.
Bonferroni correction for multiple tests (2), P<.05.

0.5 (0.6)

impression materials for qualitative ratings were done


using a Sign test, the McNemar test for paired proportions,
and the Bowker test of symmetry.27,28 In addition, 95% CIs
are reported for the frequency and differences in frequencies. Inter-rater agreement between the dental
technician and blinded clinical operator was described by
the percentage of observed agreement and Kappa statistic
along with 95% CIs for these statistics.27 The McNemar
test for paired proportions and logistic regression with
jackknife standard errors was used to compare the
different raters.29 A jackknife resampling method was
used to compute standard errors that accounted for the
pairing by impression among the evaluators. A Bonferroni
correction was used to adjust the signicance level for
multiple comparisons,27 and all analyses were performed
with software (SAS v.9.3; SAS Institute Inc).
RESULTS
Participants rated the comfort of the experimental group
(mean rating, 3.1) better than that of the control group
(5.0; P=.001) and overwhelmingly selected the experimental group (95%) over the control group (5%; Sign
test, P<.001). No signicant differences between the taste
of experimental and control group materials were found
in the participants rating (P=.46) (Table 4).
The clinical operator rated the control group better for
viscosity (mean ratings, 1.2 versus 1.7; P=.004) but rated
the experimental group better for readability of the
impression (1.0 versus 1.7; P<.001) and visibility around
the nish-line (1.0 versus 1.5; P<.001) (Table 5).
Thirteen (65%) of the experimental and 17 (85%) of
the control impressions were rated as alpha or bravo by
the clinical evaluator (P=.16). Although differences in
percentage of alpha or bravo ratings was not statistically
signicant, the 95% CI (-6% to 46%) favored the control
group (Table 6).
The dental technician rated the 2 impression materials
similarly, except for the ease of removal of the stone (RS)
cast. Ease of RS was rated better for the experimental
group (mean rating, 1.3) than the control group (1.7;
P<.001) (Table 7). No evidence was found for a preference between the 2 impression materials. The dental
technicians overall rating was 85% alpha or bravo for
the control group and 80% alpha or bravo for the
experimental group (P=.71) (Table 7). The denitive cast
selection was 55% (95% CI, 33-77) for the control group
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Bonferroni correction for multiple tests (3), P<.05.


a
Paired t test.

Table 6. Clinical and blinded operators overall rating

Rater

Experimental
Control
Alpha or Bravo Alpha or Bravo
Pa 95% CIb
N
n (%)
n (%)

Clinical operator

20

13 (65)

17 (85)

.16 -46 to 6

Dental technician

20

16 (80)

17 (85)

.71 -31 to 21

Blinded clinical evaluator 20

14 (70)

16 (80)

.53 -41 to 21

McNemar test for paired proportions, P<.05.


b
95% CI, 95% CI for differences (experimental minus control) in alpha or bravo ratings.
a

and 45% (95% CI, 23-67) for the experimental group


(Sign test, P=.65).
The blinded clinical evaluators overall rating was 80%
alpha or bravo for the control group and 70% alpha or bravo
for the experimental group (P=.53) (Table 6). The dental
technician and blinded clinical operator agreed well with
respect to the denitive cast selection. Observed agreement was 85% (95% CI, 69-100), and the Kappa statistic
was 0.70 (95% CI, 0.4-1.0). The overall ratings of the
impression materials (alpha or bravo versus charlie or delta)
were similar among the 3 different evaluators (clinical
operator, clinical evaluator, and dental technician) for both
the control group (logistic regression with jackknife standard errors; P=.66) and experimental group (P=.37).
DISCUSSION
Overall, no signicant differences between clinical performance were found in the experimental and control
impression groups. Therefore, the null hypothesis of this
study was not rejected. Thirteen (65% [95% CI, 44%86%]) of the experimental and 17 (85% [95% CI, 69%100%]) of the control impressions were rated as alpha or
bravo by the clinical evaluator. Eleven dies from the
control and 9 from the experimental group were selected
for the fabrication of the denitive crowns (P=.65). The
mean SD comfort of the experimental group (3.1 1.9)
was rated slightly better than that of the control group
(5.0 2.5; P=.001), but no differences were found in the
participants rating of taste (P=.46).
The patients level of comfort and acceptance during
the impression procedure may affect the handling and
quality of the denitive impression. No previous study
has evaluated the patients experience of comfort. In
this study, participants overwhelmingly selected the
experimental impression group (95%) over the control
impression group (5%) for comfort of impression making.
Dogan et al

2015

Table 7. Comparison of dental technicians ratings of between-impression materials


Characteristic

Experimental
Mean (SD)

Control
Mean (SD)

Difference
Mean (SD)

Overall visual assessment

20

2.6 (1.8)

2.1 (1.1)

0.5 (1.5)

.20

-0.2 to 1.2

0.3 (1.9)

.57

-0.7 to 1.1

Pa

95% CI

Overall detail reproduction

20

2.7 (2.1)

2.4 (1.5)

Ease of pouring

20

1.0 (0.0)

1.1 (0.3)

-0.1 (0.3)

.16

-0.2 to 0.04

Ease of removal

20

1.3 (0.4)

1.7 (0.5)

-0.5 (0.5)

<.001b

-0.7 to -0.2

-0.1 (0.7)

Tear resistance

20

1.7 (0.5)

1.8 (0.4)

Adhesion

20

1.9 (0.6)

1.7 (0.7)

Visibility

20

1.5 (1.1)

1.8 (0.8)

Multiple pouring

20

1.8 (0.8)

2.2 (1.6)

Finish line

20

2.4 (1.9)

1.7 (1.0)

Overall satisfaction

20

1.8 (0.7)

2.1 (1.2)

.75

-0.4 to 0.3

.10

-0.04 to 0.4

-0.3 (1.0)

.19

-0.8 to 0.2

-0.4 (1.6)

.28

-1.2 to 0.4

.11

-0.2 to 1.6

.21

-0.8 to 0.2

0.2 (0.5)

0.7 (1.9)
-0.3 (1.0)

Paired t test.
b
Bonferroni correction for multiple tests (10), a=.05.
a

Limitations of PVS impression materials include their


hydrophobic nature because of their chemical structure
and high contact angles with oral tissues and dental
stone.6-8 Newer PVS formulas include nonionic surfactants, which improve wettability and reduce contact angles. This might improve the ow and wetting process of
the material during impression making, especially in the
moist oral environment of saliva, gingival uids, and
blood.6-8 The ow characteristics of an impression material are related to its thixotropic properties, which affect
the quality of impression, especially in undercut areas
during initial impression making. Not all PVS impression
materials share the same thixotropic characteristics.6
However, in vitro studies have demonstrated adequate
thixotropic characteristics for the control PVS used in this
study and for a PVS material similar to the experimental
PVS group.6
Many clinical variables, such as proper material
handling, clinician preference for impression material,11
working time,14 and the patients adaptation and comfort, may inuence the accuracy of an impression.
Although both tested materials were HB and LB combinations, patient comfort may have been related to the
exibility of the experimental group, which was easier to
remove from the mouth when polymerized than the
more rigid control impression material. An impression
material should be exible enough to be removed easily
from undercuts. It is also clinically important to have
adequate working time. The fast-setting experimental
impression group and the conventional-setting control
impression group used in this study had the same
working time. The experimental impression group,
however, had a shorter setting time.
Although the newer PVS impression materials demonstrated adequate quality of detail reproduction,3-5
moisture control16,19,20 and soft tissue health15,17,18 are
still important for an adequate impression. Making adequate impressions is also affected by the clinicians
experience and skill and handling of materials.9,10 A
higher impression failure rate has been found when the

Dogan et al

nish lines are placed 2.0 mm subgingivally and


below.2,10,16 The more subgingival the nish line is, the
more difcult it is to record that nish line adequately. The
double-cord technique has been the most consistently
helpful for subgingival impressions.16,19,20
Studies have shown different results in terms of
accuracy between the 1-step 2-viscosity impression
technique and the 2-step 2-viscosity impression technique.12,13 After removing a plastic nonrigid tray, the
impression material might rebound buccolingually,
resulting in undersized dies and poorly tting restorations on the impressed tooth.22 To eliminate the risk of
impression recoil, use of rigid trays with a PVS putty is
recommended for the 1-step technique. In contrast, no
differences have been shown in the accuracy of stone
casts between stock and custom trays.23,24 Although
customized trays have been recommended to produce
more accurate impressions, clinically acceptable impressions can be made when stock trays are used with
PVS.21 With the 1-step impression technique, the
main concern may be the uncontrolled bulk of LB
material, especially in critical areas. The results of this
clinical study demonstrate that both experimental and
control groups performed adequately at the level of
alpha or bravo. Of a total of 40 abutment teeth
impressed in this study, only 10 were clinically rated as
unacceptable (7 in the experimental and 3 in the control group). The quality of both the experimental and
the control groups evaluated in this study by the clinical evaluator and the dental technician demonstrated
adequate impression surface quality and adequate
stone die surfaces.
Air trapped during the syringing of the LB material
into the gingival sulcus is a common reason for the
voids in critical areas of impressed surfaces.3-5 Voids
may be exacerbated by saliva contamination of the syringed material. Ratings of the impressions by the
dental technician demonstrated more voids, bubbles,
and tears for both experimental and control groups
than did the clinical evaluators ratings. However,

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no statistical difference between evaluations could be


demonstrated. The results of this clinical study are in
accordance with those of other studies, which demonstrated that the evaluation of the dental denitive cast
might be more clinically relevant than the evaluation of
the impression.3-5
The operator, the clinical evaluator, and the dental
technician who evaluated the impressions were not
blinded to the type of impression material because of the
differences in color. Selection of the denitive casts by
the clinical evaluator was blinded. These limitations may
have contributed to bias in the study.
The results of this study are limited only to the impressions of 1 abutment tooth. Another limitation of this
study may be the use of stock trays rather than
customized trays. Stock trays might provide an increased
risk of void formation on the surface of the impression
when compared with custom trays.21,23,24 Additionally,
the small sample size may not be adequate to demonstrate signicant difference in the materials.
Further clinical studies using different impression
materials with different impression techniques, multiple
abutment teeth, and multiple evaluators should be
considered with a larger sample size for the complete
clinical assessment of denitive impressions.
CONCLUSIONS
Within the limitations of this clinical study, the following
conclusions may be drawn: 1) Participants rated the
comfort of the experimental group signicantly better
than that of the control group. 2) No signicant differences were found between the experimental and control
groups in the participants rating of the impression material taste. 3) No signicant differences were found between the experimental and control groups in the ratings
made by the clinical operator and clinical evaluator.
4) The evaluation by the dental technician did not show
signicant differences in the performance of the
impression materials, except that the removal of the
impression of the cast was signicantly better for the
experimental group. 5) The evaluation by the dental
technician did not reveal a signicant difference in the
quality of the denitive casts generated by both groups.
6) There was good agreement between the dental technician and the blinded clinical operator with respect to
the denitive cast selection.
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Corresponding author:
Dr Sami Dogan
1959 NE Pacic St, HSB D767c
Box 357456
Seattle, WA 98195
Email: samido@uw.edu
Copyright 2015 by the Editorial Council for The Journal of Prosthetic Dentistry.

Dogan et al