CLINICAL SCIENCE

Clinical efficacy 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 definitive ABSTRACT

impressions is to provide accu-
rate 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, fixed dental prostheses,
veneers, inlays, onlays, implant-
supported restorations, and re-
movable partial and complete
dentures.1,2
Newer PVS impression ma-
terials have been designed to
provide optimal material prop-
erties to enhance precision and
minimize clinical challenges
such as voids, bubbles, pulls,
and tears.3-5 The rheological or
flow characteristics of newer
PVS impression materials have
improved their handling prop-
erties and adaptation to soft and
hard tissues.6-8
Factors that influence the
accuracy of an impression include proper material
handling, clinicians’ experience and skill,9,10 and prefer-
ence for impression materials,
nique, 12,13
working time, 14
number of units to be
impressed, and patient compliance. Furthermore, finish-
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 definitive 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
significantly higher than that with the control group (P=.001). No significant differences were found
in participants’ rating for the taste of the impression materials (P=.46). The viscosity for tray material
was rated as significantly better for the control group by the clinical operator (P=.004). The read-
ability of the impression and visibility around the finish line were rated as significantly 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
significantly better for the experimental group (P<.001). Eleven dies from the control and 9 from the
experimental group were selected for fabrication of the definitive crowns (P=.65).
Conclusion. Within the limitations of this clinical study, no significant 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 experi-
mental group significantly better than that of the control group. (J Prosthet Dent 2015;114:217-222)
line placement as related to the free gingival margin
(sub-, equi-, or supragingival finish lines),2,15,16 gingival
11
impression tech- health and soft tissue management,17,18 moisture con-
trol,16,19,20 and tray selection21-24 are all paramount for
making a predictable and accurate definitive impression.

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.

THE JOURNAL OF PROSTHETIC DENTISTRY 217

218
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.
With the evolution of computer-assisted design/
computer-assisted manufacturing (CAD/CAM) systems,
digital impressions are becoming more widely available
because of their efficiency and patient acceptance.25,26
However, the use of traditional impressions will remain
the gold standard until digital impression-making be-
comes 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. Howev-
er, whether the new fast-setting PVS impression mate-
rials are as accurate as the conventional-setting PVS
impression materials should be assessed.
Impression materials have been studied clinically
through the subjective evaluation of definitive impressions
and the resulting definitive 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 definitive casts by using the
1-step 2-viscosity impression technique.2 The null hy-
potheses of this study were that no differences in clinical
outcomes would be found by the patient or for the quality
of the definitive impressions and definitive 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
Subjects Division. They were selected from patients
treated at the predoctoral restorative clinic at the Uni-
versity 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 finish lines located
100% supragingivally or located 2.0 mm below the free
THE JOURNAL OF PROSTHETIC DENTISTRY
Volume 114 Issue 2
gingival margins or those who refused to give informed
consent were excluded from the study.
Two master impressions were made for each partici-
pant, using a recently introduced fast-setting impression
material (Imprint 4; 3M ESPE), defined in this study as
the fast-setting experimental group (fast set) (Fig. 1), and
a conventional-setting impression material (Imprint 3;
3M ESPE), defined as the control group (conventional
set) (Fig. 2). A total of 40 definitive 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.
Impression-making and evaluation procedures were
performed by 2 prosthodontists (S.D., the clinical oper-
ator, and E.R.S., an evaluator), following a standardized
protocol. Oral hygiene, location of the finish 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 ac-
cording to the manufacturers’ instructions. The double-
cord 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
clinician’s 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 filled
with the HB material, LB material was added on top of the
HB, and the tray was inserted into the participant’s mouth
for 2 minutes for the experimental group and 5 minutes for
the control group according to the manufacturer’s in-
structions. 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 proce-
dure 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,
flowability, and adhesion to the tray by the clinical
operator using a visual analog rating scale of 1 to 10
Dogan et al
August 2015
Figure 1. Definitive impressions made with Imprint 4 (experimental
group), rated as alpha.
Table 1. Impression materials evaluated
Brand Material Type
Imprint 4 Penta Heavy-bodied consistency, fast-setting
Heavy
Imprint 4 Light Light-bodied consistency, fast-setting
Imprint 3 Penta Heavy-bodied consistency, conventional-setting
Heavy
Imprint 3 Light Light-bodied consistency, conventional-setting
All materials were obtained from 3M ESPE.
Table 3. Quality rating criteria of definitive 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 finish line on cast
Visibility of air bubbles in cast, especially finish line
Overall satisfaction
(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
finish line) were sent to the dental technician (H.H.) for
the assessment of the impression and pouring and
assessment of the definitive casts. Questions concerning
overall assessment, handling properties, and quality of
the impression material were answered by the dental
technician by using a 1 to 10 numerical rating scale
(1=excellent, 5=acceptable, 10=poor) before the impres-
sion was poured with Type IV stone (GC Fujirock EP; GC
America) (Table 3).
A quality rating of the definitive cast was made by the
dental technician using the same numerical rating scale
Dogan et al
219
Figure 2. Definitive impressions made with Imprint 3 (control group),
rated as alpha.
Table 2. Rating criteria for overall evaluation of impression by clinical
Lot No. evaluator
511512 1. Overall evaluation (alpha to delta score)
Alpha: No defects. Impression is usable.
511295 Bravo: Small defects such as tears, voids, bubbles, which do not affect finish
500728 line or prevent use of impressions. Impression is usable.
Charlie: Good reproduction of preparation finish line. Other defects require
501772 impression to be remade.
Delta: Defects at preparation finish line. Impression needs to be remade.
2. Tears (number and location)
3. Voids (number and location)
4. Bubbles (number and location)
Figure 3. Definitive cast.
(1=excellent, 5=acceptable, 10=poor). Stone casts were
sent to the clinical evaluator, who was blinded to the
material, for selection of the definitive cast for fabricating
the definitive restoration. Only the definitive cast judged
to be the best by the dental technician and the blinded
clinical evaluator was used to make the definitive crown
(Fig. 3). In case of a disagreement between the techni-
cian’s and clinical evaluator’s selection, a consensus
evaluation was made for the definitive 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
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220 Volume 114 Issue 2

Table 4. Comparison of participant rating of comfort and taste between Table 5. Comparison of operator’s ratings of viscosity, readability, and
impression materials visibility between impression materials
Experimental Control Difference Experimental Control Difference
Characteristic N Mean (±SD) Mean (±SD) Mean (±SD) Pa 95% CI Characteristic N Mean (±SD) Mean (±SD) Mean (±SD) Pa 95% CI
b
Comfort 20 3.1 (1.9) 5.0 (2.5) -1.9 (3.0) .001 -3.3 to -0.5 Viscosity 20 1.7 (0.5) 1.2 (0.4) 0.5 (0.6) .004 0.1-0.7
Taste 20 3.3 (1.8) 2.9 (1.7) 0.4 (2.1) .46 -0.6 to 1.3 Readability 20 1.0 (0.0) 1.7 (0.5) -0.7 (0.5) <.001 -0.9 to 0.4
Paired t test.
a Visibility 20 1.0 (0.0) 1.5 (0.5) -0.5 (0.5) <.001 -0.7 to -0.3
Bonferroni correction for multiple tests (2), P<.05.
b
Bonferroni correction for multiple tests (3), P<.05.
a
Paired t test.
confirmed with a Sign test.27 In addition, 95% confidence
Table 6. Clinical and blinded operator’s overall rating
intervals (CI) were reported for the differences between
Experimental Control
impression averages. Comparisons between the 2 Alpha or Bravo Alpha or Bravo
impression materials for qualitative ratings were done Rater N n (%) n (%) Pa 95% CIb
using a Sign test, the McNemar test for paired proportions, Clinical operator 20 13 (65) 17 (85) .16 -46 to 6

and the Bowker test of symmetry.27,28 In addition, 95% CIs
are reported for the frequency and differences in fre-
quencies. 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 significance 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 experi-
mental group (95%) over the control group (5%; Sign
test, P<.001). No significant 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 finish-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
significant, 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 techni-
cian’s overall rating was 85% alpha or bravo for the control
Dental technician 20 16 (80) 17 (85) .71 -31 to 21
Blinded clinical evaluator 20 14 (70) 16 (80) .53 -41 to 21
a
McNemar test for paired proportions, P<.05.
b
95% CI, 95% CI for differences (experimental minus control) in alpha or bravo ratings.
group and 80% alpha or bravo for the experimental group
(P=.71) (Table 7). The definitive cast selection was 55%
(95% CI, 33-77) for the control group and 45% (95% CI,
23-67) for the experimental group (Sign test, P=.65).
The blinded clinical evaluator’s 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 definitive cast selection. Observed agree-
ment 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 stan-
dard errors; P=.66) and experimental group (P=.37).
DISCUSSION
Overall, no significant differences between clinical per-
formance 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 definitive 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
participant’s rating of taste (P=.46).
The patient’s level of comfort and acceptance during
the impression procedure may affect the handling and
quality of the definitive impression. No previous study
has evaluated the patient‘s experience of comfort.
In this study, participants overwhelmingly selected
the experimental impression group (95%) over the

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August 2015 221

Table 7. Comparison of dental technician’s ratings of between-impression materials

Experimental Control Difference
Characteristic N Mean (±SD) Mean (±SD) Mean (±SD) Pa 95% CI
Overall visual assessment 20 2.6 (1.8) 2.1 (1.1) 0.5 (1.5) .20 -0.2 to 1.2
Overall detail reproduction 20 2.7 (2.1) 2.4 (1.5) 0.3 (1.9) .57 -0.7 to 1.1
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
Tear resistance 20 1.7 (0.5) 1.8 (0.4) -0.1 (0.7) .75 -0.4 to 0.3
Adhesion 20 1.9 (0.6) 1.7 (0.7) 0.2 (0.5) .10 -0.04 to 0.4
Visibility 20 1.5 (1.1) 1.8 (0.8) -0.3 (1.0) .19 -0.8 to 0.2
Multiple pouring 20 1.8 (0.8) 2.2 (1.6) -0.4 (1.6) .28 -1.2 to 0.4
Finish line 20 2.4 (1.9) 1.7 (1.0) 0.7 (1.9) .11 -0.2 to 1.6
Overall satisfaction 20 1.8 (0.7) 2.1 (1.2) -0.3 (1.0) .21 -0.8 to 0.2
a
Paired t test.
b
Bonferroni correction for multiple tests (10), a=.05.

control impression group (5%) for comfort of impression
making.
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 surfac-
tants, which improve wettability and reduce contact an-
gles. This might improve the flow and wetting process of
the material during impression making, especially in the
moist oral environment of saliva, gingival fluids, and
blood.6-8 The flow 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 mate-
rials 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 com-
fort, may influence the accuracy of an impression.
Although both tested materials were HB and LB com-
binations, patient comfort may have been related to the
flexibility 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 flexible 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 dem-
onstrated 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 ad-
equate impressions is also affected by the clinician’s
experience and skill and handling of materials.9,10 A
higher impression failure rate has been found when the
finish lines are placed 2.0 mm subgingivally and
below.2,10,16 The more subgingival the finish line is, the
more difficult it is to record that finish 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 tech-
nique.12,13 After removing a plastic nonrigid tray, the
impression material might rebound buccolingually,
resulting in undersized dies and poorly fitting restora-
tions 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 impres-
sions 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 demon-
strate that both experimental and control groups per-
formed 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 exper-
imental 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 tech-
nician demonstrated more voids, bubbles, and tears for
both experimental and control groups than did the clin-
ical evaluator’s ratings. However, no statistical difference

Dogan et al THE JOURNAL OF PROSTHETIC DENTISTRY

222
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 definitive 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 definitive 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 im-
pressions 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 demon-
strate significant 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 definitive impressions.
CONCLUSIONS
Within the limitations of this clinical study, the following
conclusions may be drawn: 1) Participants rated the
comfort of the experimental group significantly better than
that of the control group. 2) No significant differences
were found between the experimental and control groups
in the participants’ rating of the impression material taste.
3) No significant differences were found between the
experimental and control groups in the ratings made by
the clinical operator and clinical evaluator. 4) The evalu-
ation by the dental technician did not show significant
differences in the performance of the impression materials,
except that the removal of the impression of the cast was
significantly better for the experimental group. 5) The
evaluation by the dental technician did not reveal a sig-
nificant difference in the quality of the definitive casts
generated by both groups. 6) There was good agreement
between the dental technician and the blinded clinical
operator with respect to the definitive cast selection.
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Corresponding author:
Dr Sami Dogan
1959 NE Pacific 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