Introduction
T. Walia, A. A Salami, R. Bashiri, O. M Hamoodi,
F. Rashid
Department of Growth and Development, College of Dentistry,
Ajman University, Ajman, UAE
e-mail: ttww@yahoo.com
A randomised
controlled trial of three
aesthetic full-coronal
restorations in primary
maxillary teeth
abstract
Aim This randomised clinical trial (RCT) compared the
clinical outcomes of three aesthetic full-coronal restorations
(composite strip crowns, pre-veneered stainless steel
crowns (SSCs) and pre-fabricated primary zirconia crowns)
in carious and traumatised primary maxillary incisors.
Materials and methods One hundred and twenty
nine teeth in 39 children aged between 3 to 5 years were
included. Children were randomly assigned to one of three
treatment groups using a permuted block randomisation
technique with a total of 43 teeth in each group. After
trainee calibration, restorations were placed and evaluated
after 6 months. Outcomes evaluated were restoration
failure, tooth wear of opposing teeth and gingival health.
Results The retention rate was highest for zirconia
crowns (100%) followed by pre-veneered SSCs (95%).
Strip crowns were the least retentive (78%). Zirconia
crowns showed low grade abrasion in four opposing teeth.
Teeth restored with resin composite and pre-veneered SSC
showed an increase in mean gingival index score, while
corresponding values decreased in zirconia crowns.
Conclusion Resin composite strip crown is a highly
sensitive technique leading to lower retention rate.
Pre-veneered stainless steel crowns showed increased
incidence of facial veneer fracture. Zirconia crowns are
highly retentive and biocompatible but cause low grade
of abrasion of their opposing natural dentition at the
6-month follow-up.
Keywords Aesthectics; Full-coverage restoration;
Primary incisors.
European Journal of Paediatric Dentistry vol. 15/2-2014
Early Childhood Caries (ECC) continues to be a public
health problem of global proportions, which entails the
early carious involvement of the primary maxillary incisors
followed by the maxillary and mandibular first primary
molars and the mandibular cuspids [Wayne, 2001].
Aesthetic restoration of these carious or traumatised
primary anterior teeth can be challenging especially
due to their small size, close proximity of pulp, relatively
thin enamel leading to lesser surface area for bonding
as well as issues related to child behaviour and cost of
treatment [Donly, 2002; Usha et al., 2007]. Nonetheless,
it is essential to restore them in order to preserve the
integrity of primary teeth until their exfoliation and
eruption of permanent teeth [Mendes et al., 2004].
Numerous treatment approaches have been proposed
to address the aesthetics and retention of restorations
in these teeth. Intra-coronal tooth-colored restorations
include glass ionomer cements, resin-modified glass
ionomers (RMGI), polyacid-modified resins or resin
composites. Full-coronal aaesthetic restorations can also
be used such as free-hand buildup of crown structure
with tooth-colored materials like RMGI [Mandrolip,
2003] and composite, using celluloid strip crowns
[Mendes et al., 2004], or ready-made crowns like pre-
veneered stainless steel crowns [Usha et al., 2007], and
the recently introduced pre-fabricated primary zirconia
crowns. Each method of restoration has its own distinct
advantages and disadvantages.
The aim of this clinical research was to evaluate and
compare three aesthetic full-coronal restorations on
primary maxillary central and lateral incisors over a period
of 6 months in terms of restoration failure, abrasion on
the opposing dentition and gingival response. The three
restoration types included were Resin Composite Strip
Crowns, Pre-Veneered Stainless Steel Crowns, and the
newly introduced Pre-Fabricated Primary Zirconia Crowns.
Materials and methods
Study design
The design of this randomised controlled clinical trial
followed the guidelines published by Consolidated
Standards of Reporting Trials (CONSORT) [Schulz et al.,
2010]. The study was approved by the Research Ethics
Committee of the College of Dentistry, AUST (no. 12-
02). Prior to enrollment, every child’s parent/guardian
received and signed an informed consent form.
Sample size
Based on the primary outcome of restoration failure,
and looking for a clinically important difference in
proportion of restoration failures of 25% between
groups (2-tailed alpha=0.05 and power of 0.80), a
minimum of 35 crowns were required in each group,
113
Walia T. et al.
totaling 105 teeth. Given the possibility of 10% attrition
in subsequent follow-ups, an additional 24 teeth were
included in the study ensuring 43 primary incisors in
each group. Therefore, a total sample of 129 teeth was
included at baseline. The subjects were allocated to one
of the following groups.
• Group A (Fig. 2): Resin composite strip crowns
(Pedoform strip crowns forms, 3M® St. Paul MN).
• Group B (Fig. 3): Pre-veneered stainless steel crowns
(NuSmile® Pediatric Crowns, Houston, TX).
• Group C (Fig. 4): Pre-fabricated primary Zirconia
crowns (Zirkiz® crowns, Hass, South Korea).
Eligibility criteria and randomisation
Forty six children/148 teeth were examined initially
and 39 children/129 teeth were then selected who met
the inclusion/exclusion criteria described in Figure 1.
Subjects selected had 3-5 years of age, enjoyed good
general health, had the mandibular primary incisors
present and showed carious primary maxillary incisors,
with minimum of two surfaces involved, out of which
one must be palatal caries and with DMFT of ≥3 (WHO
Index) [Federation Dentaire Internationale, WHO, 2006];
moreover, primary maxillary incisors requiring full coronal
restoration following trauma involving enamel or enamel
fig. 1 Flow-chart of the trial.
114
and dentine only; primary maxillary incisors with at least
two third of the root length; adequate root support with
no mobility. Children would to be managed by behavioral
management techniques and physical restraint only.
Randomisation was done by a statistician using permuted
block randomisation. Randomisation was conducted on
children rather than individual teeth. Block sizes of three
individuals were used. Each block consisted of children
who required similar number of full coronal restorations.
Therefore, a child who required multiple restorations was
only entered in the study when two other children who
required a similar number of restorations were available.
Forty-three children were randomly assigned as per the
permutation within each group; however children could
not be randomised on the basis of their dmft status as it
was difficult to find permuted blocks with similar number
of children having the same dmft and number of teeth to
be replaced. The distribution of 43 teeth in each group at
baseline is shown in Table 1.
Trainees’ calibration
Prior to study initiation, three trainees were calibrated on
tooth preparation and crown placement on 10 children,
total of 21 crowns, 7 crowns for each group. In order to
maintain consistency in restoration methods, each intern
was evaluated by two specialists with regards to their
clinical technique, and rated for each restoration prepared
on a Likert scale from 1-5, 1 being not acceptable, and
5 being highly acceptable. The consistency in ratings
between specialists for each trainee was also tested for
consistency using the Kappa test. During the calibration
for consistency in restoration methods, specialists
consistently scored high ratings for the restorations by
each intern, emphasised by a high Kappa score of 0.93.
Each intern prepared only one type of crown. A general
dental practitioner (GDP) was also selected and trained in
evaluation of: restoration failure; abrasion in the opposing
dentition (visual and photographical assessment method);
gingival health of the restored teeth and; photographic
technique. Ten percent of results of the 21 crowns
(i.e. three crowns), were re-evaluated to confirm the
reproducibility of the evaluation scores.
Methods of outcome measures evaluation
At baseline, only gingival health was measured, while
at the 6-month follow-up, all three outcome measures
were evaluated. The description of the criteria used to
record the clinical parameters is shown in Table 2.
Evaluation of restoration failure
This was clinically evaluated with visual assessment of
the restoration, according to the US Public Health Service
“USPHS”, Alpha criteria rating system [Ryge, 1980].
Evaluation of tooth wear on opposing teeth
Tooth wear was evaluated according to the Smith
and Knight Tooth Wear Index [Bardsley, 2008; Smith
European Journal of Paediatric Dentistry vol. 15/2-2014
 comparison of full crown restorations

No. of teeth No. of Total (43) Criteria Grades Description

restored per children in Restoration 0 Crown appears normal: no
child each group failure cracks, chips, or fractures
1 1 1 1 Small but noticeable area of loss
of material
2 1 2
2 Large loss of crown material
3 4 12
3 Complete loss of crown
4 7 28
Tooth wear 0 No loss of enamel surface
tabLE 1 Distribution of 43 teeth in each group at baseline. characteristics, no loss of contour
1 Loss of enamel surface
characteristics, minimal loss of
and Knight, 1984]. The incisal and labial surfaces of contour
the teeth opposing the full-coronal restorations were 2 Loss of enamel exposing dentine
clinically observed for any sign of abrasion. In addition, for less than one third of surface,
loss of enamel just exposing
photographs were taken with a Canon Digital SLR® dentin, defect less than 1 mm
camera using focus 1:3 frontal, teeth parted, 1/60 sec, f deep
22 and 1:1.5 frontal upper 1/60 sec, f 22 at baseline and 3 Loss of enamel exposing dentin
at the 6-month follow-up. for more than one third of
surface, loss of enamel and
substantial loss of dentin, defect
Evaluation of gingival health less than 1–2 mm deep
This parameter was evaluated using a blunt periodontal 4 Complete enamel loss, pulp
probe (Double ended probe Williams 1-2-3-5-7-8-9- exposure, secondary dentin
10 Goldman Fox Flat) according to the Löe and Silness exposure, pulp exposure or
exposure of secondary dentin,
gingival index [Löe, 1967]. After the selection of correct defect more than 2 mm deep,
crown size, proper isolation with rubber dam and local pulp exposure, secondary dentin
exposure IMMAGINO SIA COSI’,
anaesthesia were achieved. Caries was excavated and NON SI CAPIVA COME LO
in cases of very deep lesions, an application of a resin AVEVANO SCRITTO
modified GIC liner/base (Viterbond, 3M-ESPE Dental Gingival 0 No obvious signs of inflammation
products, St.Paul, Minn®) was applied for pulp protection. Health
The tooth was prepared using a No. 330 carbide bur to 1 Mild marginal gingivitis, tissue
reduce the incisal edge by approximately 1.5 mm and the slightly reddened and edematous
interproximal contact opened. A coarse tapered round 2 Moderate marginal gingivitis-
diamond bur was used to reduce the tooth both labially tissue obviously reddened and
swollen
and palatally by 1-1.5 mm, followed by a fine tapered
round-end diamond bur to smoothen the preparation 3 Severe gingivitis, tissue is very
swollen: spontaneous bleeding
and to refine it 1 mm subgingivally. The tooth preparation
principles followed were similar in all three groups. tabLE 2 Distribution of 43 teeth in each group at baseline.

Resin composite strip crown placement

procedures
After cutting the gingival margin of the celluloid crown
form to achieve a good fit, the shade of the resin composite
(3M, Filtek™ Z250 Universal Restorative®) was chosen and
squeezed into the celluloid crown form. The tooth surfaces
were etched for 20 seconds with a 37% phosphoric acid
solution (3M™ ESPE™ Etching Liquid®), and then the
light cure bonding adhesive (3M, Scotchbond-Universal-
Adhesive-Refill-Vial-41258®) was brushed onto the
etched tooth surfaces. The celluloid crown then inserted
and excess resin was removed and polymerised, followed
by celluloid crown form removal. Finishing and occlusal
adjustments were performed, if required, using polishing
discs (3M ESPE, Sof-Lex® Polishing-Strip).
Pre-veneered SSC placement procedures
A trial fit of the crown was carried out after the tooth
reduction ensuring that it did not sit more than 1 mm
subgingivally. The shape and length modification of
the crown was kept as minimum as possible in order to
have a proper fit if required. Contouring and crimping of
the lingual aspect was done. Final fit of the crown was
confirmed and cemented with type II GIC (Ketac® 3M
ESPE, St.Paul, Minn) applying digital pressure only.
Pre-fabricated primary zirconia crown
placement procedure
After a trial fit of the crown, adjustments were done for
labial and lingual borders only if required, with high-speed
fine diamond bur under lot of water because excess heat
could cause micro-fractures in the crown. Final passive fit
of the crown was confirmed and cemented with type II
GIC (Ketac® 3M ESPE, St.Paul, Minn).
Statistical analysis
Comparisons of the age of participants as well as

European Journal of Paediatric Dentistry vol. 15/2-2014 115

Walia T. et al.

baseline gingival health scores between groups were Primary Maxillary Incisors Count (%)
performed using a one way ANOVA and post hoc Tukey Right Lateral (52) 33 (26%)
tests. Changes in gingival health within each group
Right Central (51) 32 (25%)
between baseline and 6 months were evaluated using
paired sample T tests. Comparisons of change in gingival Left Central (61) 34 (26%)
health between the three groups were also evaluated Left Lateral (62) 30 (23%)
using a one way ANOVA and post hoc Tukey tests. Chi
square analyses for proportions were applied to test for tabLE 3 Baseline data of teeth restored.
differences in restoration failure and tooth wear indices
between groups at 6 months. Analyses were performed Outcome Group A Group B Group C
using the Statistical Package for Social Sciences (SPSS, Measures (n=36) (n=37) (n=38)
versions 20.0.0 for Windows). grades n (%) n (%) n (%)
Restoration 0 28 (78%) 35 (95%) 38 (100%)
failure
Results 1 2 (5%) 2 (5%) 0 (0%)
2 0 (0%) 0 (0%) 0 (0%)
Full-coronal restorations were placed on 129 primary 3 6 (17%) 0 (0%) 0 (0%)
maxillary incisors consisting of 66 central and 63 lateral
Tooth wear 0 31 (100%) 32 (100%) 34 (90%)
incisors of 39 children (21 male, 18 female) (Table 3) The
average age of children at the baseline was 4.5 years and 1 0 (0%) 0 (0%) 4 (10%)
dmft -5. There was a drop out of 6 children/18 teeth
tabLE 4 Restoration failure and tooth wear results at the
at the 6-month follow-up reducing the sample to 33
6-month follow up.
children /111 teeth.

Restoration failure Tooth wear of opposing dentition

Two crowns each out of 36 resin composite strip
crowns (group A) and 37 pre-veneered SSCs (group B)
respectively had small but noticeable areas of loss of
material, while 6 out of 31 resin composite strip crowns
(group A) were completely lost after 6 months (Table 4).
When comparing the 3 groups, there was a statistically
significant difference between groups A and B (p=0.04)
and between groups A and C (p=0.02) (Table 5).
Four opposing primary dentition of 38 pre-fabricated
primary zirconia crowns (group C) had shown loss of
enamel surface characteristics - minimal loss of contour
which was statistically not significant but could be
clinically significant. None of the resin composite strip
crowns (group A) and pre-fabricated Zirconia crowns
(group B) showed any sign of tooth wear. When
comparing the tooth wear results between the groups,

fiG. 2 Resin composite

strip crowns (complete loss
of restorations of central
incisors) before treatment (a)
and after six months (b).

fig. 3 Pre-veneered SS
crowns before treatment (a)
and after six months (b)..

fig. 4 Pre-fabricated primary

zirconia crowns before
treatment (a) and after six
months (b).

116 European Journal of Paediatric Dentistry vol. 15/2-2014

 comparison of full crown restorations

Mean Gingival Mean Gingival Difference p value tabLE 5

Health Health in MGH Mean gingival
(baseline) (6 months) health score
Strip Crown n 43 36 of 3 groups at
baseline & after
Mean (SD) 1.65 (0.50) 1.97 (0.44) 0.32 < 0.05
6 months.
NuSmile Crown n 43 37
Mean (SD) 1.71 (0.50) 1.95 (0.61) 0.24 0.07
Zirkiz Crown n 43 38
Mean (SD) 1.67 (0.56) 1.35 (0.60) -0.32* < 0.05
* MGH score reduced over a period of 6 months

there was no statistically significant difference between
them at the 6-month follow-up (Table 6).
Gingival health of the restored teeth
At baseline there was no statistically significant
difference in mean gingival health scores (MGI) between
the groups. At the 6-month follow up, the mean was
increased in group A and B, while in teeth restored with
Zirkiz crowns (group C) the MGI score was significantly
reduced (p=0.01). When comparing the difference in
the mean gingival health between all groups, there was
statistically significant difference only between groups A
and C and B and C (p=0.00) (Table 6).
Discussion
Primary incisors have enjoyed less retention of
intracoronal restorations with tooth colored materials
such as composite, compomer and conventional or resin
modified glass ionomer due to morphology of the pulp,
dentin and enamel as reported by Waggoner [1994],
Piyapinyo and White [1998] and Kopel & Beaver [1967].
Composite strip crowns
The success rate of these crowns in our study after
6 months was 78% and only behavior management
techniques and physical restraints were used to manage
the children. However, they were still uncooperative,
restless and stressed during the treatment, which made
moisture control inadequate for this highly technique
sensitive restoration. Eidelman et al. [1997] reported
better results for strip crowns placed by graduate
students under general anaesthesia than for those done
under sedation. General anaesthesia allows treatment
to be rendered under theoretically optimal conditions;
implying outcomes would be more successful. Success
rate between 80% - 88% were found in the studies
done by Waggoner et al. [2005]; Ram and Fuks [2006]
and Kupietzky et al. [2003]. High failure rate of 51%
over period of 2 years was seen in a study by Tate et al.
[2002], where strip crowns were placed under general
anaesthesia and endodontically treated teeth were
included as well. Endodontic treatment can also affect
Groups Restoration Tooth Gingival
Failure Wear Health
Group A - B 0.04 NA 0.93
Group B - C 0.23 0.239 0.00
Group A - C 0.02 0.238 0.00
tabLE 6 – p-value of comparison between groups.
the overall retention as these teeth are usually more
destructed [Kupietzky et al., 2005].
Pre-Veneered SSC
Preveneered SSCs are a good restoration for anterior
teeth with significant decay and do not require extensive
additional chair time [Shah et al., 2004]. Long-term
retention and resistance to fracture of the veneer has
been shown to be somewhat low [Gupta et al., 2008].
The dentist is limited in the choice of resin shades,
and the crowns are sometimes so white that they
appear artificial [Croll and Helpin, 1996; Croll, 1998;
Wickersham et al., 1998]. In the present study, only 5%
of the NuSmile crowns failed. This occurred due to partial
loss of composite veneer at the metal-resin interface
which is machine compressed on the metal labial surface
of the crown but they were never dislodged. Waggoner
[1994] stated that breakage of the veneer is probably
due to traumatic forces, and not incisive forces. Lin
[2005] concluded in his study that, due to the physical
properties associated with resin veneers over stainless
steel, the resin has minimal flexure and can dislodge
with the tensile and shear stress associated with typical
mastication. A lower failure rate of these crowns in our
study can also be attributed to the fact that children
with increased overjet and overbite were excluded and
secondly, they were followed-up for only 6 months.
Pre-fabricated primary zirconia crown
Current research on the clinical success of prefabricated
primary zirconia crowns for primary incisors is limited. In
the present study, the retention rate of Zirkiz crowns was
100% after 6 months. These monolithic crowns have
no facial upper structure, as they are made up of solid
zirconia leading to no chance of facial veneer fracture

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Walia T. et al.
[Manicone et al., 2007]. The flexural strength of zirconia
oxide materials has been reported to be in the range of
900 to 1,100 MPa. This is approximately twice as strong
as alumina oxide ceramics currently in the market and 5
times greater than standard glass ceramics [Manicone et
al., 2007]. Another important property is their fracture
toughness making them perdurable and a highly strong
restoration [Denry and Holloway, 2010].
Tooth wear
A slight tooth wear in natural dentition is considered
normal [Warren et al., 2002]. If restorative dental materials
have different wear properties compared to the natural
teeth, they can affect the wear rate of antagonist natural
teeth [Sulong and Aziz, 1990]. Therefore, wear occurring
between enamel and dental restorations is an important
factor that should always be considered in the selection
of restorative materials in clinical practice [Delong et al.,
1989]. Seghi et al. [1991] has suggested that a restorative
dental material should have a wear degree similar to that
of the enamel. There are different methods of tooth wear
evaluation such as using a three-dimensional profiling
system and ANSUR 3D software [Jung et al., 2010], but they
are not easy to perform in children. Recent research from
the University of Zurich also demonstrated that improperly
polished and only glazed zirconia can be destructive to the
opposing tooth structure [Donovan, 2008].
Gingival health
The increased mean gingival health score of teeth
restored with composite strip crowns can be affected
by tooth preparation and cementation [Hackmyer and
Donly, 2010]. Waggoner et al. [2005] also reported
similar results in their studies. It is preferable to keep the
restoration margins coronal to the free gingival margin
[Padbury et al., 2003]. Obviously, subgingival margin
placement is often unavoidable for primary teeth.
Retention of full-coverage crowns for primary teeth
comes mainly from subgingival placement [Lee, 2002].
The degree of gingival inflammation is directly related to
the location of crown margin. Newcomb [1974] stated
that as the margin goes from supra to a sub-gingival
position, the gingival health deteriorates.
Teeth restored with the NuSmile crowns also showed
an increase in the MGI score after 6 months. This could be
due to plaque retention on the labial composite veneered
surface of SSCs. Improper contouring of metal margins
and remnants of the cement in the sulcus also irritate
the gingiva causing gingival inflammation [Maclean et
al., 2007]. Teeth restored with Zirkiz crowns showed
a significant decrease in MGI score. Zirconia as tooth
material is highly biocompatible and possesses a polished
and smooth surface leading to less plaque accumulation
and hence less gingival irritation. Previously published
studies on FPDs with zirconia framework in permanent
dentition arrived at the same conclusion of lower plaque
accumulation [Schmitt et al., 2009; Sailer et al., 2007].
118
Conclusion
Resin composite strip crowns have lower success rate
and higher gingival inflammation. Pre-veneered SSCs are
retentive, but can have facial veneer fracture. Pre-fabricated
zirconia crowns are retentive and gingival friendly but cause
non-significant abrasion of opposing teeth.
Conflict of interest statement
The authors declare that they do not have any
commercial or associative interest that represents a
conflict of interest in connection with this work.
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