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A randomised controlled trial of three aesthetic full-coronal restorations in

primary maxillary teeth

Article  in  European Journal of Paediatric Dentistry · March 2014

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 Introduction
T. Walia, A. A Salami, R. Bashiri, O. M Hamoodi,
F. Rashid Early Childhood Caries (ECC) continues to be a public
health problem of global proportions, which entails the
Department of Growth and Development, College of Dentistry, early carious involvement of the primary maxillary incisors
Ajman University, Ajman, UAE followed by the maxillary and mandibular first primary
molars and the mandibular cuspids [Wayne, 2001].
e-mail: ttww@yahoo.com 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
A randomised as well as issues related to child behaviour and cost of
treatment [Donly, 2002; Usha et al., 2007]. Nonetheless,
controlled trial of three it is essential to restore them in order to preserve the
integrity of primary teeth until their exfoliation and
aesthetic full-coronal eruption of permanent teeth [Mendes et al., 2004].
Numerous treatment approaches have been proposed
restorations in primary to address the aesthetics and retention of restorations
in these teeth. Intra-coronal tooth-colored restorations
maxillary teeth 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
abstract with tooth-colored materials like RMGI [Mandrolip,
2003] and composite, using celluloid strip crowns
Aim This randomised clinical trial (RCT) compared the [Mendes et al., 2004], or ready-made crowns like pre-
clinical outcomes of three aesthetic full-coronal restorations veneered stainless steel crowns [Usha et al., 2007], and
(composite strip crowns, pre-veneered stainless steel the recently introduced pre-fabricated primary zirconia
crowns (SSCs) and pre-fabricated primary zirconia crowns) crowns. Each method of restoration has its own distinct
in carious and traumatised primary maxillary incisors. advantages and disadvantages.
Materials and methods One hundred and twenty The aim of this clinical research was to evaluate and
nine teeth in 39 children aged between 3 to 5 years were compare three aesthetic full-coronal restorations on
included. Children were randomly assigned to one of three primary maxillary central and lateral incisors over a period
treatment groups using a permuted block randomisation of 6 months in terms of restoration failure, abrasion on
technique with a total of 43 teeth in each group. After the opposing dentition and gingival response. The three
trainee calibration, restorations were placed and evaluated restoration types included were Resin Composite Strip
after 6 months. Outcomes evaluated were restoration Crowns, Pre-Veneered Stainless Steel Crowns, and the
failure, tooth wear of opposing teeth and gingival health. newly introduced Pre-Fabricated Primary Zirconia Crowns.
Results The retention rate was highest for zirconia
crowns (100%) followed by pre-veneered SSCs (95%).
Strip crowns were the least retentive (78%). Zirconia Materials and methods
crowns showed low grade abrasion in four opposing teeth.
Teeth restored with resin composite and pre-veneered SSC Study design
showed an increase in mean gingival index score, while The design of this randomised controlled clinical trial
corresponding values decreased in zirconia crowns. followed the guidelines published by Consolidated
Conclusion Resin composite strip crown is a highly Standards of Reporting Trials (CONSORT) [Schulz et al.,
sensitive technique leading to lower retention rate. 2010]. The study was approved by the Research Ethics
Pre-veneered stainless steel crowns showed increased Committee of the College of Dentistry, AUST (no. 12-
incidence of facial veneer fracture. Zirconia crowns are 02). Prior to enrollment, every child’s parent/guardian
highly retentive and biocompatible but cause low grade received and signed an informed consent form.
of abrasion of their opposing natural dentition at the
6-month follow-up. Sample size
Based on the primary outcome of restoration failure,
and looking for a clinically important difference in
Keywords Aesthectics; Full-coverage restoration; proportion of restoration failures of 25% between
Primary incisors. groups (2-tailed alpha=0.05 and power of 0.80), a
minimum of 35 crowns were required in each group,

European Journal of Paediatric Dentistry vol. 15/2-2014 113

Walia T. et al.

totaling 105 teeth. Given the possibility of 10% attrition and dentine only; primary maxillary incisors with at least
in subsequent follow-ups, an additional 24 teeth were two third of the root length; adequate root support with
included in the study ensuring 43 primary incisors in no mobility. Children would to be managed by behavioral
each group. Therefore, a total sample of 129 teeth was management techniques and physical restraint only.
included at baseline. The subjects were allocated to one Randomisation was done by a statistician using permuted
of the following groups. block randomisation. Randomisation was conducted on
• Group A (Fig. 2): Resin composite strip crowns children rather than individual teeth. Block sizes of three
(Pedoform strip crowns forms, 3M® St. Paul MN). individuals were used. Each block consisted of children
• Group B (Fig. 3): Pre-veneered stainless steel crowns who required similar number of full coronal restorations.
(NuSmile® Pediatric Crowns, Houston, TX). Therefore, a child who required multiple restorations was
• Group C (Fig. 4): Pre-fabricated primary Zirconia only entered in the study when two other children who
crowns (Zirkiz® crowns, Hass, South Korea). required a similar number of restorations were available.
Forty-three children were randomly assigned as per the
Eligibility criteria and randomisation permutation within each group; however children could
Forty six children/148 teeth were examined initially not be randomised on the basis of their dmft status as it
and 39 children/129 teeth were then selected who met was difficult to find permuted blocks with similar number
the inclusion/exclusion criteria described in Figure 1. of children having the same dmft and number of teeth to
Subjects selected had 3-5 years of age, enjoyed good be replaced. The distribution of 43 teeth in each group at
general health, had the mandibular primary incisors baseline is shown in Table 1.
present and showed carious primary maxillary incisors,
with minimum of two surfaces involved, out of which Trainees’ calibration
one must be palatal caries and with DMFT of ≥3 (WHO Prior to study initiation, three trainees were calibrated on
Index) [Federation Dentaire Internationale, WHO, 2006]; tooth preparation and crown placement on 10 children,
moreover, primary maxillary incisors requiring full coronal total of 21 crowns, 7 crowns for each group. In order to
restoration following trauma involving enamel or enamel 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
fig. 1 Flow-chart of the trial. and Knight Tooth Wear Index [Bardsley, 2008; Smith

114 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 subgingivally. The shape and length modification of
After cutting the gingival margin of the celluloid crown the crown was kept as minimum as possible in order to
form to achieve a good fit, the shade of the resin composite have a proper fit if required. Contouring and crimping of
(3M, Filtek™ Z250 Universal Restorative®) was chosen and the lingual aspect was done. Final fit of the crown was
squeezed into the celluloid crown form. The tooth surfaces confirmed and cemented with type II GIC (Ketac® 3M
were etched for 20 seconds with a 37% phosphoric acid ESPE, St.Paul, Minn) applying digital pressure only.
solution (3M™ ESPE™ Etching Liquid®), and then the
light cure bonding adhesive (3M, Scotchbond-Universal- Pre-fabricated primary zirconia crown
Adhesive-Refill-Vial-41258®) was brushed onto the placement procedure
etched tooth surfaces. The celluloid crown then inserted After a trial fit of the crown, adjustments were done for
and excess resin was removed and polymerised, followed labial and lingual borders only if required, with high-speed
by celluloid crown form removal. Finishing and occlusal fine diamond bur under lot of water because excess heat
adjustments were performed, if required, using polishing could cause micro-fractures in the crown. Final passive fit
discs (3M ESPE, Sof-Lex® Polishing-Strip). of the crown was confirmed and cemented with type II
GIC (Ketac® 3M ESPE, St.Paul, Minn).
Pre-veneered SSC placement procedures
A trial fit of the crown was carried out after the tooth Statistical analysis
reduction ensuring that it did not sit more than 1 mm 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 Four opposing primary dentition of 38 pre-fabricated
crowns (group A) and 37 pre-veneered SSCs (group B) primary zirconia crowns (group C) had shown loss of
respectively had small but noticeable areas of loss of enamel surface characteristics - minimal loss of contour
material, while 6 out of 31 resin composite strip crowns which was statistically not significant but could be
(group A) were completely lost after 6 months (Table 4). clinically significant. None of the resin composite strip
When comparing the 3 groups, there was a statistically crowns (group A) and pre-fabricated Zirconia crowns
significant difference between groups A and B (p=0.04) (group B) showed any sign of tooth wear. When
and between groups A and C (p=0.02) (Table 5). 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 Groups Restoration Tooth Gingival
them at the 6-month follow-up (Table 6). Failure Wear Health
Group A - B 0.04 NA 0.93
Gingival health of the restored teeth Group B - C 0.23 0.239 0.00
At baseline there was no statistically significant
difference in mean gingival health scores (MGI) between Group A - C 0.02 0.238 0.00
the groups. At the 6-month follow up, the mean was tabLE 6 – p-value of comparison between groups.
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 overall retention as these teeth are usually more
the mean gingival health between all groups, there was destructed [Kupietzky et al., 2005].
statistically significant difference only between groups A
and C and B and C (p=0.00) (Table 6). Pre-Veneered SSC
Preveneered SSCs are a good restoration for anterior
teeth with significant decay and do not require extensive
Discussion additional chair time [Shah et al., 2004]. Long-term
retention and resistance to fracture of the veneer has
Primary incisors have enjoyed less retention of been shown to be somewhat low [Gupta et al., 2008].
intracoronal restorations with tooth colored materials The dentist is limited in the choice of resin shades,
such as composite, compomer and conventional or resin and the crowns are sometimes so white that they
modified glass ionomer due to morphology of the pulp, appear artificial [Croll and Helpin, 1996; Croll, 1998;
dentin and enamel as reported by Waggoner [1994], Wickersham et al., 1998]. In the present study, only 5%
Piyapinyo and White [1998] and Kopel & Beaver [1967]. of the NuSmile crowns failed. This occurred due to partial
loss of composite veneer at the metal-resin interface
Composite strip crowns which is machine compressed on the metal labial surface
The success rate of these crowns in our study after of the crown but they were never dislodged. Waggoner
6 months was 78% and only behavior management [1994] stated that breakage of the veneer is probably
techniques and physical restraints were used to manage due to traumatic forces, and not incisive forces. Lin
the children. However, they were still uncooperative, [2005] concluded in his study that, due to the physical
restless and stressed during the treatment, which made properties associated with resin veneers over stainless
moisture control inadequate for this highly technique steel, the resin has minimal flexure and can dislodge
sensitive restoration. Eidelman et al. [1997] reported with the tensile and shear stress associated with typical
better results for strip crowns placed by graduate mastication. A lower failure rate of these crowns in our
students under general anaesthesia than for those done study can also be attributed to the fact that children
under sedation. General anaesthesia allows treatment with increased overjet and overbite were excluded and
to be rendered under theoretically optimal conditions; secondly, they were followed-up for only 6 months.
implying outcomes would be more successful. Success
rate between 80% - 88% were found in the studies Pre-fabricated primary zirconia crown
done by Waggoner et al. [2005]; Ram and Fuks [2006] Current research on the clinical success of prefabricated
and Kupietzky et al. [2003]. High failure rate of 51% primary zirconia crowns for primary incisors is limited. In
over period of 2 years was seen in a study by Tate et al. the present study, the retention rate of Zirkiz crowns was
[2002], where strip crowns were placed under general 100% after 6 months. These monolithic crowns have
anaesthesia and endodontically treated teeth were no facial upper structure, as they are made up of solid
included as well. Endodontic treatment can also affect zirconia leading to no chance of facial veneer fracture

European Journal of Paediatric Dentistry vol. 15/2-2014 117

 Walia T. et al.

[Manicone et al., 2007]. The flexural strength of zirconia Conclusion

oxide materials has been reported to be in the range of
900 to 1,100 MPa. This is approximately twice as strong Resin composite strip crowns have lower success rate
as alumina oxide ceramics currently in the market and 5 and higher gingival inflammation. Pre-veneered SSCs are
times greater than standard glass ceramics [Manicone et retentive, but can have facial veneer fracture. Pre-fabricated
al., 2007]. Another important property is their fracture zirconia crowns are retentive and gingival friendly but cause
toughness making them perdurable and a highly strong non-significant abrasion of opposing teeth.
restoration [Denry and Holloway, 2010].
Conflict of interest statement
The authors declare that they do not have any
Tooth wear commercial or associative interest that represents a
A slight tooth wear in natural dentition is considered conflict of interest in connection with this work.
normal [Warren et al., 2002]. If restorative dental materials
have different wear properties compared to the natural References
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