219]
Original Article
Abstract Bashaer S.
This randomized clinical trial compared the clinical outcomes of two full‑coronal Abdulhadi,
restorations (stainless steel crowns [SSCs] and zirconia crowns Nu/ZR) in carious primary molars Medhat M.
teeth. Children attending the King Abdulaziz University, Faculty of Dentistry clinics who need
restorations will be screened for inclusion criteria till 120 teeth are recruited (60 teeth for SSC Abdullah,
restorations and 60 for Nu/ZR restorations). Split mouth technique will be used to ensure equalizing Sumer M. Alaki,
variables for both groups. Randomization will be done using SPSS software version 20.0 (Armonk, Najlaa M. Alamoudi,
NY; IBM Corp., USA). A simple descriptive statistic will be used for analysis using Wilcoxon Moaz H. Attar
Signed‑Rank test. The level of significance will be set at (α = 0.05) and level of confidence Department of Pediatric
at (95%). While looking at the improvements in gingival health relative to interventions, both Dentistry, Faculty of Dentistry,
Zirconia and SSC have significant changes through all time points. However, Zirconia performed King Abdulaziz University,
better at the 3rd month with 80% compared to SSC with only 13.3% improvement with P < 0.001 Jeddah, Kingdom of Saudi
and 0.005, respectively. At 6th month, all samples under group zirconia already improved whereas Arabia
only 73.3% from SSC show improvement. The remaining samples happened to have positive
changes at the 12th month. Regarding the plaque retention also the Zirconia Crowns shows
improve performance than SSC. As both SSC and Zirconia crowns presented to be an excellent
choice for posterior teeth restorations, however, we can conclude that Zirconia crowns performed
better regarding gingival response to the material of restoration and plaque retention despite its
high cost.
Abdulhadi, et al.: Clinical evaluation between zirconia crowns and stainless steel crowns in primary molars teeth
SSCs in restoring primary molars with multi‑surface that we need a total of 120 teeth (corresponding to around
involvement.[10‑14] 60 children to achieve 80% power with 95% confidence)
assuming medium effect size in the mean change in
Usage of SSCs should also be accounted in patients with
gingival health 6 months after crown application between
heightened risk of caries whose participation is distressed
Zirconia and SSC group with the assumption of nonnormal
by age, behavior, or medical history. Most often, these
distribution. The number of crowns in each arm will be 60.
patients obtain treatment under sedatives or general
anesthetics. SSCs tends to last long in patients with Sample selection
developmental or medical conditions that do not improve A sample of 120 contralateral primary molars in 26 patients
as they age thus reducing the possible usage of sedatives were treated in the Pediatric Dental Clinics, King Abdulaziz
and general anesthetics considering that it is costly and University, Faculty of Dentistry, Jeddah. All patient who
its inherent perils. However then again, severely damaged presented from August 1, 2015, until September 30, 2015,
primary dentitions among pediatric patients is deemed to be and met specific inclusion criteria were included in the
one with immense difficulties, to treat esthetically. During study [Figure 1].
the past 50 years, the prominence on taking care of mostly
Inclusion criteria
degenerating primary dentition changed from removal
to rehabilitation. Early recovery includes employment of • Patient within the age group of four to 8 years
stainless steel binding or crowns on critically damaged • Patient with at least two matched bilateral carious
dentition. While working, they were unesthetic, and its primary molars indicated for full coverage
usage is confined to posterior dentures. The mesial buccal • Healthy children free of any systemic disease or any
area of the first primary molars and second maxillary developmental disturbances of the teeth and jaws
primary molars may be seen when the child smiles. that would have affected dietary patterns, caries,
susceptibility or the selection of restorative materials to
During the past 20 years, there was an increased demand
the best of the current knowledge
by adults in the esthetic restoration of their jeopardized
• Minimal of two surfaces of caries in the targeted tooth
dentures. Equivalently, a higher esthetic standard is
• Patient with ECC as defined by the American Academy
expected by parents for the recovery of their children’s
for Pediatric Dentistry
carious teeth. More recently, zirconia esthetic crowns
• Cooperative patient who had the behavioral rating
appeared on the market. Zirconia is a crystalline dioxide of
“no undercuts or ledges are remaining” or “definitely
zirconium that has mechanical properties similar to those of
positive” according to the Frankl behavior classification
metals, and its color is similar to that of teeth. Ready‑made
scale[17]
first zirconia crowns are now available for both, primary
• Penned authorization was obtained from the parent/
incisors and molars.
guardian after explaining the full details of the treatment
The aim of this clinical research is to evaluate and compare procedure and its possible outcomes, discomfort, risks,
two full coronal restorations on primary posterior molars and benefits
over 3, 6, and 12 months regarding recovery failure, marginal • No patient was excluded by gender, race, social, or
integrity, proximal contact, secondary caries, occlusion, economic background [Figure 1].
and gingival response. The restorations type included are Clinical procedure
prefabricated SSCs and prefabricated primary zirconia crowns.
One operator completed all teeth preparations and
Materials and Methods restorations procedures. Local anesthesia was achieved
using lidocaine hydrochloride 2% with epinephrine
Study design
1:100,000. The teeth were isolated using a rubber dam.
The study is a randomized regulated clinical trial that After caries, excavation tooth was prepared according to
followed the standards published by Consolidated Standards manufactural instructions.
of Reporting Trials.[15]
Teeth restored were assigned to a certain group according
The study is authorized by the Research Ethics Committee to the type of crown applied to each tooth. Sixty teeth
of King Abdulaziz University Faculty of Dentistry with were assigned to Group A and restored with SSCs, another
reference no. 076‑16 before enrolment, a consent form sixty teeth were assigned to Group B which restored with
were distributed to the children’s parents or guardians. zirconia crowns.
This study is also registered at ClinicalTrials.gov under
Group A (stainless steel crown)
registration number NCT03067337.
Reduction of the occlusal surface by about 1.5 mm using
Sample size
a flame shape or tapered diamond bur to produce uniform
Using G*Power 3.1.9.2 software (Franz Faul, Universität occlusal reduction. Employing gilt‑edged, long, and tapered
Kiel, Germany, 2014)[16] for power analysis, it was indicated diamond bur, adhered marginally convergent to the remote
Abdulhadi, et al.: Clinical evaluation between zirconia crowns and stainless steel crowns in primary molars teeth
access of the denture and cut interproximal slices mesially Such procedures can be administered with the use, of
and distally. The reduction should allow the probe to pass course, tapered diamond or carbide burs; a coarse football
through the contact area. diamond bur can be utilized to decrease the occlusal area
of hindmost dentition.
An appropriate size was chosen according to mesiodistal
width of the prepared tooth and trail fit carried out before Subgingival reduction
cementation. The crown should remain no more than 1 mm
The anticipated edge should be anxiously stretched out
subgingivally if there is an excessive shrinking of the gingival
and polished to a feather‑edge so that no undercuts or
tissues the segment of the crown should be decreased.
subgingival ridges stay roughly 1–2 mm subgingivally
The margins should be smoothed after reduction with white on every area. A slim, narrowed diamond bur should be
stone. utilized to prevent the breaking up of tissue during the
Group B (zirconia crowns) execution of such subgingival tooth modifications.
After anesthesia execution and rubber dam placement next Completion of the preparation
was the crown size selection. Suitable crown size can be Eliminate line and point angles to allow all areas of the
identified using NuSmile (Houston, TX, USA) Try‑In prepared denture to be marginally rounded. Now analyze
Crowns and should always be selected on the start of tooth once more for adequate occlusal allowance with the
reduction. divergent teeth as well as to ensure the lack of undercuts or
Occlusal, proximal, and supragingival reduction ledges subgingivally.
Decrease the occlusal surface next to the natural occlusal Crowns seating
profile by roughly 1–1.5 mm. Unfasten the interproximal Prepared teeth should be free from any blood or residues,
contacts. The proximal abatement should be enough to saliva, and gingival blood. Compression or hemostatic
permit the chosen crown to fit passively. The tooth should tools can be utilized for such intent as needed. NuSmile
be trimmed down circumferentially by around 20%–30%, BioCem® Universal BioActive cement, resin cement,
or 0.5–1.25 mm as needed. or resin‑modified glass ionomer can be employed to sit
NuSmile ZR Crowns. If pulpal therapy was enforced
using a eugenol based substance in the pulp compartment,
conceal the eugenol substance using glass ionomer before
cementation.
Evaluation criteria
The evaluation of each crown restoration was assessed at
the baseline which is the same day of the procedure, 3, 6,
and 12 months. Clinical failure parameters were evaluated
with visual assessment of the restoration, according to
the United States Public Health Service (USPHS), alpha
criteria rating system.[18] As if the crown appears normal,
no cracks, chips, or fracture, or small but noticeable area of
loss of material, or large loss of crown material and finally
if there was a complete loss of crown.
The performance of the two restorations was evaluated
using the modified USPHS criteria, in terms of marginal
integrity, gingival health, secondary caries, proximal
contact, and occlusion.
The gingival health and plaque index were assessed using
a blunt periodontal probe (Double ended probe Williams
1‑2‑3‑5‑7‑8‑9‑10 Goldman Fox Flat) according to the
Löe.[19]
Statistical analysis
This study will be analyzed using IBM SPSS
version 23 (Armonk, NY, USA). Simple descriptive
statistics will be applied to characterize the variables of the
Figure 1: A consort diagram showing the flow of patients study through tally and percentages for the definitive and
Abdulhadi, et al.: Clinical evaluation between zirconia crowns and stainless steel crowns in primary molars teeth
nominal variables, whereas mean and standard deviations Both groups were checked regarding the plaque index and
will represent the constant variable. In comparing the scored according to Silness, and Loe criteria at the baseline
distributions of two variables, two‑related‑samples tests all showed 100% no plaque as the treatment started after
with Wilcoxon signed‑rank will be used. These tests are prophylaxis was done to all teeth and also dental health‑care
assumed to be observing normal distribution. In rejecting instructions to the patients and their parents. Although oral
the null hypothesis, the standard P < 0.05 will be applied. hygiene training has been done for all the patients under
their parents’ supervision, 73.3% of teeth covered by zirconia
Results crowns showed a plaque film sticking to the free gingival
Application of full coronal restorations was done on margin which can only be observed with the use of the probe
maxillary and mandibular first and second primary molars in the three months’ follow‑up. Contralaterally, the teeth
summing to 120 molar teeth (60 males and 60 females). covered with SSCs presented at the same follow‑up period
The average age at the baseline was 5.57 with no drop out with 53% having moderate deposit accumulations within the
happened until the 12 months follow up [Table 1]. gingival compartment, on gingival border and neighboring
tooth façade, visible to the eye. After three more months of
Regarding the gingival health, all teeth were examined at the 6 months follow‑up, the majority of the zirconia covered
the baseline, 3, 6, and 12 months and scored according teeth improved reaching 83.3% without plaque accumulation
to the gingival health status. All molar teeth included on crowns surfaces. On the other hand, 66.7% of the teeth
in the study showed no gingival bleeding with a probe covered with SSCs still presented a plaque film sticking
at the baseline examination. On the other hand, during to free gingival margin that cannot be seen with the naked
the 3 months follow‑up, 80% of the teeth restored with eye at the 6 months follow‑up. Finally, at the 12 months
zirconia showed no gingival bleeding compared to the 13% follow‑up of the zirconia group all teeth scored zero with
no bleeding in the group of teeth restored by SSC. During 100% no plaque accumulations, whereas in the SSC group,
the 6 months follow‑up, the percentage of the teeth covered
75% of the teeth have no plaque accumulations [Table 3].
by zirconia crowns reach 100% healed gingivae with all
teeth shows no gingival bleeding upon probing. However, All teeth on both groups were presented at the 12 months
the SSC group still had 26.7% bleeding with probing on follow‑up without caries and showed normal occlusion and
the 6 months’ follow‑up. Finally, all teeth gingival health with normal appearance; no crack, chips, or fractures in the
on both groups were no signs of gingival inflammation crowns [Table 4].
when they reach the 12 months follow‑up [Table 2]. The proximal contact of all teeth was restored after crowns
placement to the same situation before restoration. All the
Table 1: Demographics criteria of resistance were met when passing floss except two
n Minimum Maximum Mean SD teeth that were spaced before doing the restoration as they
Age 120 4.0 8.0 5.57 1.1 showed floss passage without resistance but contact is present.
Demographics Count (%)
Total 120 (100.0) Moreover, all teeth included in the study showed no
Nationality recurrent caries after the whole 12 months follow‑up period.
Saudi 94 (78.3) This is also explained by the success of all restoration over
Non‑Saudi 26 (21.7) the 12 months as the teeth under full coverage crowns.
Gender
Male 60 (50.0)
Discussion
Female 60 (50.0) After the 12 months follow‑up, the success rate of both
SD: Standard deviation crowns tested in this study (Zirconia and SSC for posterior
Abdulhadi, et al.: Clinical evaluation between zirconia crowns and stainless steel crowns in primary molars teeth
teeth) showed 100% success with all crowns appear healthy compared to composite/glass ionomer reinstallations.
with no chips, cracks, or fractures. Regarding the SSCs Insufficiently shaped crown as well as set cement debris
our result comes along with many studies tested the SSCs staying associated with gum sulcus result to gingivitis
and compared it with many different restorative materials. linked to preformed metal crowns, hence precautionary
In 2008, Atieh[20] did a randomized control trial for routine which includes oral hygiene teaching is suggested
2 years concerning the restoration of primary teeth from a to be added to the treatment plan.[10]
pulpotomy procedure with a survival rate for restored teeth
This may justify the improvement of the gingival health
having performed metal crowns to be 95%. On the other
adjacent to SSCs with time as the remnant cement materials
hand, no published data yet available about zirconia crowns washed away and degraded with time and oral fluids.
restorations success for next primary molar teeth except
for the studies done by the product company (Nusmile, Regardless, the oral hygiene instructions have been given
Houston, TX, USA). to the patients and their parents. However, they still keep
coming with plaque accumulations in each follow‑up but
Results showed that gingival health was better in teeth with different percentages between the two tested groups.
restored with Zirconia crowns than those which treated with As mentioned earlier in the results, the Zirconia crowns
SSCs during 3 and 6 months follow‑up, but later 12 months group presented fewer plaque accumulations during the
follow‑up revealed both groups presented with healthy follow‑up periods and also improved with time. On the
gingiva. These results could be explained as Zirconia used other hand, SSCs showed more plaque accumulations,
for tooth component exhibits remarkable biocompatibility and statistically significant difference between the two
as well as shows smooth plus polished exterior which lead groups regarding the plaque index toward the zirconia
to the lower tendency of plaque build‑up and thus lower group (P < 0.001) was observed. Some researches have
chance of gingival irritation. Earlier publications on fixed been conducted regarding the gingival health of primary
partial dentures using zirconia structure on fixed dentition teeth restored with SSCs. Goto, et al., in 1970[25] recorded
observed similar outcomes: decreased plaque build‑up.[21,22] that the frequency of gingivitis in primary dentition
While another study done by Walia, et al., in 2014[23] replaced with nickel‑chromium crowns. It was disclosed
examined Zirconia teeth on primary anterior teeth shows that the rate of gingivitis identified including a crown above
favorable gingival health toward those crowns. the posterior portion of the mouth rather than the anterior is
Regarding gum condition with preformed SSC, a year‑long greatly correlated with badly fitted crowns. The occurrence
arbitrarily regulated test revealed a lack of disparity in of gingivitis in controlled teeth was not disclosed.
gum inflammation comparing preformed metal crowns In 1973,[26] Henderson stated that the plaque index for
plus composite restorations on pulpotomy.[24] An arbitrary SSC teeth is relatively lower than that in the whole oral
clinical research with a duration of 2 years revealed cavity. Degrees of marginal gingivitis neighboring the
an increased gum bleeding on preformed metal crowns crowns measured for the fixture as “good” or “fair” were
Abdulhadi, et al.: Clinical evaluation between zirconia crowns and stainless steel crowns in primary molars teeth
Abdulhadi, et al.: Clinical evaluation between zirconia crowns and stainless steel crowns in primary molars teeth
21. Sailer I, Fehér A, Filser F, Gauckler LJ, Lüthy H, 24. Innes NP, Ricketts DN, Evans DJ. Preformed metal crowns
Hämmerle CH, et al. Five‑year clinical results of zirconia for decayed primary molar teeth. Cochrane Database Syst Rev.
frameworks for posterior fixed partial dentures. Int J Prosthodont 2007(1):CD005512.
2007;20:383‑8. 25. Goto G, Imanishi T, Machida Y. Clinical evaluation of preformed
22. Schmitt J, Holst S, Wichmann M, Reich S, Gollner M, Hamel J, crown for deciduous teeth. Bull Tokyo Dent Coll 1970;11:169‑76.
et al. Zirconia posterior fixed partial dentures: A prospective clinical 26. Henderson HZ. Evaluation of the preformed stainless steel
3‑year follow‑up. Int J Prosthodont 2009;22:597‑603. crown. ASDC J Dent Child 1973;40:353‑8.
23. Walia T, Salami AA, Bashiri R, Hamoodi OM, Rashid F. 27. MacLean JK, Champagne CE, Waggoner WF, Ditmyer MM,
A randomised controlled trial of three aesthetic full‑coronal Casamassimo P. Clinical outcomes for primary anterior teeth
restorations in primary maxillary teeth. Eur J Paediatr Dent treated with preveneered stainless steel crowns. Pediatr Dent
2014;15:113‑8. 2007;29:377‑81.