While amalgam fillings might be a convenient,
routine and accessible option to treat carious teeth, they may behave less
optimally than needed in terms of long-term preservation of the integrity of
tooth structure and their negative appearance 3.
Adding to
these; the controversy regarding health effects of mercury as a constituent
might be the offenders beyond the declined use of this type of filling
materials over the last years 4. On the other side, stainless steel crowns
(SSCs) have been indicated as
a treatment option especially when teeth crowns are heavily destructed and the prognosis is
compromised.
Based on the
recent American Academy of Pediatric Dentistry (AAPD) recommendations; the use
of SSCs is supported on high-risk children with large or multi-surface
cavitated or non-cavitated lesions on primary molars, especially when children
require advanced behavioral guidance techniques 5.
However, multiple researchers have investigated
this issue and found greater superiority of the SSCs as a treatment modality over using different
restorative materials such as amalgam, finding that SSCs had better long-term
success 6,7. The ability of these materials to protect teeth might be related
to their embracing effect and
physical isolation from the oral environment 8. However,
despite the wide acceptance
toward using the SSCs; some studies have shown these crowns from a
negative perspective and reported that they had fewer promising advantages over
using the amalgam fillings 9,10
The satisfaction of patients and their parents
is a fundamental issue in deciding whether to choose the option of using SSCs
or not 11. Inquiries regarding the appearance and functionality of these crowns
may be of great concern 12–14. A
study performed at Jordanian sample showed low parental acceptance of using
SSCs as a treatment option for their children’s primary carious teeth and that
they favoured to choose extraction of the affected tooth 15. However, such
dissatisfaction with the SSCs was justified by the very low knowledge of the
parents in this treatment option so that the authors highlighted the impact of
parental education to overcome such negative response.
The objective of this prospective clinical study
was to evaluate children’s and parents’ acceptance toward SCCs compared with amalgam fillings as a
treatment option for primary teeth restoration with regards to their
appearance, teasing, function and cost.
METHODS
Ethical approval:
Ethical approval was gained from the Human
Research Ethics Committee at the Royal Medical Services under number 53-2-2020.
All patient’s parents were informed about the aims and methods of the study and
they provided written consents to participate.
Study Design, Setting, and
Subjects:
This was a prospective clinical study
targeted subjects from attendees at the paediatric dentistry
department of the Queen Rania Hospital for Children between January 2018 and January
2020. The inclusion criteria for candidates were based on the following:
healthy children with ages ranging from 3–10 years; good compliance with
treatment as classified by Frankl’s scale 16. Intraoral carious
primary molars (either first or second molars) on both left and right sides but
within the same arch (mandibular or maxillary arches) for which the amount of
caries necessitate the use of either heavy amalgam fillings or SSCs. The exclusion criteria involved;
uncooperative children or those who disclose difficulty
in complying with
the planned follow-up visit and also patients with missing contralateral tooth
or teeth.
The sample size was determined using a pilot
study. The effect size was estimated at 0.95. On the basis of a significance
level of alpha 0.05, the sample size was calculated to achieve 80% power and
showed that 170 subjects for each group were minimally needed. Amongst
the daily patients visiting the department
over the two years, 285 subjects were evaluated based on the inclusion criteria
adopted among which 205 patients were found suitable for the research
protocol after clinical examination by one paediatric dentist (the first
author). The other subjects were
not suitable for recruitment in the study due to reasons related to their cooperation,
the intraoral findings which are necessary for the study protocol and their
acceptance to participate in the research. A detailed explanation
concerning the study protocol was presented to the patients and their parents.
After getting their approval to participate in the research, parents were asked
to sign informed consents. The subjects were grouped into two groups according
to their ages: group 1 (3–6 years) and group 2 (7–10 years).
Study protocol:
Randomisation
was performed using a coin to choose the site of performing either procedures
(amalgam fillings or SSCs) whether the left or right sides of either jaws by one of the head administration
staff to eliminate bias that could result from involving any of the authors of
the research in this procedure. Based on a
split-mouth technique, each child received both procedures on either side for
either their first or second primary molars. It should be noted that the
procedures were performed for a similar number of teeth on each side to
standardise the results at the end. However, cases having one or two affected
teeth on each side were the only cases selected for this research, while other
more severe cases were not included.
The
procedures were performed by 2 pediatric dentists (authors; A. A. and A. O.)
for both techniques and commenced with seating the patient in the dental chair
in a supine position, performing calming procedures, applying topical
anaesthesia and then infiltration and removing caries using either high speed
and/or low speed hand-pieces. After that,
amalgam (SDI, USA) fillings were added, contoured and configured with smooth
outlines for the amalgam treatment. In the SSC treatment, temporary filling
(Dentsuply, USA) was added underneath the SSC (3M, USA) which was cemented
using glass ionomer cement (MASTER- DENT, USA).Each patient along with his parents were reassured
and given detailed instructions to follow at home to maintain both procedures
as long and safely as possible. Such instructions included; oral hygiene measures,
dietary advices, instructions related to the SSCs in cases if re-cementation
needed and for amalgam filling in cases if lost or broken. They were also
provided with the department contact number for situations
concerning inquires or emergencies encountered by the patients and their
parents regarding the procedures performed. They were asked to return after one
month to check for procedure integrity and note any complaints from either
children or their parents.
Data collection:
At six
months after the treatment visit, they were asked to visit the department and
give their evaluation of the procedures performed. Each child and parent was
separately asked to give their overall
satisfaction with the SSCs they had compared with the amalgam fillings by
either ‘yes’ or ‘no’ with respect to multiple factors: appearance, teasing,
function and cost. It should be informed
that the treatments performed for all children were provided free of cost as
they were covered by the military medical insurance. However, parents were
given informations regarding the costs of performing of each procedure (based
on the official pricing leaflet of the Jordanian Dental Association) and kindly
requested to suppose that they will pay for the procedures their children will
receive and to give their evaluation based on this.
The data
were collected by face to face interview and subjects were kindly asked to fill
in a simple questionnaire designed for this purpose (Table 1). If the answer was no, parents were
asked to precisely choose the reason beyond this dissatisfaction from the four
factors above. Regarding the children age group (3-6) the responses toward the SSCs were
collected from their parents
who were kindly requested to give these responses based on how their children have
behaved toward the crown separately from their own responses.
The resulting data
were transferred for the purpose of the analyses needed to investigate the
satisfaction with the SSCs compared with the amalgam fillings by both the
children and their parents.
The comparison was also researched in terms of age group and whether
satisfaction differed between both or not. The correlation between the
satisfaction of both children and parents besides the reasons beyond parents’
dissatisfaction were also analysed.
Statistical analysis:
The significant differences between the children’s and
parents’ satisfaction regarding the use of SSCs over amalgam fillings were
analysed by the chi-square test with Fisher’s exact analysis. All statistical
tests were performed at the P≤0.05 level of significance using the statistical
software SPSS, version 21 (IBM Corp., Armonk, NY, USA).
RESULTS
The response
rate was 72% (n = 205/285). 20
subjects were excluded from the study due to lack of completion of the needed
data and poor compliance with the scheduled visits (lost to follow up). The
remaining 185 subjects were 102 boys (55%) and 83 girls (45%) with age ranging
from 3.4-9.7 years with a mean of 5.43 ± 2.26 years.
The distribution
of frequencies and ratios of the children’s and parents’ satisfaction with SSCs
compared with amalgam fillings, as perceived relative to age group, is shown in
Table 2. 69.2% were significantly more satisfied with them over the amalgam
fillings performed (30.8%). With regards to the age groups, although the
satisfaction with the SSCs was higher in group 2, this was not statistically
significant compared with the other age group (P=0.359).A similar
result was obtained for the parents’ group (P=0.175). A statistically significant satisfaction with
the SSCs was seen over the amalgam fillings with a greater percentage in both
groups children and parents (P=0.011 , P=0.016 ), respectively.
Figure 1 shows
the distribution of the four reasons beyond dissatisfaction with the SSCs
compared with amalgam fillings as perceived by parents using a column chart
type. Parents were asked to justify their dissatisfaction with using SSCs for
their children and why they preferred using amalgam fillings instead. They were
more prevalently concerned about the appearance of these crowns (48.6%) than
the functional aspects with 28.6%, followed by teasing and finally the cost
factor which was given the least concern.
Figure
1: Distribution of the reasons beyond
dissatisfaction with the SSCs compared with amalgam fillings as perceived by
parents
Table I Questionnaire forms for children and parents
acceptance used in the study.
Table II Distribution of frequencies and ratios of
children’s and parents’ satisfaction with SSCs compared with amalgam fillings
as perceived relative to the children’s age group.
DISCUSSION
The acceptance of any dental procedure
performed for children is an essential prerequisite for the success of the
procedure and for later satisfaction. While this issue solely affects the
children who receive the treatment, their parents’ acceptance are also important as they have direct
contact on a daily basis with them. Certainly, the appearance aspect is usually
given priority when choosing between treatment options not only for adults but also for children. However,
children may be more sensitive to others’ opinions, especially in general
gatherings such as school time where teasing may occur. Moreover, the impact of
the different available treatment options on functional demands such as eating
and speech is also important. Furthermore, treatment cost is of great concern,
particularly for families of low income.
The
result of our study showed that SSCs, as a treatment option for primary molars,
were more positively perceived compared with using amalgam fillings. Both
children and their parents agreed with this result. Additionally, there was no
significant difference between the two age groups with regards to acceptance
for both children and parents. This
might be due to the simple and relative fearless procedures that could be used for
crowns placement such as; minimal use of local anaesthesia and absence of drilling
or any other preparations procedures as it is the case in Hall crown 17,18. So
that regardless of the child’s age, compliance differences between the 2 age
groups were not affected. This in line with Page et al. 19
who reported that almost 90% of children who received Hall SSCs were satisfied with the crowns and that
most individuals were worried about the pain and surgery so that they were
happy with being referred to clinics to have the Hall SSCs on their primary
molars. Furthermore, they
did not find any significant differences between children’s age and their
acceptance of the Hall SCCs. Also, Akhlaghi et al. showed that the majority of
parents reported that their children accepted the SSCs while others were not 20.
In contrary to all of this, a highly
appreciated national work by Al-Batayneh et al. reported low acceptance of the parents toward these
crowns but such negative response was justified by the very low parental knowledge
regarding the use of the SSCs 15.
The
minority of parents who were not satisfied with the SSCs justified their
dissatisfaction due to – in order – appearance, function, teasing and lastly,
cost. This was concluded from the six months experience with their children
having the two treatment options. This may be in line with the findings of Fishman
et al. as they reported that SSCs were
negatively perceived but this was due to the aesthetic fillings used in
comparison and not amalgam fillings as we have adopted 20. However, the
results of research by Sari et al. and
Bell et al. confirmed that most children were not
worried about the appearance of the SSCs when compared with posterior
restorative materials 1, 21It should be stated that the use of amalgam
as a filling material has been given much concerns at the global level with
regards to its safety. The United States Food and Drug Administration (FDA) has
provided valuable recommendations concerning the use of this material and
defined certain groups of people who might be at greater risk to the potential
adverse health effects of mercury exposure which included children younger than
6 years old. Also, the European
Commission Regulation on Mercury reported that Dental amalgam shall not be used
for dental treatment of deciduous teeth, of children under 15 years except when
deemed strictly necessary by the dental practitioner based on the specific
medical needs of the patient. For this, they advised to use other treatment
option among which the SSCs were included 22,23.
.Although
we did not find any significant differences between the children’s and parents’
acceptance with reference to the age groups, we believe that the age variable
has to be standardised when comparing different studies performed with regards
to our subject of research. Older children may look at the coloured materials
applied into their oral cavity in a more negative way compared with younger
ones. Their greater physical maturity and neural development may play a role in
their decisions. This conforms with findings by Fishman et al. 20. The age of
the children’s group selected was 7.7years, which was older than ours
(5.4years). Such older children might have different perception values compared
with younger ones.
In a
study performed at Sheffield Dental Hospital in the UK, most children found the
clinical procedure of SSCs acceptable, with 54.8% reporting it was ‘really
easy’, with no significant differences according to placement technique or the
experience level of the operator. However, only 4.8% of parents expressed
strong objections to the appearance. Both parents and children revealed that
the SSCs were a favoured option of treatment for the primary teeth 20, contrary
to the studies by Fishman et al. 20 and Zimmerman et al. 24.
It
should be noted that we have not considered the gender variable in our
research. Although this is important, we have found that most of the literature
agreed with the fact that gender in this age group (between 3–10 years) has no
significant role in affecting the acceptance
of one treatment option over the other. Evidence supporting this could be
obtained from many studies, 2,19,24,25. Another limitation in this study is
that we didn’t consider differences in class 1 and class 2 cavities and if the
tooth was first primary molar or second primary molar and whether in maxillary
or mandibular arches all these factors may affect acceptability of amalgam as
compared with SSCs.
CONCLUSION
Both children (in all age groups) and
parents showed high acceptance with significant satisfaction toward using the
SSCs over amalgam fillings.
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