occlusal template while in the test group crowns were placed using a polyvinyl siloxane occlusal template. Patients were followed up at 24h, 7days, 3months ...
European Archives of Paediatric Dentistry The role of an occlusal template during the placement of stainless steel crowns in children under general anaesthesia - A randomized control trial --Manuscript Draft-Manuscript Number:
EAPD-D-15-00082R2
Full Title:
The role of an occlusal template during the placement of stainless steel crowns in children under general anaesthesia - A randomized control trial
Article Type:
Original Article
Funding Information: Abstract:
Background and Aim: The evaluation of occlusion after the placement of stainless steel crowns (SSCs) under general anaesthesia is made difficult by the inability of the patient to actively bite. The aim of this study was to evaluate SSCs placed under general anaesthesia using an occlusal template in comparison to crowns placed without the use of a template. Methodology: CONSORT protocols were followed in the design of the study. A total of 60 children aged between 4 and 7 requiring pulpotomy and stainless steel crowns for all primary molars met the inclusion criteria for this study. The control group comprised of patients in whom the stainless steel crowns were placed without the use of an occlusal template while in the test group crowns were placed using a polyvinyl siloxane occlusal template. Patients were followed up at 24h, 7days, 3months and 6months. The time taken for the placement of crowns, post-operative discomfort, success or failure of the pulp therapy and loss of the crown were compared between the groups. Results: The mean time taken for completion of the procedure in the control group was significantly greater than the template group (t=2.566. p=0.013). Significantly fewer patients in the template group reported symptoms of discomfort or high points at the 24h recall; however these differences were not significant at the 1week 3month or 6month recall. Conclusion: The use of an occlusal template for the placement of multiple SSCs under general anaesthesia reduces the time taken for their placement and reduces the incidence of immediate post-operative discomfort.
Corresponding Author:
Sharat Chandra Pani, MDS Riyadh Colleges of Dentistry and Pharmacy SAUDI ARABIA
Corresponding Author Secondary Information: Corresponding Author's Institution:
Riyadh Colleges of Dentistry and Pharmacy
Corresponding Author's Secondary Institution: First Author:
Sharat Chandra Pani, MDS
First Author Secondary Information: Order of Authors:
Sharat Chandra Pani, MDS Mohiddin R Dimashkieh Freah AlShammery Faten Mojaleed
Order of Authors Secondary Information: Author Comments:
Dear Prof Toumba, Please find attached our revised submission titled "The role of an occlusal template during the placement of stainless steel crowns in children under general anaesthesia A randomized control trial". We have tried our best to incorporate every change mentioned by the reviewers. We realize that there are a few shortcomings pointed out by the reviewers and have addressed these in our discussion. Powered by Editorial Manager® and ProduXion Manager® from Aries Systems Corporation
We hope the revision will meet the high standards of the European Archives of Paediatric Dentistry. Yours Sincerely, Dr Sharat Pani Response to Reviewers:
Reviewer 1 Comment 1: Relevance of the study: While all pediatric dentists would agree that the crowns return to occlusion after a period of time, there is little evidence in literature about the exact nature of discomfort or the period for which this discomfort lasts. The main aim of the study was to evaluate whether this technique could reduce the immediate post-operative discomfort felt by children. While our results are not conclusive, surely our rationale in carrying our experiment is sound. We have added a section in the introduction and the discussion to address this concern. Make of the SS crowns – 3M preformed crowns were used and this has been added in the methodology Method of preparation of the tooth – Has been added to the methodology Time taken: We must keep in mind that our study was conducted in children requiring stainless steel crowns in all four quadrants. This means closing the mouth (at least) four times. There could be the fact that both operators performing this procedure were trained in it as residents and were more comfortable using this procedure than closing the mouth. we have added our explanation for the length of the procedure in the manuscript. Using a fast setting material results in a quick impression. The impressions are trimmed by the assistant and therefore do not take from the operating time of the operator. As mentioned in the text, the details of the technique are described in another article. We have added a line explaining this point though. Spacing of word – we apologize for this as it was due to the processor used. We have used an older version of word in this correction and hope this fixes the problem n 'Introduction' line 16, I would suggest inserting'extensively decayed ' between 'for' and 'posterior' The word has been added On the last page of 'Discussion', line 12, change to 'association between increased....' The change has been incorporated Reviewer 2 Comments for Page 4, lines 4-6 It seems that the authors would refer to fig. 1 and NOT fig 2 as they write in the text. The change has been made Comments for Page 5, lines 34-35 The authors refer that they evaluated the “reporting of pain, discomfort, difficulty in mastication or high points reported by the patient”. They should be more specific how they manage to gather this type of information from this age group so we can evaluate how accurate they are. The patients were evaluated on follow-up by a blinded examiner (SCP) and complaints of pain, discomfort, difficulty in mastication or high points from the child were recorded. We accept this is not as accurate as a validated Wong Baker face scale, but the aim of the study was to identify reported problems and we believe that the blinding of the study should compensate for the lack of accuracy Comments for Page 6, lines 16-28 and table 2 We apologize for the oversight and this has been corrected Comments for Page 6, lines 31-34 and table 1 In the text authors refer to table 1 suggesting that it contains statistical information on differences of patient’s discomfort between the two groups. Table 1 contains though information only on the difference of the operating time between the 2 groups. Comments for Page 6, lines 47-52 and table 2 In the text it is written that the 4 teeth presented with clinical signs of failure are in the control group. In table 2 these teeth are assigned to the template group. Which one is the correct? The text in the article is correct. We apologize for the mistake in the table as Table 2 was compiled manually.
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Comments for Page 8, lines 23-28 The text is not correct as only the control group is identified.
Overall comment Length of the procedure – we have added our explanation for the length of the procedure in the manuscript. Using a fast setting material results in a quick impression. The impressions are trimmed by the assistant and therefore do not take from the operating time of the operator. As mentioned in the text, the details of the technique are described in another article. We have added a line explaining this point though. Age of the children and validity of the reported findings – We agree that asking a child to report symptoms is not a very accurate method, however we used a blinding of the examiner and the randomization of patients, therefore, we are confident that the symptoms we have are definitely representative of symptoms reported by children after the procedure without undue bias towards either group Significance of the results – We have modified our conclusion and in hindsight agree with the reviewer that perhaps our results are not sufficient to warrant a definitive conclusion. However, we hope that the reviewers will keep in mind that the purpose of this paper is to highlight the issue of checking occlusion, and even if negative “insignificant” or inconclusive our results are certainly a valid and honest reporting of an experiment that was ethically and scientifically carried out.
The reference list has not followed the instructions to authors for the EAPD journal. In the reference list when there are 6 or more authors only the first 3 authors should be cited followed by et al. Please check and amend. We apologize for the oversight the mistake has been corrected
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Blinded Manuscript Click here to view linked References
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1
The role of an occlusal template during the placement of stainless steel crowns in children
2
under general anaesthesia – A randomized control trial
3
Abstract
4
Background and Aim: The evaluation of occlusion after the placement of stainless steel crowns (SSCs)
5
under general anaesthesia is made difficult by the inability of the patient to actively bite. The aim of this
6
study was to evaluate SSCs placed under general anaesthesia using an occlusal template in comparison to
7
crowns placed without the use of a template.
8
Methodology: CONSORT protocols were followed in the design of the study. A total of 60 children aged
9
between 4 and 7 requiring pulpotomy and stainless steel crowns for all primary molars met the inclusion
10
criteria for this study. The control group comprised of patients in whom the stainless steel crowns were
11
placed without the use of an occlusal template while in the test group crowns were placed using a
12
polyvinyl siloxane occlusal template. Patients were followed up at 24h, 7days, 3months and 6months. The
13
time taken for the placement of crowns, post-operative discomfort, success or failure of the pulp therapy
14
and loss of the crown were compared between the groups.
15
Results: The mean time taken for completion of the procedure in the control group was
16
significantly greater than the template group (t=2.566. p=0.013). Significantly fewer patients in
17
the template group reported symptoms of discomfort or high points at the 24h recall; however
18
these differences were not significant at the 1week 3month or 6month recall.
19
Conclusion: The use of an occlusal template for the placement of multiple SSCs under general
20
anaesthesia reduces the time taken for their placement and reduces the incidence of immediate
21
post-operative discomfort.
22
Keywords: Occlusion, Primary Teeth, Stainless Steel Crowns
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1 2
Introduction
3
Stainless steel crowns are arguably the most successful posterior restorations in primary teeth
4
and have been so for more than 50 years(Attari and Roberts, 2006). Stainless steel crowns offer
5
durability and success rates in excess of 95% making them the restoration of choice for
6
extensively
7
anaesthesia(Vinckier et al., 2001; Seale, 2002; Al-Eheideb and Herman, 2003; Eshghi et al.,
8
2012).
9
Failures of stainless steel crowns placed on primary teeth have been documented using several
10
criteria including marginal adaptation, recurrent caries, abscess formation or root resorption, loss
11
of the crown due to faulty retention and even perforation of the crown(Tate et al., 2002; Al-
12
Eheideb and Herman, 2003; Drummond et al., 2004; Eshghi et al., 2012; Schuler et al., 2014) .
13
Despite the probability that factors such as root resorption and failure of endodontic treatment
14
could be due to traumatic occlusion, surprisingly little evidence is available in literature on the
15
attempts made to check or evaluate the occlusion of stainless steel crowns placed under general
16
anaesthesia.
17
It is generally accepted that the occlusion for stainless steel crowns is checked clinically with the
18
dentist adjusting the bite (Nowak et al., 2011). However, this becomes extremely difficult under
19
general anaesthesia where closing the child’s mouth is both difficult and time consuming.
20
Furthermore, there is recent evidence to show that a significant number of stainless steel crowns
21
placed under local anaesthesia with adjustment of the bite by the dentist result in a temporary
22
increase in biting force(Gallagher et al., 2014). Although there have been reports that increased
decayed
posterior
primary
teeth
in
children
treated
under
general
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1
biting force, and even minor open bite reverts back to normal within 30 days; these studies have
2
been done on patients under local anesthesia. tThere is agreement that occlusion following the
3
placement of stainless steel crowns is a subject that has received little attention further
4
investigation into the matter is needed(van der Zee and van Amerongen, 2010).
5 6
Prosthodontists have traditionally used a template of the crown prepared using a putty
7
consistency rubber based addition silicone to serve as a template for the bite and guide the
8
operator during reduction of the tooth(Shillingburg et al., 2012). Recently a technique has been
9
developed that uses a faster setting bite registration paste to make a template of the tooth before
10
the placement of stainless steel crowns under general anaesthesia(Dimashkieh and Pani, 2015).
11
However, the accuracy, time taken with and overall impact on the clinical performance of
12
crowns placed under general anaesthesia needs to be verified.
13
The aim of this study was to compare the time taken for placement and the overall success of
14
bilateral multiple stainless crowns placed under general anaesthesia using an occlusal template
15
and compare them to crowns placed without such a template, using a randomized control study
16
design. The study also aimed to quantify the post-operative discomfort, if any, felt during the
17
placement of crowns using either of the above mentioned techniques.
18
Methodology
19
Ethical clearance for the study was obtained from the institutional review board and registered
20
with the research center of the university (FRP/2013/46) as well as the National Clinical Trials
21
registry (NCT02437565) of the United States National Institutes of Health.
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1
Patient Recruitment and Study Design
2
The CONSORT guidelines for recruitment and conducting a Randomized clinical trial were
3
followed in the design of the study. A total of 243 patients reporting for dental treatment under
4
general anaesthesia at the Riyadh Colleges of Dentistry and Pharmacy between April 2013 and
5
June 2014 were screened for possible inclusion in the study. Inclusion criteria for the study
6
required that the patient need bilateral formocresol pulpotomy and placement of stainless steel
7
crowns in the first and second primary molar in both the upper and lower arches. To ensure that
8
the presence of permanent teeth or the incomplete eruption of primary teeth did not confound the
9
results, only children who had a completely erupted set of primary dentition without the eruption
10
of the first permanent molar were included in the study. All patients included in the study
11
required the extraction of anterior teeth. Patients with underlying developmental conditions and
12
those who had craniofacial anomalies were excluded from the study. Patients were randomly
13
assigned to the control or impression group using their file numbers by one of the investigators
14
who did not play a role in performing the clinical procedure (MD).
15
The occlusal surface of all teeth was reduced by approximately 1.5mm using a football diamond
16
(FO-25 Dia-Bur ™, Mani Corp. Tochigi, Japan) and proximal preparation was done using a
17
needle diamond (TC-11F Dia-Bur ™, Mani Corp. Tochigi, Japan) to ensure a knife edge finish
18
line. All line angles were rounded off and the buccal and lingual surfaces of the tooth were left
19
untouched. Prepared teeth in both groups were restored using pre-trimmed, pre-contoured
20
stainless steel crowns (3M-ESPE, 3M Corp. St. Paul MN, USA).
21
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1
Impression group – Comprised of patients in whom using a specially designed tray a fast setting
2
vinyl polysiloxane bite registration material (Regisil® PB™, Dentsply, Surrey UK) was used to
3
make impressions of the quadrant, following which material was cut away
4
flange so as to provide the operator with a template that enabled visualization of the occlusal
5
surface of the crown facilitating assessment of the occlusal fit of the crown (Fig 12). The
6
trimming of the impressions was done by a dental assistant leaving the dentist free to proceed
7
with the preparation of the tooth. Details of the technique have been published elsewhere and are
8
beyond the scope of this paper(Dimashkieh and Pani, 2015).
9
Control group – Comprised of patient where occlusion was evaluated by closing the jaws of the
from the buccal
10
patient and checking the occlusion clinically.
11
A total of 60 patients (32 male and 28 female) aged between 4 and 7 years (Mean age 4.8 years,
12
SD +/- 1.09 years) who met the inclusion criteria were recruited after obtaining informed
13
consent from the parent. No financial incentives were offered for participation in the study. A
14
total of 51 (29 male and 22 female) patients completed the six month follow up requirement (Fig
15
21). The trial was concluded after the target sample (n=60) had been met and no further patients
16
were added to the study to compensate for attrition.
17
Sample Power Calculation
18
A sample power statistic was computed using the G-power sample size calculator (Universtat
19
Kiel, Kiel, Germany). Given the strict inclusion criteria of the study, a large effect size (d=0.8)
20
was assumed. The sample required to achieve a power of 0.95 with alpha of 0.05 was 37. The
21
final achieved power of the sample (n=51) with effect size 0.8 was 0.858.
22
Evaluation of the Crowns and the Procedure
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1
All patients were evaluated at 24 hours, one week, three months and six months post-operatively.
2
Clinical criteria evaluated included the reporting of pain, discomfort, difficulty in mastication or
3
high points reported by the patient. The presence or absence of these symptoms was recorded by
4
a blinded examiner (SCP) so as to prevent bias in the recording of symptoms. Tenderness on
5
percussion, presence of premature mobility and clinical evidence of an abscess or fistula were
6
checked by one of the investigators (SCP). Periapical digital radiographs were taken using a
7
digital sensor (Schick Elite, Sirona Dental Inc. Long Island NY. USA) and were evaluated by the
8
same examiner for radiographic evidence of failure. In order to ensure blinding the investigator
9
(SCP) recording the findings was not made aware of which group the patient belonged to. The
10
time taken for each procedure was calculated from the time of placement of the throat pack to the
11
time of removal of the throat pack and was obtained from the intra-operative anesthesiologist
12
notes. If failure of the crown occurred at 3 months, these teeth were excluded from the 6 month
13
evaluation.
14
Statistical Analyses
15
The parametric values of the control and case groups were compared using the student’s t test.
16
The non-parametric values of the control and case groups were compared using the Mann
17
Whitney U test. All tests were conducted at p value of 0.05
18
Results
19
Of the 51 patients who completed the six month follow up requirement 26 were from the control
20
group, while 25 were from the occlusal template group. A total of 408 (208 Control, 200
21
Occlusal Template Group) teeth were examined and included in the final analysis. The mean
22
time taken for completion of the procedure in the control group was 104.1 (+/- 13.7) minutes
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1
compared to 93.8 (+/- 15.1) minutes for the occlusal template group. The t test showed the
2
difference to be statistically significant (Table 1).
3
The number of patients reporting with discomfort or high points on biting 24 hours post
4
operatively (Table 12) was significantly lower in the occlusal template group (U=199.5,
5
p=0.006). No significant difference in reported discomfort between the control group and the
6
occlusal template group was observed at 1 week (U=265.5, p=0.064), 3 months (U=313.5,
7
p=.627) and 6 months (U=313.5, p=.627) post operatively.
8
None of the teeth showed any clinical signs of failure at the 24h and 7 week visits and tenderness
9
on percussion was not deemed necessary. At the 3 month recall four teeth in the control group
10
showed clinical signs of failure such as tenderness on percussion and abscess, while no teeth in
11
the occlusal template group showed any clinical signs of failure. At the end of 6 months, two
12
more teeth in the control group showed clinical signs of failure, while two teeth in the occlusal
13
template group showed radiographic signs of failure. Although the number of teeth showing
14
clinical failure was lower in the occlusal template group, there were not enough teeth to allow for
15
relevant statistical examination (Table 2).
16
Loss of the crown due to faulty retention was recorded at 3 months and 6 months. At 3 months
17
there were two crowns in the control group and one crown in the occlusal template group that
18
were lost due to faulty retention. No crowns were lost between the three and 6 month recall visit
19
in either group. Here again the number of crowns lost was insufficient to allow statistical
20
comparison between the groups.
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1
The total number of crowns lost due to either abscess of the teeth or loss of retention of the
2
crown in the control group was eight with a success rate of 96.2%. This was lower than the
3
control group, where only three crowns were lost with a success rate of 98.3%.
4 5 6
Discussion
7
Stainless steel crowns are universally accepted as the restoration of choice for extensive carious
8
lesions under general anaesthesia (Tate et al., 2002; Al-Eheideb and Herman, 2003; Kolisa et al.,
9
2013), yet there is little evidence in literature of the best method to ensure adequate occlusion
10
following the placement multiple stainless steel crowns in a single visit. The study aimed to
11
compare intra-operative and post-operative parameters of stainless steel crowns placed using a
12
novel occlusal template(Dimashkieh and Pani, 2015) with those of crowns placed without a pre-
13
operative occlusal template.
14
In the occlusal template group it was observed that despite the additional step of preparing the
15
template, the time taken to complete the rehabilitation under general anaesthesia was
16
significantly lower than the control group. This could be explained by the fact that the presence
17
of an occlusal template eliminated the need for repeated closure of the mouth, which is the
18
traditionally described method for checking the occlusion of stainless steel crowns under general
19
anaesthesia(Seale, 2002; Al-Eheideb and Herman, 2003). The reduced time taken could also be
20
result of the use of a fast setting bite polyvinyl siloxane bite registration material instead of the
21
slower putty impression material that is usually used in the preparation of occlusal
22
template(Luthardt et al., 2008). The fast setting time and acceptable dimensional stability of
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1
polyvinyl siloxane(Chai et al., 1994; Tejo et al., 2012) were the reason for choosing the material
2
over more accurate but slower setting materials for the preparation of the template. The
3
decreased operating time is of importance to the dentist as increased operating times for dental
4
procedures
5
drowsiness(Needleman et al., 2008). The decreased operating times observed in this technique
6
must be viewed in light of the fact that both operators (FS, FM) were trained extensively in the
7
technique before the commencement of the study and may have been more comfortable with the
8
technique than closing the patients’ mouth to check occlusion. While the reduced operating time
9
with this technique may not be generalizable, it can be concluded that the use of this technique
under
general
anaesthesia
can
result
in
increased
post-operative
10
does not prolong operating time.
11
Occlusion in children is a constantly changing dynamic(Thilander, 2009) with previous research
12
suggesting that increases in biting force, occlusal “high-points” or even increases in vertical
13
dimension correct themselves over a period of three to six months(van der Zee and van
14
Amerongen, 2010; Gallagher et al., 2014). Our findings support this argument as there was no
15
significant difference in reported discomfort between groups at either three or six months.
16
However, the occlusal template group did have significantly fewer children who complained of
17
discomfort on biting at 24 hours suggesting that the recording of occlusion prior to the placement
18
of crowns may reduce immediate post-operative discomfort.
19
The overall success rates for stainless steel crowns observed in both groups in this study are in
20
keeping with the success rates reported by previous studies(Seale, 2002; Al-Eheideb and
21
Herman, 2003; Eshghi et al., 2012). The fact that the occlusal template group had a lower
22
incidence of failure of pulp therapy raises the possibility of association between increased load
23
on the tooth and the failure of pulp therapy. However, the relatively low incidence of failure of
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 65
1
pulp therapy in both groups makes it impossible to draw a definite conclusion regarding the
2
issue.
3 4
One of the limitations of any study that looks at occlusion after the placement of stainless steel
5
crowns is that while occlusion and even biting force can be objectively measured, the impact of
6
placing a crown out of occlusion on the vertical dimension of the child is more difficult to
7
estimate(Loudon and Nguyen, 2014). This study is limited by the fact that it relied on the
8
reported symptoms of young children. While these results are not as accurate as the objective
9
measurement of occlusion using biting devices(Gallagher et al., 2014), it is reasonable to assume
10
that the blinding of the examiner and randomized distribution of the population give us a fair
11
representation of the children’s symptoms.
12
The results of this study must also be viewed keeping in mind the fact that this study only
13
focused on the effects of supra-occlusion as we were unable to quantify the effects of infra-
14
occlusion. Given that both supra-occlusion and infra-occlusion have been stated to be
15
detrimental to the overall facial development of the child (Thilander, 2009; Dias et al., 2012;
16
Loudon and Nguyen, 2014), the use of the occlusal template seems to offer the pediatric dentist a
17
useful method of quantifying the amount of tooth reduction under general anaesthesia.
18
Conclusion
19
The results of this study show that the use of an occlusal template does not prolong the duration
20
of the procedure while placing multiple stainless steel crowns. There is some evidence to suggest
21
that the technique may reduce post-operative discomfort reported by the children in the first 24
22
hours. Within the limitations of this study we can conclude that the use of an occlusal template
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 65
1
can result in a significant reduction in the intra-operative time during the placement of multiple
2
stainless steel crowns. The use of the template also seems to reduce the postoperative discomfort
3
of the child in the first 24 hours. The data from this study does not allow for definitive
4
conclusions on the long term benefits of using an occlusal template.
5
Why this paper is important to paediatric dentists
6
Addresses the issue of occlusion after the placement of a SSCs under general anaesthesia
7
Examines the role of an occlusal template in improving occlusion of the patients with
8
SSC crowns under general anaesthesia
9 10
Conflict of interest – None
11
Clinical Trials Registration – The trial was registered with the national clinical trials registry
12
and assigned the number NCT02437565. The full details of the protocol can be assessed at
13
https://www.clinicaltrials.gov/ct2/show/NCT02437565?term=NCT02437565&rank=1
14 15 16 17
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1 2
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Attari N, Roberts JF (2006). Restoration of primary teeth with crowns: a systematic review of the literature. Eur Arch Paediatr Dent 7(2):58-62; discussion 63.
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Chai J, Tan E, Pang IC (1994). A study of the surface hardness and dimensional stability of several intermaxillary registration materials. Int J Prosthodont 7(6):538-542.
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Dias C, Closs LQ, Fontanella V, de Araujo FB (2012). Vertical alveolar growth in subjects with infraoccluded mandibular deciduous molars. Am J Orthod Dentofacial Orthop 141(1):81-86.
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Dimashkieh M, Pani SC (2015). A novel technique to check the occlusion during the placement of stainless steel crowns under general anesthesia. Saudi Journal of Oral Sciences 2(1):49.
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Drummond BK, Davidson LE, Williams SM, Moffat SM, Ayers KM (2004). Outcomes two, three and four years after comprehensive care under general anaesthesia. N Z Dent J 100(2):32-37.
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Eshghi A, Samani MJ, Najafi NF, Hajiahmadi M (2012). Evaluation of efficacy of restorative dental treatment provided under general anesthesia at hospitalized pediatric dental patients of Isfahan. Dent Res J (Isfahan) 9(4):478-482.
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26 27 28 29 30 31
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1
CONSORT 2010 Flow Diagram
2 3 4
Enrollment
Assessed for eligibility (n=243 )
5 Excluded (n= 183 ) Not meeting inclusion criteria (n=178) Declined to participate (n=5 )
6 7 Randomized (n= 60 )
8 9
Allocation
Allocated to intervention (n=30 )
Allocated to intervention (n=30 ) Received allocated intervention (n= 30 )
10 Received allocated intervention (n=30 )
Did not receive allocated intervention (n= 0 )
Did not receive allocated intervention ((n= 0 )
11 12
Follow-Up
Lost to follow-up
Lost to follow-up (give reasons) (n= 5 )
13 Patient did not report for follow up (n= 4)
Patient did not report for follow up (n= 4 ) Patient left the county (n=1)
14 15
Analysis
Analysed (n= 26 ) Excluded from analysis (give reasons) (n= 0)
Analysed (n= 25 ) Excluded from analysis (give reasons) (n= 0)
16 17 18 19
Fig 1: Patient selection, allocation, follow-up and analysis
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1 2 3
Fig 2: Occlusal template fabricated before the preparation of the tooth
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1
2 3 4
Fig 3: Template used to check occlusal discrepancies prior to cementation of the crown – over-reduction of tooth number 55 is visible
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1 2
Table 1: Time taken from placement of throat pack to removal of the throat pack
3 Mean Method Control (n =26) Occlusal Template (n=25)
Sig*
Time (min) Std. Deviation 104.13
13.07
93.82
15.12
4
* Calculated using the student’s t test
5 6
** Difference significant at p
