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Summary
Objectives: To analyse whether extraction of the deciduous canines facilitates eruption of the palatal
displaced canines (PDCs), and to analyse root resorption in adjacent teeth caused by the PDCs.
Materials and methods: Eligibility criteria for participants were as follows: children at age 10-13 years
with either maxillary unilateral or bilateral PDC, persisting deciduous canine and no previous experience
of orthodontic treatment. Sixty-seven patients (40 girls and 27 boys; age: mean standard deviation:
11.41.0) with unilateral (45) or bilateral (22) PDCs were consecutively recruited and randomly allocated
using permuted block randomization method to extraction or non-extraction. No patients dropped out
after the randomization or during the study. Patients underwent a clinical examination and cone beam
computed tomography at baseline (T0), after 6 (T1) and 12months (T2). The total observation time
was 24months. Outcome measures were eruption, positional changes, length of time until eruption,
and root resorption of adjacent teeth. The baseline images were measured blinded while the 6- and
12-month control images were not, since it was not possible to blind the extracted canine.
Results: Significantly more spontaneous eruptions of the PDCs were seen in the extraction group
(EG) than in the control group (CG), with rates of 69 and 39 per cent, respectively, with a mean
eruption time of 15.65.6months in the EG and 18.85.8months in the CG. Significant differences
in changes between the groups, in favour of the EG, were found for all variables except for the
sagittal angle. In the EG, the changes in the distances of the canine cusp-tip were larger during
the first 6months, while the change of apex was larger between 6 and 12months. There were no
significant differences in resorption of adjacent teeth between the groups.
Limitations: Imputation values were used for the PDCs who had erupted atT2, since no x-rays were taken
for ethical reasons, which might have given uncertainty in the positional changes between T1 and T2.
Conclusions: Extraction of the deciduous canine is an effective treatment in patients with PDCs.
Significantly more positional changes and shorter mean eruption time were seen in the EG.
Resorptions of lateral incisors were seen in both groups, but none exceeded grade 2 (resorption
up to half of the dentine thickness to the pulp).
Registration: This trial was registered in FoU i Sverige (http://www.fou.nu/is/sverige), registration
number: 40921.
Protocol: The protocol was not published before trial commencement.
Funding: The Local Research and Development Board for Gothenburg and Sdra Bohusln and
from the Health & Medical Care Committee of the Regional Executive Board, Vstra Gtaland Region.
The Author 2014. Published by Oxford University Press on behalf of the European Orthodontic Society. All rights reserved.
For permissions, please email: journals.permissions@oup.com
Introduction
Trial design
Registration
This trial was registered in FoU i Sverige (http://www.fou.nu/is/sverige),
registration number: 40921.
Ethical issue
The research ethics committee of the Sahlgrenska Academy,
Gothenburg, Sweden, approved the protocol of the study (Dnr 57808). Children and parents received verbal and written information,
and informed consent was provided by the child and their parent or
by an adult with parental responsibilities and rights in accordance
with the Declaration of Helsinki.
Screening ofPDC
The general practitioner identified participants for the trial, who were
consecutively recruited from 15 public dental clinics in Gothenburg,
Vstra Gtaland County Council, Sweden, between September 2008 and
January 2011. During their visit to the public dental clinic, the consulting
orthodontist then invited the potential patients to participate in the study.
This randomized controlled clinical trial with an equal patient allocation to the two groups:
J. Naoumova etal.
Unilateral PDC
Baseline, T0
6 month control, T1
Allocated to extraction of
the deciduous canine
N = 23; 9 boys, 14 girls
Age (mean SD: 11.21.1)
Allocated to extraction of
the right deciduous canine
N = 22; 11 boys, 11 girls
Age (mean SD: 11.6 1.0)
Non-extraction of the
deciduous canine i.e. control
group (CG)
N = 44 PDCs
Non-extraction of the
deciduous canine i.e. control
group (CG)
N = 44 PDCs
12 month control, T2
Analysed
N = 89 PDCs
Impairment or no
change of the canine
position
Surgical exposure
and orthodontic
treatment
N = 41 PDCs
Improved position
of the canine
Clinical
examination. Xray if needed, total
observation period
24 months
N = 30 PDCs
N: number of patients, PDCs: palatally displaced canines; SD: standard deviation; CBCT: cone beam computer tomography
Figure1. Flowchart describing the protocol and the patients included in the study. No patients dropped out after the randomization or during the study.
to the pulp or more, the pulp lining being unbroken; and 4)severe
resorption, the pulp is exposed by the resorption. Resorption
grades 3 and 4 were excluded from the trial, while 1 and 2 were
included.
Allocated to non-extraction
N = 22; 7 boys, 15 girls
Age (mean SD: 11.31.1)
bilateral PDCs
4
A total of 70 patients were invited to take part in the study. Three
patients, all girls with bilateral PDCs, declined to participate at the
first visit when information was given about the study, i.e. before they
were randomized. Two out of the three patients declined due to fear
of extraction and one patient thought it was too far to travel to the
clinic of orthodontics, University Clinics of Odontology, Gothenburg,
Sweden. No patients dropped out after the randomization or during
the study. Thus, in total 67 patients were randomly allocated to the
extraction or the CG. Of these, 45 patients had unilateral PDC and
22 patients had bilateral PDCs (Figure1).
Randomization method
For randomization, the permuted block randomization method was
used and the allocations were concealed in sequentially numbered,
sealed opaque envelopes opened by a dental nurse after the written
consent was obtained.
Blinding
One oral radiologist unaware of the group to which the patients
belonged carried out all the measurements on the CBCT images in
axial, sagittal, and frontal views. The baseline images were, therefore, measured blinded, while the 6 and 12 month control images
were not because it was not possible to blind the extracted canine.
The following outcome measures were assessed:
Primary outcome
Eruption of the permanent canine, i.e. successful outcome
(defined as canine emerged through the gingiva) during the total
observation time, i.e. 24months.
Figure2. Radiographic measurements of the cone beam computed tomography images assessed in coronal, sagittal, and axial plane.
J. Naoumova etal.
Secondary outcome
Positional changes of the permanent canine over time (T1T0
and T2T1) measured from the radiographs: mesioangular angle,
sagittal angle, vertical position, canine cusp tip-dental arch plane,
canine root apex-dental arch plane, canine cusp tip-midline
(Figure 2) and changes between T1T0 and T2T1 within and
between the EG and the CG.
Root resorption of adjacent teeth.
Imputation of measurementvalues
Missing data can introduce bias and affect the results because most
statistical packages automatically discard cases with missing values.
This can be avoided by applying imputation, a statistical process of
replacing missing data with probability values based on other available information. In this case, angular and linear measurements of
fully erupted maxillary canines were imputed.
As described previously, in patients in whom the permanent
canine had started to erupt and was clinically visible, no further radiographic examinations were done. Instead, imputation values were
used (applicable only at T2, 12months), which were calculated by
measuring the mean angular and linear measurements of 10 unilateral patients (8 girls, age: mean standard deviation [SD]: 11.20.9;
2 boys, 11.7 and 10.6years of age at baseline), whose contralateral
non-PDC was fully or partial erupted.
Statistics
The data were statistically analysed using SAS, version 9.3 for
Windows (SAS Institute Inc., Cary, North Carolina, USA). Arithmetic
means and standard deviations were measured for numerical variables. Dependent and independent t-tests were used to compare
the baseline variables and changes in time between and within the
groups, respectively. The independent t-test was used to test whether
there were any significant differences in the linear and angular variables between successful versus non-successful outcome. Fishers
exact test was used to calculate differences in categorical data, such
as the success in the eruption rate between the extraction versus the
non-EG, gender, extraction site, and extraction versus non-extraction. To test whether the bilateral group would be considered independent observations or dependent paired observations, the main
outcome, i.e. eruption or non-eruption, was tested with Fishers
exact test and McNemars test. As no multiple comparisons have
been tested, adjustment or correction with statistical analysis was
not needed.
Harms
No harms were detected during the study.
Results
The extracted deciduous canines showed no root resorption or less
than one-third of the root length resorbed, and none were mobile.
Participant flow
Fifteen out of the 67 patients (3 bilateral PDC and 12 unilateral PDC
[3 from the CG and 9 from the EG]) did not have a radiographic
examination at the 12 month control because the canines had
emerged through the gingiva and were under eruption, i.e. clinically
visible between T1 and T2. Imputation values were used in thesecases
(Figure 1).
Baseline findings
There were no significant differences at T0, either for the mean age
between the unilateral and bilateral groups (Table1) or between the
angular and linear measurements in the EG and the CG (Table2).
Dividing the subject into age groups of 1011- and 1213-year-old
individuals showed that there were a larger number of patients in
the younger group. There were more females than males in total, but
no significant differences were seen in gender distribution between
the unilateral and bilateral groups or the extraction and non-EGs. In
addition, no differences were seen between the left and right extraction sites (Table1).
It was decided to analyse the whole material and not only the
unilateral group as two independent observations because there was
no difference in the correlation between extraction and successful
outcome between independent observations and dependent paired
observations in the bilateral group. Further, there were no significant
differences in the patients characteristics when the bilateral and unilateral PDC patients were put together in the EG and CG.
Table 1.Patient characteristics in the unilateral and bilateral
groups at baseline. PDC, palatal displaced canines; SD, standard
deviation
Patients (n)
Age (mean SD)
Age (y), n (%)
1011
1213
Female, n (%)
Male, n (%)
Extraction, n (%)
Right side, n (%)
Left side, n (%)
Non-extraction, n (%)
Unilateral PDC
Bilateral PDC
Total
45
11.20.9
22
11.61.0
67
11.41.0
30 (67)
15 (33)
29 (64)
16 (36)
23 (51)
7 (30)
16 (70)
22 (50)
13 (59)
9 (41)
11 (50)
11 (50)
22 (49)
13 (59)
9 (41)
22 (50)
43 (64)
24 (36)
40 (60)
27 (40)
45 (51)
20 (45)
25 (55)
44 (49)
Positive values for the variables: canine cusp tip-dental arch plane
and canine root apex-dental arch plane indicate a palatal position of
the cusp-tip or apex and a negative value buccal position in relation
to the dental archplane.
The methodology of the radiographic measurements has been
described in detail in a previously published study, in which the intraand inter-examiner error of the 3D measurement and the validity of the
measured angles were also evaluated (32). All randomized patients were
included in the groups to which they were randomly assigned regardless
of the treatment they actually received and regardless of a deviation
from the protocol as randomized. Thus, in the analysis, the intention-totreat (ITT) approach was applied.
Table 2. Baseline variables (T0) for the unilateral and bilateral groups with mean, standard deviations (SD), and P-values. CG, control
group; EG, extraction group; PDC, palatally displaced canines; SD, standard deviation.
Unilateral PDC (patients, n=45)
EG (n=23
PDC)
CG (n=22
PDC)
EG (n=22
PDC)
CG (n=22
PDC)
Mean SD
Mean SD
Mean SD
Mean SD
Variable at T0
11.20.9
11.41.1
P-value*
11.61.0
11.61.0
P-value*
P-value*
EG-CG
Mesioangular angle ()
Sagittal angle ()
Vertical position (mm)
Canine cusp tip-dental arch plane (mm)
Canine root apex-dental arch plane (mm)
Canine cusp tip-midline (mm)
105.25.4
98.08.1
15.92.2
1.91.2
2.21.6
9.72.2
107.79.6
101.19.5
14.92.4
2.52.0
2.71.7
9.22.7
0.182
0.232
0.178
0.300
0.224
0.322
106.17.1
100.18.6
14.62.7
3.01.0
2.81.7
9.72.6
108.07.1
99.68.7
15.02.3
3.22.2
2.61.8
9.31.8
0.371
0.337
0.597
0.626
0.654
0.597
NS
NS
NS
NS
NS
NS
Primary outcome
Significantly more PDCs erupted on the extraction site compared
with the untreated control site, with a prevalence rate of 69 and 39
per cent, respectively, (P=0.001). The mean eruption time in the EG
was 15.6months (SD 5.6) and in the CG was 18.3months (SD 5.8),
with no significant difference for the mean eruption time between
the younger (age 1011years) and the older patients (1213years)
(P = 0.238). At T2, 14 PDCs in the EG and 27 PDCs in the CG
had impairment or no changes of the canine position. These teeth
were surgically exposed and orthodontically treated. All remaining
PDCs that were followed up after T2 erupted in both groups, with
the latest at the 24month control (Table3). Of 10 PDCs in the CG
that were followed up, five deciduous canines without mobility were
extracted, while the mobile ones were left to spontaneously exfoliate.
Online supplementary figures 1 and 2 exemplify successful and
impaired changes in position of the PDCs with two patients.
Secondary outcome
Positional changes of the canine over time observed by
radiographic means
Between T0 and T1, five of six variables in the EG and three of six in
the CG improved significantly. Between T1 and T2, five variables out
of six in the EG and two in the CG improved significantly. Significant
differences in changes between the groups, in favour of the EG, were
found for three of six variables between T0 and T1 and for all variables except for the sagittal angle between T1 and T2 (Table4).
Table 3. Number of palatally displaced canines (PDCs) in the extraction (EG) and the control group (CG) that had erupted, were
impaired or had not changed at the 6month control (T1), 12month
control (T2), or after T2 (>T2)
Erupted PDCs
Impaired PDCs or
no changes
EG (N=45 PDCs)
CG (N=44 PDCs)
T1
T2
>T2
T1
T2
>T2
11
14
20
7
27
10*
*Note that five deciduous canines in the control group that were not mobile
(n=5) were extracted at T2.
Discussion
The effectiveness of extracting the deciduous canine as an interceptive approach to achieve spontaneous eruption of PDC compared
with non-extraction was investigated in this prospective, randomized, clinical longitudinal trial. The findings in the study show
that extraction of the deciduous canine allows the PDCs to spontaneously correct in the majority of the cases. Significantly more radiographical changes over time were noted in the EG. We can thereby
reject the first 2 null hypotheses. Although more adjacent teeth were
resorbed at T1 and T2 in the CG than the EG, significant differences
were not found, i.e. we accept our final null hypothesis.
As patients with both bilateral and unilateral PDC were
included in the study, the tooth rather than the patient was used
as the unit of analysis. The observations in the bilateral group
could preferably have been assessed as dependent paired observations but, as the same significant results were achieved when the
Significant differences between and within the groups are given in P-values.
*P-value < 0.05 is considered statistically significant.
1.27.3
1.71.6
0.91.7
0.11.3
0.61.9
0.030
0.000
0.000
0.419
0.000
1.95.9
2.71.5
1.91.5
0.21.9
2.31.5
Sagittal angle ()
Vertical position (mm)
Canine cusp tip-dental arch plane (mm)
Canine cusp apex-dental arch plane (mm)
Canine cusp tip-midline
2.6 (5.1,
0.10)
0.7 (2.1, 3.6)
0.9 (0.3, 1.6)
0.3 (1.2, 0.6)
0.2 (0.4, 0.8)
1.7 (0.9, 2.5)
0.604
0.003
0.492
0.463
0.000
0.030
2.55.3
3.21.8
0.52.4
0.61.1
1.61.6
3.36.4
P-value* Mean SD
0.000
0.000
0.195
0.000
0.000
0.000
P-value*
EG (n=45 PDCs)
0.300
0.000
0.002
0.838
0.037
0.369
0.85.8
0.000
3.45.8
Mesioangular angle ()
Mean SD P-value*
P-value*
Mean SD
Differences EG-CG
CG (n=44 PDCs)
Variable
EG (n=45 PDCs)
Differences EG-CG
1.78.6
1.91.9
0.11.9
0.01.4
0.71.3
0.55.9
0.201
0.000
0.609
0.939
0.000
0.563
1.7(1.2, 4.7)
1.2 (0.5, 2.0)
1.1 (1.8, 0.4)
0.8 (0.2, 1.4)
0.62 (1.1, 0.1)
CG (n=44 PDCs)
0.249
0.002
0.001
0.012
0.017
0.034
P-value*
Table4. Positional changes over time of the permanent canine: T1T0 (6monthsbaseline) and T2T1 (12months6months) with mean, standard deviation (SD), mean differences, and 95%
confidence interval (CI), between the extraction (EG) and non-extraction (CG) site
J. Naoumova etal.
7
Table5. Root resorption of adjacent permanent teeth during T0T2 expressed in amount of teeth (N) and % of teeth. CG, control group;
EG, extraction group
EG (N=45 PDCs)
Grade 1
(no resorption)
T0
T1
T2
Grade 2
CG (N=44 PDCs)
Grade 3
38
38
37
84.5
84.5
82.2
7
7
8
15.5
15.5
17.8
0
0
0
Grade 1
(no resorption)
Grade 4
%
N
0
0
0
Grade 3
37
34
31
84.0
77.3
70.5
7
10
13
16.0
22.7
29.5
0
0
0
Grade 4
%
0
0
0
Grade 2
J. Naoumova etal.
Limitations
As no CBCTs were taken, for ethical reasons, of the PDCs that
were erupted at T2, imputation values were used as an alternative
of excluding these cases. Using the imputation values instead of considering these patients as dropouts is, in our opinion, an advantage,
as those teeth that had erupted spontaneously probably are those in
best position and excluding them would have biased the results.
However, as imputation values of normally erupting canines at T2,
from the unilateral patient group were used in 15 patients, this
might have affected the results of the angular and positional changes
between T1 and T2. To find out how the results might change using
imputation values of normally positioned canines, a comparison
was made between the imputed values and values from the bilateral
patient group that had one PDC under eruption while the other was
still palatally displaced i.e. x-rays were taken at T2. Seven spontaneously erupting PDCs were identified and compared. No significant
differences were found either for the angular or for the positional
changes between the erupted PDCs and those with normal position.
However, an imputation can always give uncertainty in the results,
therefore the changes between T1 and T2 should be interpreted with
some caution.
Generalization
The results of the main sample obtained from the present sample can be
generalized only in a Caucasian population aged 10-13 years and in the
case that the exclusion criteria are met. The use of imputation values as
mentioned above, may curtail the generalization of the results regarding
the positional changes of the canine between T1 and T2. In addition, due
to the selective exclusion of PDCs resorbing adjacent teeth with grades
3 and 4 at the start and during the trial, may limit its representativeness, and thus limit the generalization of the frequence of root resorption
caused by PDCs in a general population.
Conclusions
Extraction of the deciduous canine in patients with PDC is an
effective interceptive approach: 69 per cent of the permanent
canines erupted when the deciduous canine was extracted, while
39 per cent erupted in the non-EG. The mean eruption time was
15.6months in the EG and 18.3months in the CG.
Significantly more angular and distance changes occurred in the
EG compared with the CG.
In the EG, the movement of the cusp-tip in relation to the dental
arch and in relation to the midline was larger during the first
6 months after extraction, while the movement of apex was
larger between 6 and 12months.
Canines with an improved position at the 12 month control
should be followed up with a clinical and if necessary a radiographic examination, as spontaneous eruption after 12months
still is possible.
No significant differences in root resorption of adjacent teeth
was found at T2 between the CG and the EG.
Supplementary material
Supplementary material is available at European Journal of
Orthodontics online.
Funding
Local Research and Development Board for Gothenburg and Sdra
Bohusln; Health and Medical Care Committee of the Regional
Executive Board for Vstra Gtaland Region.
Acknowledgements
This work is dedicated to Prof. Jri Kurol who suddenly and sadly passed away
during the work of this study. The authors wish to thank the general practitioners and the consulting orthodontists at the Department of Orthodontics,
University Clinics of Odontology, Gothenburg, Sweden, for identifying and
inviting potential patients to participate in the study.
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