Displaced Tooth Clinical Trial
Official title:
Assessment of Extraction of Primary Canines in Treating Mesioangular Displaced Permanent Canines Using Cone Beam Computed Tomography (CBCT). A Randomized Controlled Trial
This research project is important because there is no gold standard to rely on regarding the
effect of the extraction of primary canines as an interceptive treatment for children with
mesioangular displaced canines.
Further investigations are needed to assess the impact of extractions of primary canines
approach on the eruption rate or change in position of mesioangular displaced canines by
comparing to non-extraction control group in an attempt to overcome the deficiencies in study
designs of previously published studies.
Primary objective:
To assess the effect of interceptive extraction of the primary canine on success of eruption
of the permanent canine or the change in the position of displaced canine radiographically in
children with mesioangular displaced canine when compared to non-extraction control group
Secondary objectives:
1. To evaluate the patient satisfaction and pain experience during treatment
2. To assess the effect of interceptive extraction of the primary canine on the condition
of the roots of neighboring teeth
3. To evaluate the effect of stage of root development on the level of correction of
permanent canine position radiographically over time when comparing unilateral
mesioangular displaced canine subgroup with its contralateral control
4. To identify the effect of independent variables on the outcome of interceptive treatment
Materials and Methods
Study design: Randomized controlled clinical trial following CONSORT guidelines. Patients to
be allocated equally to one of the three groups: Two treatment groups and one control group
as follows:
- Group 1: Extraction of primary maxillary canine only group (EG)
- Group 2: Control group - no extraction (CG)
- Subgroup of unilateral mesioangular displaced canine vs. contralateral canine as the
control group Patients' recruitment will take place in Pediatric Dentistry Speciality
Clinic at King Abdulaziz Faculty of Dentistry.
Randomization:
The investigators plan to use a randomized block design, with blocks of varying lengths. The
block size will be 6 or 9; the lengths will be randomly chosen, with equal probability, and
the length of any given block will be unknown to investigators and clinic personnel. This
block design assures balanced allocation into the three groups.
Sample size calculation Based on previously published data (Naoumova et al., 2015); which
found 30% difference of displaced canine eruption rates between extraction of canine group
(69%) and non-extraction (39%). Based on the alpha significance level of 0.05 and a beta of
0.20 to achieve 80 percent power to detect a 30% differences between groups, two-sided
Pearson's chi-square test with normal approximation indicates that 43 patients with
unilateral mesioangular displacement were needed in each group for this group comparison.
Given the study design with two groups with equal sample size across groups, hence there will
be a total of 43x2=86 patients with unilateral needed in total.
The tooth rather than the patient will be used as the unit of analysis. Inclusion of
bilateral mesioangular displaced canines will reduce the number of patients needed; however,
one patient with bilateral mesioangular displaced canines cannot be simply counted as two
study units in analysis due to high collection within the teeth from the same patient.
Adjusting for clustering within patient of bilateral mesioangular displaced canines using the
correction by Donner et al. assuming intra patient correlation of 0.5, one bilateral
mesioangular displaced canines will be counted as 1.3 study units (2/(1+(2-1)*0.5) (Donner et
al., 1981). Naoumova's study had about one third of the patients recruited having bilateral
palatally displaced canines, so it is estimated that about 30 patients recruited in this
study will have bilateral mesioangular displaced canines, and the contribution of these 30
patients with bilateral mesioangular displaced canines will be equivalent to about 40
patients with unilateral mesioangular displaced canines. These extra (10 study units)
contributions from the patients with bilateral mesioangular displaced canines will compensate
for possible 10% dropouts during the 12 month study period. Hence, a total of 86 patients
(regardless of unilateral or bilateral mesioangular displaced canines will be recruited).
Treatment Process and Intervention:
At baseline (T0), the first CBCT scan will take place and the mesioangular displaced canine
position will be precisely localized in three planes. The extraction of the primary canines
will be carried out on the same day for the extraction groups.
Six months later the (T1) patients of both groups will undergo a simple clinical examination.
At the 12-month follow-up period (T2), a new CBCT scan will be taken if the canine has not
yet emerged through the gingival tissue.
Patients with unerupted canines with no improvement in position will be referred to the
orthodontic department for combined surgical and orthodontic treatment to be carried out.
However, if the position of the canine has improved radiographically, the patient will be
clinically followed up until the canine erupts into the oral cavity with a total observation
period of 18 months. No further radiographs will be taken.
Alginate impressions for study cast construction will be taken at baseline (T0) prior to
extraction, at 6 months (T1), and at 12 months (T2). Space analysis will be performed using
Moyers prediction values .
The root development of each mesioangular displaced canine will be assessed by the method
developed by Nolla (Nolla, 1960).
Moreover, root development stage of unilateral mesioangular displaced canines subgroup will
be measured and compared to normally developing contralateral canine that is considered as
its control.
The condition of the roots of neighbouring teeth will be assessed according to the following
classification by Ericson and Kurol. Grade 1 no resorption and an intact root surface; Grade
2 slight resorption of up to half of the dentine thickness; Grade 3 is moderate resorption
midway to the pulp or more; Grade 4 severe resorption, with the pulp being exposed through
the resorption site (Ericson and Kurol, 2000)
Pain experience in extraction groups will be recorded at baseline (T0) after extraction
procedure and at 1 week follow up using a questionnaire that will be given to patients about
their overall pain experience and discomfort .The questionnaire has been used previously and
had acceptable validity and reliability (Feldmann et al., 2007).
Patient satisfaction will also be evaluated at the end of the study by asking the parents to
fill patient satisfaction questionnaire. Validation of parent satisfaction questionnaire was
done by (Bennett et al., 2001).
Both questionnaires will be translated to Arabic and the validity and reliability will be
tested.
Variables
- Independent demographic variables include family history and gender
- Independent clinical variables include presence or absence of crowding, malocclusion
classification, presence of peg-shaped/missing laterals, disturbance of eruption
sequence , stage of root development and presence of unilateral vs. bilateral
mesioangular displaced canine.
Main outcome variables include measurements on CBCT in different views following previously
published study which compared the following measurements against measurements on dry skull
and concluded that the linear and angular measurements are accurate on CBCT images and are
considered valid diagnostic variables (Naoumova et al., 2014).
Measurements will be done using CS 3D imaging Software Carestream Company. The following
measurements will be recorded for each CBCT scan:
Linear measurements (mm)
1. Axial view: canine cusp tip- dental arch plane and canine root apex- dental arch plane .
Dental arch plane is a line that is drawn in the center of the dental arch bisecting
teeth present in the arch.
2. Coronal view: Canine cusp tip- midline
3. Sagittal view: The vertical height from canine tip to occlusal line . Occlusal line is a
line that will be drawn between the incisal edges of upper and lower incisors.
Angular measurements (°)
1. Frontal (coronal) view: measurement of the mesioangular angle relative to the reference
line (fixed line that will be drawn through the hard palate).
2. Sagittal view: measurement of sagittal angle relative to the reference line Blinding Two
examiners unaware of the group to which the patients belong will carry out all the
measurements on CBCT scan. One examiner will crop the view of the extraction site to
ensure blinding of the other examiner.
Reliability on CBCT scan measurements Two independent examiners will carry out all the linear
and angular measurements on CBCT scans. Both examiners will undergo CBCT software use
training by oral radiologist. Both examiners will undergo a calibration exercise of the
measuring technique before starting the trial to ensure inter-examiner reliability. Kappa
statistics will be used to calculate inter-examiner reproducibility.
Justification of the use of CBCT in this study
Following the principle of "as low as reasonably achievable" (ALARA); CBCT is justified to be
used to detect canine displacement if the field of view (FOV) is small and restricted to the
area of interest. The American Academy of Oral and Maxillofacial Radiology supports the safe
use of CBCT for diagnosis of anomalies in dental position prior and during treatment if the
FOV is small (AAOMR, 2013). When the effective dose (µSv) was measured on a 10-year old
phantom, it was found that 6x16 maxillary imaging resulted in significantly lower doses than
other fields. The effective dose on the maxilla with FOV 6x16 cm ranged from 4.7-38.7 µSv
(Ludlow and Walker, 2013). This wide range of exposure profile depends not only on machine
type but also on different technical parameters.
Therefore, investigators are going to do their best effort to minimize the radiation exposure
of the patient by controlling every measure in imaging protocols to reduce the radiation
dose. This can be achieved by choosing a small field of view 6x16 (cm), by selecting bigger
pixels size to get lower resolution,0.4 voxels will be selected for the resolution. QuickScan
scanning protocol (seconds) with an acquisition time of 4.8 seconds will be selected . Tube
energy (kV) will be 120 KVP and the tube current will be 10 mAs. The total effective dose
will be around 22 µSv which is in the range of taking one lateral cephalometric radiograph
and one panoramic radiograph combined together (Ludlow et al., 2015).
Statistics
- For primary objectives that assess successful eruption rate: Chi-square or Fisher exact
tests will be used to detect differences in rates among groups
- For primary objectives that assess change in position of PDC, one-way ANOVA or t-test
will be used (continuous outcome)
- The analyses of secondary objectives will be conducted in the same way. If categorical
outcome has more than two levels, logistic regression will be used.
- All data analyses will be conducted with the SAS statistical package.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT06054204 -
Retrieval of Displaced Root in the Maxillary Sinus Via Lateral Bony Window Using the Piezoelectric Device
|
N/A |