Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06149234 |
| Other study ID # |
TBZMED |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 29, 2021 |
| Est. completion date |
March 20, 2022 |
Study information
| Verified date |
November 2023 |
| Source |
Tabriz University of Medical Sciences |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Introduction: Panoramic radiography quality can be impaired by some errors such as
positioning errors. Palatoglossal air space shadow error is one of the most common
positioning errors and it's due to the tongue not sticking to the roof of the palate.
Techniques used to deal with this error might help prevent unnecessary radiation to patients
and save them time and money. The study aimed to investigate to investigate the effects of
using celluloid matrix and edible tapes (fruit leather and chewing gum) on reducing the
palatoglossal air space shadow error in panoramic imaging Methods: In our study, 270 patients
referred to the Department of Radiology were randomised into three groups: a control group, a
celluloid matrix group, and an edible tapes group. Before panoramic imaging, all patients
were instructed to adhere their tongues to the roof of their mouths, with the distinction
that for the celluloid matrix and edible tapes groups, patients were asked to place celluloid
tapes, fruit leathers, or chewing gums on their tongues before doing so. The routine imaging
process was then performed, and the results were compared across groups to evaluate the
incidence of palatoglossal air space shadow error.
Results: *** Conclusion: ***
Description:
Introduction Panoramic radiography is an extra-oral imaging technique and is considered an
effective, fast, and relatively inexpensive diagnostic tool to examine dentofacial
structures.Various errors such as open lips, shifted or tilted head position, inappropriate
exposure parameters, movement of the patients, etc., have been reported for panoramic
imaging, which reduce the quality of the images. The low quality of the radiographic images
can result in misinterpretation by dentists, eventually leading to incorrect treatment plans.
In addition, panoramic imaging errors ultimately can cause the repetition of radiography. In
addition to wasting time and money, radiography repeating causes excess radiation exposure
and increases the risk of potential damage in patients and medical radiation operators,
including meningioma, brain tumors, and cancers, especially thyroid and Leukemia. Considering
that the number of exposures to diagnostic radiation is relatively high during the lifetime,
even a small increase related to the risk of cancer is of significant public importance.
Thus, numerous studies have highlighted the necessity of minimising medical and dental
diagnostic radiation exposure as much as possible. Patient positional errors have been
identified as the most frequent panoramic imaging errors, with some studies suggesting this
is the case for nearly 95 percent of reported errors. Positional error and patient movement
are two common reasons to reject dental imaging including intra-oral, extra-oral, and
Cone-Beam Computed Tomography (CBCT). Thus, it is suggested that all dental radiography staff
receive regular training focused on correct positioning techniques and reduction of patient
movement.
The typical patient positioning errors in panoramic radiography include failure to rest the
tongue against the palate, head positioned forward, head positioned backward, head twisted
towards the left or right, head tilted to the left or right, the chin too high, the chin too
low, a slumped position and inadequate neck extension, not resting the chin on the chin
support, failing to use the bite guide, lips opened, patient movement during imaging and not
removing the metal objects or prostheses. Among all the positional errors mentioned above,
the most common error is the failure to keep the tongue against the palate.
Due to the failure of holding the tongue against the palate, the palatoglossal airspace (PGA)
appears in panoramic radiographs as a dark radiolucent band under the hard palate and on the
apices of the anterior maxillary teeth. This artefact significantly reduces the quality of
the panoramic radiograph as it may be difficult or impossible to interpret the desired
periapical region for correct diagnosis and treatment planning (for example, making it
difficult to interpret cystic lesions in the anterior area of the upper jaw). In addition,
when PGA falls on the ramus of the mandible, it may be mistaken for a fracture.
PGA may be seen unilaterally and asymmetrically as a localised radiolucent area if the
patient swallows during panoramic imaging and momentarily does not touch the roof of the
mouth. If the patient places only the tongue tip behind the maxillary teeth, a larger
airspace is formed between the tongue and the hard palate.
As previous studies suggest, the average incidence of the error of not holding the tongue
against the palate is nearly 40 percent. However, some studies have estimated that the
frequency of this error in panoramic radiography can even reach 80-90 percent. Also, the
tongue not being in contact with the palate is considered the most common error in the mixed
dentition period. Overall, the incidence of positional errors, particularly the distance
between tongue and palate, is reportedly higher in the mixed dentition period than in the
permanent dentition period.
The main cause of PGA error is the patient's lack of understanding of the tongue-palate
position and the radiography technicians' inability to clearly explain this issue to the
patient and the lack of effective explanation and communication between the technician and
the patient. During panoramic imaging, patients often cannot hold their tongue in a still
position without moving, fully attached to the palate, and the technician cannot check that
the patient has followed the instructions and that the tongue is in the correct position.
Therefore, the operator should allocate sufficient time and use appropriate techniques to
position the patient.
Although several studies have emphasised the importance and necessity of minimising PGA
error, there is little research on the practical methods to achieve this goal.
It seems necessary to minimise the mentioned error using simple and practical techniques. In
this regard, the present study evaluates the effect of using celluloid matrix tapes and oral
tapes as a simple, and cheap method for proper positioning of the tongue on reducing the
palatoglossal airway shadow error in panoramic imaging.
Materials and methods This study was conducted at the Oral and Maxillofacial Radiology
Department, Faculty of Dentistry, Tabriz University of Medical Sciences, Iran, between
2021-09-29 and 2022-02-20. The study protocol was approved by the ethics committee of the
university (Institutional Review Board: IR.TBZMED.REC.1399.730) Since there weren't similar
studies to refer to, a pilot study was done with 30 patients from the oral and maxillofacial
radiology department to figure out a suitable sample size. The patients were randomly divided
and assessed in two groups of 15, each testing different materials: celluloid matrix tape and
strips of food material. The initial results were promising, with a 99% success rate in the
celluloid matrix tape group and 90% in the strips of food material group. Considering a Type
I error of 0.05 and study power of 80%, 76 samples for each study group were calculated. To
be on the safe side, this number was raised by an additional 20%, meaning 90 samples per
group were used in the study. So, in total, the study worked with 270 samples, split evenly
into three groups.
A total of 270 panoramic radiographs were acquired using a dental X-ray System (DR imaging
system, RAYSCAN α-P, South Korea) according to the instructions of the manufacturer at 50/60
Hertz, 60-90 kW, 4-17 mA, and acquisition time of 14 s in the Scanner 2.0.1 software. The
images were displayed and examined on an LCD (Liquid-Crystal Display) monitor (Dell E2014HF)
with dimensions of 14.1 × 6.5 × 18.7 inches and a pixel pitch of 0.27 millimeters.
In this experimental study, all panoramic images were taken by a technician according to the
patient positioning standards. The exposure settings were selected based on the patient's
size and weight.
The main inclusion criterion was age above 15 years. Patients with a history of trauma,
lesion, swelling, disseminated infection, physical and mental disabilities, severe gag
reflex, cleft palate, difficulty in speech and tongue movement, allergy to the materials used
in this study, and those reluctant to cooperate were excluded from the study.
The patients were randomised into three groups. Ninety patients received celluloid matrix
strips of transparent polyester (Maquira Dental Products, Maringá, Brazil) with a 10 mm width
and 30 mm length. In the second group, ninety patients were given edible strips. They were
divided into two subgroups of 45 people. 45 patients received 10 × 30 mm strips of either
commercial chewing gum (Banana Orion) with sweet banana flavor and 45 patients received sour
fruit leather. Finally, as the third group, 90 patients were selected as the control group
without giving any specific instructions.
Instruction of patients:
Panoramic imaging was carried out in the control group without any intervention (except for
as a routine procedure, all of the patients in the control group were instructed to stick
their tongue to the palate) and in accordance with the standard protocols of the Department
of Oral and Maxillofacial Radiology.
Before panoramic imaging, the patients in edible and celluloid strip groups were instructed
to put the given strips on their tongues. The strips were positioned in the
anterior-posterior dimension at the middle third of the tongue, and in the transverse
dimension in such a way that the centerline of the strip was placed in the central groove of
the tongue. When adjusting the final head position in the machine, they were asked to elevate
the strip to the roof of the mouth and hold it against the palate during the imaging
procedure.
Assessment of radiographs An oral and maxillofacial radiologist assessed the radiographs in
single-blinded random selection to identify and record the errors. The radiographs were
classified as diagnostically acceptable, unacceptable, and excellent based on the degree of
the palatoglossal air space shadow error.
Data analysis The statistical analyses were carried out using SPSSTM version 26 (IBM Corp.,
New York, NY; formerly SPSS Inc., Chicago, IL). The qualitative data were represented as
frequency (percentage), and normal quantitative data were expressed as mean ± standard
deviation. The Chi-square test compared the qualitative variables, and one-way analysis of
variance (ANOVA) was used for quantitative variables with normal distribution. The
intervention outcomes were evaluated using the logistic regression model. The differences
with P<0.05 were considered statistically significant for all tests.
