Investigation of the Reliability of Ultrasonography Usage in the Diagnosis of Temporomandibular Joint Diseases: A Prospective Study
Conditions: Device Reliability
Sponsor: Istanbul University

 
REPUBLIC OF TURKEY 
ISTANBUL UNIVERSITY INSTITUTE of HALTH SCIENCES 
DEPARTMENT OF ORAL AND MAXILLOFACIAL RADIOLOGY 
 
RESEARCH PROTOCOL 
 
Number of Protocol: 2019/73                                                           Date: 09/09/2019 
 
NAME OF THE RESEARCH 
 
Investigation of the Reliability of Ultrasonography Usage in
 
 
 
 
 
 
  
the Diagnosis of Temporomandibular Joint Diseases: A
 
 
 
 
 
 
 
Prospective Study 
 
RESOURCES OF THE 
RESEARCH AND RATIONALE 
Today,
a
significant
increase
in
the
prevalence
of
 
 
 
 
 
 
 
 
temporomandibular joint diseases is observed.In addition to
 
 
  
 
  
the basic clinical examination, there are several methods
 
 
 
 
 
 
 
 
and techniques for the diagnosis of temporomandibular joint
 
 
 
 
 
 
 
 
diseases. Magnetic resonance imaging is considered the
 
 
 
 
 
 
 
gold standard in the evaluation of the articular disc as well
 
 
 
 
 
 
 
 
 
 
 
as soft tissues. Computed tomography is used to diagnose
 
 
 
 
  
 
 
 
bone lesions such as bone erosion, fractures, postoperative
 
 
 
 
 
 
 
 
deformities, and deformities of the adjacent temporal bone.
 
 
 
 
 
 
 
 
All of these methods have limitations. Ultrasound imaging
 
 
 
 
 
 
 
 
of the joints and surrounding soft tissues is an alternative
 
 
 
 
 
 
  
 
 
method for the diagnosis of temporomandibular joint
 
 
 
 
 
 
 
diseases(1). However, the use of ultrasonography in the
 
 
 
 
 
 
 
 
diagnosis of temporomandibular joint diseases is rare, but
 
 
 
 
  
 
 
although there are several reports suggested in the literature,
 
 
 
 
 
  
 
 
it is less expensive, less time consuming and easy to apply
  
 
 
 
 
 
 
 
 
 
than other conventional imaging tools such as magnetic
 
 
 
 
 
 
 
 
resonance imaging, arthrography and computed tomography
 
 
 
 
 
 
scanning. recently gained attention and importance in terms
 
 
 
 
 
  
 
of both research and patient care(2,3). The main expectation
 
 
 
 
 
 
 
 
 
regarding the use of ultrasound devices in the diagnosis of
 
 
 
 
 
 
 
 
 
 
temporomandibular joint diseases is the use of this method
 
 
  
 
 
 
 
 
as a screening test. Magnetic resonance imaging, which is
  
 
 
 
 
 
  
associated
with
exposure to magnetic fields, is very
 
 
 
 
 
 
 
 
expensive, not found in most medical facilities, and is
 
 
 
 
 
 
 
 
 
impossible
in
patients
with claustrophobia. Computed
 
 
 
 
 
 
tomography and cone beam computed tomography do not
 
 
 
 
 
 
 
 
show soft tissues such as joint disc. Computed tomography
 
 
 
 
 
 
 
 
 
scans are not performed more than once or twice a year due
 
 
 
 
 
 
 
 
  
 
 
to exposure to x-rays. Panoramic radiographs available in
 
 
 
 
 
 
 
 
many dentist clinics show only very advanced changes in
 
 
 
 
 
 
 
 
 
the
temporomandibular
joint.
Accurate
diagnosis
of
 
 
 
 
 
 
temporomandibular diseases is not possible only with
 
 
 
 
 
 
 
clinical examination(1).  
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1.
Klatkiewicz, T., et al., Ultrasonography in the
 
 
 
 
 
 
 
Diagnosis
of
Temporomandibular
Disorders:
A
 
 
 
 
 
Meta-Analysis. Med Sci Monit, 2018. 24: p. 812-817. 
 
2.
Su, N., et al., Diagnostic value of ultrasonography
 
 
 
 
 
 
 
 
for
the
detection
of
disc
displacements
in
the
 
 
 
 
 
 
 
 
temporomandibular
joint:
a
systematic
review
and
 
 
 
 
 
 
meta-analysis.
Clin
Oral
Investig,
2018.
22(7):
p.
 
 
 
 
 
 
 
2599-2614. 
 
3.
Melis, M., S. Secci, and C. Ceneviz, Use of
 
 
 
 
 
 
 
 
 
ultrasonography for the diagnosis of temporomandibular
 
 
 
 
 
 
joint disorders: a review. Am J Dent, 2007. 20(2): p. 73-8. 
 
PURPOSE OF THE RESEARCH 
In the literature, there are not many studies on the diagnostic
 
 
 
 
 
 
 
 
 
 
 
value of the use of ultrasonography in the diagnosis of
 
 
 
 
 
 
 
 
 
 
temporomandibular joint diseases in dentistry. In this study,
 
 
 
 
 
 
 
 
it is aimed to contribute to the literature in terms of
 
 
 
 
 
 
 
 
 
 
 
revealing the reliability of the use of ultrasonography in the
 
 
 
 
 
 
 
  
 
diagnosis of temporomandibular joint diseases. 
 
BENEFITS EXPECTED AT THE 
END OF THE RESEARCH 
By revealing the efficacy and reliability of ultrasonography
 
 
 
 
 
 
 
 
in the diagnosis of temporomandibular joint diseases, to
 
 
 
 
 
 
 
 
eliminate the disadvantages of MR and other imaging
 
 
 
 
 
 
 
 
methods. 
 
RESEARCH METHOD 
Functional
joint
examination
and
ultrasonographic
 
 
 
 
 
examination (USG) will be applied to all volunteers who
 
 
 
 
 
 
 
 
 
will participate in the research. In the USG application,
 
 
 
 
 
 
 
 
 
when the mouth is open and closed, the right and left joint
 
 
  
 
 
 
 
 
 
 
 
intervals will be measured and a note will be taken. At the
 
 
 
 
  
 
 
 
 
 
 
same time, right and left masseter muscle thicknesses will
 
 
 
 
 
 
 
 
 
be measured separately at free-closing and tight-closing and
 
 
  
 
 
 
 
a grade will be taken for all groups.. 
Volunteers to participate in the research will be divided into
 
 
 
 
 
 
 
 
 
 
4
groups.(I,II,III,IV).For
volunteers
in
group
1
with
 
 
 
 
 
 
 
previously taken MR images, USG and MR findings will be
 
 
 
 
 
 
 
 
 
 
compared. In volunteers in group 2, the values ​obtained
 
 
 
 
 
 
 
 
 
using
different
probes
(linear,
hockeystick)
will
be
 
 
 
 
 
 
 
compared. In the third group of volunteers, the values ​to be
 
 
 
 
 
 
 
 
  
 
obtained by using the USG probe at different angles
 
 
 
 
 
 
 
 
 
(horizontal / longitudinal) will be compared. In volunteers
  
 
 
 
 
 
 
in group 4, the megahertz values ​of the probe are changed
 
 
 
 
 
 
 
 
 
 
 
and the findings obtained by examining them separately will
 
 
 
 
 
 
 
 
 
be compared. 
In addition to evaluating 4 groups separately, at the end of
 
 
 
  
 
  
 
 
 
the research, USG data applied to all 4 groups will be
 
 
 
 
 
 
  
 
 
 
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analyzed
by
comparing
all
the
findings
obtained
in
 
 
 
 
 
 
 
 
functional joint examination. 
 
 
Research Design 
 
 
Observational 
Research 
Experimental Research 
 
Descriptive 
Research 
Yes ☐ 
 
 
 
 
 
 
 
Yes  ☐ 
 
 
 
 
 
Retrospect
ive 
Research 
 
Yes  X 
 
 
 
 
 
Prospectiv
e Research 
Analytical 
Research 
Yes ☐ 
 
 
 
 
 
 
 
 
Yes  ☐ 
 
 
 
 
 
Retrospect
ive 
Research 
 
Yes  ☐ 
 
 
 
 
 
Prospectiv
e Research 
Controlled 
Research 
 
 
Yes   ☐ 
 
 
 
 
Blind 
Research 
 
 
Yes   ☐ 
 
 
 
 
Double-bli
nd 
Research  
 
 
Yes   ☐ 
 
 
 
 
Open 
Research  
 
 
 
Yes  ☐ 
 
 
 
 
 
 
 
 
Yes  ☐  
 
 
 
 
 
 
 
Yes  ☐ 
 
 
Uncontrolled 
Research 
 
 
 
 
 
 
Yes 
☐ 
 
 
Cross 
Sectional 
Research 
Longitudin
al Research 
Randomized 
Controlled 
Research 
Non-Rando
mized 
Controlled 
Research 
Cross- 
Random
ination 
Before 
and After
 
 
Research 
 
 
PROCESS 
 
What are the damages, risks
 
 
 
 
 
and process problems that can
 
 
 
 
 
be
encountered
during
the
 
 
 
 
research? 
NO 
 
What are the measures that
 
 
 
 
 
can be taken against them? 
NO 
 
 
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SAMPLE INFORMATION 
 
How
was
the
number
of
 
 
 
 
 
volunteers to participate in the
 
 
 
 
 
research determined? Explain 
When calculating the sample size of our study, reference
 
 
 
 
 
 
 
 
 
values
​in
previous
similar
studies
were
taken
into
 
 
 
 
 
 
 
 
consideration. When similar dental studies are examined;
 
 
 
 
 
 
 
(µ1-µ2) and sd values ​are seen to range from 0.01 to 0.05
 
 
 
 
 
 
 
 
 
 
 
 
(Odacı E. v.d, 2003). When determining the sample size of
 
 
 
 
 
 
 
 
 
 
the study (α=0,05, 1-β=%80)
=7,85, sd =0,05 and
 
 
 
 f (α, )
β
 
 
 
 
(µ1-µ2) = 0,02 when taken, it is seen that the sample size is
  
 
 
   
 
 
 
 
  
n = 100. It is planned to include 100 volunteers in our
 
 
 
 
 
 
 
 
 
 
 
 
research. 
Sampling method 
Volunteers will be selected from patients who applied to our
 
 
 
 
 
 
 
  
 
clinic and who have complaints of temporomandibular
 
 
 
 
 
 
 
joints. 
 
VOLUNTEER POPULATION INFORMATION 
 
Volunteers' inclusion criteria 
-Patients over the age of 18 who apply with TMJ problems 
-Patients with pain in the joint and chewing muscle area 
 
Volunteers' criteria for exclusion 
from research 
-Syndromic patients 
-Patients under the age of 18 
-Patients with a history of orthognathic surgery 
-Pregnants 
-Antidepressant Users 
-Patients Using Removable Dentures 
-Patients who have had joint treatment in the past six months 
 
Age range 
☐ 
Child Age Group (0-17) 
 
 
Number:0 
X 
Over 18 years old 
 
 
Number:100 
 
Total:100 
Sex  
X 
Female 
X 
Male 
 
Total: 100 
 
WHAT ARE THE DATA TOOLS USED IN THE RESEARCH? 
 
With the Information-Questionnaire 
X 
■
Self-answer 
☐ 
■
Answering under observation 
☐ 
■
Answering through the interviewer 
X 
Observation  
☐ 
Laboratory Review 
☐ 
Registration from the archive 
☐ 
Other 
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WHICH STATISTICAL METHODS WILL BE
 
 
 
 
 
EVALUATED 
 
 
In our study, SPSS application will be used for
 
 
 
 
 
 
 
 
 
statistical analysis. 
In
evaluating
the
categorical
variables,
the
 
 
 
 
 
 
Chi-Square test will be used to look for a difference
 
 
 
 
 
 
 
  
 
between the groups. Normality control of continuous
 
 
 
 
 
 
 
variables will be done with Kolmogorov-Smirnov
 
 
 
 
 
 
test. 
Difference
evaluations
of
continuous
variables
 
 
 
 
 
between groups will be made with Student's t test in
 
 
 
 
 
 
  
  
data with normal distribution. Group comparisons
 
 
 
 
 
 
for data that are not suitable for normal distribution
 
 
 
 
 
 
 
 
 
will be performed with Mann Whitney U test. 
Descriptive statistics will be specified by giving
 
 
 
 
 
 
 
mean, standard deviation, minimum and maximum
 
 
 
 
 
 
values
​of
all
continuous
variables.
Frequency
 
 
 
 
 
 
distributions and percentages of categorical variables
 
 
 
 
 
 
will be specified. 
 
 
RESEARCH BUDGET 
 
Total research expenses 
****** TRY 
Source of research expenses 
 
☐ 
■
The researcher himself 
 
■
Supporting 
X 
o
University (Scientific Research Projects Unit) 
☐ 
o
TÜBİTAK 
☐ 
o
DPT 
☐ 
o
Industry and Other Institutions 
 
CENTERS PARTICIPATED IN THE RESEARCH 
 
X 
o
Single Center 
☐ 
o
Multi Center 
 
RESPONSIBLE RESEARCHER  
o
Name Surname: İlknur ÖZCAN 
o
Title: Professor 
o
Profession: Oral and Maxillofacial Radiology 
o
Adress:
Istanbul
University
Faculty
of Dentistry Department of Oral and
 
 
 
 
 
 
 
 
 
 
Maxillofacial Radiology Fatih/İSTANBUL 
o
e-mail: ilknurozcan1@gmail.com 
 
 
 
 
 
 
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AUXILIARY RESEARCHER(S): 
 
o
Name Surname: Bilge GÖKÇEN RÖHLİG 
o
Title: Professor 
o
Profession: Prosthetic Dental Treatment 
o
Adress: Istanbul University Faculty of Dentistry Department of Prosthetic Dental
 
 
 
 
 
 
 
 
 
 
Treatment Fatih/İSTANBUL 
o
E-mail: bgokcen@istanbul.edu.tr 
 
o
Name Surname: Demirhan DIRAÇOĞLU 
o
Title: Professor 
o
Profession: Physical Therapy and Rehabilitation 
o
Adress: Istanbul University Faculty of Medicine Department of Physical Therapy and
 
 
 
 
 
 
 
 
 
 
 
Rehabilitation Fatih/İSTANBUL 
o
E-mail: demirhan1@yahoo.com 
 
o
Name Surname: Ahmet Faruk ERTÜRK 
o
Title: PhD Student 
o
Profession: Oral and Maxillofacial Radiology 
o
Adress:
Istanbul
University
Faculty
of Dentistry Department of Oral and
 
 
 
 
 
 
 
 
 
 
Maxillofacial Radiology Fatih/İSTANBUL 
o
e-mail: afebty@gmail.com 
 
PLANNING TIME OF THE RESEARCH: 
 
■
Planned Start Date​: ​01.01.2020 
■
Planned End Date : ​01.01.2021 
 
THE PERSON TO BE CONTACTED ABOUT THE PROJECT: 
 
Name:  Ahmet  Faruk ERTÜRK 
■
Istanbul University Faculty of Dentistry Department of Oral and Maxillofacial
 
 
 
 
 
 
 
 
 
 
Radiology Fatih/İSTANBUL 
■
Phone Number: +905057828844 
■
e-mail: afebty@gmail.com 
 
 
 
 
. 
 
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