Prospective Investigation of the Effects of Different Treatment Techniques on Myofascial Trigger Points in Patients With Temporomandibular Dysfunction (TMD)
Phase: NA
Conditions: Low Level Laser and Occlusal Splint
Sponsor: Istanbul University

 
 
 
 
 
THE RESEARCH PROTOCOL 
 
Protocol number: 2019/72  Revision Number:  Date:12/09/2019 
 
 
1. THE 
NAME 
OF 
RESEARCH: 
 
Temporomandibular Dysfunction (TMD) patients with 
myofascial trigger points 
treatment techniques in 
a 
prospective investigation of the impact on different 
 
 
2. The basis and rationale 
of the research: (up to 
2500 characters) 
 
Temporomandibular 
dysfunction 
(TMD); 
and 
Nov 
orthopedic-skeletal system changes, symptomatic pain, joint 
sounds, limitation of mandibular movement and fatigue of the 
chewing muscles characterized by(1). Emotional stress, 
caused by disease or TMJ occlusal disturbances, increased or 
dysfunctional Nov activities, it is believed that the cause of 
temporomandibular disorders. Nowadays, a significant 
increase is observed prevalencia temporomandibular joint 
disease(3). Usually the symptoms of TMD are complex and 
temporal, and occipital regions in the region that is distributed 
over the front preaurikuler pain is the main symptom(1).Heat, 
cryotherapy, 
local 
anesthesia, 
occlusal 
apparatus, 
physiotherapy, subcutaneous electrical neural stimulation 
that can reduce pain and inflammation and relaxes the 
chewing muscles which can reduce low-level laser (LLL) as 
various treatments are available for pain associated with 
TMD(1).The red and infrared wavelengths is used to reduce 
pain associated with TMD, including different pain types of 
clinical 
LLL(1).The 
functional 
relationship 
of 
the 
masticatory system is 
also commonly called 
splint 
interokluzal plaques are also temporarily healed, and is used 
as 
routine 
in 
the 
treatment 
of 
temporomandibular 
disorders(2). Temporarily removes plaque stabilization 
occlusal forces set up correctly and properly bring them back 
to the external contacts, Nov are expected to improve the 
symmetry of(2). 
1.Cavalcanti, M. F., et al., Comparative study 
of 
physiotherapeutic and drug the Protocol and low-level laser 
irradiation in the treatment of pain associated with 
Temporomandibular Dysfunction. Photomed Laser Surg, 
2016. 34(12): p. 652-656. 
2.Alajbeg, I. Z., et al., Influence of asymmetric occlusal 
stabilization splints in patients with temporomandibular 
dysfunction of masticatory muscles activity. Coll Antropol, 
2003. 27(1): p. 361-71. 
3.Slatkiewicz, T., et al., Ultrasonography diagnosis of 
temporomandibular disorders: a meta-analysis. Med Sci 
Monitor, 2018. 24: p. 812-817. 
 
26/09/2019

 
 
 
 
 
 
3. Purpose of study: 
(describe in detail) 
 
In the literature, comparing and TMD occlusal splint in the 
treatment of these parameters that included the use of USG 
and lll yi  studies , there are no. In this study, the use of 
occlusal splint in the treatment of TMD and lll as a result of 
USG at certain intervals and other parameters by evaluating 
changes in the chewing muscles, which is the treatment 
method is more efficient and at the same time also evaluating 
the parameter which is the parameters that are used in its own 
right is more effective because it demonstrates it is aimed to 
contribute to the literature. 
 
 
4. The expected benefits of 
the research: (describe in 
detail) 
Treatment method in the treatment of TMD, which is more 
efficient and can be assessed more accurately by the 
parameters of what they are putting forward the success of 
the treatment in patients with TMD. 
 
5. RESEARCH METHOD: 
(describe in detail) 
Summarize activities you can 
do to 
perform 
the 
work: 
(research questions which you 
will answer with the work plan 
of the volunteer what kind of 
information will be collected, 
how the laboratory tests if you 
have these measurements, the 
methods 
determined 
to 
be 
(EXAMPLE: if you have a cell 
separation, which will be done 
how the instrument or ready-
made kits to be used with, what 
are 
their 
technical 
characteristics, etc) 
All volunteers will participate in the research that pre-
treatment 
of 
joint 
examination 
and 
functional 
Ultrasonographic examination (USG) shall be governed by. 
The USG open and closed mouth in the application, the 
measurements made will be deducted from the note intervals 
of the left and right joints. At the same time closing the right 
and left masseter in closing free Nov thicknesses measured 
separately for all groups and will be deducted from the note 
and tight. 
To participate in the research volunteers will be divided into 
2 groups(Laser Group: I.; Splint Group: II. Group). A 
randomized group of 30 people selected to be low-dose, 
randomized 30 will be selected again to be applied to the 
Laser II. the group and the group prepared by the 
conventional method will be applied to record the night. After 
treatment 1.month 3.months and 6.functional examination 
and the joint tests are invoked by patients for checkups month 
by applying the data obtained for control purposes the Note 
will be deducted from the USG. Laser splint after the 
investigation and the findings compared with each other 
groups, low-dose efficacy of laser therapy will be analyzed 
statistically. 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
Research Design 
 
 
Observational 
Research 
Experimental Research  
 
Descriptive 
Research 
Yes 
between 
 
 
 
 
 
 
 
Yes 
between 
 
 
 
 
 
Backward 
Research 
 
Yes 
between 
 
 
 
 
 
Future Research 
Analytical 
Research  
Yes 
between 
 
 
 
 
 
 
 
 
Yes 
between 
 
 
 
 
 
Backward 
Research 
 
Yes 
between 
 
 
 
 
 
Future Research 
Controlled 
Research  
 
 
Yes 
between 
 
 
 
 
Blind Research 
 
 
Yes X 
 
 
 
 
Double-blind 
Research  
 
 
Yes 
between 
 
 
 
 
Outdoor Research  
 
 
 
Yes 
between 
 
 
 
 
 
 
 
 
Yes between  
 
 
 
 
 
 
 
Yes 
between 
 
 
Uncontrolled 
Research  
 
 
 
 
 
 
Yes 
between 
 
 
Cross-
Sectional 
Research 
Longitudinal 
Research  
A 
Randomized 
Controlled 
Trial  
Non-
randomised 
controlled 
trial  
Cross-
randomization 
Before and 
after 
Research 
 
Other comments you may have 
[Please enter information.]  
 
6. PROCESS 
 
Operational damage during 
your research, what are the 
issues and risks that could 
process?  
 
NO 
 
What are the precautions? 
(If you have a plan describe 
related)  
 
NO 
 
 
 
 
 
 

 
 
 
 
 
7. SAMPLE INFORMATION: 
 
The number of volunteers 
that will participate in the 
research were, How explain: 
(used power, confidence 
level, average, standard 
deviation, and frequency 
(rate), etc.)  
 
Previously a sample size of similar studies, which is located 
in our work are taken into consideration when calculating the 
reference values. Similar dental research examined; (µ1-µ2) 
and SD is in the range 0.01 to 0.05 and values (E. V. D 
Chamber, 2003). When determining the sample size of the 
study, (at α=0.05, 1-β=80%) and 𝑓(𝛼,𝛽)=7,85, sd =0,02 and 
(µ1-µ2) = 0,01 is received, the sample size n=65 in. Our 
research of 60 volunteers is planned to be included. 
Sampling method : 
(Examples, how and where 
will be achieved, todo how to 
choose the clinic?)  
 
Patients admitted to our clinic with complaints of 
temporomandibular joint volunteers will be selected and 
randomized. 
 
8. VOLUNTEER (SAMPLE) POPULATION INFORMATION:  
 
Volunteers (e.g. to study) 
inclusion criteria : (itemized 
List)  
-The applicant is over the age of 18 patients with TMJ 
problems 
-Joint and masticatory muscles of patients with pain in the 
region 
 
Volunteers criteria for being 
included in the research : 
(itemized List) 
 
-Syndromic patients 
Patients under the age of 18 
-Patients with a history of orthognathic surgery 
-Pregnant women 
-Antidepressant users 
-Patients Who Use Removable Dentures 
-Patients who have had joint treatment within the last six 
months. 
If you have a control group, 
which number shall be 
provided where functionality 
and how?  
 
 
The control group consists of patients to be treated with 
splint produced by the conventional method. Patients 
randomized to the clinic, which will be held as a result of a 
joint examination by selecting this group of 30 people will 
be included. 
 
Age range: (please specify the number of anticipated or age limits.)  
between Children's Age Group:  
 
Number: 
X 
Over 18 years of age : 60  
 
Number:60 
 
TOTAL NUMBER:60 
Gender: (the gender distribution of the number planned please specify)  
X 
Women 
X 
Male 
 
TOTAL NUMBER:60 
Informed Consent Form: 

 
 
 
 
X 
Research, in a language that the participant can understand the medical words in one 
adjusted (as necessary medical terms given in parentheses) and is prepared in 
accordance with the rules?  
Example 1: LINK 
Example 2: LINK 
 
9. WHAT ARE THE DATA TOOLS TO BE USED IN RESEARCH? (Please attach 
examples of the form.) 
 
 
Information-question form 
between 
■ Self-reply  
between 
■ Under observation answer 
between 
■ Reply through the interviewer 
X 
Observation  
between Lab review 
between Recording from the archives 
between Other (Please Specify.) 
 
NOTE: a detailed list of where and in which data received from laboratory investigations 
on clinical and laboratory provided on-let's the word in addition to your presentation. 
 
 
 
10. WHICH statistical methods will 
be 
evaluated with the data: explain in detail 
the methods that will be used for 
statistical analysis).  
 
 
 
In our study, for statistical analysis the SPSS 
program will be used. 
Assessments to be made of the difference 
between groups to be taken between 
categorical variables The Chi-square test will 
be used. The control of continuous variables 
normality Kolmogorov-Smirnov test will be 
made. Reviews the difference between the 
groups for continuous variables, normally 
distributed data student's t-test will be made. 
The normal distribution is not appropriate for 
group comparisons, Mann Whitney U test 
will be performed with that data. 
The average of all the continuous variables, 
standard deviation, minimum and maximum 
values given, descriptive statistics shall be 
specified. 
Frequency 
distributions 
of 
categorical variables and percentages shall 
be specified. 
 
 
11. RESEARCH BUDGET: (fill in also the form of the research budget.) 
 
Research expenses total 
TRY 24834 
The source of the cost of research  
 
■ The researcher himself 
 
■ Supporting 
X 
o University (BAP) 
 
o TUBITAK 

 
 
 
 
 
o DPT 
 
o Industry and other institutions (please specify.) 
 
 
12. THE SURVEYED CENTRES 
 
X 
Single-Center 
 
Very Central