The Frequency of Trigeminocardiac Reflex During the Extraction of Impacted Mandibular Wisdom Teeth and the Effect of Anesthesia Technique on the Development of the Reflex
Phase: NA
Conditions: Trigemino-Cardiac Reflex, Impacted Third Molar Tooth
Sponsor: Kutahya Health Sciences University

 
  
 
 
  
KÜTAHYA UNIVERSITY OF HEALTH SCIENCES 
RECTORATE 
 
 
 
INTERVENTIONAL CLINICAL TRIALS 
TO THE CHAIRMAN OF THE ETHICS COMMITTEE 
 
 
I kindly request your information and necessity for the examination of our research titled  
“Evaluation of trigeminocardiac reflex development during extraction of mandibular impacted 
wisdom teeth " by your board. 
 
 
                                                                                        Responsible Researcher 
 
 
 
 
 
 
 
   
      Assistant Professor Bedreddin Cavlı 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
KÜTAHYA HEALTH SCIENCES UNIVERSITY RECTORATE INTERVENTIONAL CLINICAL 
RESEARCH ETHICS COMMITTEE RESEARCH BUDGET FORM 
 
 
A. RESEARCH INFORMATION 
  
 
Supportive 
Asst. Professor, Bedreddin Cavlı 
bedreddin.cavlı@ksbu.edu.tr 
05051590606 
Legal Representative 
Bedreddin Cavlı 
bedreddin.cavlı@ksbu.edu.tr 
+905051590606 
 
Name of the study 
Evaluation of trigeminocardiac reflex development during extraction of mandibular impacted 
wisdom teeth 
Protocol number/code 
 
The number/code given to the research by the Turkish Medicines and Medical Devices 
Agency (TİTCK) and the Ethics Committee (EK) 
TİTCK 
 
EK 
 
 
B. RESEARCH CENTRES 
 
Please indicate the centres participating in the research from our country: 
1. Kütahya Health Sciences University Faculty of Dentistry, Department of Oral, Dental and 
Maxillofacial Surgery 
 
 
 

 
 
 
C. SERVICE PROCUREMENT 
  
Services to be received from Turkey 
1. Specify the services to be received from the research centre and their number 
Process Name 
Number of 
transactions for one 
volunteer 
Monitoring of patients 
1 
 
2. Specify the services to be received from outside the research centres and their number 
 Process Name 
Number of 
transactions for one 
volunteer 
- 
- 
 
Services to be received from outside Turkey 
3. Specify the services to be received from outside Turkey and their number 
Process Name 
Number of 
transactions for one 
volunteer 
- 
- 
 
D. PAYMENTS 
Please indicate the amounts stated in this section in Turkish Lira. 
  
 
1. Please indicate the amount to be paid to the research centre, excluding researcher 
payments, for each subject who completes the study: 
Centre Name 
Amount (for 1 volunteer) 
 - 
0 TL 
 
 
2. State the amount to be paid to the research centre on behalf of the researcher for each 
volunteer who completes the study: 
Centre Name 
Amount (for 1 volunteer) 
 - 
0 TL 
 
 

 
 
 
3. If volunteers will be paid, explain in detail and indicate the maximum amount of 
payment planned to be paid to a volunteer during the study: 
Volunteer patients will not receive any payment. 
 
4. Indicate other payments, if any, and the amount: 
Process name 
Amount 
- 
- 
 
E. BUDGET SOURCE 
The researcher himself 
X 
Finance organisation/institution 
☐ 
Description: 
Disposable ECG electrodes used to monitor patients will be paid for by the 
investigators. 
                       
F. SUPPORTER'S DECLARATION (SIGNATURE) 
 . 
Please indicate the total* budget allocated for the research in 
Turkey (in Turkish Lira) 
 340 TL 
The budget was calculated considering the transaction costs dated. It is not the total amount 
allocated for one volunteer, but the total amount including investigator payments, centre payments 
and operational expenses allocated for our country during the whole research. 
 
 Work with this budget form; 
- The information stated in the form is correct, 
- I undertake that the payments related to the research protocol, other concurrent treatment and 
research-induced rescue treatment costs foreseen to be made during the research specified in the 
research protocol will not be paid to the volunteer and the Social Security Institution, and will be 
paid by the sponsor (person or organisation). 
 
Handwritten name and 
surname 
  
 
Telephone number 
 
 
Email address 
 
 
Date (in days/months/years) 
 
 
Signature 
 
 
 

 
 
 
 
 
KÜTAHYA HEALTH SCIENCES UNIVERSITY RECTORATE INTERVENTIONAL CLINICAL 
RESEARCH ETHICS COMMITTEE RESEARCH PROTOCOL FORM 
 
 
Title of the study: Evaluation of trigeminocardiac reflex development during extraction of 
mandibular impacted wisdom teeth  
Title, name, field of specialization and place of duty of the principal investigator: Asst. Professor 
Bedreddin Cavlı 
Oral and Maxillofacial Surgery- Kütahya Health Sciences University Faculty of Dentistry 
 
Title, names, fields of specialization and duty stations of all researchers who will be involved in 
the study: 
Responsible Researcher: Asst. Professor, Bedreddin Cavlı 
Oral and Maxillofacial Surgery- Kütahya Health Sciences University Faculty of Dentistry 
Assistant Researcher: Research Assistant, Aykut Şaylığ 
Oral and Maxillofacial Surgery- Kütahya Health Sciences University Faculty of Dentistry 
Assistant Researcher: Research Assistant, Şeyma Kale 
Oral and Maxillofacial Surgery- Kütahya Health Sciences University Faculty of Dentistry 
Counsellors: 
Asst. Professor Necmiye Şengel  
Anesthesiology and Reanimation- Gazi University Faculty of Dentistry 
Professor Ziver Ergun Yücel 
Oral and Maxillofacial Surgery- Gazi University Faculty of Dentistry 
 
Place of the study: Kütahya Health Sciences University Faculty of Dentistry, Department of Oral, 
Dental and Maxillofacial Surger 
PHASE 
AND 
TYPE 
OF 
RESEARCH 
 
Phase 1 
 
Phase 2 
 
Phase 3 
 
Phase 4 
 
Observational drug study 
 
Medical device clinical research 
 

 
 
 
  
Research hypothesis:  
µ ≠ 0 hypothesis:: During extraction of mandibular impacted wisdom teeth, the trigeminocardiac 
reflex does not occur with stimulation of the peripheral branches of the trigeminal nerve. 
µ = 0 hypothesis:: During extraction of mandibular impacted wisdom teeth, a trigeminocardiac reflex 
occurs by stimulation of the peripheral branches of the trigeminal nerve. 
 
Introduction-Purpose Section 
The trigeminocardiac reflex (TCR) has entered the scientific literature as an oculocardiac reflex with 
strabismus surgeries (1). In cases where the V1 branch of the trigeminal nerve forms the afferent 
pathway of the V1 branch of the trigeminal nerve, a clinical phenomenon with vagal stimulation 
findings has been encountered. Since the publication of TCR in ophthalmological surgery in 1908, it 
has become a well-known clinical picture for ophthalmologists and anesthetists (2). The anesthetist's 
mastery and experience in this picture, which is met by manipulation of the ocular muscles, is of great 
importance. Recognition that the picture is a brainstem reflex involving the vagal pathway is critical 
in mastering the clinical situation. In the literature, it has been reported that V2 and V3 branches of 
the trigeminal nerve can also produce the reflex picture and the reflex can be seen under local 
anesthesia. (3,4). Reflex is diagnosed under local anesthesia as well as under general anesthesia with 
hemodynamic data (blood pressure, heart rate) that can be monitored non-invasively. 
TCR is a physiological, life-threatening response with sudden onset of severe bradycardia, 
hypotension and asystole with parasympathetic activation of the heart due to stimulation of the vagal 
nerve as a result of stimulation of any of the three branches of the trigeminal nerve. (1).  It is defined 
as a decrease in heart rate and mean arterial blood pressure by more than 20% from baseline or a heart 
rate of less than 60 beats per minute due to intraoperative traction or manipulation of the trigeminal 
nerve. The afferent branch of the trigeminocardiac reflex arc is formed by the sensory nerve endings 
of the fifth cranial nerve. Neuronal signals are sent to the trigeminal sensory nucleus via the Gasserian 
ganglion. The sensory nucleus of the afferent reflex branch of the trigeminal nerve connects to the 
efferent pathway via short internuncial fibres in the reticular formation with the more distant motor 
nucleus of the vagus nerve. Cardioinhibitory efferent fibres originate from the motor nucleus of the 
vagus nerve. It transmits vagus-mediated negative chronotropic and inotropic responses to the heart 
and terminates in the myocardium (5). 
Performance evaluation studies 
conducted with in vitro medical 
diagnostic devices 
 
Non-drug clinical research 
 
Please specify if other:   

 
 
 
 
In the maxillofacial surgery literature, there are case reports reporting the development of 
trigeminocardiac reflex in orthognathic surgery, dental implant surgery and maxillofacial trauma 
surgery and prevalence studies for major surgeries (6,7,8). Haemodynamic changes and neurological-
based emergencies (e.g. vasovagal syncope) are quite common in routine oral surgical procedures 
performed under local anaesthesia (9). 
In addition, in a study, it was noted that a significant decrease in heart rate and blood pressure occurred 
during extraction of posterior mandibular teeth and this may be related to the trigeminocardiac reflex 
(10).  Extraction of impacted wisdom teeth is one of the commonly performed procedures in the field 
of oral and maxillofacial surgery. To the best of our knowledge, there is no study in the literature 
evaluating the development of TCR during mandibular impacted wisdom tooth extraction.  
Our aim was to investigate the trigeminocardiac reflex during oral surgical procedures routinely 
performed under local anaesthesia. Our reasons for choosing mandibular impacted wisdom tooth 
surgery among oral surgeries for this purpose are; the proximity of the inferior alveolar nerve, which 
is the largest terminal branch of the V3 branch of the trigeminal nerve, to the tooth roots and the 
frequent observation of traction on the nerve, the fact that there may be differences in the depth of 
effect between anaesthetic techniques due to the variation of the mandibular nerve, and our clinical 
experience. There are no studies in the literature evaluating the development of trigeminocardiac 
reflex during surgical treatment of mandibular wisdom teeth. 
 
Materials and Methods Section: 
The study will be conducted on patients referred to KSBÜ Faculty of Dentistry, Department of Oral, 
Dental and Maxillofacial Surgery from Oral, Dental and Maxillofacial Radiology, who have an 
indication for extraction of impacted mandibular wisdom teeth under local anesthesia, who will 
undergo extraction of impacted wisdom teeth for the first time, who agree to have the surgical 
extraction of these teeth performed at KSBÜ Faculty of Dentistry, Department of Oral, Dental and 
Maxillofacial Surgery and who agree to participate in the study. 
If there is a clinical necessity, cone beam computed tomography will be taken to evaluate the 
relationship of impacted wisdom teeth with the nervus alveolaris inferior and to evaluate their 
localization in the mandible in three dimensions. In patients who do not need tomography, the 
evaluation will be performed with Orthopantomogram film. The distance of the relevant wisdom 
tooth roots from the inferior alveolar nerve will be recorded. 
During the procedure, Gow-Gates and nervus alveolaris inferior anesthesia techniques, which are the 
two most commonly used local anesthesia techniques in oral, dental and maxillofacial surgery 
practice, will be applied for the extraction of mandibular impacted teeth.  
Patients will be divided into 2 groups according to the proximity of the wisdom tooth roots to the 
inferior alveolar nerve (1 mm and closer to the nerve / more than 1 mm away from the nerve) and 2 
groups according to the anesthesia technique to be applied (Gow-Gates Block - Inferior alveolar 
block). Total research arm is 4. 
In the research arms we have established, the follow-up of TKR that may occur during the procedure 
will be provided by monitoring the patients (Contec Medical Systems, Hebei, China.) Heart rate, 
systolic and diastolic blood pressure, oxygen saturation will be recorded during the procedure. The 
records will be taken in 4 stages: before starting the surgical procedure, during the application of local 
anaesthesia, during the incision, during the elevation of the crown and root. Sudden changes that 
occur during the procedure will be recorded together with the process in which they occur.  

 
 
 
(e.g. during local anesthesia)  
Initial heart rate: 80 beats/min  
End of procedure heart rate: 78 beats/min 
Sudden presence of bradycardia or tachycardia during the procedure;  
Sudden change in heart rate: 80>58 or 80>98) 
 
During extraction of impacted wisdom teeth, a 20% decrease in heart rate and a decrease in heart rate 
below 60 will be considered as the development of TCR in parallel with the literature. The prevalence 
of TKR will be evaluated in 4 separate groups according to whether Gow-Gates anaesthesia or nervus 
alveolaris inferior anaesthesia is applied and whether the wisdom teeth are closer than 1 mm and 1 
mm or further than 1 mm from the nervus alveolaris inferior. 
During mandibular impacted wisdom tooth extraction, patients will be monitored and the following 
parameters will be evaluated: 
1. Systolic blood pressure 
2. Diastolic blood pressure 
4. Oxygen saturation 
5. Heart rate 
 
The anxiety level of the patients will be assessed with the Amsterdam Preoperative Anxiety and 
Information Score Scale (APAIS) and State-Trait Anxiety Inventory (STAI-S) in order to 
differentiate TKR from common neurological emergencies (e.g. vasovagal syncope) due to dental 
phobia.  State Anxiety Scale was developed in 1970 and its Turkish form was adapted in 1983 and 
validity and reliability study was conducted.  APAIS was translated into Turkish for the first time in 
our country in 2007 and it was found that APAIS and STAI-S were correlated with each other in the 
studies conducted(11). 

 
 
 
STAI-S  ( The State-Trait Anxiety Inventory) 
Amsterdam Preoperative Anxiety and Information Scale (APAIS)    
 
 
 
 
 
Inclusion criteria: 
Patients aged 18-30 years 
Patients without any systemic problems 
Patients with an indication for extraction of mandibular wisdom teeth 
Patients have no previous experience of impacted tooth extraction 
 
 
No
t at 
all 
A 
little 
So
me
wha
t 
Very Much 
So 
1. 
I feel calm 
(1) 
(2) 
(3) 
(4) 
2. 
I feel secure 
(1) 
(2) 
(3) 
(4) 
3. 
I feel tense 
(1) 
(2) 
(3) 
(4) 
4. 
I feel strained 
(1) 
(2) 
(3) 
(4) 
5. 
I feel at ease 
(1) 
(2) 
(3) 
(4)  
6. 
I feel upset 
(1) 
(2) 
(3) 
(4) 
7. 
I am presently worrying over possible misfortunes 
(1) 
(2) 
(3)  
(4) 
8. 
. I feel satisfied 
(1) 
(2) 
(3) 
(4) 
9. 
I feel frightened 
(1) 
(2) 
(3) 
(4) 
10. I feel uncomfortable 
 (1) (2) 
 (3) 
(4) 
11. I feel self confident 
(1) 
(2) 
(3) 
(4) 
12. I feel nervous 
(1) 
(2) 
(3) 
(4) 
13. I feel jittery 
(1) 
(2) 
(3) 
(4) 
14. I feel indecisive 
(1) 
(2) 
(3) 
(4) 
15. I am relaxed 
(1) 
(2) 
(3) 
(4) 
16. I feel content. 
(1) 
(2) 
(3) 
(4) 
17. I am worried 
(1) 
(2) 
(3) 
(4)  
18. I feel confused 
(1) 
(2) 
(3) 
(4) 
19. I feel steady 
(1) 
(2) 
(3) 
(4) 
20. I feel pleasant. 
(1) 
(2) 
(3) 
(4) 
 
 Not 
all 1 
 2 
3 
 4 
 Very 
much 5 
I am worried the about anesthetics 
 
 
 
 
 
 The anesthetics is on my mind continually 
 
 
 
 
 
. I would like to know as much as possible 
about the anesthetic 
 
 
 
 
 
I am worried about the procedure. 
 
 
 
 
 
The procedure is on my mind continually. 
 
 
 
 
 
 I would like to know as much as possible 
about the procedure 
 
 
 
 
 

 
 
 
Exclusion criteria: 
Female patients who are pregnant or breastfeeding  
Patients with systemic problems 
Patients with mental or neurological disorders 
Patients taking antidepressants 
Patients with cardiovascular problems 
Sample Selection and the statistical method to be used: 
Since the study population was not known, the power and sample level of the study were calculated 
with reference to the study of Bohluli (2011).  Bohluli (2011) studied with n=20 patients in his study. 
According to the study of Bohluli (2011), it is seen that n=20 patients planned to be included in the 
study planned the study with 90% power (in studies, values of 0.70 and above are considered valid 
and 0.80 is considered to be quite sufficient). In the study, it was determined that the effect size level 
was 0.42.  The study is planned to be conducted on a total of 40 patients. The groups were determined 
equally as Group 1 (IAS / less than 1 mm distance) n=10, Group 2 (IAS / more than 1 mm distance) 
n=10, Group 3 (IAS / less than 1 mm distance) n=10 and Group 4 (IAS / more than 1 mm distance) 
n=10.   
Regarding the analysis of the data; descriptive statistics will be presented with mean-d.deviation, 
median-IQR, frequency and percentage values. In order to examine whether the measurements in the 
study are different according to the characteristics of the study groups, independent Mann Wihtney 
U test and Kruskall Wallis test analyses are considered. Paired Wilcoxon test and Friedman test 
analysis can be applied in the evaluations of repeated measurements. In determining the times that 
are significant as a result of Friedman test, it is considered to be determined by All-pairwise method. 
Spearman correlation analysis will be applied to examine the relationships between the measurement 
values of the groups. Chi-square analysis will be performed for the proportional evaluations of the 
groups. In the study, p values less than 0.05 are considered significant. The analyses will be analysed 
with SPSS 25.0. Power level and effect size calculations calculated in the study were determined with 
G*PowerVersion 3.1.7. 
 
List of References 
1. 
Schaller, B., Probst, R., Strebel, S., & Gratzl, O. (1999). Trigeminocardiac reflex during 
surgery in the cerebellopontine angle. Journal of neurosurgery, 90(2), 215-220. 
2. 
Aschner, B. (1908). Ueber einen Bisher noch nicht Beschriebenen Reflex vom Auge auf 
Kreislauf und Atmung: Verschwinden des Radialispulses bei Druck auf das. Review of Oculocardiac 
Reflex When Facial Surgery. 
3. 
James, I., Huang, S., Yu, H. C., & Chang, Y. C. (2017). Occurrence of trigeminocardiac reflex 
during dental implant surgery: an observational prospective study. Journal of the Formosan Medical 
Association, 116(10), 742-747. 
4. 
James, I., Huang, S., Chang, H. H., Lin, C. P., Liao, W. C., Kao, C. T., & Huang, T. H. (2018). 
Trigeminocardiac reflex during non-surgical root canal treatment of teeth with irreversible pulpitis. 
Journal of the Formosan Medical Association, 117(6), 512-517. 
5. 
Meuwly, C., Golanov, E., Chowdhury, T., Erne, P., & Schaller, B. (2015). Trigeminal cardiac 
reflex: new thinking model about the definition based on a literature review. Medicine, 94(5). 

 
 
 
6. 
Bohluli, B., Schaller, B. J., Khorshidi-Khiavi, R., Dalband, M., Sadr-Eshkevari, P., & Maurer, 
P. (2011). Trigeminocardiac reflex, bilateral sagittal split ramus osteotomy, Gow-Gates block: a 
randomized controlled clinical trial. Journal of oral and maxillofacial surgery, 69(9), 2316-2320. 
7. 
Mhamunkar, P. A., Kolari, V., & Sequeira, J. (2022). Evaluation of Trigeminocardiac Reflex 
in Patients Undergoing Elevation of Zygomatic Fractures. Cureus, 14(2). 
8. 
Elsayed, S. A. H., Hegab, A. F., & Alkatsh, S. S. Y. (2019). Does surgical release of TMJ 
bony ankylosis increase the risk of trigeminocardiac reflex? A retrospective cohort study. Journal of 
Oral and Maxillofacial Surgery, 77(2), 391-397. 
9. 
Edmondson, H. D., Gordon, P. H., Lloyd, J. M., Meeson, J. E., & Whitehead, F. I. H. (1978). 
Vasovagal episodes in the dental surgery. Journal of Dentistry, 6(3), 189-195 
10. 
Alemany-Martínez, A., Valmaseda-Castellón, E., Berini-Aytés, L., & Gay-Escoda, C. (2008). 
Hemodynamic changes during the surgical removal of lower third molars. Journal of oral and 
maxillofacial surgery, 66(3), 453-461. 
11. 
ARLI, Ş. K. (2017). Ameliyat öncesi anksiyetenin APAIS ve STAI-I ölçekleri ile 
değerlendirilmesi. Hacettepe Üniversitesi Hemşirelik Fakültesi Dergisi, 4(3), 38-47. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
KÜTAHYA HEALTH SCIENCES UNIVERSITY RECTORATE INTERVENTIONAL CLINICAL 
RESEARCH ETHICS COMMITTEE APPLICATION FORMS 
 
1. 
APPLICATION PETITION 
 
2. 
APPLICATION CONTENT FORM 
 
3. 
APPLICATION FORM 
 
4. 
CONTRACT 
 
 
4.       RESEARCH BUDGET  
 
 
5.       CVS  
 
6.      INFORMED CONSENT FORM   
 
7.      MATERIAL PURCHASE CONSENT FORM  (if necessary) 
 
8.      QUESTIONNAIRE ETC. FORMS USED  
 
9.      APPROVAL CERTIFICATE OF THE RELEVANT DEPARTMENT HEAD / HEAD OF THE 
MAIN DISCIPLINE / LABORATORY SUPERVISORS 
 
10.    INSTITUTIONAL PERMISSION CERTIFICATE     
 
11.    CONFIRMATION WRITTEN THAT YOU ARE A STUDENT OF THE RELATED 
INSTITUTE (if the research is a thesis and the researcher is a student of the institute) 
 
12.    3 PUBLICATIONS RELATED TO RESEARCH 
 
13.    DATA SECURITY AGREEMENT (For necessary researches) 
 
14.    GCP, GLP AND HELSINKI DECLARATION COMMITMENT       
           
 
15.   Delivery of the application file to the Ethics Committee secretariat 
 
 
Tick the relevant boxes with a cross. 
 
Researches with incomplete application forms will not be evaluated.  
I undertake that I have submitted all documents completely. 
 
Title of the Study : Evaluation of trigeminocardiac reflex development during extraction of 
mandibular impacted wisdom teeth 
Responsible Researcher: Asst. Professor Bedreddin Cavlı 
Signature and Date : 
 
 
 
 
 

 
 
 
 
 
KÜTAHYA HEALTH SCIENCES UNIVERSITY RECTORATE INTERVENTIONAL CLINICAL 
RESEARCH ETHICS COMMITTEE CLINICAL RESEARCH APPLİCATİON FORM 
 
 
 
 
A. SUMMARY OF RESEARCH 
Supportive 
DDS, Asst. Professor, Bedreddin Cavlı  
bedreddin.cavlı@ksbu.edu.tr 
05051590606 
Legal 
representative 
DDS, Asst. Professor, Bedreddin Cavlı  
Tittle of the 
research 
Evaluation of trigeminocardiac reflex development during extraction 
of mandibular impacted wisdom teeth 
Protocol code 
 - 
Status of research 
National 
− For academic purposes (Individual research project)   
Nature of the 
research 
− Method clinical trial 
Phase of 
− It is not a phase study. 
Investigated 
medical condition 
or disease 
Investigation of the frequency of trigeminocardiac reflex development 
during extraction of mandibular impacted wisdom teeth 
Research 
methodology 
In mandibular impacted wisdom tooth extractions, patients will be 
monitored (heart rate, blood pressure, oxygen saturation) and 
trigeminocardiac reflex development will be followed. 
Place of production 
Research product will not be used . 
Comparison 
product / method 
Research product will not be used 
Place of production 
Research product will not be used 
Placebo 
Research product will not be used 
Place of production 
Research product will not be used 
Research 
arms(Arms- 
Interventions)  
The study will include impacted wisdom teeth in the mandible. There 
will be 2 separate groups with the 2 most commonly used anaesthetic 
techniques (gow-gates (GG)/inferior alveolar nerve block (IAS)). The 

 
 
 
tooth roots will be categorised as those that are between 1 mm and 
more than 1 mm closer to the nervus alveolaris inferior (Y-1) or more 
than 1 mm further away (Y-2).  The research arms were planned as 
GG/Y-1, GG/Y-2, IAS/Y-1 and IAS/Y-2. 
Purpose of the 
research 
Trigeminocardiac reflex (TCR) was introduced to the scientific 
literature as an oculocardiac reflex with strabismus surgeries (1). In 
cases in which the V1 branch of the trigeminal nerve formed the afferent 
pathway, a clinical phenomenon in which vagal stimulation findings 
were 
observed 
was 
encountered. 
Since 
its 
publication 
in 
ophthalmological surgery in 1908, it has become a clinical picture well 
known to ophthalmologists and anaesthesiologists (2). The mastery and 
experience of the anaesthetist is of great importance in this picture 
which is met by manipulation of the ocular muscles. Recognition that 
the picture is a brainstem reflex involving the vagal pathway is critical 
in mastering the clinical situation. In the literature, it has been reported 
that V2 and V3 branches of the trigeminal nerve can also produce the 
reflex picture and the reflex can also be observed under local 
anaesthesia (3,4). The reflex is diagnosed with haemodynamic data 
(blood pressure, heart rate) which can be monitored non-invasively 
under local anaesthesia as well as under general anaesthesia. 
 
TCHR is a physiological, life-threatening response characterised by 
sudden onset of severe bradycardia, hypotension and asystole, in which 
parasympathetic activation of the heart is observed with stimulation of 
the vagal nerve as a result of stimulation of any of the three branches of 
the trigeminal nerve (1).  It is defined as a decrease in heart rate and 
mean arterial blood pressure by more than 20% compared to baseline or 
a heart rate of less than 60 beats per minute due to intraoperative traction 
or manipulation of the trigeminal nerve. The patients are normotensive 
or hypotensive (5). The afferent branch of the TKR arc is formed by the 
sensory nerve endings of the fifth cranial nerve and neuronal signals are 
sent to the trigeminal sensory nucleus via the Gasserian ganglion. The 
sensory nucleus of the afferent reflex branch of the trigeminal nerve is 
connected to the efferent pathway via short internuncial fibres in the 
reticular formation with the more distant motor nucleus of the vagus 
nerve. Cardioinhibitory efferent fibres originate from the motor nucleus 
of the vagus nerve and transmit vagus-mediated negative chronotropic 
and inotropic responses to the heart, terminating in the myocardium.  
In the maxillofacial surgery literature, there are case reports reporting 
the development of trigeminocardiac reflex in orthognathic surgery, 
dental implant surgery and maxillofacial trauma surgery and prevalence 
studies for major surgeries (6,7,8). Haemodynamic changes and 
neurological-based emergencies (e.g. vasovagal syncope) are quite 

 
 
 
common in routine oral surgical procedures performed under local 
anaesthesia (9). 
In addition, in a study, a significant decrease in heart rate and blood 
pressure occurred during extraction of posterior mandibular teeth and it 
was pointed out that this may be related to the trigeminocardiac reflex 
(10).  Extraction of impacted wisdom teeth is one of the commonly 
performed procedures in the field of oral and maxillofacial surgery. To 
the best of our knowledge, there is no study in the literature evaluating 
the development of TCR during mandibular impacted wisdom tooth 
extraction.  
Our aim was to investigate the trigeminocardiac reflex during oral 
surgical procedures routinely performed under local anaesthesia. Our 
reasons for choosing mandibular impacted wisdom tooth surgery 
among oral surgeries for this purpose are; the proximity of the inferior 
alveolar nerve, which is the largest terminal branch of the V3 branch of 
the trigeminal nerve, to the tooth roots and the frequent observation of 
traction on the nerve, the fact that there may be differences in the depth 
of effect between anaesthetic techniques due to the variation of the 
mandibular nerve, and our clinical experience. There is no study in the 
literature evaluating the development of trigeminocardiac reflex during 
surgical treatment of mandibular wisdom teeth. 
Scope of the 
research 
The study will be conducted on patients referred to KSBÜ Faculty of 
Dentistry, Department of Oral, Dental and Maxillofacial Surgery from 
Oral, Dental and Maxillofacial Radiology, who have an indication for 
extraction of impacted mandibular wisdom teeth under local anesthesia, 
who will undergo extraction of impacted wisdom teeth for the first time, 
who agree to have the surgical extraction of these teeth performed at 
KSBÜ Faculty of Dentistry, Department of Oral, Dental and 
Maxillofacial Surgery and who agree to participate in the study. 
If there is a clinical necessity, cone beam computed tomography will be 
taken to evaluate the relationship of impacted wisdom teeth with the 
nervus alveolaris inferior and to evaluate their localization in the 
mandible in three dimensions. In patients who do not need tomography, 
the evaluation will be performed with Orthopantomogram film. The 
distance of the relevant wisdom tooth roots from the inferior alveolar 
nerve will be recorded. 
During the procedure, Gow-Gates and nervus alveolaris inferior 
anesthesia techniques, which are the two most commonly used local 
anesthesia techniques in oral, dental and maxillofacial surgery practice, 
will be applied for the extraction of mandibular impacted teeth.  
Patients will be divided into 2 groups according to the proximity of the 
wisdom tooth roots to the inferior alveolar nerve (1 mm and closer to 
the nerve / more than 1 mm away from the nerve) and 2 groups 
according to the anesthesia technique to be applied (Gow-Gates Block 
- Inferior alveolar block). Total research arm is 4. 

 
 
 
In the research arms we have established, the follow-up of TKR that 
may occur during the procedure will be provided by monitoring the 
patients (Contec Medical Systems, Hebei, China.) Heart rate, systolic 
and diastolic blood pressure, oxygen saturation will be recorded during 
the procedure. The records will be taken in 4 stages: before starting the 
surgical procedure, during the application of local anesthesia, during the 
incision, during the elevation of the crown and root. Sudden changes 
that occur during the procedure will be recorded together with the 
process in which they occur.  
(e.g. during local anesthesia)  
Initial heart rate: 80 beats/min  
End of procedure heart rate: 78 beats/min 
Sudden presence of bradycardia or tachycardia during the procedure;  
Sudden change in heart rate: 80>58 or 80>98) 
 
During extraction of impacted wisdom teeth, a 20% decrease in heart 
rate and a decrease in heart rate below 60 will be considered as the 
development of TCR in parallel with the literature.   The prevalence of 
TKR will be evaluated in 4 separate groups according to whether Gow-
Gates anesthesia or nervus alveolaris inferior anesthesia is applied and 
whether the wisdom teeth are closer than 1 mm and 1 mm or further 
than 1 mm from the nervus alveolaris inferior. 
During mandibular impacted wisdom tooth extraction, patients will be 
monitored and the following parameters will be evaluated: 
1. Systolic blood pressure 
2. Diastolic blood pressure 
3. Oxygen saturation 
4. Heart rate 
 
The anxiety level of the patients will be assessed with the Amsterdam 
Preoperative Anxiety and Information Score Scale (APAIS) and State-
Trait Anxiety Inventory (STAI-S) in order to differentiate TKR from 
common neurological emergencies (e.g. vasovagal syncope) due to 
dental phobia.  State Anxiety Scale was developed in 1970 and its 
Turkish form was adapted in 1983 and validity and reliability study 
was conducted.  APAIS was translated into Turkish for the first time 
in our country in 2007 and it was found that APAIS and STAI-S were 
correlated with each other in the studies conducted(11). 
 
References 

 
 
 
1. Schaller, B., Probst, R., Strebel, S., & Gratzl, O. (1999). 
Trigeminocardiac reflex during surgery in the cerebellopontine 
angle. Journal of neurosurgery, 90(2), 215-220. 
2. Aschner, B. (1908). Ueber einen Bisher noch nicht Beschriebenen 
Reflex vom Auge auf Kreislauf und Atmung: Verschwinden des 
Radialispulses bei Druck auf das. Review of Oculocardiac 
Reflex When Facial Surgery. 
3. James, I., Huang, S., Yu, H. C., & Chang, Y. C. (2017). 
Occurrence of trigeminocardiac reflex during dental implant 
surgery: an observational prospective study. Journal of the 
Formosan Medical Association, 116(10), 742-747. 
4. James, I., Huang, S., Chang, H. H., Lin, C. P., Liao, W. C., Kao, 
C. T., & Huang, T. H. (2018). Trigeminocardiac reflex during 
non-surgical root canal treatment of teeth with irreversible 
pulpitis. Journal of the Formosan Medical Association, 117(6), 
512-517. 
5. Meuwly, C., Golanov, E., Chowdhury, T., Erne, P., & Schaller, B. 
(2015). Trigeminal cardiac reflex: new thinking model about the 
definition based on a literature review. Medicine, 94(5). 
6. Bohluli, B., Schaller, B. J., Khorshidi-Khiavi, R., Dalband, M., 
Sadr-Eshkevari, P., & Maurer, P. (2011). Trigeminocardiac 
reflex, bilateral sagittal split ramus osteotomy, Gow-Gates 
block: a randomized controlled clinical trial. Journal of oral and 
maxillofacial surgery, 69(9), 2316-2320. 
7. Mhamunkar, P. A., Kolari, V., & Sequeira, J. (2022). Evaluation 
of Trigeminocardiac Reflex in Patients Undergoing Elevation of 
Zygomatic Fractures. Cureus, 14(2). 
8. Elsayed, S. A. H., Hegab, A. F., & Alkatsh, S. S. Y. (2019). 
Does surgical release of TMJ bony ankylosis increase the risk 
of 
trigeminocardiac 
reflex? 
A 
retrospective 
cohort 
study. Journal of Oral and Maxillofacial Surgery, 77(2), 391-
397. 
9. Edmondson, H. D., Gordon, P. H., Lloyd, J. M., Meeson, J. E., 
& Whitehead, F. I. H. (1978). Vasovagal episodes in the dental 
surgery. Journal of Dentistry, 6(3), 189-195 
10. Alemany-Martínez, A., Valmaseda-Castellón, E., Berini-Aytés, 
L., & Gay-Escoda, C. (2008). Hemodynamic changes during the 
surgical removal of lower third molars. Journal of oral and 
maxillofacial surgery, 66(3), 453-461. 
11. ARLI, Ş. K. (2017). Ameliyat öncesi anksiyetenin APAIS ve 
STAI-I ölçekleri ile değerlendirilmesi. Hacettepe Üniversitesi 
Hemşirelik Fakültesi Dergisi, 4(3), 38-47. 

 
 
 
Design of the 
research 
Cross-sectional, prospective cohort 
Volunteer group 
- 
Healthy volunteers 
- 
 Male 
- 
 Women 
- 
Adults 
Volunteer age 
range 
 18-30 age range 
Volunteers 
Total 
40 
Distribution 
GG/Y-1 --- n=10 
GG/Y-2 --- n=10 
İAS/Y-1 --- n=10 
İAS/Y-2 --- n=10 
Inclusion criteria: 
 
Patients aged 18-30 years 
Patients without any systemic problems 
Patients with an indication for extraction of mandibular wisdom teeth 
Patients have no previous experience of impacted tooth extraction 
 
  Exclusion criteria 
Female patients who are pregnant or breastfeeding  
Patients with systemic problems 
Patients with mental or neurological disorders 
Patients taking antidepressants 
Patients with cardiovascular problems 
 
Duration of 
research 
Duration of 
research 
Total  
3 months 
Volunteer 
Recruitment Start 
(Beginning of the 
research) 
 
  
Volunteer 
Recruitment End 
 
   
  
Endpoint 
The study will be finalised when information on the relevant 
parameters is obtained from 40 patients during the extraction of 
mandibular impacted teeth. . 

 
 
 
Evaluation of 
results 
(Outcome/Endpoint) 
During extraction of impacted wisdom teeth, a 20% decrease in heart 
rate and a decrease in heart rate below 60 will be considered as the 
development of TCR in parallel with the literature. The prevalence of 
TKR will be evaluated in 4 separate groups according to whether Gow-
Gates anaesthesia or nervus alveolaris inferior anaesthesia is applied 
and whether the wisdom teeth are closer than 1 mm and 1 mm or further 
than 1 mm from the nervus alveolaris inferior. 
During mandibular impacted wisdom tooth extraction, patients will be 
monitorised and the following parameters will be evaluated: 
1. Systolic blood pressure 
2. Diastolic blood pressure 
3. Oxygen saturation 
4. Heart rate 
Patients will be asked to fill out the Situational Anxiety Inventory 
(STAI-S) and the Amsterdam Preoperative Anxiety and Information 
Scale (APAIS) forms before the procedure in order to evaluate the 
relationship between the haemodynamic changes that may occur and 
anxiety.. 
Statistical Analysis 
Since the study population was not known, the power and sample level 
of the study were calculated with reference to the study of Bohluli 
(2011).  Bohluli (2011) studied with n=20 patients in his study. 
According to the study of Bohluli (2011), it is seen that n=20 patients 
planned to be included in the study planned the study with 90% power 
(in studies, values of 0.70 and above are considered valid and 0.80 is 
considered to be quite sufficient). In the study, it was determined that 
the effect size level was 0.42.  The study is planned to be conducted on 
a total of 40 patients. The groups were determined equally as Group 1 
(IAS / less than 1 mm distance) n=10, Group 2 (IAS / more than 1 mm 
distance) n=10, Group 3 (IAS / less than 1 mm distance) n=10 and 
Group 4 (IAS / more than 1 mm distance) n=10.   
Regarding the analysis of the data; descriptive statistics will be 
presented with mean-d.deviation, median-IQR, frequency and 
percentage values. In order to examine whether the measurements in the 
study are different according to the characteristics of the study groups, 
independent Mann Wihtney U test and Kruskall Wallis test analyses are 
considered. Paired Wilcoxon test and Friedman test analysis can be 
applied in the evaluations of repeated measurements. In determining the 
times that are significant as a result of Friedman test, it is considered to 
be determined by All-pairwise method. Spearman correlation analysis 
will be applied to examine the relationships between the measurement 
values of the groups. Chi-square analysis will be performed for the 
proportional evaluations of the groups. In the study, p values less than 
0.05 are considered significant. The analyses will be analysed with 

 
 
 
SPSS 25.0. Power level and effect size calculations calculated in the 
study were determined with G*PowerVersion 3.1.7. 
 
Coordinator 
Coordinating centre 
Kütahya Health Sciences 
University Faculty of Dentistry 
Department of Oral, Dental and 
Maxillofacial Surgery Kütahya 
Health Sciences University 
Faculty of Dentistry Department 
of Oral, Dental and Maxillofacial 
Surgery 
Coordinator 
(principal investigator in single-
centre studies) 
  Bedreddin Cavlı 
 Contact 
+905051590606 
bedreddin.cavlı@ksbu.edu.tr 
Administrative 
Responsible 
(if applicable) 
Name and surname 
 - 
Place of assignment 
 - 
Contact 
 - 
Research centres 
 
Research centres 
Principal Investigator 
(Area of Expertise) (Telephone) 
1 
Kütahya Health Sciences University 
Faculty of Dentistry Oral, Dental and 
Maxillofacial Surgery 
Bedreddin Cavlı 
+905051590606 
 
Information for bioavailability/bioequivalence studies 
Licence status 
Not a bioavailability/bioequivalence study. 
Analytical 
centre/department 
Not a bioavailability/bioequivalence study. 
Tested research 
product 
Not a bioavailability/bioequivalence study. 
Reference product 
Not a bioavailability/bioequivalence study. 
Study design 
Not a bioavailability/bioequivalence study. 
Working periods 
Not a bioavailability/bioequivalence study. 
Previous studies 
Not a bioavailability/bioequivalence study. 
Properties of active substance 
 

 
 
 
 
 
 
 
 
Resolution 
No active substance will be used. 
Bioavailability 
No active substance will be used. 
AUC 
No active substance will be used. 
Cmax 
No active substance will be used. 
tmax 
No active substance will be used. 
Elimination Half 
Life (t1/2) 
No active substance will be used. 
Volume of 
Dispersion 
No active substance will be used. 
Binding to Proteins 
No active substance will be used. 
Food Effect 
No active substance will be used. 
Metabolism and 
Metabolites 
No active substance will be used. 
Breakthrough 
No active substance will be used. 
Accumulation 
No active substance will be used. 
Blood collection 
times 
No active substance will be used. 
Substance covered 
by biosafety 
No active substance will be used. 
Intra-individual 
variability constant 
of the active 
substance (%CV) 
No active substance will be used. 
Substance to be 
analysed 
No active substance will be used. 

 
 
 
B. OTHER INFORMATION 
Risk / Benefit evaluation 
There were no risk factors related to the study. 
In this study, the development of trigeminocardiac reflex, which is an important issue during the 
extraction of impacted wisdom teeth and can be life-threatening in some cases, will be evaluated 
and important information about the frequency of trigeminocardiac reflex will be obtained. 
Sensitive population/Vulnerable Group  (Vulnerable subjects) 
No sensitive population/vulnerable groups. 
Payment to volunteers 
Volunteers will not receive any payment. 
Volunteer services 
Volunteers will not receive any payment.. 
 
Research / volunteer documents (additional documentation and recruitment procedure)  
In the study, patient cards will be created to note the age, gender, distance of the mandibular 
impacted wisdom teeth to the nervus alveolaris, systolic-diastolic blood pressure, heart rate, 
oxygen saturation and changes in these during the procedure.  
At the same time, STAI-S (Situational Anxiety Test) and APAIS (Amsterdam Preoperative 
Anxiety and Information Form) will be used in adult patients to evaluate stress-anxiety and 
trigeminocardiac reflex development.   The study will be conducted by including patients 
referred to KSBU Faculty of Dentistry, Department of Oral, Dental and Maxillofacial Surgery 
from Oral, Dental and Maxillofacial Radiology. 

 
 
 
Independent data monitoring committee 
There is no independent data monitoring committee in the study. 
Sub-study 
There is no sub-study in the research. 
Biological material management 
Biological material will not be transferred. 
Facility / laboratory 
 No central technical facilities or laboratories will be used in the study 
 
Delegation of tasks 
There are no delegated duties. 
 

 
 
 
Referral to other health authorities  
There is no other country where research has been approved  
Research-specific information 
The trigeminocardiac reflex has been overshadowed by other vasovagal reflexes and is a well-
defined clinical picture in ophthalmology. We believe that it should attract more attention in oral 
surgery where procedures are usually performed under local anaesthesia. 
The study includes the addition of monitoring of patients to the treatment processes routinely 
performed in our clinic. 

 
 
  
C. RESEARCH TEAM LIST 
 
  
 
 
 
 
Centre Name 
Kütahya Health Sciences University Faculty of Dentistry Oral, Dental and Maxillofacial Surgery 
Address 
 İstiklal Neighbourhood Lala Hüseyin Paşa Street No:271 43100 KÜTAHYA 
Mission 
Name Surname 
Title 
Education 
İKU Training 
(present/absent)) 
Principal Investigator 
Bedreddin Cavlı 
Asst. Professor 
Oral and Maxillofacial Surgery 
None 
Assistant Researcher 
Aykut Şaylığ 
Resarch Asst 
Oral and Maxillofacial Surgery 
None 
Assistant Researcher 
Şeyma Kale 
Resarch Asst 
Oral and Maxillofacial Surgery 
None 
Counsellor  
Necmiye Şengel 
Asst.  Professor 
Anaesthesiology and Reanimation 
None 
Counsellor 
Ziver Ergun Yücel 
Professor 
Oral and Maxillofacial Surgery 
None 

 
 
  
 
   
 
 
 
 
D. RESEARCH DESIGN DIAGRAM 
           
 
Scanning                     Cross-Sectional Scan                 Intraoperative Measurements 
Scanning 
 
OPG/CBCT 
Mandibular impacted wisdom teeth 1 mm and 
closer than 1 mm to the nervus alveolaris 
inferior (Y-1 group) 
 
Mandibular impacted wisdom teeth more than 1 
mm from the nervus alveolaris inferior (Y-2 
group)  
 
Patient monitoring 
1. Systolic blood pressure 
2. Diastolic blood pressure 
3. Oxygen saturation 
4. Heart rate 

 
 
  
E. ASSESSMENT CHART (Schedule of Assessments) 
 
  
 
 
Evaluation 
Tarama 
 Operasyon 
 
Informed Voluntary Consent Form   
   
 X 
 
Demographic information 
 X 
   
 
Medical history/ General physical 
examination 
X 
  
 
Clinical data 
  
X 
 
CBCT 
X 
  
 
Inclusion/exclusion criteria  
X 
  
 
Intra-op data 
  
 X 
 

 
  
 
  
 
 
F. ETHICS COMMITTEE INFORMATION 
☒ There is a previous rejection decision by the ethics committee of the research 
Name of the ethics 
committee 
Kütahya Health Sciences University Non-Interventional Clinical 
Research Ethics Committee 
Date of decision 
 
Decision no. 
 
This section must be filled in when applying to the Turkish Medicines and Medical Devices Agency. 
☐ Ethics committee application was made for approval of the research 
Name of the ethics 
committee 
- 
Application date 
- 
☐ There is ethics committee approval for the research.. 
Name of the ethics 
committee 
 - 
Date of decision 
- 
Decision no. 
- 
 
G. RELATED DOCUMENTS 
1. Research protocol 
2. Protocol signature page (signed by the coordinator in multicentre studies and the principal 
investigator in single-centre studies)Bilgilendirilmiş gönüllü olur formu (BGOF) 
3. Research brochure  
4. Case report form 
5. Insurance documents 
6. (insurance certificate, insurance policy, insurance endorsements, general and special 
conditions of the policy) 
7. Research budget form 
8. CVs  
9. (of the principal investigators) 
10. Authorisation documents (if valid) 
11. (with Turkish translations certified by a notary public or sworn translator) 
12. Research team documents (if applicable) 
13. (all documents used only by the research team or used to inform the research team, such as 
application instructions, information texts, doctors' letters, etc.) 
14. Volunteer documents (if applicable) 

 
  
 
  
 
 
15. (patient card, patient diary, questionnaire, instructions for use, application instructions, 
information texts, posters, brochures, information documents explaining the intended use of 
the materials to be given to volunteers (electronic diary, cooler bag, etc.)) 
16. Ethics committee decision (original and certified copy of the original) 
17. Research product file (if required) 
18. GMP Certificate/Document (apostilled) (if applicable)  
19. If the research is for academic purposes, a wet signed document approved by an authorised 
person other than the applicant stating that the research is for academic purposes 
Only for bioavailability/bioequivalence studies; 
20. Certificate of supply of the investigational product and reference product(s)  
(invoice/package photocopy with serial number and expiry date) 
21. Certificate of analysis of the research product 
 
H. DOCUMENTS TO BE PHYSICALLY SUBMITTED 
This section is only valid for applications to the Turkish Medicines and Medical Devices Agency.  
All interested parties who are users of the Electronic Application System of the Agency must make 
their applications through the system. Documents that do not need to be physically submitted are 
submitted only through the Electronic Application System. The scanned versions of the documents 
that need to be physically submitted are submitted through the Electronic Application System; the 
originals are submitted by submitting them to the document unit of the Agency. 
For applications made by real persons who are not users of the Electronic Application System of 
the Institution, all documents must be submitted physically. 
The following documents should be submitted physically with wet signatures or preferably with 
electronic signatures.  
1. Ethics committee decision 
It is essential to submit the following documents with electronic signatures through the 
electronic application system. However, if these documents cannot be submitted with 
electronic signatures, their wet signed versions can be physically submitted.  
1. 
Research budget form 
2. 
Insurance documents 
3. 
Authorisation certificate 
4. 
CV 
5. 
Protocol signature page 
6. 
Proof that the research is for academic purposes 
7. 
GMP certificate/document (apostilled) 1 
 
İ. SIGNATURE OF THE APPLICANT 
• All documents attached to the application file are identical to the original,  
• The information provided in the application is correct, 
• The research will be conducted in accordance with the protocol, relevant legislation, the 
current Helsinki Declaration and the principles of good clinical practice, 

 
  
 
  
 
 
• The investigational product (including placebo) is manufactured in accordance with GMP 
rules, 
• The Turkish label sample of the investigational product (including placebo) was prepared in 
accordance with GMP guidelines, 
• That the research team (including laboratory team, research nurse, research pharmacist, etc.) 
is informed about the research 
• That the proposed clinical trial is feasible, 
• The research application is not made to more than one of the ethics committees established 
within the scope of the relevant Regulation at the same time, 
• The progress of the research will be reported at least annually (with an annual notification 
form), 
• Reports on serious adverse events/reactions and periodic safety reports will be submitted 
inaccordance with the periods specified in the legislation, 
• That the research is recorded in a public database, provided that the confidentiality of personal 
data is respected, 
• The publication of the information and research results of the research in a public database by 
the Authority, provided that the confidentiality of trade secrets and personal data is respected 
within the conditions determined by the Authority, 
I agree and undertake to submit a copy of the summary of the final report within a maximum period 
of 1 (one) year after the end of the research (in all countries, if it is an international research). 
Name and surname 
Bedreddin Cavlı 
Telephone number 
+905051590606 
Email address 
bedreddin.cavlı@ksbu.edu.tr 
Date (in days/months/years) 
 
Signature 
 
 
 
 
 
 
 
 
 
 
 
 

 
  
 
  
 
 
 
 
KÜTAHYA HEALTH SCIENCES UNIVERSITY RECTORATE INTERVENTIONAL 
CLINICAL RESEARCH ETHICS COMMITTEE RESEARCHERS CV FORM  
 
A.  PERSONAL INFORMATION  
Name Surname 
Bedreddin Cavlı 
Academic title/position 
Asst. Professor 
Place of assignment 
Kütahya Health Sciences University Faculty of Dentistry 
Department of Oral and Maxillofacial Surgery 
Telephone number 
 05051590606 
Email address 
bedreddin.cavlı@ksbu.edu.tr 
 
 
B. EDUCATION INFORMATION  
  
Year 
Section 
Institution 
Degree 
2015 
Faculty of Dentistry 
Selcuk University 
- 
2020 
Department of Oral and 
Maxillofacial Surgery 
Gazi University 
- 
 
 
C. INFORMATION ON WORK EXPERIENCE 
  
Date Range 
Institution 
Mission 
2021-... 
Kütahya University of Health Sciences / Department of Oral 
and Maxillofacial Surgery 
 Asst. Professor 
2021 
Eskisehir Oral and Dental Health Hospital 
Specialist Dentist 
2016-2020 
Gazi University / Department of Oral and Maxillofacial 
Surgery 
Research Asst. 
 
 
D. GENERAL INFORMATION ABOUT CLINICAL RESEARCH 
 
4. Training/certificate information on Good Clinical Practices (GCP) and clinical research: 
If there is a certificate regarding the training you have received, please attach a copy. 
Name and place of training/certificate 
Date 
 - 
-  
  
  
5. Clinical research information: 

 
  
 
  
 
 
Responsible Investigator, Co-Investigator, Co-ordinator, Field Officer, Monitor, Pharmacist, 
etc. should be specified. 
Write the information in this section in date order. 
Clinical research 
 Date Range 
Mission 
 - 
 - 
-  
 
 
E. SIGNATURE OF THE CV OWNER 
I accept and declare that the information I have declared above is correct and up-to-date and that I will 
comply with the provisions of the relevant legislation and good clinical practices regarding the conduct 
of clinical trials. 
Name Surname 
Bedreddin CAVLI 
Date (in days/months/years) 
 
Signature 
 
 
A. PERSONAL INFORMATION  
Name Surname 
Aykut Şaylığ 
Academic title/position 
Research Asst 
Place of assignment 
Kütahya Health Sciences University Faculty of Dentistry 
Department of Oral and Maxillofacial Surgery 
Telephone number 
 05315643315 
Email address 
Aykut.saylıg@ksbu.edu.tr 
 
 
B. EDUCATION INFORMATION  
  
  
Year 
Section 
Institution 
Degree 
2018 
Faculty of Dentistry 
Ankara University 
 
 
 
C. INFORMATION ON WORK EXPERIENCE 
   
Date Range 
Institution 
Mission 
2020-…. 
Kütahya University of Health Sciences / Department of Oral 
and Maxillofacial Surgery 
Research Asst. 
 
 

 
  
 
  
 
 
D. GENERAL INFORMATION ABOUT CLINICAL RESEARCH  
 . 
1.Training/certificate information on Good Clinical Practices (GCP) and clinical research: 
If there is a certificate regarding the training you have received, please attach a copy: 
  
Name and place of training/certificate 
Date 
 -- 
-  
2. Clinical research information: 
Responsible Investigator, Co-Investigator, Co-ordinator, Field Officer, Monitor, Pharmacist, 
etc. should be specified. 
Write the information in this section in date order.. 
Clinical research 
 Date Range 
Mission 
- 
- 
- 
 
 
E. SIGNATURE OF THE CV OWNER 
I accept and declare that the information I have declared above is correct and up-to-date and that I will 
comply with the provisions of the relevant legislation and good clinical practices regarding the conduct 
of clinical trials. 
 
Name and Surname 
Aykut Şaylığ 
Date (in days/months/years) 
  
Signature 
 
 
 
A. PERSONAL INFORMATION  
Name Surname 
Şeyma Kale 
Academic title/position 
Research Asst 
Place of assignment 
Kütahya Health Sciences University Faculty of Dentistry 
Department of Oral and Maxillofacial Surgery 
Telephone number 
 05533618111 
Email address 
seyma.kale@ksbu.edu.tr 
 
 
B. EDUCATION INFORMATION  
  
Year 
Section 
Institution 
Degree 

 
  
 
  
 
 
2018 
Faculty of Dentistry 
Eskişehir Osmangazi University 
 
 
 
C. INFORMATION ON WORK EXPERIENCE 
   
Date Range 
Institution 
Mission 
2020-…. 
Kütahya University of Health Sciences / Department of Oral 
and Maxillofacial Surgery 
Research Asst. 
D. GENERAL INFORMATION ABOUT CLINICAL RESEARCH  
 . 
1.Training/certificate information on Good Clinical Practices (GCP) and clinical research: 
If there is a certificate regarding the training you have received, please attach a copy: 
  
Name and place of training/certificate 
Date 
 -- 
-  
2. Clinical research information: 
Responsible Investigator, Co-Investigator, Co-ordinator, Field Officer, Monitor, Pharmacist, 
etc. should be specified. 
Write the information in this section in date order.. 
Clinical research 
 Date Range 
Mission 
- 
- 
- 
 
 
E. SIGNATURE OF THE CV OWNER 
I accept and declare that the information I have declared above is correct and up-to-date and that I will 
comply with the provisions of the relevant legislation and good clinical practices regarding the conduct 
of clinical trials. 
 
Name and Surname 
Şeyma KALE 
Date (in days/months/years) 
  
Signature 
 
 
A. PERSONAL INFORMATION 
Name Surname 
Necmiye Şengel 
Academic title/position 
Asst. Professor 
Place of assignment 
Anaesthesiology and Reanimation - Gazi University Faculty of 
Dentistry 

 
  
 
  
 
 
Telephone number 
  0505 629 10 06 
Email address 
 necmiyesengel@hotmail.com 
 
 
B. EDUCATION INFORMATION . 
Year 
Section 
Institution 
Degree 
 2008 
 Faculty of Medicine 
 Gazi University 
Licence 
 2013 
Anaesthesiology and 
Reanimation 
 Gazi University 
Expertise 
 
 
C. INFORMATION ON WORK EXPERIENCE 
  
Date Range 
Institution 
Mission 
 2018 
Gazi University Faculty of Dentistry 
 Asst. Professor 
 2008-2013 
Gazi University Department of Anaesthesiology and 
Reanimation 
 Research Asst. 
 
 
D. GENERAL INFORMATION ABOUT CLINICAL RESEARCH  
 . 
1.Training/certificate information on Good Clinical Practices (GCP) and clinical research: 
If there is a certificate regarding the training you have received, please attach a copy: 
  
Name and place of training/certificate 
Date 
 -- 
-  
2. Clinical research information: 
Responsible Investigator, Co-Investigator, Co-ordinator, Field Officer, Monitor, Pharmacist, 
etc. should be specified. 
Write the information in this section in date order.. 
Clinical research 
 Date Range 
Mission 
- 
- 
- 
 
 
 
E. SIGNATURE OF THE CV OWNER 
I accept and declare that the information I have declared above is correct and up-to-date and that I will 
comply with the provisions of the relevant legislation and good clinical practices regarding the conduct 
of clinical trials.  
 
Name and Surname 
Necmiye Şengel 
Date (in days/months/years) 
 

 
  
 
  
 
 
Signature 
 
 
A. PERSONAL INFORMATION  
Name Surname 
Ziver Ergun Yücel 
Academic title/position 
Professor 
Place of assignment 
Oral and Maxillofacial Surgery- Gazi University Faculty of 
Dentistry 
Telephone number 
 0532 395 55 58 
Email address 
 erguny@gazi.edu.tr 
 
 
B. EDUCATION INFORMATION  
Year 
Section 
Institution 
Degree 
1980 
Faculty of Dentistry 
Ankara University 
 
 1984 
Department of Oral and 
Maxillofacial Surgery 
Gazi University 
 
 
 
C. INFORMATION ON WORK EXPERIENCE 
  
Date Range 
Institution 
Mission 
 1984 
 Gazi University Department of Oral and Maxillofacial 
Surgery 
 Research Asst. 
 1985 
 Gazi University Department of Oral and Maxillofacial 
Surgery 
 Asst. Profesor 
 1986 
 Department of Maxillofacial Surgery, Freie Universität 
Berlin 
 Researcher 
 1988 
 Gazi University Department of Oral and Maxillofacial 
Surgery 
 Assoc. Professor 
1991-1992 
Guys & St. Thomas Hospital, University of London 
Researcher 
1995 
Gazi University Department of Oral and Maxillofacial 
Surgery 
Profesor 
 
 
D. GENERAL INFORMATION ABOUT CLINICAL RESEARCH  
 . 
1.Training/certificate information on Good Clinical Practices (GCP) and clinical research: 
If there is a certificate regarding the training you have received, please attach a copy: 
  
Name and place of training/certificate 
Date 

 
  
 
  
 
 
 -- 
-  
2. Clinical research information: 
Responsible Investigator, Co-Investigator, Co-ordinator, Field Officer, Monitor, Pharmacist, 
etc. should be specified. 
Write the information in this section in date order.. 
Clinical research 
 Date Range 
Mission 
- 
- 
- 
 
 
 
E. SIGNATURE OF THE CV OWNER 
I accept and declare that the information I have declared above is correct and up-to-date and that I will 
comply with the provisions of the relevant legislation and good clinical practices regarding the conduct 
of clinical trials. 
 
Name and Surname 
Ziver Ergun Yücel 
Date (in days/months/years) 
 
Signature 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
  
 
  
 
 
 
 
COMMITMENT 
KÜTAHYA UNIVERSITY OF HEALTH SCIENCES 
CHAIRMAN OF THE ETHICS COMMITTEE FOR CLINICAL RESEARCH 
 
 
As the undersigned researchers participating in the study titled " Evaluation of trigeminocardiac reflex 
development during extraction of mandibular impacted wisdom teeth ", we declare and undertake that 
we have read the latest version of the World Medical Association Declaration of Helsinki and the current 
Good Clinical Practices Guide / Good Laboratory Practices Guide published by the Ministry of Health, 
that the study will be conducted in accordance with the World Medical Association Declaration of 
Helsinki, GCP / GLP, that we assume all legal and financial responsibilities that may arise in the study, 
and that all units and staff participating in the study have been informed about the study. 
 
 
 
 
Responsible Researcher: 
 
Asst. Professor Bedreddin Cavlı 
 
 
 
 
 
 
Signature 
 
 
Assistant Researcher  
Reacher Asst. Aykut Şaylığ  
 
 
 
 
 
           Signature 
 
 
Assistant Researcher  
Reacher Asst. Şeyma Kale 
 
 
 
 
 
 
           Signature 
 
 
Counsellor 
Asst. Professor Necmiye Şengel 
 
 
 
 
 
 
Signature 
 
 
Counsellor 
Professor Ergun Yücel 
 
 
 
 
 
 
 
Signature 
 
 
 
 
 
 
 

 
  
 
  
 
 
 
 
COMMITMENT 
KÜTAHYA UNIVERSITY OF HEALTH SCIENCES 
CHAIRMAN OF THE ETHICS COMMITTEE FOR CLINICAL RESEARCH 
 
 
Title of the Study: Evaluation of trigeminocardiac reflex development during extraction of mandibular 
impacted wisdom teeth  
During the above-mentioned research, I undertake that no procedure that is not included in the research 
budget and that will impose an additional burden on the volunteer or the social security institution will 
not be applied and that I will fulfil my responsibilities in this regard. 
 
 
 
Research Responsible  
Name-Surname-Title  
 
 
 
Signature 
 
Date: 
Asst. Professor Bedreddin CAVLI                                                                             
 
 
 
 
 
 
 
 
 
 
RESPONSIBLE RESEARCHER COMMITMENT FOR THE PROTECTION OF PERSONAL 
DATA 
This confidentiality undertaking ("Undertaking") has been signed on 01.09.2023 between Kütahya 
Health Sciences University Oral and Dental Health Application and Research Centre ("Centre") 
located at İstiklal Neighbourhood Lala Hüseyin Pasha Street No:271 and the principal investigator 
[Dr. Bedreddin Cavlı] residing at [KSBÜ Oral and Dental Health Application and Research Centre 
Department of Oral, Dental and Maxillofacial Surgery].  
With the Letter of Undertaking, the Employee irrevocably accepts, declares and undertakes the 
following matters, fully understanding and assimilating the consequences. 
MATTER 1 
PROTECTION OF PERSONAL DATA 
a) Within the scope of the relationship established between the Centre and the Responsible Researcher, 
the Centre processes the personal data of all employees and patients as a data processor in accordance 
with the General Data Protection Regulation  No. 6698 ("GDPR") in order to fulfil its obligations 
arising from the relevant legislation, especially Law No. 2547, to protect its justified and legitimate 

 
  
 
  
 
 
interests regarding the management of the Centre and scientific research, to fulfil its obligations to 
authorised third parties, competent administrative and judicial bodies, public institutions and 
organisations, and to ensure data security, and may be transferred to third parties, especially authorized 
public institutions and organisations, within the scope of Article 8 of the GDPR 
b) The scientific research officer and the entire team involved in the study will show the highest level 
of sensitivity and care regarding the processing and protection of personal and special quality personal 
data that they have learnt due to their duties and made available to them. In the event that the 
employee causes the disclosure of personal data or in case of security vulnerability, cyber-attack, data 
leakage or accidental loss or destruction of data in any way, the employee accepts, declares and 
undertakes that he / she will notify Kütahya University of Health Sciences, which has the title of data 
controller ("Data Controller") and the persons authorised by the Data Controller immediately and in 
writing from the date he / she becomes aware of the event in question. 
c) The Principal Investigator and the entire team involved in the study 01.10.2023 between 31.12.2023 
for the research titled " Evaluation of trigeminocardiac reflex development during extraction of 
mandibular impacted wisdom teeth ", agrees, declares and undertakes that they will not illegally record 
the personal data of any person during and after the research, that they will anonymise all data to be 
used by the patients and destroy them after the end of the data usage period, that they will forward the 
records regarding the destruction to the Centre, and that they will not illegally give, disseminate or 
seize the personal data of any person. The responsible researcher and the entire team involved in the 
study accept and declare that they are aware that the acts in question constitute a criminal offence 
under the Turkish Penal Code.  
RESPONSIBLE RESEARCHER DECLARATION 
 
RESEARCHER DECLARATION 
Asst. Professor Bedreddin Cavlı 
 
 
  
Research Assistant Aykut Şaylığ