Assessing the Frequency of Trigeminocardiac Reflex in Maxillary and Mandibular Cyst Operations
Phase: NA
Conditions: Trigeminocardiac Reflex, Jaw Cysts, Hemodynamic Instability
Sponsor: Kutahya Health Sciences University

 
 
 
  
KÜTAHYA HEALTH SCIENCES UNIVERSITY CLİNİCAL RESEARCH ETHİCS 
COMMİTTEE APPLİCATİON FORM 
 
 
 
 
 
 
STUDY NAME: ASSESSİNG THE FREQUENCY OF TRİGEMİNOCARDİAC REFLEX İN 
MAXİLLARY AND MANDİBULAR CYST OPERATİONS 
 
 
 
 
FORM DATE: December 2022 
 
 
 
NCT number: Not yet received 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
  
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 
"Assessing the Frequency of Trigeminocardiac Reflex in Maxillary and Mandibular Cyst 
Operations " 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 
Assessing the Frequency of Trigeminocardiac Reflex in Maxillary and Mandibular Cyst 
Operations 
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: 
 
                       
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: Assessing the Frequency of Trigeminocardiac Reflex in Maxillary and Mandibular 
Cyst Operations.  
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, 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 
 
Performance evaluation studies 
conducted with in vitro medical 
diagnostic devices 
 

 
 
 
  
Research hypothesis:  
µ ≠ 0 hypothesis:: The location of the cyst in the maxilla or mandible does not affect the prevalence 
of reflex during the enucleation of cystic structures. 
µ = 0 hypothesis:: The location of the cyst in the maxilla or mandible influences the prevalence of 
reflex during the enucleation of cystic structures.. 
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 
anaesthesia. (3,4). Reflex is diagnosed under local anaesthesia 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). 
 
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). Hemodynamic changes and neurological-
based emergencies (e.g. vasovagal syncope) are quite common in routine oral surgical procedures 
performed under local anesthesia (9). Our aim was to investigate the trigeminocardiac reflex in oral 
surgical procedures routinely performed under local anesthesia. For this purpose, we prefer surgery 
of maxillary and mandibular cysts primarily among oral surgeries because of the inclusion of large 
tissues in the surgical field, the proximity of the cysts to the surrounding vital units (inferior alveolar 
nerve, nasal floor, maxillary sinus floor) and our clinical experience. There are no studies in the 
Non-drug clinical research 
 
Please specify if other:   

 
 
 
literature evaluating the development of the trigeminocardiac reflex during surgical treatment of 
maxillary and mandibular cystic lesions. 
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 maxillary or mandibular 
intraosseous cystic lesion with a diameter of at least 1 cm, who accept the treatment of this lesion in KSBÜ 
Faculty of Dentistry, Department of Oral, Dental and Maxillofacial Surgery and agree to participate in the 
study.  
Surgical treatment of cystic lesions will be performed under local anesthesia.  Heart rate, systolic and diastolic 
blood pressure, oxygen saturation will be monitored and evaluated during the cyst enucleation procedure.  
Records will be made before the start of the surgical procedure, during the administration of local anesthesia, 
incision, removal of the bone barrier to reach the cystic lesion and manipulation of the nerve in the enucleation 
of lesions associated with the nervus alvelolaris inferior.  Sudden changes will be recorded as they develop 
with continuous follow-up for the relevant phase. 
In our study, trigeminocardiac reflex findings included the following criteria in parallel with the literature; a 
sudden decrease of 20% in heart rate or a decrease in heart rate below 60 per minute (1,10).   
In our study, we will compare the related afferent nerve branches (trigeminal nerve V2/V3) in terms of the risk 
of trigeminocardiac reflex development.  
Parameters to 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). 
 Amsterdam Preoperative Anxiety and Information Scale (APAIS)                                                       
 
 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  
 
 
 
 
 

 
 
 
     STAI-S  ( The State-Trait Anxiety Inventory) 
 
 
Not 
at all 
A 
littl
e 
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) 
 
Inclusion criteria: 
Adults aged 18 years and over 
Patients with cystic lesions at least 1 cm in diameter in the maxilla or mandible 
Individuals without any systemic disease 
 
Exclusion criteria: 
Female subjects who are pregnant or breastfeeding  
Presence of systemic disease 

 
 
 
Presence of mental or neurological illness 
Antidepressant use 
 
Sample selection and statistical method to be used: 
Last year, it was determined that the number of patients who applied to the Department of Oral and 
Maxillofacial Surgery for the treatment of intraosseous lesions was around n=60. With the simple random 
sampling method, it was seen that 33 patients could represent the universe with 5% error and 95% 
confidence level.  It was seen that at least 33 patients should be included in the study.  In the study of Bohluli 
(2010), which is the reference article, n=23 patients included in the study, 95% power and effect size level 
was 0.48.   In summary, it is seen that the study has sufficient power and the effect size level is quite 
sufficient.  It was planned to include 34 patients in the study in order to divide the research arms into 
balanced groups. 
Regarding the analysis of data; descriptive statistics will be presented with mean, standard deviation values.  
In order to examine whether the measurements in the study are different according to the characteristics of 
the study groups, Mann Whitney U test and Kruskall Wallis test analyses are considered.  Friedman and 
Wilcoxon sign test will be used in the evaluation of measurements to be made at different times.  Spearman 
correlation analysis will be applied to examine the relationships between measurement values.  Chi-Square 
analysis will be performed for proportional evaluations of the groups.  In the study, p values less than 0.05 
will be considered significant.  Analyses will be analyses with SPSS 25.0 .  The power level and effect size 
calculations calculated in the study were determined with G*Power Version 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., Bayat, M., Sarkarat, F., Moradi, B., Tabrizi, M. H. S., & Sadr-Eshkevari, P. (2010). 
Trigeminocardiac reflex during Le Fort I osteotomy: a case-crossover study. Oral Surgery, Oral 
Medicine, Oral Pathology, Oral Radiology, and Endodontology, 110(2), 178-181. 

 
 
 
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. Schaller, B. J., Filis, A., & Buchfelder, M. (2008). Trigemino-cardiac reflex in humans initiated by 
peripheral stimulation during neurosurgical skull-base operations. Its first description. Acta 
Neurochirurgica, 150(7), 715-718. 
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 : Assessing the Frequency of Trigeminocardiac Reflex in Maxillary and Mandibular 
Cyst Operations 
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 
Assessing the Frequency of Trigeminocardiac Reflex in Maxillary and 
Mandibular Cyst Operations 
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 
Evaluation of the frequency of trigeminocardiac reflex development during 
surgical treatment of jaw cysts 
Research 
methodology 
During the surgical treatment of cysts in the jaws, patients will be monitored 
(heart rate, blood pressure, oxygen saturation) and trigeminocardiac reflex 
development will be monitored. 
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 
  
Arms- Interventions  
Cystic lesions in the maxilla and mandible will be evaluated by comparing 
the activity of the V2 and V3 branches of the trigeminal nerve in the 
development of the trigeminocardiac reflex.  
The code Group 1 will be used for cystic lesions in the maxilla and Group 2 
will be used for cystic lesions in the mandible.  
There is no control group in the study. 

 
 
 
Purpose of the 
research 
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, a 
clinical phenomenon with vagal stimulation findings has been 
encountered.  Since its publication 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 patients are normotensive or hypotensive (5).  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.  
 
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).  Hemodynamic changes and 
neurological-based emergencies (e.g. vasovagal syncope) are quite 
common in routine oral surgical procedures performed under local 
anesthesia (9).  Our aim was to investigate the trigeminocardiac reflex 
in oral surgical procedures routinely performed under local anesthesia.  
For this purpose, we prefer surgery of maxillary and mandibular cysts 
primarily among oral surgeries because of the inclusion of large tissues 

 
 
 
in the surgical field, the proximity of the cysts to the surrounding vital 
units (inferior alveolar nerve, nasal floor, maxillary sinus floor) and our 
clinical experience.  There are no studies in the literature evaluating the 
development of the trigeminocardiac reflex during surgical treatment of 
maxillary and mandibular cystic lesions. 
 
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 maxillary or 
mandibular intraosseous cystic lesion with a diameter of at least 1 cm, 
who accept the treatment of this lesion in KSBÜ Faculty of Dentistry, 
Department of Oral, Dental and Maxillofacial Surgery and agree to 
participate in the study.  
Surgical treatment of cystic lesions will be performed under local 
anesthesia.  Heart rate, systolic and diastolic blood pressure, oxygen 
saturation will be monitored and evaluated during the cyst enucleation 
procedure.  Records will be made before the start of the surgical 
procedure, during the administration of local anesthesia, incision, 
removal of the bone barrier to reach the cystic lesion and manipulation 
of the nerve in the enucleation of lesions associated with the nervus 
alvelolaris inferior.  Sudden changes will be recorded as they develop 
with continuous follow-up for the relevant phase. 
In our study, trigeminocardiac reflex findings included the following 
criteria in parallel with the literature; a sudden decrease of 20% in heart 
rate or a decrease in heart rate below 60 per minute (1,10).  In our study, 
we will compare the related afferent nerve branches (trigeminal nerve 
V2/V3) in terms of the risk of trigeminocardiac reflex development.  
Parameters to 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). 
 

 
 
 
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., Bayat, M., Sarkarat, F., Moradi, B., Tabrizi, M. H. S., & Sadr-
Eshkevari, P. (2010). Trigeminocardiac reflex during Le Fort I osteotomy: 
a case-crossover study. Oral Surgery, Oral Medicine, Oral Pathology, 
Oral Radiology, and Endodontology, 110(2), 178-181 
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. Schaller, B. J., Filis, A., & Buchfelder, M. (2008). Trigemino-cardiac 
reflex in humans initiated by peripheral stimulation during neurosurgical 
skull-base operations. Its first description. Acta Neurochirurgica, 150(7), 
715-718 
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 
Patients aged 18 years and older 
Volunteers 
Total 
34 adults 
Distribution 
17- Patients with maxilla cyst 
17- Patients with mandibular cyst 
Inclusion criteria 
Patients over 18 years of age 
Patients with cystic lesions up to 1 cm in diameter in the maxilla and 
mandible 
Patients without any systemic problems 
Exclusion criteria 
Female patients who are pregnant or breastfeeding  
Patients with systemic problems 
Patients with mental or neurological disorders 
Patients taking antidepressants 
Duration of research 
Total  
1 year 
Volunteer 
Recruitment Start 
(Beginning of the 
research) 
 
 
Volunteer 
Recruitment End 
 
 End point 
The study will be finalised after data from 34 patients are obtained. 
Evaluation of results 
(Outcome/Endpoint) 
Heart rate, systolic and diastolic blood pressure, oxygen saturation will be 
monitored during the cyst enucleation procedure (Contec Medical Systems, 
Hebei, China).  Records during the process will be taken in 5 stages: before 
starting the surgical procedure, application of local anesthesia, incision, 
removal of the bone barrier to reach the cystic lesion, manipulation of the 
cystic lesion.  Sudden changes that occur during the process 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) 
 
Patients will be asked to complete 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 
hemodynamic changes that may occur and anxiety. 
 
Statistical Analysis 
Last year, it was determined that the number of patients who applied to the 
Department of Oral and Maxillofacial Surgery for the treatment of 
intraosseous lesions was around n=60.  With the simple random sampling 
method, it was seen that 33 patients could represent the universe with 5% error 

 
 
 
and 95% confidence level.  It was seen that at least 33 patients should be 
included in the study.  In the study of Bohluli (2010), which is the reference 
article, n=23 patients included in the study, 95% power and effect size level 
was 0.48.   In summary, it is seen that the study has sufficient power and the 
effect size level is quite sufficient.  It was planned to include 34 patients in the 
study in order to divide the research arms into balanced groups. 
Regarding the analysis of data; descriptive statistics will be presented with 
mean, standard deviation values.  In order to examine whether the 
measurements in the study are different according to the characteristics of the 
study groups, Mann Whitney U test and Kruskall Wallis test analyses are 
considered.  Friedman and Wilcoxon sign test will be used in the evaluation 
of measurements to be made at different times.  Spearman correlation analysis 
will be applied to examine the relationships between measurement values.  
Chi-Square analysis will be performed for proportional evaluations of the 
groups.  In the study, p values less than 0.05 will be considered significant.  
Analyses will be analyses with SPSS 25.0 .  The power level and effect size 
calculations calculated in the study were determined with G*Power Version 
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 
 05051590606 
bedreddin.cavlı@ksbu.edu.tr 
Administrative 
Responsible 
(if applicable) 
Name and surname 
 - 
Place of assignment 
 - 
Contact 
 - 
Research centers 
 
Research centres 
Principal Investigator 
(Area of Expertise) (Telephone) 
1 
Kütahya Health Sciences University Faculty of 
Dentistry Oral, Dental and Maxillofacial 
Surgery 
Bedreddin Cavlı 
05051590606 
 
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 are no risk factors related to the study. 
If the study is completed, it will provide important data on the frequency of trigeminocardiac reflex 
development, a serious clinical condition, in maxillofacial surgical procedures performed under local 
anaesthesia. At the same time, the effect of whether the lesion is located in the maxilla or mandible on 
reflex development will be evaluated. To our knowledge, there is no study on this subject in the literature 
and this study will provide important information to the literature for the development of 
trigeminocardiac reflex. 
Sensitive population/Vulnerable Group  (Vulnerable subjects) 
No sensitive population/vulnerable groups. 
Privacy 
In the study, the age and gender of the patients, the jaw in which the cystic lesion is located, and the 
systolic and diastolic blood pressure, heart rate, oxygen saturation and changes in them during the 
procedure will be noted. Only the research team will have access to the documents. 
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 in which we will note the age, gender of the patients, in which 
jaw the cystic lesion is located and the changes in systolic-diastolic blood pressure, heart rate, oxygen 
saturation and their changes during the procedure.  
In addition, STAI-T (Situational Anxiety Test) and APAIS (Amsterdam Preoperative Anxiety and 
Information Form) will be used to evaluate stress-anxiety and trigeminocardiac reflex development.    
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. 

 
 
 
 
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 
Dentistry-Mouth, Dental and 
Maxillofacial Surgery 
None 
Assistant Researcher 
Şeyma Kale 
Resarch Asistant 
 
Dentistry- Dental and Maxillofacial 
Surgery 
None 
Counsellor  
Necmiye Şengel 
Asst. Professor 
Anaesthesiology and Reanimation 
None 
Counsellor 
Ziver Ergun Yücel 
Professor 
Dentistry-Mouth, Dental and 
Maxillofacial Surgery 
None 
 
 
 

 
 
 
 
  
 
 
 
 
D. RESEARCH DESIGN DIAGRAM 
           
 
Scanning                      Cross-Sectional Scan                 Intraoperative Measurements 
Scanning 
OPG/CBCT 
Maxillary cystic lesions (Max group)  
Mandibular cystic lesions (Mand group)  
Patient monitoring 
1. Systolic blood pressure 
2. Diastolic blood pressure 
3. Oxygen saturation 
4. Heart rate  

 
 
 
 
 
E. ASSESSMENT CHART (Schedule of Assessments) 
 
  
 
 
Evaluation 
Scanning 
Operation 
 
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)  
3. Informed consent form 
4. Research brochure  
5. Case report form 
6. Insurance documents 
(insurance certificate, insurance policy, insurance endorsements, general and special conditions of the 
policy) 
7. Research budget form 
8. CVs  
(of the principal investigators) 
9. Authorisation documents (if valid) 
(with Turkish translations certified by a notary public or sworn translator) 
10. Research team documents (if applicable) 
(all documents used only by the research team or used to inform the research team, such as application 
instructions, information texts, doctors' letters, etc.) 
11. Volunteer documents (if applicable) 

 
  
 
 
  
 
 
(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.)) 
12. Ethics committee decision (original and certified copy of the original) 
13. Research product file (if required) 
14. GMP Certificate/Document (apostilled) (if applicable)  
15. 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; 
16. Certificate of supply of the investigational product and reference product(s)  
(invoice/package photocopy with serial number and expiry date) 
17. 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 
05051590606 
Email address 
bedreddin.cavli@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.cavli@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 
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 "Assessing the Frequency of 
Trigeminocardiac Reflex in Maxillary and Mandibular Cyst Operations ", 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. 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: Assessing the Frequency of Trigeminocardiac Reflex in Maxillary and Mandibular 
Cyst Operations 
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 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 for the research titled " 
Assessing the Frequency of Trigeminocardiac Reflex in Maxillary and Mandibular Cyst Operations ", 
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  Şeyma Kale