Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04654819 |
Other study ID # |
AnkaraU 14/16 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
September 1, 2018 |
Est. completion date |
July 1, 2020 |
Study information
Verified date |
December 2020 |
Source |
Ankara University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
The present study investigates confidence levels reported among intern dentists who used
dental anesthesia simulators, before performing local anesthesia on patients as well as
patient reports on intern dentist confidence levels to deliver anesthesia injections and
compare them to those who did not receive dental anesthesia simulator education. Application
success rates will also be investigated and compared.
The study was carried out in the dental anesthesia simulator laboratory and in the faculty
clinics of Ankara University, Faculty of Dentistry. A hundred volunteer intern dentists who
completed the third year of the 5-year undergraduate education program and who had not
performed local anesthesia on a patient contributed. Seventy intern dentists received
training on dental anesthesia simulators, and made applications on patients, while 30 intern
dentists made applications without training on the dental anesthesia simulators and served as
control. With a prepared single questionnaire, intern dentists made self-assessment of
preparedness and confidence, educators made assessment of application success rates and
treated patients evaluated intern dentists' confidence levels.
Description:
Ethical approval was obtained from the Ankara University Faculty of Dentistry Clinical
Research Ethics Committee (Approval no: 14/16). The study was carried out in the dental
anesthesia simulator laboratory and in the faculty clinics of Ankara University, Faculty of
Dentistry within a 2-year period. During the first year of the study, the faculty did not
have DAS availability. During this first year 30 intern dentists who had completed the third
year of the 5-year undergraduate education program and who could not receive DAS training
before their first anesthesia application on a patient, were recruited as a control group
among consent to participate. During the second year of the study after DAS became available,
70 intern dentists who had completed the third year of the 5-year undergraduate education
program and who had not applied local anesthesia to a patient, were recruited as a study
group among consent to participate. The study group applied their first anesthesia
application on a patient after DAS education.
For the study 10 conduction anesthesia models mounted on metal rods, (CAM SUG2005-UL-SP,
Nissin Dental Products Kyoto, Japan, Figure.1), were provided. The part-task simulators had
11 anesthetic contact sensor points (7 in the upper jaw and 4 in the lower jaw) with 32
anatomically shaped teeth, audio signal and light signal indicators when correct position and
angle was achieved. The models had clear pink upper and lower gingivae allowing view of
injection, making it ideal for beginner intern dentists, while allowing a more realistic
training experience.
Both groups attended theoretical presentations an interactive lesson about IANB from an oral
and maxillofacial surgery professor. Technical information about DAS were also covered for
the study group lessons. Following lessons, both groups answered a questionnaire concerning
preparedness. Afterwards, intern dentists in the control group carried on with patient
application whereas the study group carried on with DAS education before continuing on
patients.
During DAS lessons the intern dentists applied IANB on simulators. The illumination of the
light and sound indicator on the model as a result of injection to the pterygomandibular
region was accepted as a successful application. The results of the first five IANB
applications made by the intern dentists were recorded. Intern dentists who completed the DAS
training completed a questionnaire.
After trainings, both groups applied IANB to a patient for the first time in the clinic and
completed another questionnaire. The intraoperative and immediate postoperative complications
were monitored. Tingling sensation on the lip and tongue, reported by the patient, was
accepted as criteria for profound anesthesia. After achieving anesthesia, the questionnaire,
was answered by the patient on whom the application was performed.
Questionnaire:
Section 1: Expectations After Theoretical Education
- The theoretical training adequately prepared me for my first anesthesia application. *
- I feel ready for my first anesthesia application. * Section 2: Expectations After DASM
Training
- The DASM training adequately prepared me for my first anesthesia application. *
- I feel ready for my first anesthesia application. *
- It was useful to work on the DASM before my first anesthesia application. * Section 3:
IANB application
- Explain if complications developed during anesthesia application.
- I was nervous during anesthesia application. *
- I was sure of myself during anesthesia application. *
- I was confident in determining the front edge of the mandible. *
- I was sure of myself when determining the area to enter the dental injector. *
- I was sure of myself as the dental injector entered soft tissue. *
- I was sure of myself as the dental injector progressed through the soft tissue. *
- I felt that the dental injector touched the mandible. *
- I provided anesthesia. **
- I do not need surveillance in my next application. *
- It was/would have been useful to work on the DASM before my first anesthesia
application. * Section 4: To be filled out by your patient
- The intern dentist was confident. *
- The intern dentist gave me confidence. *
- The sting of the needle was painful. *
- The injection of the solution was painful. *
- I felt tingling on my lip. **
- I felt tingling in my tongue. **
- Questions with answer key: Strongly agree, Agree, Indecisive, Disagree, Strongly
disagree.
- Questions with answer key: Strongly agree, Indecisive, Strongly disagree.