Confidence, SelfNCT04654819
Analysis of Student Confidence Levels and Application Success Rates in Simulator Based Dental Anesthesia Education
A study testing Dental anesthesia simulator usage in people with Confidence, Self, run by Ankara University at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Confidence, Self
- What is being tested?
- Dental anesthesia simulator usage
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2018to 1 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Intern dentists who had completed the third year of the 5-year undergraduate education program
- Not applied local anesthesia to a patient
- Consent to participate
Who cannot join
- Applied local anesthesia to a patient
- Not consenting to participate
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara University Faculty of Dentistry
Ankara, 06940
About this study
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.
Read the detailed 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.
- Conditions
- Confidence, Self
- Being tested
- Dental anesthesia simulator usage
- Keywords
- Dental anesthesia, Dental education, Simulators, Technology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental anesthesia simulator usageDevice
Training on dental anesthesia simulator
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | This group made anesthesia application on patients without training on simulators. |
| Study group | Experimental | This group made anesthesia application on patients after training on simulators. Receives: Device: Dental anesthesia simulator usage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported preparedeness and confidence levels of intern dentists
Intern preparedeness and confidence levels was assesed with a questionnaire answered by the intern dentists. Questions will be answered on a 5 point scale: Strongly agree, Agree, Indecisive, Disagree, Strongly disagree.
Measured: 2 years
Patients perception of intern dentist confidence levels
Patients perception of intern dentist confidence was assesed with a prepared questionnaire answered by the patients. Questions will be answered on a 5 point scale: Strongly agree, Agree, Indecisive, Disagree, Strongly disagree.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2020
- Study start1 Sep 2018
- Primary completion1 Jul 2020
- Study completion1 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Confidence, SelfStudies of the same condition, open and under way.
- More trials run by Ankara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cahit UCOK, Ankara University
- Investigators
- Cahit Üçok, Prof. Dr., Study director, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04654819
- Sponsor's protocol ID
- AnkaraU 14/16
- Status last verified
- Dec 2020
- First submitted
- 26 Nov 2020
- Last updated
- 4 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Student Confidence Levels and Application Success Rates in Simulator Based Dental Anesthesia Education
- ClinicalTrials.gov ID
- NCT04654819
- Acronym / sponsor ID
- AnkaraU 14/16
- Conditions
- Confidence, Self
- Keywords
- Dental anesthesia, Dental education, Simulators, Technology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 4 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –This group made anesthesia application on patients without training on simulators. |
| Study group | Experimental | Device: Dental anesthesia simulator usageThis group made anesthesia application on patients after training on simulators. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Intern dentists who had completed the third year of the 5-year undergraduate education program
- Not applied local anesthesia to a patient
- Consent to participate
Key exclusion criteria (2 listed)
- Applied local anesthesia to a patient
- Not consenting to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dental anesthesia simulator usageTraining on dental anesthesia simulator | Device | Study group |
Primary outcome
Self-reported preparedeness and confidence levels of intern dentists
Time frame: 2 years
Intern preparedeness and confidence levels was assesed with a questionnaire answered by the intern dentists. Questions will be answered on a 5 point scale: Strongly agree, Agree, Indecisive, Disagree, Strongly disagree.
Patients perception of intern dentist confidence levels
Time frame: 2 years
Patients perception of intern dentist confidence was assesed with a prepared questionnaire answered by the patients. Questions will be answered on a 5 point scale: Strongly agree, Agree, Indecisive, Disagree, Strongly disagree.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cahit Üçok, Prof. Dr. study director
Ankara University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dental anesthesia simulator usage in people with Confidence, Self, run by Ankara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported preparedeness and confidence levels of intern dentists (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2020.