Preclinical EducationNCT06593873
Effect of Preclinical Training in Periodontal Instrumentation on Undergraduate Students' Anxiety, Clinical Performance and Satisfaction
A study testing Use of typodont head model in addition to theoretical periodontal education and Theoretical periodontal education in people with Preclinical Education and Typodont-phantom Head, run by Okan University at 2 sites in Turkey (Türkiye).
Trial summary
The purpose of this study was to evaluate the effect of periodontal instrumentation preclinical training using a teaching typodont-phantom head model on undergraduate students; anxiety levels, clinical performance, and educational satisfaction. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Preclinical Education, Typodont-phantom Head, Anxiety
- What is being tested?
- Use of typodont head model in addition to theoretical periodontal education and Theoretical periodontal education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Apr 2024to 1 Sep 2024
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- To be a fourth year student of the Faculty of Dentistry
- To successfully complete pre-clinical theoretical and practical training
- To perform periodontal treatment for the first time in the undergraduate clinic
Who cannot join
- Not being a fourth year student of the Faculty of Dentistry
- Lack of attendance to pre-clinical theoretical training
- Failure to demonstrate competence in pre-clinical theoretical education
- Having previously performed periodontal treatment in undergraduate clinic
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Istanbul Okan Universitiy
Istanbul
Sibel Kayaaltı Yüksek
Istanbul
About this study
The purpose of this study was to evaluate the effect of periodontal instrumentation preclinical training using a teaching typodont-phantom head model on undergraduate students; anxiety levels, clinical performance, and educational satisfaction.
Read the detailed description
Sixty fourth-year undergraduate dental students will be randomly divided into two groups. Both groups will receive one hour of theoretical periodontal training.
Group 1 will receive only theoretical training, while Group 2 will complete this training as well as pre-clinical practical training with a typodont-phantom head with synthetic calculus. Before performing supragingival instrumentation on their first patient, students in both groups will be administered a state anxiety test. After the procedures, participants will complete a Visual Analog Scale (VAS) to assess training satisfaction. Students\' clinical performance will be evaluated using the scaling procedure score sheet.
- Conditions
- Preclinical Education, Typodont-phantom Head, Anxiety
- Being tested
- Use of typodont head model in addition to theoretical periodontal education, Theoretical periodontal education
- Keywords
- Preclinical education, Typodont-phantom head, Anxiety
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of typodont head model in addition to theoretical periodontal educationOther
Use of typodont phantom head model in addition to theoretical periodontal education
Theoretical periodontal educationOther
Theoretical periodontal training only
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Theoretical training only (Control Group) | Other | Group 1 (control group) will receive only theoretical training. Receives: Other: Theoretical periodontal education |
| Group 2: Theoretical training+ Preclinical practical training with typodont-phantom head(Test group) | Other | Group 2 (test group) will receive training with typodont-fantom head in addition to theoretical training. Receives: Other: Use of typodont head model in addition to theoretical periodontal education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of state anxiety scores of the participants
After completing training, students in both groups took a state anxiety test using the State-Trait Anxiety Inventory (STAI) before performing supragingival instrumentation. The STAI, which assesses current anxiety levels with 20 items, provides a total score from 20 to 80 points.The STAI was completed using a 4-point Likert scale for each question. Items 3, 4, 6, 7, 9, 12, 13, 14, 17, and 18 contribute positive scores, which increased the total anxiety score. Conversely, items 1, 2, 5, 8, 10, 11, 15, 16, 19, and 20 contributed negative scores, which decreased the total anxiety score. Each item was scored between 1 (or -1) and 4 (or -4) based on its positive or negative nature, and a constant of 50 is added to the total score. Higher scores indicated higher levels of state anxiety.
Measured: baseline
Comparison of scaling operation scores among study groups
The clinical performance of the participants was evaluated by a blind periodontologist using a scaling operation score sheet.The scale assessed clinical performance across four categories: preoperative preparation, intraoperative operation, periodontal probing, and supragingival instrumentation. Each category included specific criteria with assigned points, resulting in a maximum score of 100. The evaluation focused on fundamental aspects including equipment preparation, positioning, probing techniques, and supragingival scaling.
Measured: baseline
Secondary outcomes (1)
Evaluating participants' satisfaction levels
The evaluation of students\' satisfaction with their training following the intervention was conducted using a Visual Analog Scale (VAS). The VAS was presented as a horizontal line, 10 centimeters in length, with endpoints labeled to represent the extremes of satisfaction. One end of the line was labeled 0 to represent very low satisfaction, and the other end was labeled 10 to represent very high satisfaction. Participants marked a point on the line that best reflected their level of satisfaction. The distance from the 0 end to the participant's mark was measured in millimeters, providing a quantitative score of their satisfaction level.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Apr 2024
- Primary completion1 Jul 2024
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Preclinical EducationStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study included 60 fourth-year undergraduate students from Faculty of Dentistry, randomly divided into two groups. Both groups received one hour of theoretical periodontal training: the first, lasting 30 minutes, covered detailed instruction on comprehensive periodontal examination and supragingival instrumentation process through a multimedia presentation, and the second, also 30 minutes, demonstrated practical aspects (working area, support techniques, and positioning) on a patient. Group 1 received theoretical training, while Group 2 had the theoretical plus 60 minutes of preclinical practical training using a typodont-phantom head with artificial calculus. Immediately before performing supragingival instrumentation on their first patients, students completed a state anxiety test. After the procedures, participants completed VAS to rate training satisfaction. The student\'s clinical performance was evaluated using the scaling operation score sheet.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Okan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sibel Kayaalti-Yuksek, Okan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06593873
- Sponsor's protocol ID
- 2024/176
- Status last verified
- Sep 2024
- First submitted
- 3 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kayaalti-Yuksek S, Besiroglu-Turgut E, Agirman M, Keles GC. Effect of preclinical training in periodontal instrumentation on undergraduate students' anxiety, clinical performance, satisfaction. BMC Oral Health. 2025 Jul 15;25(1):1167. doi: 10.1186/s12903-025-06041-y.
PubMed 40665307
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Preclinical Training in Periodontal Instrumentation on Undergraduate Students' Anxiety, Clinical Performance and Satisfaction
- ClinicalTrials.gov ID
- NCT06593873
- Acronym / sponsor ID
- 2024/176
- Conditions
- Preclinical Education, Typodont-phantom Head, Anxiety
- Keywords
- Preclinical education, Typodont-phantom head, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Okan UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 19 Sep 2024 (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 purpose of this study was to evaluate the effect of periodontal instrumentation preclinical training using a teaching typodont-phantom head model on undergraduate students; anxiety levels, clinical performance, and educational satisfaction.
Detailed description
Sixty fourth-year undergraduate dental students will be randomly divided into two groups. Both groups will receive one hour of theoretical periodontal training.
Group 1 will receive only theoretical training, while Group 2 will complete this training as well as pre-clinical practical training with a typodont-phantom head with synthetic calculus. Before performing supragingival instrumentation on their first patient, students in both groups will be administered a state anxiety test. After the procedures, participants will complete a Visual Analog Scale (VAS) to assess training satisfaction. Students\' clinical performance will be evaluated using the scaling procedure score sheet.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study included 60 fourth-year undergraduate students from Faculty of Dentistry, randomly divided into two groups. Both groups received one hour of theoretical periodontal training: the first, lasting 30 minutes, covered detailed instruction on comprehensive periodontal examination and supragingival instrumentation process through a multimedia presentation, and the second, also 30 minutes, demonstrated practical aspects (working area, support techniques, and positioning) on a patient. Group 1 received theoretical training, while Group 2 had the theoretical plus 60 minutes of preclinical practical training using a typodont-phantom head with artificial calculus. Immediately before performing supragingival instrumentation on their first patients, students completed a state anxiety test. After the procedures, participants completed VAS to rate training satisfaction. The student\'s clinical performance was evaluated using the scaling operation score sheet.
| Arm | Type | Receives |
|---|---|---|
| Group 1: Theoretical training only (Control Group) | Other | Other: Theoretical periodontal educationGroup 1 (control group) will receive only theoretical training. |
| Group 2: Theoretical training+ Preclinical practical training with typodont-phantom head(Test group) | Other | Other: Use of typodont head model in addition to theoretical periodontal educationGroup 2 (test group) will receive training with typodont-fantom head in addition to theoretical training. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- To be a fourth year student of the Faculty of Dentistry
- To successfully complete pre-clinical theoretical and practical training
- To perform periodontal treatment for the first time in the undergraduate clinic
Key exclusion criteria (4 listed)
- Not being a fourth year student of the Faculty of Dentistry
- Lack of attendance to pre-clinical theoretical training
- Failure to demonstrate competence in pre-clinical theoretical education
- Having previously performed periodontal treatment in undergraduate clinic
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 |
|---|---|---|
| Use of typodont head model in addition to theoretical periodontal educationUse of typodont phantom head model in addition to theoretical periodontal education | Other | Group 2: Theoretical training+ Preclinical practical training with typodont-phantom head(Test group) |
| Theoretical periodontal educationTheoretical periodontal training only | Other | Group 1: Theoretical training only (Control Group) |
Primary outcome
Comparison of state anxiety scores of the participants
Time frame: baseline
After completing training, students in both groups took a state anxiety test using the State-Trait Anxiety Inventory (STAI) before performing supragingival instrumentation. The STAI, which assesses current anxiety levels with 20 items, provides a total score from 20 to 80 points.The STAI was completed using a 4-point Likert scale for each question. Items 3, 4, 6, 7, 9, 12, 13, 14, 17, and 18 contribute positive scores, which increased the total anxiety score. Conversely, items 1, 2, 5, 8, 10, 11, 15, 16, 19, and 20 contributed negative scores, which decreased the total anxiety score. Each item was scored between 1 (or -1) and 4 (or -4) based on its positive or negative nature, and a constant of 50 is added to the total score. Higher scores indicated higher levels of state anxiety.
Comparison of scaling operation scores among study groups
Time frame: baseline
The clinical performance of the participants was evaluated by a blind periodontologist using a scaling operation score sheet.The scale assessed clinical performance across four categories: preoperative preparation, intraoperative operation, periodontal probing, and supragingival instrumentation. Each category included specific criteria with assigned points, resulting in a maximum score of 100. The evaluation focused on fundamental aspects including equipment preparation, positioning, probing techniques, and supragingival scaling.
1 secondary outcome
Evaluating participants' satisfaction levels
Time frame: baseline
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 19 Sep 2024.
- Derived from this study: PubMed 40665307Kayaalti-Yuksek S, Besiroglu-Turgut E, Agirman M, Keles GC. Effect of preclinical training in periodontal instrumentation on undergraduate students' anxiety, clinical performance, satisfaction. BMC Oral Health. 2025 Jul 15;25(1):1167. doi: 10.1186/s12903-025-06041-y.
- Individual participant dataSharing planned: No
Related trials for Preclinical Education
Active, not recruiting
Stepping-Up: Partnering With the Community to Prevent Early Mobility Decline
Mobility Limitation
Not yet recruitingObservational study
Alpha-synuclein Education and Disclosure in Individuals With Preclinical and Symptomatic Lewy Body Disease
Lewy Body Disease
Recruiting
AI-Driven Digital Self-Assessment Framework for Preclinical Tooth Preparation
Dental Education
Not yet recruiting
Low Back and Neck Pain in Nursing Students at The University of The West Indies
Back Pain, Low Back Pain
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of typodont head model in addition to theoretical periodontal education and Theoretical periodontal education in people with Preclinical Education and Typodont-phantom Head, run by Okan University at 2 sites 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 4 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Comparison of state anxiety scores of the participants (time frame: baseline). 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?
On the ClinicalTrials.gov record for NCT06593873, which also lists 1 linked publication.
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 19 Sep 2024.