Root Canal TherapyNCT07413276
Prospective Evaluation of Clinical Endodontic Performance Assessment Methods
An observational study of Root Canal Therapy, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial summary
This prospective cohort study evaluates dental students' self-assessment of clinical endodontic performance and compares it with independent evaluations conducted in a dental education clinical setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Root Canal Therapy
- What is being tested?
- Not applicable- observational study
- How many people
- 201 participants
- Where
- 1 siteGreece
- Study dates
- 30 Jan 2025to 30 Apr 2026
- How long will I take part?
- 2 Weeks
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients requiring initial endodontic treatment of an upper or lower molar and deemed fit to undergo endodontic treatment performed by dental students in the undergraduate dental clinic of the Aristotle University of Thessaloniki.
Who may be able to join
- Healthy patients or with a controlled systemic condition
- 18 Years and older
- Completion and acceptance of a patient consent form for the study
- Patient in need of an initial endodontic treatment of an upper or lower molar
Who cannot join
- Existence of a systemic disease or usage of drugs that makes the patient unfit to undergo endodontic treatment by students in an Undergraduate Clinic.
- Teeth with previous endodontic treatment
- Teeth with doubtful prognosis - unrestorable
- Teeth with severe periodontal damage
- Alcohol or drug use
- Pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country.
Greece1 site
School of Dentitry, Aristotle University of Thessaloniki
Thessaloniki, Central Macedonia, 54124
About this study
Official title: Self- Assessment of Clinical Endodontic Performance by Dental Students Using Two Distinct Rotary File Systems: A Prospective Cohort Study
This prospective cohort study evaluates dental students' self-assessment of clinical endodontic performance and compares it with independent evaluations conducted in a dental education clinical setting. Endodontic treatments are performed by undergraduate dental students using two distinct rotary file systems selected according to routine clinical practice. Students' self-assessments are prospectively collected using a structured questionnaire and compared with evaluations performed by two experienced evaluators with access to clinical and radiographic information, considered the reference standard, as well as by two different experienced evaluators using radiographic information only. Secondary analyses examine whether assessment outcomes differ according to the rotary file system used. The null hypothesis is that there is no difference between dental students' self-assessments and reference standard evaluations of endodontic treatment quality, and that assessment outcomes do not differ according to the rotary file system used.
Read the detailed description
This prospective cohort observational study examines dental students' self-assessment of clinical endodontic performance in a dental education clinical setting and compares these assessments with independent evaluations. Endodontic treatments are performed by undergraduate dental students as part of routine clinical practice under standard supervision. Treatments are carried out using one of two distinct rotary file systems selected according to routine clinical practice, without assignment by the study protocol.
Following completion of each endodontic treatment, operators prospectively complete a structured self-assessment questionnaire evaluating the quality of their clinical performance. These self-assessments are compared with evaluations performed by experienced external evaluators. Two experienced evaluators assess each case using both clinical and radiographic information and serve as the reference standard, while two different experienced evaluators perform an assessment based on radiographic information only.
The primary objective is to evaluate the agreement between dental students' self-assessments and the reference standard evaluation of endodontic treatment quality. Secondary objectives include assessment of agreement between radiographic-only and reference standard evaluations, as well as examination of whether assessment outcomes differ according to the rotary file system used across operator self-assessments and independent evaluations.
- Conditions
- Root Canal Therapy
- Being tested
- Not applicable- observational study
- Keywords
- Root Canal Therapy, Education, Dental, Students, Dental, Self Assessment, Observer Variation, Radiography, Dental
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Not applicable- observational studyOther
No study-defined intervention; treatments were performed as part of routine clinical care.
| Study group | Role | What they receive |
|---|---|---|
| Endodontic Treatment Cohort | Adult patients in need of initial endodontic treatment of an upper or lower molar and deemed fit to undergo endodontic treatment performed by dental students in the undergraduate dental clinic of the Aristotle University of Thessaloniki. Receives: Other: Not applicable- observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement between dental students' self-assessment and reference standard evaluation of endodontic treatment quality
The level of agreement between dental students' self-assessment of completed endodontic treatments and evaluations performed by two experienced evaluators with access to both clinical and radiographic information, considered the reference standard.
Measured: Up to 2 weeks (at completion of endodontic treatment)
Secondary outcomes (4)
Agreement between radiographic-only evaluation and reference standard evaluation of endodontic treatment quality
The level of agreement between evaluations of endodontic treatments performed by two independent evaluators using radiographic information only and evaluations performed by two experienced evaluators with access to both clinical and radiographic information, considered the reference standard.
Measured: Up to 2 weeks (at completion of endodontic treatment)
Proportion of self-reported assessment findings by rotary file system based on dental students' self-assessment
The proportion of specific findings reported in dental students' self-assessments of completed endodontic treatments, based on a structured self-assessment questionnaire, compared between two rotary file systems used as part of routine clinical practice. Results will be reported as percentages of self-reported findings for each rotary file system.
Measured: Up to 2 weeks (at completion of endodontic treatment)
Proportion of reference standard evaluation findings by rotary file system
The proportion of specific evaluation findings identified by experienced evaluators using combined clinical and radiographic information, considered the reference standard, for completed endodontic treatments. The proportions of these evaluation findings will be compared between two rotary file systems used as part of routine clinical practice and reported as percentages for each system.
Measured: Up to 2 weeks (at completion of endodontic treatment)
Proportion of radiographic-only evaluation findings by rotary file system
The proportion of specific evaluation findings identified through radiographic-only assessment of completed endodontic treatments. The proportions of these radiographic evaluation findings will be compared between two rotary file systems used as part of routine clinical practice and reported as percentages for each system.
Measured: Up to 2 weeks (at completion of endodontic treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start30 Jan 2025
- Primary completion30 Apr 2026
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Root Canal TherapyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 201 participants (actual)
- Target duration
- 2 Weeks
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nikolaos Economides, Study director, School of Dentistry, Aristotle University of Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07413276
- Sponsor's protocol ID
- 262/10-01-2025
- Status last verified
- May 2026
- First submitted
- 30 Jan 2026
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self- Assessment of Clinical Endodontic Performance by Dental Students Using Two Distinct Rotary File Systems: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07413276
- Acronym / sponsor ID
- 262/10-01-2025
- Conditions
- Root Canal Therapy
- Keywords
- Root Canal Therapy, Education, Dental, Students, Dental, Self Assessment, Observer Variation, Radiography, Dental
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- 30 Jan 2025 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 17 Feb 2026 (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.
This prospective cohort study evaluates dental students' self-assessment of clinical endodontic performance and compares it with independent evaluations conducted in a dental education clinical setting. Endodontic treatments are performed by undergraduate dental students using two distinct rotary file systems selected according to routine clinical practice. Students' self-assessments are prospectively collected using a structured questionnaire and compared with evaluations performed by two experienced evaluators with access to clinical and radiographic information, considered the reference standard, as well as by two different experienced evaluators using radiographic information only. Secondary analyses examine whether assessment outcomes differ according to the rotary file system used. The null hypothesis is that there is no difference between dental students' self-assessments and reference standard evaluations of endodontic treatment quality, and that assessment outcomes do not differ according to the rotary file system used.
Detailed description
This prospective cohort observational study examines dental students' self-assessment of clinical endodontic performance in a dental education clinical setting and compares these assessments with independent evaluations. Endodontic treatments are performed by undergraduate dental students as part of routine clinical practice under standard supervision. Treatments are carried out using one of two distinct rotary file systems selected according to routine clinical practice, without assignment by the study protocol.
Following completion of each endodontic treatment, operators prospectively complete a structured self-assessment questionnaire evaluating the quality of their clinical performance. These self-assessments are compared with evaluations performed by experienced external evaluators. Two experienced evaluators assess each case using both clinical and radiographic information and serve as the reference standard, while two different experienced evaluators perform an assessment based on radiographic information only.
The primary objective is to evaluate the agreement between dental students' self-assessments and the reference standard evaluation of endodontic treatment quality. Secondary objectives include assessment of agreement between radiographic-only and reference standard evaluations, as well as examination of whether assessment outcomes differ according to the rotary file system used across operator self-assessments and independent evaluations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endodontic Treatment Cohort | – | Other: Not applicable- observational studyAdult patients in need of initial endodontic treatment of an upper or lower molar and deemed fit to undergo endodontic treatment performed by dental students in the undergraduate dental clinic of the Aristotle University of Thessaloniki. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients requiring initial endodontic treatment of an upper or lower molar and deemed fit to undergo endodontic treatment performed by dental students in the undergraduate dental clinic of the Aristotle University of Thessaloniki.
Key inclusion criteria (4 listed)
- Healthy patients or with a controlled systemic condition
- 18 Years and older
- Completion and acceptance of a patient consent form for the study
- Patient in need of an initial endodontic treatment of an upper or lower molar
Key exclusion criteria (6 listed)
- Existence of a systemic disease or usage of drugs that makes the patient unfit to undergo endodontic treatment by students in an Undergraduate Clinic.
- Teeth with previous endodontic treatment
- Teeth with doubtful prognosis - unrestorable
- Teeth with severe periodontal damage
- Alcohol or drug use
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 |
|---|---|---|
| Not applicable- observational studyNo study-defined intervention; treatments were performed as part of routine clinical care. | Other | Endodontic Treatment Cohort |
Primary outcome
Agreement between dental students' self-assessment and reference standard evaluation of endodontic treatment quality
Time frame: Up to 2 weeks (at completion of endodontic treatment)
The level of agreement between dental students' self-assessment of completed endodontic treatments and evaluations performed by two experienced evaluators with access to both clinical and radiographic information, considered the reference standard.
4 secondary outcomes
Agreement between radiographic-only evaluation and reference standard evaluation of endodontic treatment quality
Time frame: Up to 2 weeks (at completion of endodontic treatment)
Proportion of self-reported assessment findings by rotary file system based on dental students' self-assessment
Time frame: Up to 2 weeks (at completion of endodontic treatment)
Proportion of reference standard evaluation findings by rotary file system
Time frame: Up to 2 weeks (at completion of endodontic treatment)
Proportion of radiographic-only evaluation findings by rotary file system
Time frame: Up to 2 weeks (at completion of endodontic treatment)
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 2 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Root Canal Therapy
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Treatment Outcome and Patient-reported Outcomes in Patient Undergoing Non-surgical Root Canal Treatment With Different Irrigation Protocols
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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.
Nikolaos Economides study director
School of Dentistry, Aristotle University of Thessaloniki
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Root Canal Therapy, run by Aristotle University Of Thessaloniki at 1 site in Greece.
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 4 inclusion and 6 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 2 Jun 2026. 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 Greece. 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?
Agreement between dental students' self-assessment and reference standard evaluation of endodontic treatment quality (time frame: Up to 2 weeks (at completion of endodontic treatment)). 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 2 Jun 2026; AzTrials last refreshed its copy on 31 Oct 2026.