Prospective Evaluation of Clinical Endodontic Performance Assessment Methods

May 30, 2026 updated by: Aristotle University Of Thessaloniki

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
201

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
    • Central Macedonia
      • Thessaloniki, Central Macedonia, Greece, 54124
        • School of Dentitry, Aristotle University of Thessaloniki

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

  1. Healthy patients or with a controlled systemic condition
  2. 18 Years and older
  3. Completion and acceptance of a patient consent form for the study
  4. Patient in need of an initial endodontic treatment of an upper or lower molar

Exclusion Criteria:

  1. Existence of a systemic disease or usage of drugs that makes the patient unfit to undergo endodontic treatment by students in an Undergraduate Clinic.
  2. Teeth with previous endodontic treatment
  3. Teeth with doubtful prognosis - unrestorable
  4. Teeth with severe periodontal damage
  5. Alcohol or drug use
  6. Pregnancy or breastfeeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Not applicable- observational study
No study-defined intervention; treatments were performed as part of routine clinical care.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Up to 2 weeks (at completion of endodontic treatment)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Agreement between radiographic-only evaluation and reference standard evaluation of endodontic treatment quality
Time Frame: Up to 2 weeks (at completion of endodontic treatment)
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.
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)
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.
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)
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.
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)
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.
Up to 2 weeks (at completion of endodontic treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Aristotle University Of Thessaloniki

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Nikolaos Economides, School of Dentistry, Aristotle University of Thessaloniki

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 30, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 30, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 9, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 17, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 30, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 262/10-01-2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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