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

Completed

Conditions

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

Observational

Enrollment (Actual)

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

    • 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

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
Intervention / Treatment
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.
No study-defined intervention; treatments were performed as part of routine clinical care.

What is the study measuring?

Primary Outcome Measures

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

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.

Investigators

  • 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)

January 30, 2025

Primary Completion (Actual)

April 30, 2026

Study Completion (Actual)

April 30, 2026

Study Registration Dates

First Submitted

January 30, 2026

First Submitted That Met QC Criteria

February 9, 2026

First Posted (Actual)

February 17, 2026

Study Record Updates

Last Update Posted (Actual)

June 2, 2026

Last Update Submitted That Met QC Criteria

May 30, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

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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