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NCT Number: NCT07413276

Prospective Evaluation of Clinical Endodontic Performance Assessment Methods

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.

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Key information

Conditions

Root Canal Therapy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

School of Dentitry, Aristotle University of Thessaloniki

Thessaloniki, Central Macedonia, 54124, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Not applicable- observational study

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Aristotle University Of Thessaloniki

Other

Registry information

Official study title

Self- Assessment of Clinical Endodontic Performance by Dental Students Using Two Distinct Rotary File Systems: A Prospective Cohort Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 17, 2026
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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