- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07413276
Prospective Evaluation of Clinical Endodontic Performance Assessment Methods
Self- Assessment of Clinical Endodontic Performance by Dental Students Using Two Distinct Rotary File Systems: A Prospective Cohort Study
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Central Macedonia
-
Thessaloniki, Central Macedonia, Greece, 54124
- School of Dentitry, Aristotle University of Thessaloniki
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
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
Investigators
- Study Director: Nikolaos Economides, School of Dentistry, Aristotle University of Thessaloniki
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 262/10-01-2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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