Effect of Endodontic Case Difficulty on Endodontic MishapsNCT06640790
Effect of Endodontic Case Difficulty on Endodontic Mishaps: Clinical Study
An observational study of Effect of Endodontic Case Difficulty on Endodontic Mishaps and Root Canal Treatment, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study investigate the influence of endodontic case difficulty, as categorized by the American Association of Endodontists (AAE) assessment form (low, moderate, high), on the incidence of endodontic mishaps and treatment visit requirements in postgraduate dental students. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Effect of Endodontic Case Difficulty on Endodontic Mishaps, Root Canal Treatment
- What is being tested?
- Case Group
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2024to 1 Oct 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who refer to our clinic for routine endodontic treatment
Who may be able to join
- Primary root canal treatment
- Retreatment
Who cannot join
- Patients who do not accept to participate to study
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study investigate the influence of endodontic case difficulty, as categorized by the American Association of Endodontists (AAE) assessment form (low, moderate, high), on the incidence of endodontic mishaps and treatment visit requirements in postgraduate dental students.
- Being tested
- Case Group
- Keywords
- Case Difficulty, Endodontic Mishaps, Postgraduate Dental Education, Root Canal Treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Case GroupOther
Root canal treated were categorized based on the AAE case difficulty assessment form. Endodontic mishaps investigated included over-instrumentation, working length loss, underfilling, overfilling, apical transportation, instrument fracture, and perforation.
What is being measured
The primary outcome is the main question the study is designed to answer.
Case difficulty category
The American Association of Endodontists (AAE) has developed a case difficulty form to categorize endodontic cases into three levels: minimal, moderate, and high. This form encompasses three sections: general health status, diagnostic and treatment status, and contributing factors such as trauma, previous treatment, and periodontal disease.
Measured: Radiographic images were taken at the final treatment appointment. Case difficulty classification of cases was performed according to AEE case difficulty form data, and all radiographs were evaluated in terms of endodontic mishaps within 24 hours.
Endodontic mishaps
Endodontic mishaps were classified as follows: over-instrumentation, underfilling (≥2 mm from the radiographic apex), overfilling (≥2 mm from the radiographic apex), canal transportation, instrument separation, lateral or strip perforation.
Measured: Radiographic images were taken at the final treatment appointment. Case difficulty classification of cases was performed according to AEE case difficulty form data, and all radiographs were evaluated in terms of endodontic mishaps within 24 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start1 Jan 2024
- Primary completion1 Aug 2024
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Effect of Endodontic Case Difficulty on Endodontic MishapsStudies of the same condition, open and under way.
- More trials run by Kutahya Health Sciences UniversityThe sponsor's other registered studies.
- 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
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arzu Kaya Mumcu, Kutahya Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06640790
- Sponsor's protocol ID
- KutahyaHSU-1
- Status last verified
- Oct 2024
- First submitted
- 9 Oct 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kaya Mumcu A, Corak M, Kurnaz S, Kiraz G. Effect of endodontic case difficulty on endodontic mishaps and the number of treatment visits: a clinical study. BMC Med Educ. 2025 Dec 9;26(1):63. doi: 10.1186/s12909-025-08437-4.
PubMed 41366378
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Endodontic Case Difficulty on Endodontic Mishaps: Clinical Study
- ClinicalTrials.gov ID
- NCT06640790
- Acronym / sponsor ID
- KutahyaHSU-1
- Keywords
- Case Difficulty, Endodontic Mishaps, Postgraduate Dental Education, Root Canal Treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 15 Oct 2024 (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.
The aim of this study investigate the influence of endodontic case difficulty, as categorized by the American Association of Endodontists (AAE) assessment form (low, moderate, high), on the incidence of endodontic mishaps and treatment visit requirements in postgraduate dental students.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who refer to our clinic for routine endodontic treatment
Key inclusion criteria (2 listed)
- Primary root canal treatment
- Retreatment
Key exclusion criteria (1 listed)
- Patients who do not accept to participate to study
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 |
|---|---|---|
| Case GroupRoot canal treated were categorized based on the AAE case difficulty assessment form. Endodontic mishaps investigated included over-instrumentation, working length loss, underfilling, overfilling, apical transportation, instrument fracture, and perforation. | Other | – |
Primary outcome
Case difficulty category
Time frame: Radiographic images were taken at the final treatment appointment. Case difficulty classification of cases was performed according to AEE case difficulty form data, and all radiographs were evaluated in terms of endodontic mishaps within 24 hours.
The American Association of Endodontists (AAE) has developed a case difficulty form to categorize endodontic cases into three levels: minimal, moderate, and high. This form encompasses three sections: general health status, diagnostic and treatment status, and contributing factors such as trauma, previous treatment, and periodontal disease.
Endodontic mishaps
Time frame: Radiographic images were taken at the final treatment appointment. Case difficulty classification of cases was performed according to AEE case difficulty form data, and all radiographs were evaluated in terms of endodontic mishaps within 24 hours.
Endodontic mishaps were classified as follows: over-instrumentation, underfilling (≥2 mm from the radiographic apex), overfilling (≥2 mm from the radiographic apex), canal transportation, instrument separation, lateral or strip perforation.
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 15 Oct 2024.
- Derived from this study: PubMed 41366378Kaya Mumcu A, Corak M, Kurnaz S, Kiraz G. Effect of endodontic case difficulty on endodontic mishaps and the number of treatment visits: a clinical study. BMC Med Educ. 2025 Dec 9;26(1):63. doi: 10.1186/s12909-025-08437-4.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Effect of Endodontic Case Difficulty on Endodontic Mishaps and Root Canal Treatment, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
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 2 inclusion and 1 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 15 Oct 2024. 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 Turkey (Türkiye). 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?
Case difficulty category (time frame: Radiographic images were taken at the final treatment appointment. Case difficulty classification of cases was performed according to AEE case difficulty form data, and all radiographs were evaluated in terms of endodontic mishaps within 24 hours.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06640790, which also lists 1 linked publication.
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 15 Oct 2024.