Root Canal TreatmentAINCT07056998
On Previously Root Canal-treated Patients Using an AI Program, Detect the Accuracy of it in the Detection of Root Canal Obturation Quality on CBCT Compared With Conventional PA Radiography, e.g., Voids, Length of Obturation, and Density, and Then do Retreatment if Any Failure is Recorded.
A study testing root canal retreatment in people with Root Canal Treatment, run by Tala Ghassan Hassan Odeh at 1 site in Egypt.
Trial summary
aims to evaluate the accuracy of clinicians (conventional radiograph) compared to cone beam computed tomography (CBCT) and artificial intelligence software's ability to identify the quality of root canal obturation. Will the use of artificial intelligence software be compared to conventional software in accuracy? Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Root Canal Treatment
- What is being tested?
- root canal retreatment
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2025to 30 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Medically free patients with no systemic disease: (American Society of Anesthesiologists / (ASA Class I or II).
- Age range is between18 to 50 years
- No sex predilection.
- All patients must have good oral hygiene. 5 -patients with root canal-treated teeth.
- 6- restorable teeth. 7- Positive patient acceptance for participating in the study. 8- Patients can sign informed consent.
Who cannot join
- 1-Patients with very poor oral hygiene. 2-Patients above 50 years and below 18 years. 3-Pregnant and lactating women 4-Psychologically disturbed patients. 5-nonrestorable teeth.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Faculty of Oral and Dental Medicine future university
Cairo, Cairo Governorate, 11835
About this study
Official title: Accuracy of Artificial Intelligence Technology in Detecting the Quality of Endodontic Treatment Diagnostic Accuracy Experimental Study.
aims to evaluate the accuracy of clinicians (conventional radiograph) compared to cone beam computed tomography (CBCT) and artificial intelligence software's ability to identify the quality of root canal obturation. Will the use of artificial intelligence software be compared to conventional software in accuracy?
Read the detailed description
AI is a new method used in the medical field, specifically dentistry. aiming to detect the accuracy of AI in the field of endodontics, specifically in root canal quality (correct length, density, taper, and coronal seal) compared to the skill of the endodontist using 2D radiograph and CBCT, and if any signs and symptoms of failure are detected in the treatment, retreatment is done according to the needs of each case.
- Conditions
- Root Canal Treatment
- Being tested
- root canal retreatment
- Keywords
- quality of root canal , Artificial intelligence, CBCT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
root canal retreatmentProcedure or surgery
if Retreatment was needed, local anesthesia using 1.8 ml (one cartridge) of 4% articaine with 1:100,000 epinephrine local anesthetic solution, administered with end -loading cartridge aspirating syringe and a 27-gauge long needle. Under rubber dam isolation, All carious tissue and existing coronal restorations were thoroughly removed using a round bur, an endodontic access cavity, canal preparation and removal of existing root canal filling, irrigation with 2.6% NAOCL and saline, determining the working length using apex locator and PA radiograph, to be 0.5 to 1 mm shorter than radiographic apex, Drying the canal with paper point and obturation to achieve a dense, well adapted Monoblock obturation. A post-obturation periapical radiograph was taken to confirm the quality of the fill in terms of length, density, then sealed by a temporary restorative material.
| Study group | Role | What they receive |
|---|---|---|
| Length of Root Filling | Active comparator | 1. Length of Root Filling Ideal: 0-2 mm short of the radiographic apex Overfilling: Beyond the apex - may lead to periapical irritation Underfilling: More than 2 mm short - associated with poor prognosis Measuring unit: millimeters (mm) from the radiographic apex Receives: Procedure: root canal retreatment |
| Density/Homogeneity | Active comparator | Criteria: No visible voids in: Canal system, Between gutta-percha and canal wall Assessment: Radiographic inspection (digital or analog) Measuring tool: Qualitative (visual rating) or CBCT grayscale values for homogeneity Receives: Procedure: root canal retreatment |
| Presence of Voids | Active comparator | Criteria: Voids indicate poor condensation or adaptation Assessment tools: Periapical radiographs, CBCT. Measuring unit: Number, size (mm or μm), or volume (%) of voids Receives: Procedure: root canal retreatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
root canal quality Length of Root Filling
Length of Root Filling Ideal: 0-2 mm short of the radiographic apex Overfilling: Beyond the apex - may lead to periapical irritation Underfilling: More than 2 mm short - associated with poor prognosis Measuring unit: millimeters (mm) from the radiographic apex
Measured: preprocedural(day 1) and if treatment needed after the completion of the it up to 1month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2025
- Study start1 Apr 2025
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Root Canal TreatmentStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 3 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tala Ghassan Hassan Odeh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tala Ghassan Hassan Odeh, Future University in Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07056998
- Sponsor's protocol ID
- FUE.REC(44)/11-2024
- Acronym
- AI
- Status last verified
- Jul 2025
- First submitted
- 25 Jun 2025
- Last updated
- 9 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: only IPD used in the results publication
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Artificial Intelligence Technology in Detecting the Quality of Endodontic Treatment Diagnostic Accuracy Experimental Study.
- ClinicalTrials.gov ID
- NCT07056998
- Acronym / sponsor ID
- AI / FUE.REC(44)/11-2024
- Conditions
- Root Canal Treatment
- Keywords
- quality of root canal , Artificial intelligence, CBCT
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 3 participants (estimated)
- Lead sponsor
- Tala Ghassan Hassan OdehUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Oct 2025 (estimated)
- First posted
- 9 Jul 2025 (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.
aims to evaluate the accuracy of clinicians (conventional radiograph) compared to cone beam computed tomography (CBCT) and artificial intelligence software's ability to identify the quality of root canal obturation. Will the use of artificial intelligence software be compared to conventional software in accuracy?
Detailed description
AI is a new method used in the medical field, specifically dentistry. aiming to detect the accuracy of AI in the field of endodontics, specifically in root canal quality (correct length, density, taper, and coronal seal) compared to the skill of the endodontist using 2D radiograph and CBCT, and if any signs and symptoms of failure are detected in the treatment, retreatment is done according to the needs of each case.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Length of Root Filling | Active comparator | Procedure: root canal retreatment1. Length of Root Filling Ideal: 0-2 mm short of the radiographic apex Overfilling: Beyond the apex - may lead to periapical irritation Underfilling: More than 2 mm short - associated with poor prognosis Measuring unit: millimeters (mm) from the radiographic apex |
| Density/Homogeneity | Active comparator | Procedure: root canal retreatmentCriteria: No visible voids in: Canal system, Between gutta-percha and canal wall Assessment: Radiographic inspection (digital or analog) Measuring tool: Qualitative (visual rating) or CBCT grayscale values for homogeneity |
| Presence of Voids | Active comparator | Procedure: root canal retreatmentCriteria: Voids indicate poor condensation or adaptation Assessment tools: Periapical radiographs, CBCT. Measuring unit: Number, size (mm or μm), or volume (%) of voids |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Medically free patients with no systemic disease: (American Society of Anesthesiologists / (ASA Class I or II).
- Age range is between18 to 50 years
- No sex predilection.
- All patients must have good oral hygiene. 5 -patients with root canal-treated teeth.
- 6- restorable teeth. 7- Positive patient acceptance for participating in the study. 8- Patients can sign informed consent.
Key exclusion criteria (1 listed)
- 1-Patients with very poor oral hygiene. 2-Patients above 50 years and below 18 years. 3-Pregnant and lactating women 4-Psychologically disturbed patients. 5-nonrestorable teeth.
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 |
|---|---|---|
| root canal retreatmentif Retreatment was needed, local anesthesia using 1.8 ml (one cartridge) of 4% articaine with 1:100,000 epinephrine local anesthetic solution, administered with end -loading cartridge aspirating syringe and a 27-gauge long needle. Under rubber dam isolation, All carious tissue and existing coronal restorations were thoroughly removed using a round bur, an endodontic access cavity, canal preparation and removal of existing root canal filling, irrigation with 2.6% NAOCL and saline, determining the working length using apex locator and PA radiograph, to be 0.5 to 1 mm shorter than radiographic apex, Drying the canal with paper point and obturation to achieve a dense, well adapted Monoblock obturation. A post-obturation periapical radiograph was taken to confirm the quality of the fill in terms of length, density, then sealed by a temporary restorative material. | Procedure or surgery | Density/Homogeneity, Length of Root Filling, Presence of Voids |
Primary outcome
root canal quality Length of Root Filling
Time frame: preprocedural(day 1) and if treatment needed after the completion of the it up to 1month
Length of Root Filling Ideal: 0-2 mm short of the radiographic apex Overfilling: Beyond the apex - may lead to periapical irritation Underfilling: More than 2 mm short - associated with poor prognosis Measuring unit: millimeters (mm) from the radiographic apex
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2025.
- Individual participant dataSharing planned: Yes. only IPD used in the results publication
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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.
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?
A study testing root canal retreatment in people with Root Canal Treatment, run by Tala Ghassan Hassan Odeh at 1 site in Egypt.
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 5 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: enrolling by invitation, as of the sponsor's last update on 9 Jul 2025. 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
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?
root canal quality Length of Root Filling (time frame: preprocedural(day 1) and if treatment needed after the completion of the it up to 1month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jul 2025.