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. (AI)

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?

Study Overview

• Status: Enrolling by invitation
• Conditions: Root Canal Treatment
• Intervention / Treatment: Procedure: root canal retreatment

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 Type: Interventional
• Enrollment (Estimated): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11835
    • Faculty of Oral and Dental Medicine future university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Medically free patients with no systemic disease: (American Society of Anesthesiologists / (ASA Class I or II).
2. Age range is between18 to 50 years
3. No sex predilection.
4. 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Length of Root Filling; 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	Procedure: root canal retreatment; 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.
Active Comparator: Density/Homogeneity; 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	Procedure: root canal retreatment; 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.
Active Comparator: Presence of Voids; Criteria: Voids indicate poor condensation or adaptation Assessment tools: Periapical radiographs, CBCT. Measuring unit: Number, size (mm or μm), or volume (%) of voids	Procedure: root canal retreatment; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	preprocedural(day 1) and if treatment needed after the completion of the it up to 1month

Collaborators and Investigators

• Sponsor: Tala Ghassan Hassan Odeh

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2025
• Primary Completion (Estimated): September 30, 2025
• Study Completion (Estimated): October 30, 2025

Study Registration Dates

• First Submitted: June 25, 2025
• First Submitted That Met QC Criteria: July 6, 2025
• First Posted (Actual): July 9, 2025

Study Record Updates

• Last Update Posted (Actual): July 9, 2025
• Last Update Submitted That Met QC Criteria: July 6, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: quality of root canal , Artificial intelligence, CBCT
• Other Study ID Numbers: FUE.REC(44)/11-2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: only IPD used in the results publication
• IPD Sharing Time Frame: Beginning of 2026, a year after publication, with no end date
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No