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.

NCT07056998 | Enrolling By Invitation DMC

• 1 other identifier: FUE.REC(44)/11-2024
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief 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?

Conditions

Root Canal Treatment

Keywords

quality of root canal , Artificial intelligence, CBCT

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

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

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

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

Procedure: root canal retreatment

Interventions

root canal retreatment PROCEDURE

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.

Density/Homogeneity; Length of Root Filling; Presence of Voids

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• restorable teeth. 7- Positive patient acceptance for participating in the study. 8- Patients can sign informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tala Ghassan Hassan Odeh: lead

Study Sites (1)

Faculty of Oral and Dental Medicine future university

Cairo, Cairo Governorate, 11835, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: B.D.S. Dental College

Study Record Dates

• First Submitted: June 25, 2025
• First Posted: July 9, 2025
• Study Start: April 1, 2025
• Primary Completion: September 30, 2025
• Study Completion: October 30, 2025
• Last Updated: July 9, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Beginning of 2026, a year after publication, with no end date

Locations

EG (1)