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.

NCT ID: NCT07056998

Last Updated: 2025-07-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-01

Study Completion Date

2025-10-30

Brief Summary

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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

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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

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Root Canal Treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Investigators

Study Groups

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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

Group Type ACTIVE_COMPARATOR

root canal retreatment

Intervention Type 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

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

Group Type ACTIVE_COMPARATOR

root canal retreatment

Intervention Type 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.

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

Group Type ACTIVE_COMPARATOR

root canal retreatment

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tala Ghassan Hassan Odeh

OTHER

Sponsor Role lead

Responsible Party

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Tala Ghassan Hassan Odeh

B.D.S. Dental College

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Faculty of Oral and Dental Medicine future university

Cairo, Cairo Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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FUE.REC(44)/11-2024

Identifier Type: -

Identifier Source: org_study_id

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