Accuracy of Artificial Intelligence Technology in Detecting Periapical Lesions in Human Teeth. (AI)

Accuracy of Artificial Intelligence Technology in Detecting Periapical Lesions in Human Teeth. Diagnostic Accuracy Experimental Study.

Aims to evaluate the accuracy of using Artificial intelligence software in detecting the presence of periapical lesion compared to CBCT imaging.

Study Overview

• Status: Completed
• Conditions: Periapical Lesion
• Intervention / Treatment: Other: Cone beam computed tomography; Other: artificial intelligence software

Detailed Description

In this research, patients referred to endodontic department in the university will undergo clinical examination (percussion, palpation) tests. These will be recorded. Then the patient will undergo a periapical radiograph to detect the presence of periapical lesion. Patients with periapical lesions will then undergo a cone beam computed tomography and this scan will be uploaded into the Artificial intelligence software to detect the accuracy of the software in detecting the presence of the periapical lesion. Any patient with a periapical lesion in need of root canal treatment will undergo the treatment.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Future University in Egypt

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. All patients must be medically free from any systemic disease that can affect root canal treatment.
2. 18 to 50 years old patients with permanent teeth presenting with periapical pathosis.
3. No sex predilection.
4. All patients must have good oral hygiene.
5. Restorable teeth
6. Positive patient's acceptance for participating in the study.
7. Patients able to sign informed consent

Exclusion Criteria:

1. Patients above 50 years or patients below 18 years.
2. Patients with very poor oral hygiene.
3. Pregnant women after taking detailed history and pregnancy test must be in the first visit.
4. Psychologically disturbed patients.

Teeth that have:

• Periodontally affected with grade 2 or 3 mobility.
• Not restorable teeth.
• Abnormal anatomy and calcified canals

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: cone beam computed tomography; detecting radiolucent periapical lesions using cone beam computed tomography	Other: Cone beam computed tomography; Cone beam computed tomography scans to detect the presence of periapical lesion by specialized investigators.
Active Comparator: artificial intelligence software; Cone beam CT scan will be uploaded to artificial intelligence software to ensure that the software will detect radiolucent periapical lesion compared to Cone beam CT scans.	Other: artificial intelligence software; artificial intelligence software that aids in diagnosis in dentistry

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CBCT scans	Presence of periapical lesion on CBCT scans	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of Artificial intelligence software	Comparing results from CBCT scans to Artificial intelligence software in detection of periapcial lesions.	1 year

Collaborators and Investigators

• Sponsor: Future University in Egypt

Study record dates

Study Major Dates

• Study Start (Actual): December 6, 2024
• Primary Completion (Actual): November 1, 2025
• Study Completion (Actual): December 21, 2025

Study Registration Dates

• First Submitted: December 21, 2025
• First Submitted That Met QC Criteria: December 21, 2025
• First Posted (Actual): January 6, 2026

Study Record Updates

• Last Update Posted (Actual): January 6, 2026
• Last Update Submitted That Met QC Criteria: December 21, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: artificial intelligence, periapical lesion, CBCT
• Other Study ID Numbers: (52)/11-2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: within 1 year from registering the study protocol
• IPD Sharing Access Criteria: within 1 year from registering the study protocol
• 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