NCT07319182

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 6, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 21, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 6, 2026

Completed
Last Updated

January 6, 2026

Status Verified

December 1, 2025

Enrollment Period

11 months

First QC Date

December 21, 2025

Last Update Submit

December 21, 2025

Conditions

Keywords

artificial intelligence, periapical lesion, CBCT

Outcome Measures

Primary Outcomes (1)

  • CBCT scans

    Presence of periapical lesion on CBCT scans

    1 year

Secondary Outcomes (1)

  • Accuracy of Artificial intelligence software

    1 year

Study Arms (2)

cone beam computed tomography

ACTIVE COMPARATOR

detecting radiolucent periapical lesions using cone beam computed tomography

Other: Cone beam computed tomography

artificial intelligence software

ACTIVE COMPARATOR

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

Interventions

Cone beam computed tomography scans to detect the presence of periapical lesion by specialized investigators.

cone beam computed tomography

artificial intelligence software that aids in diagnosis in dentistry

artificial intelligence software

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Patients above 50 years or patients below 18 years.
  • Patients with very poor oral hygiene.
  • Pregnant women after taking detailed history and pregnancy test must be in the first visit.
  • Psychologically disturbed patients.
  • Teeth that have:
  • Periodontally affected with grade 2 or 3 mobility.
  • Not restorable teeth.
  • Abnormal anatomy and calcified canals

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Future University in Egypt

Cairo, 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
PRINCIPAL INVESTIGATOR
PI Title
Master Student

Study Record Dates

First Submitted

December 21, 2025

First Posted

January 6, 2026

Study Start

December 6, 2024

Primary Completion

November 1, 2025

Study Completion

December 21, 2025

Last Updated

January 6, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, ICF
Time Frame
within 1 year from registering the study protocol
Access Criteria
within 1 year from registering the study protocol

Locations