NCT07319221

Brief Summary

to detect the Accuracy of Artificial Intelligence Technology in Detecting Number of Root Canal of Human Mandibular Second Molar: Diagnostic Accuracy Experimental Study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 29, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 29, 2025

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2025

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

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

1 year

First QC Date

December 21, 2025

Last Update Submit

December 21, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of root canals detected

    Detected by AI software

    within one year

Study Arms (2)

morphology of canals in lower second mandibular molar

EXPERIMENTAL

Anatomical variations in root canal systems, such as the presence of an additional root canal, are common, and failure to detect all canals can lead to treatment failure.

Procedure: CBCT

Number of canals in lower second mandibular molar

EXPERIMENTAL

Number of canals in lower second mandibular molar

Procedure: AI

Interventions

AIPROCEDURE

Detection of all canals in patients indicated for root canal therapy in lower second molars by Artificial Intelligence Dental operating microscope and CBCT

Number of canals in lower second mandibular molar
CBCTPROCEDURE

CBCT scans performed to all participants, will be randomly distributed upon postgraduate students using randomization software

morphology of canals in lower second mandibular molar

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients must be medically free from any systemic disease that can affect root canal treatment.
  • Age range of the patients should be 18-40 with permanent mandibular second molars indicated for root canal treatment.
  • No sex predilection.
  • 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:

  • Lower second molars which are non-restorable, having large perforations, external root resorption, vertical root fracture, internal root resorption, grade 2/3 mobility, previous successful/non-successful root canal treatment
  • 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. 12
  • Not restorable teeth.
  • Abnormal anatomy and calcified canals.
  • Previous root canal treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Future University Dental Hospital

Cairo, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
B.D.S Dental College

Study Record Dates

First Submitted

December 21, 2025

First Posted

January 6, 2026

Study Start

November 29, 2024

Primary Completion

November 29, 2025

Study Completion

December 20, 2025

Last Updated

January 6, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, ICF
Time Frame
with in one year

Locations