ClinicalTrials.gg
CompletedNCT06325514Updated Jun 4, 2025

Artificial Intelligence Based Program to Classify Oral Cavity Findings Based on Clinical Image Analysis

An observational study in Oral Cancer, Oral Lichen Planus and Fordyce Granule, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-04.

Sponsored by Cairo University · Observational

Study type
Observational
Model
Ecologic or community
Time perspective
Cross-sectional
Enrollment
241
Ages
18 Years and older
Sex
All
01

Study summary

This study aims to develop an AI program that can classify oral findings into Normal/variation of normal or an oral disease by clinical photos analysis, aiding in lowering the percentages of false positive and false negative diagnosis of oral diseases.

Read the detailed description

Early diagnosis of oral lesions, particularly oral cancer, is crucial for enhancing prognosis, facilitating early intervention and care with the intention of lowering disease-related mortality.

Since conventional oral examination (COE) is the most used method in identifying oral lesions, the average dental practitioner's experience is a decisive factor in early diagnosis.

Visual examination lacks specificity and sensitivity since its highly subjective. Unfortunately, Studies show that the majority of dentists lack expertise in early detection of the disease, resulting in false negative diagnosis of oral lesions.

General practitioners are found to either delay the referral of a suspected oral lesion to an Oral Medicine specialist, or referring numerous false positive cases, unnecessarily pushing the patients into a state of anxiousness and cancer phobia. False positive referrals overburden the specialists, which will eventually cause delayed diagnosis of true positive cases due to the oversaturation with false positive ones.

diagnostic research scope shifts towards noninvasive, easy chair side methods with higher accuracy for early detection of oral lesions. Recent approaches towards using machine based programs indicate that this machine-learning method may be useful in the detection and diagnosis of oral cancer.

02

Conditions studied

  • Oral Cancer
  • Oral Lichen Planus
  • Fordyce Granule
  • Leukoplakia
  • Erythroplakia
  • Leukoedemas, Oral
  • Lichenoid Reaction
03

In context

Mouth Neoplasms

446 studies on the registry are indexed under Mouth Neoplasms; 130 are open to participants now.

This study's enrollment of 241 is above the median of 100 across 113 observational studies indexed under Mouth Neoplasms.

Browse Mouth Neoplasms studies →

Lead sponsor

Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

patients should be above 18 years old, with no maximum age limit. Normal oral cavity findings, variations of oral anatomical landmarks, patients with oral lesions are all included in the study.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients above 18 years old
  • Candidates with normal oral cavity findings
  • Candidates with variations of oral cavity findings
  • Candidates with different oral lesions

Exclusion criteria

Exclusion Criteria:

  • Patients less than 18 years old
05

Study design

Observational model
Ecologic or community
Time perspective
Cross-sectional
Enrollment
241 participants (actual)
Patient registry
No

Groups and cohorts

  • normal/variations of normal anatomical landmarks

    patients that have normal oral findings or variations of normal anatomical landmarks such as: leukoedema, fordyce granules, linea alba, physiological pigmentations, torus palatinus, torus mandibularis, geographic tongue, fissured tongue

    Diagnostic Test: Artificial intelligence based program

  • low risk referral

    patients that needs referral for a low risk of malignant transformation disease, such as: hemangiomas, fibromas, oral apthous ulcers, candidal infections, pemphigus valgaris, petechiae, frictional keratosis, smokers' melanosis.

    Diagnostic Test: Artificial intelligence based program

  • high risk referral

    patients that needs referral for a high risk of malignancy or a premalignant disease, such as: oral lichen planus, leukoplakia, erythroplakia, squamous cell carcinoma.

    Diagnostic Test: Artificial intelligence based program

Interventions

  • Diagnostic testArtificial intelligence based program

    the AI based program is based on image analysis

06

What researchers measure

Primary outcomes

  1. risk stratification

    patient is either normal with no risk or need for referral, low risk of malignant transformation disease, high risk of malignant transformation disease.

    Time frame: 3 months to develop the program

07

Study locations

1 site
  • Faculty of dentistry, CairoU
    Cairo, 11553, Egypt
08

References and documents

Publications

  • Khanagar SB, Al-Ehaideb A, Maganur PC, Vishwanathaiah S, Patil S, Baeshen HA, Sarode SC, Bhandi S. Developments, application, and performance of artificial intelligence in dentistry - A systematic review. J Dent Sci. 2021 Jan;16(1):508-522. doi: 10.1016/j.jds.2020.06.019. Epub 2020 Jun 30. PubMed 33384840 ↗
  • Varela-Centelles P, Lopez-Cedrun JL, Fernandez-Sanroman J, Seoane-Romero JM, Santos de Melo N, Alvarez-Novoa P, Gomez I, Seoane J. Key points and time intervals for early diagnosis in symptomatic oral cancer: a systematic review. Int J Oral Maxillofac Surg. 2017 Jan;46(1):1-10. doi: 10.1016/j.ijom.2016.09.017. Epub 2016 Oct 15. PubMed 27751768 ↗
  • Seoane Leston JM, Aguado Santos A, Varela-Centelles PI, Vazquez Garcia J, Romero MA, Pias Villamor L. Oral mucosa: variations from normalcy, part I. Cutis. 2002 Feb;69(2):131-4. PubMed 11871397 ↗
  • Tanriver G, Soluk Tekkesin M, Ergen O. Automated Detection and Classification of Oral Lesions Using Deep Learning to Detect Oral Potentially Malignant Disorders. Cancers (Basel). 2021 Jun 2;13(11):2766. doi: 10.3390/cancers13112766. PubMed 34199471 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Apr 2024 to primary completion in Oct 2024, 6 months.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 16, 2024
First posted
Mar 22, 2024
StartActual
Apr 1, 2024
Primary completionActual
Oct 1, 2024
CompletionActual
Dec 1, 2024
Last update
Jun 4, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06325514
Lead sponsor
Cairo University
Responsible party
Noran Ayman Mohammad Ismael Abdel-Moaty (Principal Investigator, Cairo University) — Principal investigator
First posted
Mar 22, 2024
Start date
Apr 1, 2024
Primary completion
Oct 1, 2024
Completion
Dec 1, 2024
Last update
Jun 4, 2025

Study contacts

Noran AM AbdelMoaty, MsC
principal investigator · Cairo University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion