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

NCT06325514 | Completed

• 1 other identifier: NA2024
• Study Type: observational
• Target: 241
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

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.

  3 months to develop the program

Study Arms (3)

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

Artificial intelligence based program DIAGNOSTIC_TEST

the AI based program is based on image analysis

high risk referral; low risk referral; normal/variations of normal anatomical landmarks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Patients less than 18 years old

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of dentistry, CairoU

Cairo, 11553, Egypt

Location

Related Publications (4)

• 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.

  PMID: 33384840 BACKGROUND

• 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.

  PMID: 27751768 BACKGROUND

• 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.

  PMID: 11871397 BACKGROUND

• 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.

  PMID: 34199471 BACKGROUND

MeSH Terms

Conditions

Mouth Neoplasms; Lichen Planus, Oral; Leukoplakia; Erythroplasia; Leukoedema, Oral; Lichenoid Eruptions

Condition Hierarchy (Ancestors)

Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases; Lichen Planus; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Precancerous Conditions; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Noran AM AbdelMoaty, MsC

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 16, 2024
• First Posted: March 22, 2024
• Study Start: April 1, 2024
• Primary Completion: October 1, 2024
• Study Completion: December 1, 2024
• Last Updated: June 4, 2025

Record last verified: 2025-06

Locations

EG (1)