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

Not yet recruiting

• Conditions: Oral Cancer; Erythroplakia; Oral Lichen Planus; Fordyce Granule; Leukoplakia; Leukoedemas, Oral; Lichenoid Reaction
• Interventions: Diagnostic Test: Artificial intelligence based program

• Registration Number: NCT06325514
• Lead Sponsor: Cairo University

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.

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.

Study Timeline

• Status Verified: 2024-03
• Study First Submitted: 2024-03-16
• Study First Submitted QC: 2024-03-16
• Study First Posted: 2024-03-22
• Last Update Submitted: 2024-03-25
• Last Update Posted: 2024-03-26
• Study Start: 2024-04-01
• Primary Completion: 2024-08-01
• Study Completion: 2024-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 241

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

Read More

Exclusion Criteria

• Patients less than 18 years old

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
low risk referral	Artificial intelligence based program	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.
normal/variations of normal anatomical landmarks	Artificial intelligence based program	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
high risk referral	Artificial intelligence based program	patients that needs referral for a high risk of malignancy or a premalignant disease, such as: oral lichen planus, leukoplakia, erythroplakia, squamous cell carcinoma.

Primary Outcome Measures

Name	Time	Method
risk stratification	3 months to develop the program	patient is either normal with no risk or need for referral, low risk of malignant transformation disease, high risk of malignant transformation disease.