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OpenTrials
Completed

NCT Number: NCT06325514

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • Patients less than 18 years old

Treatment and study plan

Artificial intelligence based program

Diagnostic Test

the AI based program is based on image analysis

Primary outcomes

  1. risk stratification

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

The Application of an Artificial Intelligence Based Program to Classify Oral Cavity Findings Based on Clinical Image Analysis

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 22, 2024
Registry last updated
Jun 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.