Oral Lichen PlanusNCT07318922
Evaluation of Artificial Intelligence in Diagnosis and Risk Assessment of Oral Potentially Malignant Disorders
An observational study of Oral Lichen Planus and Oral Leukoplakia, run by Ain Shams University.
Trial summary
Oral potentially malignant disorders (OPMDs) are mucosal lesions that carry a risk of malignant transformation into oral cancer. Unfortunately, a general lack of knowledge and awareness of OPMDs is common among general dental practitioners. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Oral Lichen Planus, Oral Leukoplakia, Traumatic Ulcer of Oral Mucosa
- What is being tested?
- Toluidine blue staining of the lesion and cytological smears
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 16 Dec 2025to 20 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- Adult, Older adult
Study population: Patients with oral lesions has Potential Malignant transformation
Who may be able to join
- 1- Patients have no signs of super infection of candida on the lesions. 2- A lesion with a provisional clinical diagnosis of (OLP, OLK, OEP, non-healing ulcers) at any site in the oral cavity (buccal mucosa, hard palate, labial mucosa, tongue, gingiva).
- -
Who cannot join
- Any other mucosal lesions.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of Artificial Intelligence in Diagnosis and Risk Assessment of Oral Potentially Malignant Disorders Using Clinical and Exfoliative Cytology Imaging
Oral potentially malignant disorders (OPMDs) are mucosal lesions that carry a risk of malignant transformation into oral cancer. Unfortunately, a general lack of knowledge and awareness of OPMDs is common among general dental practitioners. While thorough clinical examinations coupled with biopsy can identify most OPMDs, the absence of reliable non-invasive diagnostic tools and standardized risk stratification often delays early diagnosis and treatment of oral squamous cell carcinoma (OSCC).Early detection of suspicious oral lesions is crucial for reducing OSCC-related mortality and improving patient outcomes. Histopathological assessment of biopsied tissue remains the gold standard for diagnosis. However, since biopsy is invasive and may be associated with patient discomfort; numerous noninvasive diagnostic technologies have emerged to enhance the detection and diagnosis of oral mucosal lesions.Toluidine blue (TB) staining is one such adjunctive tool, where the degree of color retention aids in lesion characterization. Dark blue staining is considered positive for lesions highly suspicious for malignancy; light blue retention is considered positive for premalignant lesions pending histopathological confirmation, while lesions showing no stain retention are classified as negative.Exfoliative cytology represents another non-invasive diagnostic approach, wherein cells obtained via brushing the oral mucosa are spread on a slide for cytological evaluation. This technique, widely accepted and increasingly utilized, has proven valuable for early cancer detection. Notably, confocal microscopy has demonstrated high sensitivity and specificity (93%) in detecting malignant cells in exfoliative cytology specimens. Currently, TB staining and confocal microscopy remain the most commonly utilized non-invasive screening techniques in clinical practice.In recent years, artificial intelligence (AI) applications have shown remarkable promise in oncology, achieving high diagnostic accuracy across various cancer types. Deep learning models, in particular, offer exceptional performance, suggesting that AI-based solutions may be feasible for widespread community screening programs following further validation. In many cases, AI models have produced diagnostic outcomes that match or surpass those of experienced pathologists. Moreover, the combined application of AI with expert human evaluation has been shown to reduce diagnostic errors and improve diagnostic precision, particularly for poorly differentiated tumors and rare cases.Several studies have been done using different AI Models and revealed a promising application of AI in diagnosing OPMDs and cancers in different body sites.
Read the detailed description
Oral potentially malignant disorders (OPMDs) are described as the mucosal lesions that have the potential to be oral cancer. It is consisted of oral leukoplakia (OLK), oral lichen planus (OLP), oral erythroplakia (OEK), discoid lupus erythematosus, proliferative verrucous leukoplakia, candida leukoplakia, reverse smoker's palate, verrucous hyperplasia, dyskeratosis congenita, actinic cheilosis, keratoacanthoma, and oral submucous fibrosis. Up to 5% prevalence was reported in the literature for OPMDs and common localizations were described as tongue, the floor of the mouth, and gingiva. The malignant transformation rate of OEK, OLK, and OLP was estimated approximately 14.3%-50%, 0.13%-17.5%, and 0.4%-6.5%, respectively.Since many oral squamous cell carcinomas (OSCCs) develop from OPMDs, clinicians must distinguish those lesions with thorough diagnosis and management to prevent malignant transformation. Lack of knowledge and awareness about OPMDs are common in the general public and studies demonstrated that general dental practitioners are not fully informed/ prepared for those entities . Diagnosing OPMDs as definable diseases is also challenging due to the numerous varieties, various forms, and overlapping features. However, studies have found that when an OPMD changes to a nonhomogeneous presentation, it is more likely to be considered as an adverse progression, in other words, nonhomogeneous lesions have a greater risk of malignant transformation as against homogeneous lesions.Oral tissue biopsy and histopathological analysis are often considered as the gold standard for cancer risk assessment of OPMDs. However, since biopsy is an invasive assay, it may not be suitable for monitoring the chronic development of OPMDs when compared to non-invasive detection techniques. Another disadvantage that the biopsy requires, on average, a day and half for a report. Although, thorough clinical examinations with the help of biopsy may reveal most of the OPMDs and OCs, other diagnostic methods such as vital staining, microfluidics, salivary diagnostics, and cytopathology platforms could be utilized. Toluidine blue (TB) stain is a basic metachromatic dye of thiazine group that shows affinity for the perinuclear cristernae of DNA and RNA with greater penetration and temporary retention of the dye in the intercellular spaces of rapidly dividing cells in-vivo RNA . It has high sensitivity (73.9%) and low specificity (30%). Reports have concluded that toluidine blue retention in high risk OPMDs and high-risk molecular clones, even in lesions with minimal or no dysplasia have documented .While, acridine orange (AO) is a histochemicalfluorochrome with a selective affinity for nucleic acids. At a concentration of 0.01% and a pH of 6, recommended by Von Bertalanffy, the DNA fluoresces yellow to whitish green and the RNA red. AO is a low molecular weight, weakly basic dye that easily penetrates cell membranes. AO has ametachromatic properties and upon excitation with blue light, (488 nm) it emits green fluorescence. Exfoliative cytology is a diagnostic procedure which has been generally accepted for early diagnosis of cancer.Confocal laser scanning microscopy is an advanced microscopic imaging technique which was found to have good sensitivity in the identification of malignant cells in exfoliative cytology. The advantages offered by this technique are the rapidity of processing and screening the specimen and addingobjectivity to the process of clinical diagnosis. Acridine orange-stained confocal microscopic images has showed good sensitivity and specificity (93%) for detection of OPMDs.Artificial intelligence (AI) is a branch of computer science which can be defined as the ability for a computer to mimic the cognitive abilities of a human being. AI corresponds to a large array of techniques. Among them, deep learning is a potential disruptive technology that attempts to model high-level abstractions in medical images to determine diagnostic meaning. Deep learning, specifically as implemented using convolutional neural networks (CNNs), has become a conventional technique for classifying, detecting, and segmenting the objects in medical images. Artificial Intelligence (AI) and Machine Learning (ML) have gained extensive attention in dentistry to achieve cognitive functions of clinicians such as differentiation, problem-solving, and learning. Nowadays, computer-aided diagnosis systems (CAD) which were powered by convolutional neural networks (CNN) were able to detect and classify some cancerous lesions. Some of recent studies regarding using of AI in oral cancer early detection, diagnosis, and treatment outcome concluded that the Machine learning technique has the potential to help in oral cancer screening and diagnosis based on the datasets. Also the deep and conventional learning algorithms are successful in predicting the malignant transformation of oral leukoplakia and oral lichenoid lesions.The Deep CNNs can be an effective method to build vision devices with limited memory capacity for the diagnosis of oral cancer, while Faster R-CNN models have the highest detection performance, with an AUC of 74.34% and potential for classification with high sensitivity and specificity ( 100% and 90%) respectively For the CNN-based classification model. So this study is aiming to have a deep learning algorithm model that is capable for risk assessment in addition to detection and classification of OPMDs with high accuracy, sensitivity and specificitycompared to experts.
- Conditions
- Oral Lichen Planus, Oral Leukoplakia, Traumatic Ulcer of Oral Mucosa, Erythroleukoplakia of Mouth
- Being tested
- Toluidine blue staining of the lesion and cytological smears
- Keywords
- OPMDs, Artificial Intelligence, Toluidine blue stain, Confocal microscope, Exfoliative Cytology, Acridine orange stain, Tissue biopsy
- Medical subject headings
- Lichen Planus, Oral, Leukoplakia, Oral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Toluidine blue staining of the lesion and cytological smearsDiagnostic test
Staining lesions with toluidine blue stain and Exfoliative cytological smears
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparing accuracy, sensitivity and specificity of the model with specialist's opinion for the same datasets.
Measured: 1 year
Developing a machine learning model to identify, categorise, and evaluate the risk of oral potentially malignant disorders using datasets of personal criteria, clinical digital photographs and confocal microscopic images of exfoliative cytological smears
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2026
- Study start16 Dec 2025 (estimated)
- Primary completion22 Nov 2026 (estimated)
- Study completion20 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Lichen PlanusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ali, Study chair, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07318922
- Sponsor's protocol ID
- FDASU-Rec IM 112301
- Status last verified
- Nov 2025
- First submitted
- 20 Dec 2025
- Last updated
- 6 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Artificial Intelligence in Diagnosis and Risk Assessment of Oral Potentially Malignant Disorders Using Clinical and Exfoliative Cytology Imaging
- ClinicalTrials.gov ID
- NCT07318922
- Acronym / sponsor ID
- FDASU-Rec IM 112301
- Conditions
- Oral Lichen Planus, Oral Leukoplakia, Traumatic Ulcer of Oral Mucosa, Erythroleukoplakia of Mouth
- Keywords
- OPMDs, Artificial Intelligence, Toluidine blue stain, Confocal microscope, Exfoliative Cytology, Acridine orange stain, Tissue biopsy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 16 Dec 2025 (estimated)
- Primary completion
- 22 Nov 2026 (estimated)
- Study completion
- 20 Dec 2026 (estimated)
- First posted
- 6 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Oral potentially malignant disorders (OPMDs) are mucosal lesions that carry a risk of malignant transformation into oral cancer. Unfortunately, a general lack of knowledge and awareness of OPMDs is common among general dental practitioners. While thorough clinical examinations coupled with biopsy can identify most OPMDs, the absence of reliable non-invasive diagnostic tools and standardized risk stratification often delays early diagnosis and treatment of oral squamous cell carcinoma (OSCC).Early detection of suspicious oral lesions is crucial for reducing OSCC-related mortality and improving patient outcomes. Histopathological assessment of biopsied tissue remains the gold standard for diagnosis. However, since biopsy is invasive and may be associated with patient discomfort; numerous noninvasive diagnostic technologies have emerged to enhance the detection and diagnosis of oral mucosal lesions.Toluidine blue (TB) staining is one such adjunctive tool, where the degree of color retention aids in lesion characterization. Dark blue staining is considered positive for lesions highly suspicious for malignancy; light blue retention is considered positive for premalignant lesions pending histopathological confirmation, while lesions showing no stain retention are classified as negative.Exfoliative cytology represents another non-invasive diagnostic approach, wherein cells obtained via brushing the oral mucosa are spread on a slide for cytological evaluation. This technique, widely accepted and increasingly utilized, has proven valuable for early cancer detection. Notably, confocal microscopy has demonstrated high sensitivity and specificity (93%) in detecting malignant cells in exfoliative cytology specimens. Currently, TB staining and confocal microscopy remain the most commonly utilized non-invasive screening techniques in clinical practice.In recent years, artificial intelligence (AI) applications have shown remarkable promise in oncology, achieving high diagnostic accuracy across various cancer types. Deep learning models, in particular, offer exceptional performance, suggesting that AI-based solutions may be feasible for widespread community screening programs following further validation. In many cases, AI models have produced diagnostic outcomes that match or surpass those of experienced pathologists. Moreover, the combined application of AI with expert human evaluation has been shown to reduce diagnostic errors and improve diagnostic precision, particularly for poorly differentiated tumors and rare cases.Several studies have been done using different AI Models and revealed a promising application of AI in diagnosing OPMDs and cancers in different body sites.
Detailed description
Oral potentially malignant disorders (OPMDs) are described as the mucosal lesions that have the potential to be oral cancer. It is consisted of oral leukoplakia (OLK), oral lichen planus (OLP), oral erythroplakia (OEK), discoid lupus erythematosus, proliferative verrucous leukoplakia, candida leukoplakia, reverse smoker's palate, verrucous hyperplasia, dyskeratosis congenita, actinic cheilosis, keratoacanthoma, and oral submucous fibrosis. Up to 5% prevalence was reported in the literature for OPMDs and common localizations were described as tongue, the floor of the mouth, and gingiva. The malignant transformation rate of OEK, OLK, and OLP was estimated approximately 14.3%-50%, 0.13%-17.5%, and 0.4%-6.5%, respectively.Since many oral squamous cell carcinomas (OSCCs) develop from OPMDs, clinicians must distinguish those lesions with thorough diagnosis and management to prevent malignant transformation. Lack of knowledge and awareness about OPMDs are common in the general public and studies demonstrated that general dental practitioners are not fully informed/ prepared for those entities . Diagnosing OPMDs as definable diseases is also challenging due to the numerous varieties, various forms, and overlapping features. However, studies have found that when an OPMD changes to a nonhomogeneous presentation, it is more likely to be considered as an adverse progression, in other words, nonhomogeneous lesions have a greater risk of malignant transformation as against homogeneous lesions.Oral tissue biopsy and histopathological analysis are often considered as the gold standard for cancer risk assessment of OPMDs. However, since biopsy is an invasive assay, it may not be suitable for monitoring the chronic development of OPMDs when compared to non-invasive detection techniques. Another disadvantage that the biopsy requires, on average, a day and half for a report. Although, thorough clinical examinations with the help of biopsy may reveal most of the OPMDs and OCs, other diagnostic methods such as vital staining, microfluidics, salivary diagnostics, and cytopathology platforms could be utilized. Toluidine blue (TB) stain is a basic metachromatic dye of thiazine group that shows affinity for the perinuclear cristernae of DNA and RNA with greater penetration and temporary retention of the dye in the intercellular spaces of rapidly dividing cells in-vivo RNA . It has high sensitivity (73.9%) and low specificity (30%). Reports have concluded that toluidine blue retention in high risk OPMDs and high-risk molecular clones, even in lesions with minimal or no dysplasia have documented .While, acridine orange (AO) is a histochemicalfluorochrome with a selective affinity for nucleic acids. At a concentration of 0.01% and a pH of 6, recommended by Von Bertalanffy, the DNA fluoresces yellow to whitish green and the RNA red. AO is a low molecular weight, weakly basic dye that easily penetrates cell membranes. AO has ametachromatic properties and upon excitation with blue light, (488 nm) it emits green fluorescence. Exfoliative cytology is a diagnostic procedure which has been generally accepted for early diagnosis of cancer.Confocal laser scanning microscopy is an advanced microscopic imaging technique which was found to have good sensitivity in the identification of malignant cells in exfoliative cytology. The advantages offered by this technique are the rapidity of processing and screening the specimen and addingobjectivity to the process of clinical diagnosis. Acridine orange-stained confocal microscopic images has showed good sensitivity and specificity (93%) for detection of OPMDs.Artificial intelligence (AI) is a branch of computer science which can be defined as the ability for a computer to mimic the cognitive abilities of a human being. AI corresponds to a large array of techniques. Among them, deep learning is a potential disruptive technology that attempts to model high-level abstractions in medical images to determine diagnostic meaning. Deep learning, specifically as implemented using convolutional neural networks (CNNs), has become a conventional technique for classifying, detecting, and segmenting the objects in medical images. Artificial Intelligence (AI) and Machine Learning (ML) have gained extensive attention in dentistry to achieve cognitive functions of clinicians such as differentiation, problem-solving, and learning. Nowadays, computer-aided diagnosis systems (CAD) which were powered by convolutional neural networks (CNN) were able to detect and classify some cancerous lesions. Some of recent studies regarding using of AI in oral cancer early detection, diagnosis, and treatment outcome concluded that the Machine learning technique has the potential to help in oral cancer screening and diagnosis based on the datasets. Also the deep and conventional learning algorithms are successful in predicting the malignant transformation of oral leukoplakia and oral lichenoid lesions.The Deep CNNs can be an effective method to build vision devices with limited memory capacity for the diagnosis of oral cancer, while Faster R-CNN models have the highest detection performance, with an AUC of 74.34% and potential for classification with high sensitivity and specificity ( 100% and 90%) respectively For the CNN-based classification model. So this study is aiming to have a deep learning algorithm model that is capable for risk assessment in addition to detection and classification of OPMDs with high accuracy, sensitivity and specificitycompared to experts.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with oral lesions has Potential Malignant transformation
Key inclusion criteria (2 listed)
- 1- Patients have no signs of super infection of candida on the lesions. 2- A lesion with a provisional clinical diagnosis of (OLP, OLK, OEP, non-healing ulcers) at any site in the oral cavity (buccal mucosa, hard palate, labial mucosa, tongue, gingiva).
- -
Key exclusion criteria (1 listed)
- Any other mucosal lesions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Toluidine blue staining of the lesion and cytological smearsStaining lesions with toluidine blue stain and Exfoliative cytological smears | Diagnostic test | – |
Primary outcome
Comparing accuracy, sensitivity and specificity of the model with specialist's opinion for the same datasets.
Time frame: 1 year
Developing a machine learning model to identify, categorise, and evaluate the risk of oral potentially malignant disorders using datasets of personal criteria, clinical digital photographs and confocal microscopic images of exfoliative cytological smears
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ali study chair
Ain Shams University
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Lichen Planus and Oral Leukoplakia, run by Ain Shams University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aya Mostafa Ali, Bachelor of dentistry (+20 01140126541, ayamms1591997@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparing accuracy, sensitivity and specificity of the model with specialist's opinion for the same datasets. (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.