Diagnostic Accuracy of Mobile Phone Imaging Compared to Conventional Clinical Examination for Oral Cancer Screening

Study Overview
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Brief Summary
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The aim of study is to evaluate the sensitivity and specificity of using mobile phone photographs versus conventional clinical examination as a screening tool for early detection of oral cancer.

Detailed Description
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Tele-dentistry is a method of providing oral healthcare and dental services through real-time transmission of clinical information using electronic medical records, digital imaging, photography, ICT, and the internet. Oral medicine is a dental specialty that uses tele-dentistry services to manage patients with systemic diseases and comorbidities. However, some oral disorders may have systemic consequences, necessitating additional diagnostic techniques and skilled doctors. Issues such as lack of oral medicine specialists, inexperienced community health workers, and inadequate training for managing complex oral conditions also pose challenges. Delayed diagnosis of oral cancers in underserved communities, poor patient management, high transportation costs, and lengthy waiting lists are some of the challenges faced by patients. The COVID-19 pandemic has further complicated these issues, causing disruptions in educational programs and access to oral medicine services. Tele-dentistry can facilitate efficient communication between patients and healthcare professionals for various purposes. There is limited research on using tele-dentistry in oral medicine, especially for results like accuracy. Consequently, the present study is designed to evaluate the sensitivity and specificity of using mobile phone images versus conventional clinical examination as a screening tool for early detection of oral cancer.

Official Title
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Diagnostic Accuracy of Mobile Phone Imaging Compared to Conventional Clinical Examination for Oral Cancer Screening

Conditions
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Premalignant Lesion, Oral Cancer

Intervention / Treatment
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* Diagnostic Test: Diagnosis by mobile phone imaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients have any visible oral mucosal lesions including: Normal Variants Reactive and inflammatory lesions Potentially malignant lesions (PML) Oral cancer Exclusion Criteria: - 1. Patients unable to open their mouth properly due to trismus, pain, fibrosis or scleroderma. 2. Patients unable to follow instructions such as mental disability and children below 12-year-old.

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Diagnosis by mobile phone imaging|The photographs will be taken with a smartphone iPhone 14 Pro in a one-year period. Imaging will follow the recommendations regarding intraoral photography in oral mucosal screening set by (Lin et al., 2021). Personal data and a brief description of the present illness concerning the main complaint will be informed by the patients and recorded in a diagnosis chart of the Oral medicine department Cairo University. Complete intraoral physical examination will be performed by the main investigator under supervision of the main supervisor and the co-supervisor using dental equipment with artificial light.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Categorization of oral mucosal lesions | to categorize the oral lesions into: Normal variance Reactive or inflammatory lesions Potentially malignant lesions Oral cancer | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Referral decision | when to take a decision of referral to a specialist | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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teledentistry, oral cancer screening, oral potentially malignant lesions