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Clinical Trials/NCT06060288
NCT06060288
Not yet recruiting
Not Applicable

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

Cairo University0 sites174 target enrollmentOctober 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Premalignant Lesion
Sponsor
Cairo University
Enrollment
174
Primary Endpoint
Categorization of oral mucosal lesions
Status
Not yet recruiting
Last Updated
2 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
October 2023
End Date
October 2024
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mary Fayez Farag Mikhail

Resident Doctor in Department of Oral Medicine ,diagnosis and Periodontology , Faculty of Dentistry Fayoum University

Cairo University

Eligibility Criteria

Inclusion Criteria

  • Patients have any visible oral mucosal lesions including:
  • Normal Variants
  • Reactive and inflammatory lesions
  • Potentially malignant lesions (PML)
  • Oral cancer

Exclusion Criteria

  • Patients unable to open their mouth properly due to trismus, pain, fibrosis or scleroderma.
  • Patients unable to follow instructions such as mental disability and children below 12-year-old.

Outcomes

Primary Outcomes

Categorization of oral mucosal lesions

Time Frame: one year

to categorize the oral lesions into: 1. Normal variance 2. Reactive or inflammatory lesions 3. Potentially malignant lesions 4. Oral cancer

Secondary Outcomes

  • Referral decision(one year)

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