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

Not yet recruiting

• Conditions: Premalignant Lesion; Oral Cancer

• Registration Number: NCT06060288
• Lead Sponsor: Cairo University

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.

Study Timeline

• Status Verified: 2023-09
• Study First Submitted: 2023-09-23
• Study First Submitted QC: 2023-09-23
• Study First Posted: 2023-09-29
• Last Update Submitted: 2023-09-29
• Study Start: 2023-10
• Last Update Posted: 2023-10-03
• Primary Completion: 2024-08
• Study Completion: 2024-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 174

Inclusion Criteria

• Patients have any visible oral mucosal lesions including:

  1. Normal Variants
  2. Reactive and inflammatory lesions
  3. Potentially malignant lesions (PML)
  4. 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Categorization of oral mucosal lesions	one year	to categorize the oral lesions into: 1. Normal variance; 2. Reactive or inflammatory lesions; 3. Potentially malignant lesions; 4. Oral cancer

Secondary Outcome Measures

Name	Time	Method
Referral decision	one year	when to take a decision of referral to a specialist