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

Sponsor
Cairo University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06060288
Collaborator
(none)
174
12

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Diagnosis by mobile phone imaging

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 Design

Study Type:
Observational
Anticipated Enrollment :
174 participants
Observational Model:
Other
Time Perspective:
Cross-Sectional
Official Title:
Diagnostic Accuracy of Mobile Phone Imaging Compared to Conventional Clinical Examination for Oral Cancer Screening
Anticipated Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
Aug 1, 2024
Anticipated Study Completion Date :
Oct 1, 2024

Outcome Measures

Primary Outcome Measures

  1. Categorization of oral mucosal lesions [one year]

    to categorize the oral lesions into: Normal variance Reactive or inflammatory lesions Potentially malignant lesions Oral cancer

Secondary Outcome Measures

  1. Referral decision [one year]

    when to take a decision of referral to a specialist

Eligibility Criteria

Criteria

Ages Eligible for Study:
12 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.
  1. Patients unable to follow instructions such as mental disability and children below 12-year-old.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Cairo University

Investigators

  • Principal Investigator: Mary F Mikhail, TA, master candidate in Cairo University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Mary Fayez Farag Mikhail, Resident Doctor in Department of Oral Medicine ,diagnosis and Periodontology , Faculty of Dentistry Fayoum University, Cairo University
ClinicalTrials.gov Identifier:
NCT06060288
Other Study ID Numbers:
  • 14081996
First Posted:
Sep 29, 2023
Last Update Posted:
Oct 3, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Mary Fayez Farag Mikhail, Resident Doctor in Department of Oral Medicine ,diagnosis and Periodontology , Faculty of Dentistry Fayoum University, Cairo University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 3, 2023