Clinical trial NCT06060288: Diagnostic Accuracy of Mobile Phone Imaging Compared to Conventional Clinical Examination for Oral Cancer Screening
Official title: Diagnostic Accuracy of Mobile Phone Imaging Compared to Conventional Clinical Examination for Oral Cancer Screening
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Premalignant Lesion
Oral Cancer
Keywords: teledentistry
oral cancer screening
oral potentially malignant lesions
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-09-29
Enrollment: 174
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: - Patients have any visible oral mucosal lesions including normal variants, reactive and inflammatory lesions and potentially malignant lesions (PML)

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Categorization of oral mucosal lesions
timeFrame: one year
Secondary outcomes:
measure: Referral decision
timeFrame: one year
Other outcomes:
Locations:
Study officials:
affiliation: master candidate in Cairo University
name: Mary F Mikhail, TA
role: PRINCIPAL_INVESTIGATOR
References:
citation: Haron N, Zain RB, Nabillah WM, Saleh A, Kallarakkal TG, Ramanathan A, Sinon SH, Razak IA, Cheong SC. Mobile Phone Imaging in Low Resource Settings for Early Detection of Oral Cancer and Concordance with Clinical Oral Examination. Telemed J E Health. 2017 Mar;23(3):192-199. doi: 10.1089/tmj.2016.0128. Epub 2016 Aug 19.
citation: Lin I, Datta M, Laronde DM, Rosin MP, Chan B. Intraoral Photography Recommendations for Remote Risk Assessment and Monitoring of Oral Mucosal Lesions. Int Dent J. 2021 Oct;71(5):384-389. doi: 10.1016/j.identj.2020.12.020. Epub 2021 Feb 20.