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

Oral Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06060288
• Other study ID #: 14081996
• Status: Not yet recruiting
• Start date: October 2023
• Est. completion date: October 2024

Study information

• Verified date: September 2023
• Source: Cairo University
• Contact: Mary F Mikhail, TA
• Phone: 00201091026115
• Email: mary.mikhail[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 174
• Est. completion date: October 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lip Neoplasms
• Mouth Neoplasms
• Oral Cancer
• Precancerous Conditions
• Premalignant Lesion

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Referral decision	when to take a decision of referral to a specialist	one year