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

NCT ID: NCT06060288

Last Updated: 2023-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

174 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-31

Study Completion Date

2024-10-31

Brief Summary

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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

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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.

Conditions

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Premalignant Lesion Oral Cancer

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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smartphone iPhone 14 Pro

Eligibility Criteria

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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.
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Mary Fayez Farag Mikhail

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

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mary F Mikhail, TA

Role: PRINCIPAL_INVESTIGATOR

master candidate in Cairo University

Central Contacts

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Mary F Mikhail, TA

Role: CONTACT

00201091026115

Salsabeel A Afifi, Lecturer

Role: CONTACT

References

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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.

Reference Type BACKGROUND
PMID: 27541205 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33618833 (View on PubMed)

Other Identifiers

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14081996

Identifier Type: -

Identifier Source: org_study_id

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