The Importance of Mucosal Screening in the Prevention of Oral Cancer.

NCT07682883 | Enrolling By Invitation

• 2 other identifiers: KB/53/2024WLS5/1/Z/MB/N/25/26
• Study Type: interventional
• Target: 1,383
• Locations: 1 country
• Sites: 1

Brief Summary

Patients attending the Department of Oral Mucosal and Periodontal Diseases at the University Dental Center of the Medical University of Warsaw who provide written informed consent will be invited to participate in the study. Participation will begin with completing a short, anonymous questionnaire. The questions will focus on factors that may increase the risk of developing oral potentially malignant disorders and oral cancer, such as tobacco use, alcohol consumption, dietary habits, chronic diseases, and other health-related information. Next, a comprehensive oral examination will be performed by a qualified dental hygienist according to a standardized examination protocol. The examination will include assessment of the lips, cheeks, gums, hard and soft palate, tongue, floor of the mouth, and throat. The oral mucosa will be evaluated for its appearance, colour, moisture, and the presence of any abnormalities, such as white or red patches, ulcers, erosions, nodules, or other lesions. A palpation examination of selected lymph nodes in the head and neck region will also be performed. During the visit, oral hygiene will be assessed using an oral hygiene index. The condition of the teeth and any prosthetic restorations will also be evaluated to identify areas where dental plaque may accumulate or where chronic irritation of the oral mucosa may occur. The final stage of the examination will involve assessment of the oral mucosa using the Oralitest fluorescence device. This is a painless, non-invasive procedure that uses light of a specific wavelength to examine the oral mucosa. The examination takes only a few minutes, requires no special preparation, and the device does not come into direct contact with the oral tissues. Healthy oral mucosa emits a characteristic green fluorescence, whereas areas that may require further investigation appear as darker regions. The result of the fluorescence examination is available immediately after the procedure.

Conditions

OPMD; Leukoplakia Oral; Oral Mucosa; Oral Mucosal Disease; Oral Cancer , Oral Squamous Cell Carcinoma, Oral Cavity Cancer; Oral Potentially Malignant Lesions

Keywords

AUTOFLUORESCENCE TISSUE; ORAL MUCOSAL DISEASE; ORAL POTTENTIALY MALIGNANT DISORDERS; ORAL CANCER

Outcome Measures

Primary Outcomes (1)

• presence of OPMD (Oral Potentially Malignant Disorders)

  detection of abnormalities on the oral mucosa: white, red, or white-and-red lesions classified as Oral Potentially Malignant Disorders.

  From the start of the conventional examination until the completion of the subsequent fluorescence examination-all during the same visit.

Study Arms (1)

Adult Patients Attending Routine Oral Mucosal Examination

EXPERIMENTAL

Adult participants (≥18 years) consecutively recruited from patients attending the Department of Oral Mucosal Diseases and Periodontology, University Dental Center, Medical University of Warsaw, for the prevention and treatment of oral mucosal and periodontal diseases. Participants with previously diagnosed and actively treated oral potentially malignant disorders (OPMD) will be excluded. All participants will complete a study-specific questionnaire assessing risk factors for OPMD and oral cancer and will undergo both conventional clinical oral examination and fluorescence screening oral examination. Based on questionnaire responses, participants will subsequently be classified into high-risk and low-risk categories for secondary analyses; however, all participants will undergo the same study procedures.

Device: Fluorescent oral examination (FOE); Diagnostic Test: Conventional oral examination

Interventions

Fluorescent oral examination (FOE) DEVICE

Oral Fluorescence Examination Fluorescent oral examination (FOE) - an intraoral examination - was conducted by a single dental hygienist (the study author) according to a predetermined protocol. Intraorally: the examination areas are identical to those in the COE intervention-the red of the lips, as well as specific areas of the oral mucosa (mucosa of the lips, cheeks, hard and soft palate, gums, alveolar ridge, tongue, and floor of the mouth). The mucosa will be examined for the presence of lesions that may suggest dysplasia-dark, irregular, often asymmetrical patches that stand out distinctly from the healthy, green-glowing tissue. This allows for the clear distinction of diseased, altered tissue-which appears as a darkened, irregular area-from the healthy background, which reflects light with its characteristic bright color.

Adult Patients Attending Routine Oral Mucosal Examination

Conventional oral examination DIAGNOSTIC_TEST

Conventional oral examination (COE)-including conventional external and intraoral examinations-was conducted by a single researcher, a dental hygienist and the author of the study, according to a predetermined, standardized protocol. Extroral: examination of lymph node palpability at the following sites: preauricular nodes, retroauricular nodes, parauricular node, and submandibular nodes. Intraoral: examination of the mucosal membranes of the lips, cheeks, hard and soft palate, gums, oral cavity floor, and tongue, as well as the presence of lesions (spots/patches-white, red, purple, black). In clinical material, the mucous membrane reveals the location, moisture level, and presence of lesions: spot/stain (white, red, purple, black), papule, nodule, tumor, blister, vesicle, bubble, pustule, abrasion, erosion, fissure, ulcer, scale, scab, scar. In order to implement corrective measures that may result in API effects.

Adult Patients Attending Routine Oral Mucosal Examination

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older

You may not qualify if:

• under 18 years of age
• patients with diagnosed and actively treated OPMD-related lesions.

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (1)

Medical University of Warsaw

Warsaw, Masovian Voivodeship, 02-091, Poland

Location

MeSH Terms

Conditions

Mouth Neoplasms; Squamous Cell Carcinoma of Head and Neck; Leukokeratosis, Hereditary Mucosal

Condition Hierarchy (Ancestors)

Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Marta Sawczuk, MPH

  Warszawski Uniwersytet Medyczny - Doktorant

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master of Public Health

Model Details: In the first part of the study, the study group will consist of patients at high risk for OPMD and oral cancer who report the following in the questionnaire: age \> 40 years, smoking or use of tobacco products,alcohol abuse confirmed HPV infection,frequent injuries to the oral mucosa,use of,immunosuppressive medications,cancer of the upper respiratory tract or,digestive system-in the patient or family,poor oral hygiene (API \>70%) The control group will consist of patients who do not meet the criteria for inclusion in the high-risk group for OPMD and oral cancer.

Study Record Dates

• First Submitted: June 25, 2026
• First Posted: July 6, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): October 30, 2027
• Last Updated: July 6, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)