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Sponsor study identifier
Secondary identifiers
OTHER_GRANT · Medical Univerisity of Warsaw
interventional
1,383
1 country
1
Study Start
June 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
August 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
October 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 25, 2026
Actual (reported)July 6, 2026
Actual (reported)August 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
October 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
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.
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.
Medical University of Warsaw
Warsaw, Masovian Voivodeship, 02-091, Poland
Marta Sawczuk, MPH
Warszawski Uniwersytet Medyczny - Doktorant
First Submitted
June 25, 2026
First Posted
July 6, 2026
Study Start
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.
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June 1, 2026
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
August 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
October 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
July 6, 2026
Record last verified: 2026-06
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Source: ClinicalTrials.gov.
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