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

30 juni 2026 bijgewerkt door: Marta Sawczuk, Medical University of Warsaw

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.

Studie Overzicht

Gedetailleerde beschrijving

The study will be conducted among patients who consent to complete the questionnaire and participate in the study-those who visit the Department of Oral Mucosal and Periodontal Diseases at the University Dental Center of the Medical University of Warsaw for the prevention and treatment of oral mucosal and periodontal diseases. Each participant will be asked to complete a proprietary questionnaire designed for the study, consisting of questions regarding risk factors for potentially neoplastic lesions and oral cancer

. Subsequently, the following examinations will be conducted sequentially: a conventional external and intraoral examination, and an examination of the oral mucosa using fluorescence methods with the selected Oralitest device. A curing light is required to perform the fluorescence method. When epithelial tissue is exposed to light of a specific wavelength, fluorescence examination can reveal changes in its structure-down to the basement membrane, where precancerous lesions typically originate. This allows for the clear distinction of diseased, altered tissue, which appears as a darkened, irregular area, sharply contrasting with the healthy background that reflects light with a characteristic bright color. Both the clinical examination and the fluorescence examination will be conducted by a single dental hygienist-the project author-according to a specific, standardized protocol covering the labial red and individual parts of the oral mucosa (mucosa of the lips, cheeks, hard and soft palate, gums, oropharynx, tongue, and floor of the mouth). In the clinical examination, the mucosa will be assessed for color, moisture, and the presence of the following lesions: spot/stain (white, red, purple, black), papule, nodule, tumor, blister, vesicle, bulla, pustule, abrasion, erosion, fissure, ulcer, scale, scab, scar. A lymph node palpation examination will also be conducted according to a specific protocol: preauricular nodes, parotid nodes, paratracheal node, submandibular nodes. To assess oral hygiene, the API index will be determined, and the dentition and prosthetic restorations will be evaluated for areas where bacterial plaque can accumulate and for factors that irritate the mucous membrane. During the examination using fluorescence methods with the Oralitest device, the mucosa will be assessed for the presence of lesions that may suggest dysplasia-dark, irregular, often asymmetrical spots clearly contrasting with healthy, green-glowing tissue. The presence of lesions, their location and size, or any deviations from normal tissue fluorescence will be recorded in the oral mucosa examination chart. Patients in whom potentially malignant neoplastic changes are detected will be immediately referred for consultation with a periodontist.

Studietype

Ingrijpend

Inschrijving (Geschat)

1383

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Polen, 02-091
        • Medical University of Warsaw

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Ja

Beschrijving

Inclusion Criteria:

  • 18 years of age or older

Exclusion Criteria:

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Diagnostisch
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Adult Patients Attending Routine Oral Mucosal Examination
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.

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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
presence of OPMD (Oral Potentially Malignant Disorders)
Tijdsspanne: From the start of the conventional examination until the completion of the subsequent fluorescence examination-all during the same visit.
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.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

  • Hoofdonderzoeker: Marta Sawczuk, MPH, Warszawski Uniwersytet Medyczny - Doktorant

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 juni 2026

Primaire voltooiing (Geschat)

31 augustus 2027

Studie voltooiing (Geschat)

30 oktober 2027

Studieregistratiedata

Eerst ingediend

25 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

30 juni 2026

Eerst geplaatst (Werkelijk)

6 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

6 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

30 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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