- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07682883
The Importance of Mucosal Screening in the Prevention of Oral Cancer.
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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Masovian Voivodeship
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Warsaw, Masovian Voivodeship, Polen, 02-091
- Medical University of Warsaw
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
Inclusion Criteria:
- 18 years of age or older
Exclusion Criteria:
- under 18 years of age
- patients with diagnosed and actively treated OPMD-related lesions.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Diagnose
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 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.
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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.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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presence of OPMD (Oral Potentially Malignant Disorders)
Zeitfenster: From the start of the conventional examination until the completion of the subsequent fluorescence examination-all during the same visit.
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detection of abnormalities on the oral mucosa: white, red, or white-and-red lesions classified as Oral Potentially Malignant Disorders.
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From the start of the conventional examination until the completion of the subsequent fluorescence examination-all during the same visit.
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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Marta Sawczuk, MPH, Warszawski Uniwersytet Medyczny - Doktorant
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Mundkrankheiten
- Stomatognathe Erkrankungen
- Neubildungen nach Standort
- Neubildungen
- Genetische Krankheiten, angeboren
- Neubildungen nach histologischem Typ
- Kopf-Hals-Neubildungen
- Neubildungen, Drüsen und Epithelien
- Hautkrankheiten
- Karzinom
- Hautkrankheiten, genetisch
- Karzinom, Plattenepithel
- Angeborene, erbliche und neonatale Krankheiten und Anomalien
- Haut- und Bindegewebserkrankungen
- Plattenepithelkarzinom von Kopf und Hals
- Neubildungen im Mund
- Leukokeratose, erbliche Schleimhaut
Andere Studien-ID-Nummern
- KB/53/2024
- WLS5/1/Z/MB/N/25/26 (Andere Zuschuss-/Finanzierungsnummer: Medical Univerisity of Warsaw)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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