OPMDNCT07682883
The Importance of Mucosal Screening in the Prevention of Oral Cancer.
A study testing Fluorescent oral examination (FOE) and Conventional oral examination in people with OPMD and Oral Cancer , Oral Squamous Cell Carcinoma, Oral Cavity Cancer, run by Medical University of Warsaw at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- OPMD, Oral Cancer , Oral Squamous Cell Carcinoma, Oral Cavity Cancer, Oral Potentially Malignant Lesions
- What is being tested?
- Fluorescent oral examination (FOE) and Conventional oral examination
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,383 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jun 2026to 30 Oct 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age or older
Who cannot join
- under 18 years of age
- patients with diagnosed and actively treated OPMD-related lesions.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read more
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.
Read the detailed description
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.
- Conditions
- OPMD, Oral Cancer , Oral Squamous Cell Carcinoma, Oral Cavity Cancer, Oral Potentially Malignant Lesions, Leukoplakia Oral, Oral Mucosa, Oral Mucosal Disease
- Being tested
- Fluorescent oral examination (FOE), Conventional oral examination
- Keywords
- AUTOFLUORESCENCE TISSUE, ORAL MUCOSAL DISEASE, ORAL POTTENTIALY MALIGNANT DISORDERS, ORAL CANCER
- Medical subject headings
- Mouth Neoplasms, Squamous Cell Carcinoma of Head and Neck, Leukokeratosis, Hereditary Mucosal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Conventional oral examinationDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Fluorescent oral examination (FOE); Diagnostic Test: Conventional oral examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From the start of the conventional examination until the completion of the subsequent fluorescence examination-all during the same visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start1 Jun 2026 (estimated)
- Primary completion31 Aug 2027 (estimated)
- Study completion30 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OPMDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 1,383 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marta Sawczuk, Medical University of Warsaw
- Investigators
- Marta Sawczuk, MPH, Principal investigator, Warszawski Uniwersytet Medyczny - Doktorant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07682883
- Sponsor's protocol ID
- KB/53/2024
- Other IDs
- WLS5/1/Z/MB/N/25/26
- Status last verified
- Jun 2026
- First submitted
- 25 Jun 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No