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An Investigation into the Biofluorescence Patterns of Precancerous Oral Lesions

Clinical trial using Qraycam Pro to observe and characterize fluorescence expression in oral potentially malignant disorders (OPMDs) lesions and normal mucosa

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CRIS
Registry ID
KCT0012023
Enrollment
25
Registered
2026-05-21
Start date
2025-10-15
Completion date
Unknown
Last updated
2026-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

None listed

Sponsors

Yonsei University Health System, Dental Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: ? Adults aged 19 years or older ? Subjects who, after receiving an explanation of the clinical trial, voluntarily sign the informed consent form and do not meet any of the exclusion criteria ? Subjects with oral precancerous lesions affecting only one side, allowing for comparison of the fluorescence characteristics of the normal tissue and mucosa on the opposite side, if possible ? Participants for whom a tissue biopsy is performed by an oral and maxillofacial surgeon and who are confirmed through pathological analysis to have one or more of the following five diagnoses (leukoplakia, proliferative papillary leukoplakia, erythroplakia, oral lichen planus, or lichen-like lesions) among the oral precancerous conditions classified by the WHO

Exclusion criteria

Exclusion criteria: ? Pregnant women ? Individuals for whom tissue biopsy is contraindicated: those with bleeding disorders or uncontrolled systemic diseases (this will be determined, if necessary, through consultation with the patient’s primary care physician or referral to other departments) ? Patients taking photosensitizing medications ? Patients with erythropoietic protoporphyria or solar urticaria ? Patients who are light-sensitive or have ophthalmic conditions (Although the light used by Qraycam Pro is visible light and no objective adverse effects on the eyes have been reported, these patients are excluded as a precautionary measure) ? Patients with extensive lesions where it is difficult to identify normal tissue symmetrical to the lesion within the subject, making the location for obtaining a control sample unclear

Design outcomes

Primary

MeasureTime frame
Comparison of Fluorescence Patterns by Lesion Type Based on Visual Classification

Secondary

MeasureTime frame
Autofluorescence intensity value

Countries

Korea, Republic of

Contacts

Public ContactEun Po

Yonsei University Health System, Dental Hospital

poeun2@yuhs.ac+82-2-2228-3070

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: May 30, 2026