An interventional study of Screening examination in Oral Leukoplakia, Autofluorescence and Secondary Prevention, sponsored by Federico II University. Completed at 1 site in Italy. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-02.
Sponsored by Federico II University · Not applicable, Interventional, and Screening
The aim of the study will be to evaluate the efficacy of a tissue autofluorescence detection system as an aid to clinical screening in identifying lesions of the oral mucosa. The screening process will be performed by 3 clinicians with a different level of experience. Sensitivity and specificity tests will be conducted.
Tissue autofluorescence analysis will be performed using GOOCLES® glasses, a device capable of detecting variations in fluorescence when the examined area is illuminated with a common photopolymerising lamp. Three clinical professionals will be identified:
All patients will be included in the study after receiving an initial dental visit, in order to rule out patients with noticeable oral lesions.
Dental hygienist (1) will collect the patient's data by filling the "anamnestic record". Furthermore, (1) will perform the first clinical examination (with and without GOOCLES®), reporting his observations on his own "operator module".
The same screening (with and without GOOCLES®) will be conducted blindly by the general dentist (2) who, if he deems it necessary, will refer the patient to the oral pathologist (3), who will confirm or not (with and without GOOCLES®) the presence of an oral region such as to be further investigated (follow up or biopsy) and will report the observations on its own "operator module".
Inter-operator and intra-operator comparisons will be performed and the data thus obtained will be processed for statistical processing.
48 studies on the registry are indexed under Leukoplakia, Oral; 11 are open to participants now.
This study's enrollment of 200 is above the median of 36 across 23 interventional studies indexed under Leukoplakia, Oral.
Browse Leukoplakia, Oral studies →Federico II University is the lead sponsor of 366 studies on the registry; 61 are open to participants now.
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Exclusion Criteria:
All patients will undergo a screening examination (with or without GOCCLES ® glasses) by all three operators.
Device: Screening examination
After an initial clinical visit, all three operators will wear the tissue autofluorescence detection device (GOCCLES®), reporting both observations on their "operator-module".
Clinical change of oral mucosa
Presence of a white, red, or mixed mucosal area with an exophytic or vegetative appearance or with loss of substance
Time frame: baseline and after 21 days
Fluorescence change of oral mucosa
Presence of a mucosal area with reduced or increased fluorescence
Time frame: baseline and after 21 day
Plan to share: No
No publications or documents are linked to this record.
Ran from Jun 2023 to primary completion in Mar 2024, 9 months.
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This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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