Skip to content

Identification of Oral Lesions Through an Autofluorescence System

Use of a Tissue Autofluorescence Detection System for Identification of Oral Mucosal Lesions

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05942794
Enrollment
200
Registered
2023-07-12
Start date
2023-06-01
Completion date
2024-10-01
Last updated
2026-09-02

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

Conditions

Autofluorescence, Keratosis, Oral Cancer, Oral Disease, Oral Leukoplakia, Oral Lichen Planus, Secondary Prevention

Keywords

Oral Leukoplakia, Lichen Planus, Squamous cell carcinoma, Keratosis

Brief summary

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.

Detailed description

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: * Dental hygienist (1); * General dentist (2); * Dentist expert in Medicine and Oral Pathology (3). 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.

Interventions

DEVICEScreening examination

After an initial clinical visit, all three operators will wear the tissue autofluorescence detection device (GOCCLES®), reporting both observations on their "operator-module".

Sponsors

Federico II University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE

Intervention model description

The screening will start after a first oral examination, in order to rule out noticeable mucosal lesions.

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

Inclusion criteria

* Male and female; * Age ≥ 18 years; * Non-smokers and smokers

Exclusion criteria

* Cancer patients; * Patients presenting a histological diagnosis of oral mucosal dysplasia/carcinoma.

Design outcomes

Primary

MeasureTime frameDescription
Clinical change of oral mucosabaseline and after 21 daysPresence of a white, red, or mixed mucosal area with an exophytic or vegetative appearance or with loss of substance
Fluorescence change of oral mucosabaseline and after 21 dayPresence of a mucosal area with reduced or increased fluorescence

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 3, 2026