Identification of Oral Lesions Through an Autofluorescence System

Federico II University

Status: Enrolling

Conditions: Oral Lichen Planus; Keratosis; Autofluorescence; Secondary Prevention; Oral Cancer; Oral Disease; Oral Leukoplakia

Treatments: Device: Screening examination

Study type: Interventional

Funder types: Other

Identifiers

NCT05942794

177/2023

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

Screening examination

Experimental group

Description:

All patients will undergo a screening examination (with or without GOCCLES ® glasses) by all three operators.

Treatment:

Device: Screening examination