NCT05942794

Identification of Oral Lesions Through an Autofluorescence System

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Federico II University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

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

Interventions

Type	Name	Description
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".

Timeline

• Start date: 2023-06-01
• Primary completion: 2024-03-01
• Completion: 2024-10-01
• First posted: 2023-07-12
• Last updated: 2024-02-28

Locations

1 site across 1 country: Italy