Identification of Oral Lesions Through an Autofluorescence System

Sponsor

Federico II University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05942794

Collaborator

(none)

200

Enrollment

Location

Arm

Anticipated Duration (Months)

49.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Oral Leukoplakia Autofluorescence Secondary Prevention Keratosis Oral Lichen Planus Oral Cancer Oral Disease	Device: Screening examination	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

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

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

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

Actual Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Aug 1, 2023

Anticipated Study Completion Date :

Oct 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Screening examination 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".

Arm

Intervention/Treatment

Experimental: Screening examination

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".

Outcome Measures

Primary Outcome Measures

Clinical change of oral mucosa [baseline and after 21 days]
Presence of a white, red, or mixed mucosal area with an exophytic or vegetative appearance or with loss of substance
Fluorescence change of oral mucosa [baseline and after 21 day]
Presence of a mucosal area with reduced or increased fluorescence