Identification of Oral Lesions Through an Autofluorescence System

Study Overview
=================
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.

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

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

Intervention / Treatment
-----------------
* Device: Screening examination


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Interventional Model Description: The screening will start after a first oral examination, in order to rule out noticeable mucosal lesions.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Screening examination<br>All patients will undergo a screening examination (with or without GOCCLES ® glasses) by all three operators. | Device: Screening examination<br>* After an initial clinical visit, all three operators will wear the tissue autofluorescence detection device (GOCCLES®), reporting both observations on their operator-module.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | baseline and after 21 days | 
| Fluorescence change of oral mucosa | Presence of a mucosal area with reduced or increased fluorescence | baseline and after 21 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Oral Leukoplakia, Lichen Planus, Squamous cell carcinoma, Keratosis