Identification of Oral Lesions Through an Autofluorescence System

Not Applicable

Recruiting

• Conditions: Oral Lichen Planus; Autofluorescence; Secondary Prevention; Oral Leukoplakia; Oral Disease; Keratosis; Oral Cancer
• Interventions: Device: Screening examination

• Registration Number: NCT05942794
• Lead Sponsor: Federico II University

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.

Study Timeline

• Study Start: 2023-06-01
• Study First Submitted: 2023-06-29
• Study First Submitted QC: 2023-07-10
• Study First Posted: 2023-07-12
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-26
• Last Update Posted: 2024-02-28
• Primary Completion: 2024-03-01
• Study Completion: 2024-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Fluorescence change of oral mucosa	baseline and after 21 day	Presence of a mucosal area with reduced or increased fluorescence
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

Trial Locations

Locations (1)

University of Naples Federico II; 🇮🇹 Napoli, Italy