Identification of Oral Lesions Through an Autofluorescence System

Oral Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05942794
• Other study ID #: 177/2023
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: October 1, 2024

Study information

• Verified date: February 2024
• Source: Federico II University
• Contact: Luca Ramaglia
• Phone: +393476912911
• Email: luca.ramaglia[@]unina.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: October 1, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Keratosis
• Keratosis, Actinic
• Leukoplakia
• Leukoplakia, Oral
• Lichen Planus
• Lichen Planus, Oral
• Mouth Neoplasms
• Oral Cancer
• Oral Disease
• Oral Leukoplakia
• Oral Lichen Planus
• Secondary Prevention

Intervention

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".

Locations

Country	Name	City	State
Italy	University of Naples Federico II	Napoli

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Fluorescence change of oral mucosa	Presence of a mucosal area with reduced or increased fluorescence	baseline and after 21 day