Identification of Oral Lesions Through an Autofluorescence System

NCT ID: NCT05942794

Last Updated: 2024-02-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2024-10-01

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Screening examination

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

Group Type: EXPERIMENTAL

Screening examination

Intervention Type: DEVICE

After an initial clinical visit, all three operators will wear the tissue autofluorescence detection device (GOCCLES®), reporting both observations on their "operator-module".

Interventions

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".

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Federico II University

OTHER

Sponsor Role: lead

Responsible Party

Luca Ramaglia

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Naples Federico II

Napoli, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Luca Ramaglia

Role: CONTACT

luca.ramaglia@unina.it

+393476912911

Facility Contacts

Luca Ramaglia

Role: primary

luca.ramaglia@unina.it

+393476912911

Other Identifiers

177/2023

Identifier Type: -

Identifier Source: org_study_id