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OpenTrials
Completed

NCT Number: NCT05942794

Identification of Oral Lesions Through an Autofluorescence System

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.

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Key information

Conditions

Oral Leukoplakia Autofluorescence Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Keratosis Leukoplakia Leukoplakia, Oral Lichen Planus Lichen Planus, Oral Lichenoid Eruptions Mouth Diseases Mouth Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell Oral Cancer Oral Disease Oral Lichen Planus Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Precancerous Conditions Secondary Prevention Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Stomatognathic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Naples Federico II

Naples, Italy, 80131

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Screening examination

Device

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

Primary outcomes

  1. Clinical change of oral mucosa

    Time frame: 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

  2. Fluorescence change of oral mucosa

    Time frame: baseline and after 21 day

    Presence of a mucosal area with reduced or increased fluorescence

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 12, 2023
Registry last updated
Sep 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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