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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05942794
Other study ID # 177/2023
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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