Identification of Oral Lesions Through an Autofluorescence System
Primary Purpose
Oral Leukoplakia, Autofluorescence, Secondary Prevention
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Screening examination
Sponsored by
About this trial
This is an interventional screening trial for Oral Leukoplakia focused on measuring Oral Leukoplakia, Lichen Planus, Squamous cell carcinoma, Keratosis
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.
Sites / Locations
- University of Naples Federico IIRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Screening examination
Arm Description
All patients will undergo a screening examination (with or without GOCCLES ® glasses) by all three operators.
Outcomes
Primary Outcome Measures
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
Fluorescence change of oral mucosa
Presence of a mucosal area with reduced or increased fluorescence
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05942794
Brief Title
Identification of Oral Lesions Through an Autofluorescence System
Official Title
Use of a Tissue Autofluorescence Detection System for Identification of Oral Mucosal Lesions
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2023 (Actual)
Primary Completion Date
August 1, 2023 (Anticipated)
Study Completion Date
October 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federico II University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Leukoplakia, Autofluorescence, Secondary Prevention, Keratosis, Oral Lichen Planus, Oral Cancer, Oral Disease
Keywords
Oral Leukoplakia, Lichen Planus, Squamous cell carcinoma, Keratosis
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
The screening will start after a first oral examination, in order to rule out noticeable mucosal lesions.
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Screening examination
Arm Type
Experimental
Arm Description
All patients will undergo a screening examination (with or without GOCCLES ® glasses) by all three operators.
Intervention Type
Device
Intervention Name(s)
Screening examination
Intervention Description
After an initial clinical visit, all three operators will wear the tissue autofluorescence detection device (GOCCLES®), reporting both observations on their "operator-module".
Primary Outcome Measure Information:
Title
Clinical change of oral mucosa
Description
Presence of a white, red, or mixed mucosal area with an exophytic or vegetative appearance or with loss of substance
Time Frame
baseline and after 21 days
Title
Fluorescence change of oral mucosa
Description
Presence of a mucosal area with reduced or increased fluorescence
Time Frame
baseline and after 21 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Luca Ramaglia
Phone
+393476912911
Email
luca.ramaglia@unina.it
Facility Information:
Facility Name
University of Naples Federico II
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luca Ramaglia
Phone
+393476912911
Email
luca.ramaglia@unina.it
12. IPD Sharing Statement
Plan to Share IPD
No
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Identification of Oral Lesions Through an Autofluorescence System
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