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Trial Title:
Identification of Oral Lesions Through an Autofluorescence System
NCT ID:
NCT05942794
Condition:
Oral Leukoplakia
Autofluorescence
Secondary Prevention
Keratosis
Oral Lichen Planus
Oral Cancer
Oral Disease
Conditions: Official terms:
Keratosis, Actinic
Mouth Neoplasms
Leukoplakia
Leukoplakia, Oral
Lichen Planus, Oral
Keratosis
Lichen Planus
Conditions: Keywords:
Oral Leukoplakia
Lichen Planus
Squamous cell carcinoma
Keratosis
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
The screening will start after a first oral examination, in order to rule out noticeable
mucosal lesions.
Primary purpose:
Screening
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Screening examination
Description:
After an initial clinical visit, all three operators will wear the tissue
autofluorescence detection device (GOCCLES®), reporting both observations on their
"operator-module".
Arm group label:
Screening examination
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
University of Naples Federico II
Address:
City:
Napoli
Zip:
80131
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Luca Ramaglia
Phone:
+393476912911
Email:
luca.ramaglia@unina.it
Start date:
June 1, 2023
Completion date:
October 1, 2024
Lead sponsor:
Agency:
Federico II University
Agency class:
Other
Source:
Federico II University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05942794
