Clinical Trial Finder
Identification of Oral Lesions Through an Autofluorescence System
Study Purpose
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.
Recruitment Criteria
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
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An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
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Inclusion Criteria:
Exclusion Criteria:
Trial Details
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
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The disease, disorder, syndrome, illness, or injury that is being studied.
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.Arms
Experimental: Screening examination
All patients will undergo a screening examination (with or without GOCCLES ® glasses) by all three operators.
Interventions
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".
Contact a Trial Team
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International Sites
Status
Recruiting
Address
University of Naples Federico II
Napoli, , 80131
Site Contact
Luca Ramaglia
[email protected]
+393476912911
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