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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Screening examination | Experimental | All patients will undergo a screening examination (with or without GOCCLES ® glasses) by all three operators. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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". |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Fluorescence change of oral mucosa | Presence of a mucosal area with reduced or increased fluorescence | baseline and after 21 day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Luca Ramaglia | Contact | +393476912911 | luca.ramaglia@unina.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Naples Federico II | Recruiting | Naples | 80131 | Italy |
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| ID | Term |
|---|---|
| D007972 | Leukoplakia, Oral |
| D007642 | Keratosis |
| D017676 | Lichen Planus, Oral |
| D009062 | Mouth Neoplasms |
| D009059 | Mouth Diseases |
| D008010 | Lichen Planus |
| D002294 | Carcinoma, Squamous Cell |
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D007971 | Leukoplakia |
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The screening will start after a first oral examination, in order to rule out noticeable mucosal lesions.
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| D011230 |
| Precancerous Conditions |
| D009057 | Stomatognathic Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017512 | Lichenoid Eruptions |
| D017444 | Skin Diseases, Papulosquamous |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D018307 | Neoplasms, Squamous Cell |