Oral LeukoplakiaNCT05942794
Identification of Oral Lesions Through an Autofluorescence System
A study testing Screening examination in people with Oral Leukoplakia and Autofluorescence, run by Federico II University at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Leukoplakia, Autofluorescence, Secondary Prevention
- What is being tested?
- Screening examination
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2023to 1 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female;
- Age ≥ 18 years;
- Non-smokers and smokers
Who cannot join
- Cancer patients;
- Patients presenting a histological diagnosis of oral mucosal dysplasia/carcinoma.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of a Tissue Autofluorescence Detection System for Identification of Oral Mucosal Lesions
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.
Read the 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.
- Conditions
- Oral Leukoplakia, Autofluorescence, Secondary Prevention, Keratosis, Oral Lichen Planus, Oral Cancer
- Being tested
- Screening examination
- Keywords
- Oral Leukoplakia, Lichen Planus, Squamous cell carcinoma, Keratosis
- Medical subject headings
- Leukoplakia, Oral, Keratosis, Lichen Planus, Oral, Mouth Neoplasms, Mouth Diseases, Lichen Planus, Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screening examinationDevice
After an initial clinical visit, all three operators will wear the tissue autofluorescence detection device (GOCCLES®), reporting both observations on their "operator-module".
| Study group | Role | What they receive |
|---|---|---|
| Screening examination | Experimental | All patients will undergo a screening examination (with or without GOCCLES ® glasses) by all three operators. Receives: Device: Screening examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline and after 21 days
Fluorescence change of oral mucosa
Presence of a mucosal area with reduced or increased fluorescence
Measured: baseline and after 21 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2023
- Study start1 Jun 2023
- Primary completion1 Mar 2024
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral LeukoplakiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The screening will start after a first oral examination, in order to rule out noticeable mucosal lesions.
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luca Ramaglia, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05942794
- Sponsor's protocol ID
- 177/2023
- Status last verified
- Feb 2024
- First submitted
- 29 Jun 2023
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of a Tissue Autofluorescence Detection System for Identification of Oral Mucosal Lesions
- ClinicalTrials.gov ID
- NCT05942794
- Acronym / sponsor ID
- 177/2023
- Conditions
- Oral Leukoplakia, Autofluorescence, Secondary Prevention, Keratosis, Oral Lichen Planus, Oral Cancer
- Keywords
- Oral Leukoplakia, Lichen Planus, Squamous cell carcinoma, Keratosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 12 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The screening will start after a first oral examination, in order to rule out noticeable mucosal lesions.
| Arm | Type | Receives |
|---|---|---|
| Screening examination | Experimental | Device: Screening examinationAll patients will undergo a screening examination (with or without GOCCLES ® glasses) by all three operators. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and female;
- Age ≥ 18 years;
- Non-smokers and smokers
Key exclusion criteria (2 listed)
- Cancer patients;
- Patients presenting a histological diagnosis of oral mucosal dysplasia/carcinoma.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Screening examinationAfter an initial clinical visit, all three operators will wear the tissue autofluorescence detection device (GOCCLES®), reporting both observations on their "operator-module". | Device | Screening examination |
Primary outcome
Clinical change of oral mucosa
Time frame: baseline and after 21 days
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
Time frame: baseline and after 21 day
Presence of a mucosal area with reduced or increased fluorescence
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Screening examination in people with Oral Leukoplakia and Autofluorescence, run by Federico II University at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical change of oral mucosa (time frame: baseline and after 21 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.