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Can a glowing light reveal hidden mouth lesions?

NCT ID NCT05942794

Diagnosis Sponsor: Federico II University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 02, 2026 · Last updated Sep 03, 2026 · Updated 1 time

Summary

Researchers are testing whether a handheld device that shines a special light on the inside of the mouth can help clinicians spot suspicious areas that might be precancerous or cancerous. The study will have three dentists with different levels of experience examine 200 adults, including smokers and non-smokers, first with a standard visual check and then with the autofluorescence device. The goal is to see if the device improves the accuracy of identifying oral mucosal lesions, which could lead to earlier detection and treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
A tissue autofluorescence detection device (GOCCLES®) used as an aid during oral screening examinations
What this could lead to
If the device proves accurate, it could become a standard aid for dentists and doctors to spot early signs of oral cancer during routine checkups.
What could go wrong
The study is a screening accuracy test, not a treatment trial. The device may not reliably distinguish benign from dangerous lesions, and results depend on the clinician's skill.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

200 people

The number who actually took part.

Started

Jun 2023

Finished

Oct 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

keratosis lichen planus lichen planus, oral lip and oral cavity carcinoma mouth disorder Mouth Neoplasms oral mucosa leukoplakia squamous cell carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Autofluorescence Keratosis Oral cancer Oral disease Oral leukoplakia Oral lichen planus Secondary prevention

Contacts and locations

Locations

  • University of Naples Federico II

    Naples, Italy, 80131, Italy

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