Using autofluorescence to identify oral lesions
Use of a Tissue Autofluorescence Detection System for Identification of Oral Mucosal Lesions
This study tests if a special light device can help dentists and dental hygienists find mouth lesions more accurately during check-ups.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Federico II University Academic / other |
| Locations | 1 site (Napoli) |
| Trial ID | NCT05942794 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a tissue autofluorescence detection system in identifying lesions of the oral mucosa during clinical screenings. The screening will involve three clinicians with varying levels of experience, including a dental hygienist, a general dentist, and an oral pathology expert. Each clinician will perform examinations with and without the autofluorescence device, and the results will be compared for sensitivity and specificity. Data collected will undergo statistical analysis to assess the efficacy of the autofluorescence system.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older, both smokers and non-smokers, without a history of oral cancer or dysplasia.
Not a fit: Patients with a histological diagnosis of oral mucosal dysplasia or carcinoma will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance early detection of oral lesions, potentially leading to better patient outcomes.
How similar studies have performed: While the use of autofluorescence in oral lesion detection is a growing field, this specific approach has not been widely tested, making it a novel investigation.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Napoli
- University of Naples Federico II — Napoli, Italy (Recruiting)
Study contacts
- Study coordinator: Luca Ramaglia
- Email: luca.ramaglia@unina.it
- Phone: +393476912911
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.