Predictive Value of GOCCLES® Device for Early Diagnosis of Oral Potentially Malignant Disorders
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversidad Rey Juan Carlos
About this trial
Oral potentially malignant disorders (OPMDs) are chronic pathologies which can suffer dysplastic alterations and evolve into oral cancer.
The diagnosis of those pathologies is commonly done by visual inspection, which is not capable of determining the presence or not of dysplasia. Furthermore, this type of diagnosis depends greatly on the expertise and training of the professional.
In recent years, new methods that can help early oral cancer diagnosis have been developed. A new device has been commercialized, named GOCCLES® (Glasses for Oral Cancer Curing Light Exposed Screening), based on the autofluorescence principle.
The hypothesis of this study is that GOCCLES® device could be an effective tool to help in early detection of oral cancer.
Eligibility criteria
Qualifiers
Patients older than 18.
Patients that present oral mucosa injuries compatible with OPMD.
Patients that understand the purpose of the study and express consent
Disqualifiers
Patients that don't have the capability to express consent.
Patients with systemic pathologies that contraindicate a biopsy.
Patients with a recent biopsy at the oral cavity
Trial design
Treatments tested in this trial
- GOCCLES
- Toluidine blue stain
- Biopsy
Treatment groups
73 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov