RecruitingNot ApplicableNCT05562375

Predictive Value of GOCCLES® Device for Early Diagnosis of Oral Potentially Malignant Disorders

Predictive Value of GOCCLES® (Glasses for Oral Cancer Curing Light Exposed Screening), Device for Early Diagnosis of Oral Potentially Malignant Disorders

Sponsor

Universidad Rey Juan Carlos

Enrollment

73 participants

Start Date

Jan 8, 2022

Study Type

INTERVENTIONAL

Conditions

Oral Cancer Oral Potentially Malignant Disorders

Summary

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating a special light-based device called GOCCLES® to see if it can help detect potentially precancerous changes in the mouth (called oral potentially malignant disorders) earlier and more accurately than standard examination alone. Early detection of these changes can reduce the risk of developing oral cancer. **You may be eligible if...** - You are older than 18 years - You have a suspicious lesion or sore in your mouth that may be a potentially malignant disorder - You understand the purpose of the study and agree to participate **You may NOT be eligible if...** - You are unable to give informed consent - You have conditions that would make a biopsy unsafe - You recently had a biopsy taken from your mouth Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEGOCCLES

Inspection using GOCCLES®. An UV light source will be administered, with polymerization lamp sdi radii xpert, with a potency of 1500 mW/cm2 and a wavelength of 440-480nm, applied at 20cm of the injury. Notes will be taken on the location and size of the injury observed with the device. Image register using the GOCCLES® photographic filter for mobile devices. The same light source will be used.

DIAGNOSTIC_TESTToluidine blue stain

To value the toluidine blue diagnosis capacity, the sequence described by Mashberg will be followed: The patient will realize a mouthwash with acetic acid at 1% for 20 seconds. Two using water for 20 seconds. Toluidine blue at 1% will be applied for 20 seconds. New mouthwash with acetic acid for 60 seconds and a final mouthwash with water. Notes on the and pictures will be taken on the location and size of the injury.

PROCEDUREBiopsy

The area to biopsy will be chosen, and, using local anaesthesia, it will be resected. The specimens will be sent to the oral and maxillofacial pathology diagnostic service of the University of Basque Country for anatomopathological study