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Predictive Value of GOCCLES® Device for Early Diagnosis of Oral Potentially Malignant Disorders
Sponsor: Universidad Rey Juan Carlos
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.
Official title: Predictive Value of GOCCLES® (Glasses for Oral Cancer Curing Light Exposed Screening), Device for Early Diagnosis of Oral Potentially Malignant Disorders
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
73
Start Date
2022-01-08
Completion Date
2026-09-30
Last Updated
2022-10-04
Healthy Volunteers
No
Interventions
GOCCLES
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.
Toluidine 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.
Biopsy
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
Locations (1)
Universidad Rey Juan Carlos de Madrid
Alcorcón, Madrid, Spain