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

NARecruitingINTERVENTIONAL
Enrollment

73

Participants

Timeline

Start Date

January 8, 2022

Primary Completion Date

June 30, 2026

Study Completion Date

September 30, 2026

Conditions
Oral Potentially Malignant DisordersOral Cancer
Interventions
DEVICE

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."

DIAGNOSTIC_TEST

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."

PROCEDURE

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

Trial Locations (1)

28922

RECRUITING

Universidad Rey Juan Carlos de Madrid, Alcorcón

All Listed Sponsors
lead

Universidad Rey Juan Carlos

OTHER