Predictive Value of GOCCLES® Device for Early Diagnosis of 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.

Conditions

• Oral Potentially Malignant Disorders
• Oral 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

Sponsors & Collaborators

• Universidad Rey Juan Carlos

  lead OTHER

Principal Investigators

• Rocío Teresa Martín Muñoz · Universidad Rey Juan Carlos de Madrid

• Antonio Francisco López Sánchez · Universidad Rey Juan Carlos de Madrid

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-01-08

Primary Completion

2026-06-30

Completion

2026-09-30

Countries

• Spain

Study Locations