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

ConditionsOral Potentially Malignant DisordersOral Cancer
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • GOCCLES

    Device

    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

    Diagnostic test

    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

    Procedure/Surgery

    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

Treatment groups

73 Participants
are divided into 1 treatment group
Group A: PatientsExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Intraoral examination. Location of the lesion

Intraoral examination of the injury with white light. Information about location will be recorded in a data collection document, individual for each patient.

Time frame
This procedure will be realised in the first appointment, at day 1, and it will take a time of five minutes
2

Intraoral examination. Size of the lesion

Intraoral examination of the injury with white light. The size of the injury will be measured with an acetate rule. This information will be recorded in a data collection document, individual for each patient.

Time frame
This procedure will be realised in the first appointment, at day 1, and it will take a time of five minutes
3

Intraoral examination. Photographic record

Photographs of the lesion will be recorded with a Canon EFS 60 mm camera and Canon Macro Ring Lite MR-14EX ring flash

Time frame
This procedure will be realised in the first appointment, at day 1, and it will take a time of five minutes
4

Oral examination with GOCCLES device

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.

Time frame
This procedure will be realised in the first appointment, at day 1, immediately after intraoral examination, and it will take a time of ten minutes.

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universidad Rey Juan Carlos

Lead sponsor

Source ClinicalTrials.gov
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