The GOCCLES® medical device is effective in detecting oral cancer and dysplasia in dental clinical setting. Results from a multicentre clinical trial

Abstract

The purpose of this study is to demonstrate that the GOCCLES® medical device allows proper autofluorescence examination of the oral mucosa in a dental care setting. This is a non-randomised multicentre clinical trial on consecutive patients at risk for oral cancer. Patients underwent a classical naked eye inspection of the oral cavity followed by autofluorescence examination wearing the GOCCLES® spectacles while the light from a dental curing light irradiated the oral mucosa. Lesions were defined as visible potentially malignant lesions and/or fluorescence loss areas. All persisting lesions underwent excisional or incisional biopsy. Sixty-one patients were enrolled. Data from 64 biopsies were analysed. Of the 62 lesions identified by the device, 31 were true positives. The device identified 31 of 32 true positive lesions. One lesion (an invasive carcinoma) was not visible to the naked eye. The device identified all lesions classified as moderate dysplasia to invasive cancer. In 56.7% of cases, true positive lesions showed greater extension when observed through the device. The GOCCLES® medical device allowed the direct visualisation of fluorescence loss in patients suffering from mild to severe dysplasia and in situ to invasive oral cancer. It allowed autofluorescence examination with each source of light used during the study. These results suggest that the role of the autofluorescence visualisation is that of a complementary inspection following naked eye examination when dealing with patients at risk for oral cancer. The device allows detection of otherwise invisible lesions and otherwise impossible complete resections.

Keywords: Curing Lights; Dental; Dentistry; Early Detection of Cancer; Fluorescence; Oral cancer.

Conflict of interest statement

This study was funded by Pierrel S.p.A., owner of the rights on the GOCCLES medical device. Three researchers involved in this study (SP, AM, FDN) have royalty percentages on the sales of the device.

Figures

Fig. 1.

The GOCCLES (Glasses for Oral Cancer - Curing Light Exposed - Screening) medical device.

Fig. 2.

Oral cancer in an edentulous patient in follow-up after surgical resection of a malignant lesion. Autofluorescence examination (on the left) vs. conventional visual examination (on the right). The lesion is barely visible if the oral examination is performed with superficiality. Loss of fluorescence increased contrast making it easier to see the tumour. Also visible in this figure is a clear difference in the extension of the margins of the lesion: fluorescence loss extended beyond the margins, which were visible to the naked eye. The arrow points to the main lesion. The margins of the lesion (as visible on the autofluorescence examination) are also highlighted.