Journal article
The GOCCLES® medical device is effective in detecting oral cancer and dysplasia in dental clinical setting. Results from a multicentre clinical trial
A Moro, C De Waure, F Di Nardo, F Spadari, MD Mignogna, M Giuliani, L Califano, AB Giannì, L Cardarelli, A Celentano, G Bombeccari, S Pelo
Acta Otorhinolaryngologica Italica | PACINI EDITORE | Published : 2015
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 wer..
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Funding Acknowledgements
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.