title: 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.
authors.affiliation: Unit of Maxillofacial Surgery, Nuovo Ospedale San Giovanni Battista. Foligno, Italy;; Unit of Maxillofacial Surgery, Policlinico Gemelli, C.I. Columbus, Università Cattolica del Sacro Cuore, Rome, Italy;
authors.forename: A
authors.initials: A
authors.lastname: Moro
authors.affiliation: Institute of Public Health, Università Cattolica del Sacro Cuore, Rome, Italy;
authors.forename: C
authors.initials: C
authors.lastname: De Waure
authors.affiliation: Institute of Public Health, Università Cattolica del Sacro Cuore, Rome, Italy;
authors.forename: F
authors.initials: F
authors.lastname: Di Nardo
authors.affiliation: Department of Reconstructive and Diagnostic Surgical Sciences, Unit of Oral Pathology and Medicine, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, University of Milan, Italy;
authors.forename: F
authors.initials: F
authors.lastname: Spadari
authors.affiliation: Department of Integrated Activities Head-Neck, Unit of Oral Medicine, Università di Napoli Federico II. Naples, Italy;
authors.forename: M D
authors.initials: MD
authors.lastname: Mignogna
authors.affiliation: Department of Dentistry, Università Cattolica del Sacro Cuore, Rome, Italy;
authors.forename: M
authors.initials: M
authors.lastname: Giuliani
authors.affiliation: Department of Integrated Activities Head-Neck, Unit of Maxillofacial Surgery, Università di Napoli Federico II. Naples, Italy;
authors.forename: L
authors.initials: L
authors.lastname: Califano
authors.affiliation: Department of Reconstructive and Diagnostic Surgical Sciences, Complex Unit of Maxillofacial Surgery, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, University of Milan, Italy.
authors.forename: A B
authors.initials: AB
authors.lastname: Giannì
authors.affiliation: Unit of Maxillofacial Surgery, Nuovo Ospedale San Giovanni Battista. Foligno, Italy;
authors.forename: L
authors.initials: L
authors.lastname: Cardarelli
authors.affiliation: Department of Integrated Activities Head-Neck, Unit of Oral Medicine, Università di Napoli Federico II. Naples, Italy;
authors.forename: A
authors.initials: A
authors.lastname: Celentano
authors.affiliation: Department of Reconstructive and Diagnostic Surgical Sciences, Unit of Oral Pathology and Medicine, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, University of Milan, Italy;
authors.forename: G
authors.initials: G
authors.lastname: Bombeccari
authors.affiliation: Unit of Maxillofacial Surgery, Policlinico Gemelli, C.I. Columbus, Università Cattolica del Sacro Cuore, Rome, Italy;
authors.forename: S
authors.initials: S
authors.lastname: Pelo
mesh_terms: D002294:Carcinoma, Squamous Cell / Q000175:diagnosis*; D006801:Humans; D008027:Light; D009061:Mouth Mucosa; D009062:Mouth Neoplasms / Q000175:diagnosis*; D061848:Optical Imaging; D011230:Precancerous Conditions / Q000175:diagnosis*; D012680:Sensitivity and Specificity
keywords: Curing Lights; Dental; Dentistry; Early Detection of Cancer; Fluorescence; Oral cancer