Clinical validation of a novel bioluminescence imaging technology for aiding the assessment of carious lesion activity status
| Autor: | Neil Shanks, Bruce Vernon, Nigel Pitts, Marjory Willins, Christopher Longbottom |
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| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
Technology
Dental Caries lesions Clinical study Bioluminescence imaging Medicine Humans Prospective Studies Dental Enamel General Dentistry caries Enamel paint business.industry activity Tooth surface RK1-715 Original Articles bioluminescence Activity Status visual_art Dentistry visual_art.visual_art_medium Original Article Carious lesion Nuclear medicine business Tooth |
| Zdroj: | Clinical and Experimental Dental Research, Vol 7, Iss 5, Pp 772-785 (2021) Clinical and Experimental Dental Research |
| ISSN: | 2057-4347 |
| Popis: | Objectives Clinical validation of a bioluminescence imaging system (Cis) as measured by the level of agreement between clinician visual and tactile assessment of carious lesion presence and activity and the presence/absence of elevated luminescence on a tooth surface determined from intraoral image mapping. Materials and Methods This was a regulatory clinical study designed in consultation with the FDA. The design was a prospective, five‐investigator, nonrandomized, post‐approval, clinical study utilizing the Cis to provide images of elevated calcium ion concentration (indicative of active demineralization) on tooth surfaces via use of a photoprotein. Imaged teeth were identified as “sound” or having “active lesions.” Images were scored independently for luminescence. Results A total of 110 participants aged 7–74 years were imaged. Of the 90 teeth assessed as “sound,” 88 were deemed to show no luminescence by the reviewing investigator, a negative percentage agreement of 97.8% (significantly >50% agreement [p 50% agreement [p |
| Databáze: | OpenAIRE |
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