Kurzfassung

Dental plaque is a causative factor for oral diseases and thus its removal and control are an important aspect of oral health maintenance. Young and fresh plaque that has adhered to the
surface for a short time has a little pathogenicity, but old and mature dental plaque (for example by a lack of oral hygiene) can cause plaque-associated disease such as gingivitis. Therefore, it is clinically important to monitor the progression of plaque accumulation with respect to its age and its degree of...Dental plaque is a causative factor for oral diseases and thus its removal and control are an important aspect of oral health maintenance. Young and fresh plaque that has adhered to the
surface for a short time has a little pathogenicity, but old and mature dental plaque (for example by a lack of oral hygiene) can cause plaque-associated disease such as gingivitis. Therefore, it is clinically important to monitor the progression of plaque accumulation with respect to its age and its degree of coverage on dental surfaces.Since dental plaque is hard to be observed by the naked eye, it is usually disclosed with a staining agent that allows visual identification in dental plaque assessment. More recently, a novel technology has been developed and applied to optically assess dental plaque without a disclosing agent. Quantitative Light-induced Fluorescence (QLF) is an optical method to detect porphyrin
caused red-fluorescence occurring in plaque bacteria which are contributing or adhering to caries (including early white spot lesions), tartar, fluorosis and others. QLF is a light-based, noninvasive, nondestructive, and subject compliant method without the need of using any disclosing agent. The objective of this study is to evaluate a newly developed QLF- and AI- (Artificial Intelligence) based intra-oral camera, called “oral scanner” and compare it to a modified examiner-based index measuring plaque.
One key difference between this oral scanner and market known QLF-based devices, like Qraycam from Inspektor/Aiobio, is the newly developed AI (Artificial Intelligence) algorithms. These
algorithms, running on a smartphone, wirelessly connected to the oral scanner, will enable to automatically identify and record areas of porphyrin based red fluorescence that can signal the occurrence of plaque (from young/fresh to old/mature), enamel ecalcification/white spot lesions, remineralized caries at the fissures and accessory cusps, tartar and fluorosis. A clinical assessment should evaluate the same clinical endpoints by the use of standardized clinical methods allowing a comparison between the oral scanner reads and the clinical assessment. In contrast to former known and published studies (e.g., C. Ganss: Red fluorescence of plaque in the dentition-a comparison of Quantitative Light-induced Fluorescence-Digital (QLF-D) images and conventional images of disclosed plaque) using a QLF device were limited to assess the vestibular surfaces of front teeth, this study will assess all teeth in the mouth from all sides enabled by the use of the oral scanner. In addition to the assessment done with the oral scanner and by the clinical professional, subject’s teeth will be digitally captured/recorded by use of the Primescan AC device from Dentsply Sirona as a reference. This is a non-randomized, single-center, supervised use, observational pilot study with two visits in total: One screening and one study visit. 50 adult and adolescent (13+) subjects who meet inclusion criteria will be enrolled in this study. The reason why adolescents (13+) are enrolled in this clinical study is due to a high likelihood of showing white spot lesions after completing orthodontic treatment with fixed brackets.An oral examination (OST) will be assessed at screening and at visit one. Screening should evaluate if subjects present at least two of the following focused clinical endpoints, while one of those must be plaque:

- plaque (any age of plaque, from young/fresh to old/mature)
- demineralized enamel/white spot lesions
- remineralized caries at the fissures and accessory cusps
- caries
- tartar
- fluorosis

At visit one, an evaluation will be made for each of the available endpoints assessed by a trained dental professional, and the detection and visualization using the QLF-AI-based oral scanner. For
the assessment of plaque subjects will be instructed to refrain from all oral hygiene procedures for approximately 24 hours prior their appointment. The examiner will assess the oral conditions. Then subjects will be asked to use the oral scanner to scan their teeth on their own once before the dental professional scans the subject’s teeth. Additionally, subject s’ teeth will be scanned/captured twice by the use of a professional 3D dental scanner “Primescan AC".» weiterlesen» einklappen