None listed
Conditions
Brief summary
This protocol describes is a method comparison study which aims to determine the reproducibility of on-screen assessment of 3D images featuring colour and fluorescence produced by intraoral scanners for dental disease detection amongst populations of Australian children. Intraoral Scanners (IOS) are devices used for taking digital impressions in dentistry. They have recently been introduced into clinical practice to support caries diagnostics due to the addition of technology such as fluorescence within IOS hardware. However, there is little research into their diagnostic performance in clinical settings. Dental examination data and Intraoral scans will be sourced from participants who underwent dental examination at the 60 months study visit as part of a broader clinical trial (MISBAIR). Consenting participants who meet study inclusion criteria, will have the intra oral scans examined by a qualified dental practitioner for the purpose of detecting and classifying dental caries. 3D images will first be examined based on 3D geometry and colour, followed 4 weeks later by 3D geometry, colour and fluorescence. The diagnostic agreement between each method compared to conventional visual examination will be determined. The findings of these investigations will inform if novel technologies are equivalent to conventional methods used for dental diagnostics in children. If the methods agree 3D images could have broad application in supporting clinical diagnostics, early disease detection and potentially substitute clinical examination for the purpose of teledentistry and epidemiological research.
Interventions
This is a cross-sectional method comparison study. The aim of the study is determine the diagnostic agreement and reliability between visual dental examination, on-screen visual assessment of 3D images in approximate true colour and fluorescence (415nm) and computational methods for detection and classification of dental caries in primary teeth. Clinical examination records and 3D images will be sourced retrospectively from a population of Victorian children who were enrolled in a clinical trial cohort called MISBAIR (NCT01906853). There will be no direct participant involvement in this study. Dental examination records and 3D scans will be screened to see if they meet inclusion/exclusion criteria. Included 3D scans will be subject to on-screen dental examination by a qualified dental practitioner. All teeth will be examined using the following methods for detection and classification of dental caries. 1. On-screen visual assessment of 3D images based on tissue geometry & approximate true colours using. The validated International Caries Detection and Assessment System (ICDAS) will be used for caries detection and classification. 2. On-screen visual assessment of 3D images based on tissue geometry, approximate true colours and fluorescence (415nm). A validated ICDAS combined with fluorescence scoring method will be used for caries detection and classification. 3. Application of an automated caries scoring algorithm, using commercial software (TRIOS and Dental Desktop, 3Shape TRIOS A/S, Denmark). The algorithm is designed for the TRIOS 4 scanner and classifies the tooth surface as sound, initial or moderate caries and each cut off is indicative of relative caries depth.
Sponsors
Eligibility
Inclusion criteria
Eligibility Criteria Participants data will be included in this study if they meet the following criteria: (1) they have a completed dental examination at the 5-year-old study visit, (2) an intraoral scan was completed at the same appointment as the dental examination. Inclusion Criteria Tooth surfaces will be eligible for scoring and analysis if they: (3) have been examined as part of the dental exam, (4) are a primary tooth (5) are visible on the 3D image, and, (6) consent was provided for analysis of dental data.
Exclusion criteria
Exclusion Criteria Tooth surfaces will be excluded from on-screen visual assessment if they are: (1) restored or sealed (2) crowned (3) the tooth surface visibility on the 3D image is impeded by calculus, debris, or plaque (4) there is less than 1/3 of the surface visible due to insufficient/missing scan data. Tooth surfaces will be excluded from the application of the automated caries scoring algorithm if they are: (1) restored or sealed (2) crowned (3) are not a primary molar occlusal surface (4) there is less than 1/3 of the surface visible due to insufficient/missing scan data. (5) Enamel Defects are present