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Trial registered on ANZCTR


Registration number
ACTRN12622001237774
Ethics application status
Approved
Date submitted
6/09/2022
Date registered
13/09/2022
Date last updated
24/01/2023
Date data sharing statement initially provided
13/09/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
A diagnostic agreement study comparing visual dental examination and 3D images featuring colour and fluorescence (415nm) produced from an Intraoral Scanner (IOS) for caries detection and classification in primary teeth.
Scientific title
A diagnostic agreement study comparing visual dental examination and 3D images featuring colour and fluorescence (415nm) produced from an Intraoral Scanner (IOS) for caries detection and classification in primary teeth.
Secondary ID [1] 307917 0
Nil Known
Universal Trial Number (UTN)
Nil Known
Trial acronym
Linked study record
This registration is a diagnostic agreement study using dental records obtained from a cohort of participants recruited from study NCT01906853 registered with clinical trials.gov

Health condition
Health condition(s) or problem(s) studied:
dental caries 327570 0
Condition category
Condition code
Oral and Gastrointestinal 324658 324658 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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.

Intervention code [1] 324381 0
Diagnosis / Prognosis
Comparator / control treatment
All methods will be compared to the conventional methods for caries detection: visual dental examination by a qualified dental practitioner using a valid scoring system (ICDAS).
Control group
Active

Outcomes
Primary outcome [1] 332472 0
Diagnostic agreement between on-screen visual assessment of 3D images in approximate true colours and conventional dental examination. Presence and severity of primary coronal dental caries lesions will be based on the validated International Caries Detection and Assessment System (ICDAS).
Examination data and 3D scans collected by audit of NCT01906853 study records.
Timepoint [1] 332472 0
Baseline
Primary outcome [2] 332512 0
Diagnostic agreement between on-screen visual assessment of 3D images in approximate true colours featuring fluorescence (415nm) and conventional dental examination. Presence and severity of primary coronal dental caries lesions will be based on the ICDAS combined with fluorescence scoring method.
Examination data and 3D scans collected by audit of NCT01906853 study records.
Timepoint [2] 332512 0
Baseline
Primary outcome [3] 332522 0
Diagnostic agreement between Automated Caries Scoring System and conventional dental examination for occlusal caries detection. Presence and severity of caries will be determined using the Automated Caries Scoring System (Trios Dental Desktop) which is an algorithm which classifies the tooth surface as sound, initial or moderate caries and each cut off is indicative of relative caries depth.
Examination data and 3D scans collected by audit of NCT01906853 study records.
Timepoint [3] 332522 0
Baseline
Secondary outcome [1] 413790 0
Inter-examiner reliability for 3D images assessed by ICDAS and 3D images assessed by ICDAS combined with fluorescence scoring method will be determined by having an additional examiner examine a subset of the data, and comparing the variability between examiners. Data collected by audit of NCT01906853 study records.

Timepoint [1] 413790 0
Baseline
Secondary outcome [2] 413819 0
Intra-examiner reliability for 3D images assessed by ICDAS and 3D images assessed by ICDAS combined with fluorescence scoring method will be determined by having the examiner repeat assessments on a subset of the data, comparing the variability within examiners. Data collected by audit of NCT01906853 study records.
Timepoint [2] 413819 0
4 weeks after Baseline.

Eligibility
Key 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.

Minimum age
4 Years
Maximum age
6 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Convenience sample
Timing
Retrospective
Statistical methods / analysis
Descriptive statistics for patient characteristics such as age, sex, caries, and enamel defects will be reported.
The total number of tooth sites included in the analysis will be reported.
ICDAS codes will be collapsed into four categories labelled (0) sound tooth, (1) initial caries, (2) moderate and (3) severe caries.
We will use logistic regression with generalised estimating equations (GEE).
Variables Method, Rater, Time, and the interaction between Rater and Time will be fitted in the model.
The difference between the estimates of Method will be used as measures of agreement.
Sensitivity analysis will be undertaken to explore the impact of caries threshold, tooth surface examined and presence of enamel defects on the reported agreement estimates between caries detection methods.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
6/03/2023
Actual
Date of last participant enrolment
Anticipated
31/03/2023
Actual
Date of last data collection
Anticipated
31/03/2023
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 312190 0
Commercial sector/Industry
Name [1] 312190 0
3Shape TRIOS A/S
Country [1] 312190 0
Denmark
Funding source category [2] 312195 0
Charities/Societies/Foundations
Name [2] 312195 0
Royal Childrens Campus
Country [2] 312195 0
Australia
Funding source category [3] 312196 0
Government body
Name [3] 312196 0
NHMRC
Country [3] 312196 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Murdoch Children’s Research Institute
Address
50 Flemington Road, Parkville VIC 3052
Country
Australia
Secondary sponsor category [1] 313722 0
None
Name [1] 313722 0
Address [1] 313722 0
Country [1] 313722 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311577 0
Royal Children's Hospital Human Research Ethics Committee
Ethics committee address [1] 311577 0
50 Flemington Road, Parkville VIC 3052
Ethics committee country [1] 311577 0
Australia
Date submitted for ethics approval [1] 311577 0
19/09/2022
Approval date [1] 311577 0
09/01/2023
Ethics approval number [1] 311577 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 121586 0
Ms Bree Jones
Address 121586 0
Murdoch Children's Research Institute
50 Flemington Road
Parkville VIC 3052
Country 121586 0
Australia
Phone 121586 0
+61 039933 5162
Fax 121586 0
Email 121586 0
bree.jones@mcri.edu.au
Contact person for public queries
Name 121587 0
Ms Bree Jones
Address 121587 0
Murdoch Children's Research Institute
50 Flemington Road
Parkville VIC 3052
Country 121587 0
Australia
Phone 121587 0
+61 039933 5162
Fax 121587 0
Email 121587 0
bree.jones@mcri.edu.au
Contact person for scientific queries
Name 121588 0
Ms Bree Jones
Address 121588 0
Murdoch Children's Research Institute
50 Flemington Road
Parkville VIC 3052
Country 121588 0
Australia
Phone 121588 0
+61 03 9933 5162
Fax 121588 0
Email 121588 0
bree.jones@mcri.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
17093Study protocol    Not currently available but will eventually be pub... [More Details]



Results publications and other study-related documents

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