Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001233112
Ethics application status
Approved
Date submitted
9/08/2019
Date registered
6/09/2019
Date last updated
16/04/2021
Date data sharing statement initially provided
6/09/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
The use of digital technology to increase school children access to dental services
Scientific title
Teledentistry as a novel pathway to improve school children dental health: Randomised controlled trial
Secondary ID [1] 298461 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dental caries 313219 0
Access to dental care 313220 0
Condition category
Condition code
Oral and Gastrointestinal 311668 311668 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Public Health 312415 312415 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The proposed study involves evaluating the efficacy of a new model of dental care that involves dental assessment of school children on the basis of dental images reviewed by registered oral health therapists from a distance. In addition to the provision of dental advice/recommendation (that may include referrals, oral health promotion leaflets or instructions to parents) based on the photographic assessment. The oral health promotion leaflets are readily available on the Dental Health Services WA website (https://www.dental.wa.gov.au/). Permission has been obtained to use these leaflets for this research.

Six schools from different geographical locations in WA agreed to join the study. Schools will be randomly allocated to the study (3 schools) or control (3 schools) group.

At the baseline, participants (children, age 4-15 years) in the study group (teledental) will receive a standard visual dental inspection (without radiography) and dental photography using a smartphone camera performed by trained oral health therapists.

Four registered oral health therapists will first conduct visual dental inspection using a disposable mirror, probe and head-mounted light. Visual dental inspection along with reporting of findings will take on average 10 minutes. Then trained research assistants will acquire standard five dental images (of different views) from the child’s mouth using a smartphone camera and a mobile app designed for a dental screening. The image acquisition App called 'Teledental’ developed and validated by software scientists at the CSIRO and will be used to facilitate entry of patient information, capturing dental images, and transferring data to a server using a Wi-Fi or 4G network. Disposable oral retractors will be used during photography. Acquiring dental images and transmission of data to a secure server located in CSIRO will take up to 10 minutes. Dental photography will take place within the schools so no transportation is required. Two independent oral health therapists based in Sydney will review dental images from a distance. Reviewing dental images online and preparing the screening report will take on average 20 minutes per child.

Parents of participants in the study group (3 schools) will receive a copy of screening result on the basis of dental images assessment which could include oral health promotion leaflets or referrals to a dental school provider/dentist depending on the urgency and severity.

After 9 months from the initial dental screening and dental photography, all participants in both study and control groups will be invited to attend only visual dental inspection follow up performed by a dentist.

Regular auditing for participating oral health therapists will be conducted to assess the fidelity to the intervention.

Intervention code [1] 314706 0
Treatment: Other
Intervention code [2] 315286 0
Prevention
Intervention code [3] 315287 0
Early detection / Screening
Comparator / control treatment
The only difference to the study/interventional group is that participants in the control/comparator group (3 schools) will receive a copy of the screening result on the basis of visual dental inspection only that performed by onsite oral health therapists at the baseline.

Note: All participants (either in the study or control group) will receive visual dental inspection and dental photography at the baseline. The reason for this is to allow the assessment of the diagnostic performance of photographic assessment. Participants will be unaware whether the screening results received are based on visual dental inspection or photographic caries assessments.
Control group
Active

Outcomes
Primary outcome [1] 320391 0
Decay experience (referring to the presence of dental caries) measured by DFT/dft (decay, filled teeth) index.
DFT/dft index counts the number of decayed and filled teeth resulting from dental caries
(with lowercase letters representing primary dentition and capital letters representing permanent dentition). The DFT/dft index thus captures an individual’s cumulative experience of past and present dental caries, whether untreated (the number of decayed teeth) or treated (filled teeth because of caries).
Timepoint [1] 320391 0
At the baseline and 9 months follow up.
Primary outcome [2] 321068 0
The proportion of children become caries active.
Refers to conversion from caries-free at the baseline to caries-active states at the follow-up,
It also refers to the percentage of children developing one or more new caries in any of the previously caries-free teeth when assessed at the baseline.
Timepoint [2] 321068 0
At the 9 months follow up.
Secondary outcome [1] 371450 0
The diagnostic accuracy of dental screening on the basis of dental images relative to the reference visual dental assessment using the measure of sensitivity and specificity.
Timepoint [1] 371450 0
At the baseline only.
Secondary outcome [2] 373873 0
Cost comparison between two pathways of dental care.

A cost minimisation analysis will be undertaken to compare the costs associated with teledental versus the usual pathway of dental care over 9 months. This will include both the cost of the baseline dental screening and any subsequent interventions occurring over the 9 months. The resources for the usual pathway of dental care will include vehicle costs, admin costs (e.g. telephone appointments, printing services and postage) and costs of consumables used in visual dental screening and the dental practitioner’s time. The resources for the teledental pathway of dental care include: software licence fees, ICT equipment, Internet and software engineer’s time, admin costs (e.g. telephone appointments, printing services and postage), costs of consumables used in dental photography, research assistants (photographer) time, and offsite dental practitioners’ time for reviewing dental images. Dental care costs for all children include the following: restorations, restorations with crowns and extractions. The data costs will be based on those incurred by the health system only and will be derived from a survey and web-based open-access sources (Department of Veterans' Affairs, 2019).
The survey is designed specifically for this study (i.e. not validated) and will be used to obtain information from the oral health therapists about travel and accommodation expenses and the average time taken to perform dental checkup per child as well as any expense incurred during the conduct of the visual dental inspection.
Timepoint [2] 373873 0
At 9 months follow up.
Secondary outcome [3] 373874 0
Participants’ dental care utilisation patterns collected by a survey. This survey was adopted from another published study by Kopycka-Kedzierawski and Billings, 2011.
Timepoint [3] 373874 0
At the baseline.
Secondary outcome [4] 374303 0
The diagnostic performance of dental screening on the basis of dental images relative to the reference visual dental assessment using the measure of intra-examiner and inter-examiner reliability (Kappa coefficient).
Timepoint [4] 374303 0
At the baseline only.

Eligibility
Key inclusion criteria
Children aged 4-15 years, enrolled in one of the six schools agreed to join the study.
Minimum age
4 Years
Maximum age
15 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Parents or caregivers of children unable to provide written consent in English.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central study coordinator will assign allocation upon receipt of consent from caregivers of participants.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Cluster randomisation will be employed due to the high risk of randomisation. Many participants are expected to be a sibling. Random allocation of schools to the study or control arm occurs through central randomisation by computer
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
Actual
11/03/2019
Date of last participant enrolment
Anticipated
Actual
1/12/2019
Date of last data collection
Anticipated
Actual
15/02/2020
Sample size
Target
250
Accrual to date
Final
176
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 303004 0
Charities/Societies/Foundations
Name [1] 303004 0
Financial Markets Foundation for Children
Country [1] 303004 0
Australia
Primary sponsor type
Other Collaborative groups
Name
CSIRO's Australian eHealth Research Centre
Address
CSIRO Leeuwin Centre, 65 Brockway Rd,
Floreat WA 6014
Country
Australia
Secondary sponsor category [1] 302972 0
None
Name [1] 302972 0
Address [1] 302972 0
Country [1] 302972 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303554 0
CSIRO Health and Medical Human Research Ethics Committee
Ethics committee address [1] 303554 0
Ethics committee country [1] 303554 0
Australia
Date submitted for ethics approval [1] 303554 0
14/09/2018
Approval date [1] 303554 0
06/11/2018
Ethics approval number [1] 303554 0
HREC 9/2018
Ethics committee name [2] 303571 0
Catholic Education Association WA
Ethics committee address [2] 303571 0
Ethics committee country [2] 303571 0
Australia
Date submitted for ethics approval [2] 303571 0
10/12/2018
Approval date [2] 303571 0
04/02/2019
Ethics approval number [2] 303571 0
RP2018/54

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 94066 0
Prof Yogesan Kanagasingam
Address 94066 0
University of Notre Dame
32 Mouat St, Fremantle WA 6160
Country 94066 0
Australia
Phone 94066 0
+61 409878610
Fax 94066 0
Email 94066 0
[email protected]
Contact person for public queries
Name 94067 0
Marc Tennant
Address 94067 0
University of Western Australia
School of Human Sciences (M309),
35 Stirling Highway, 6009 WA
Country 94067 0
Australia
Phone 94067 0
+61 478 202 491
Fax 94067 0
Email 94067 0
[email protected]
Contact person for scientific queries
Name 94068 0
Mohamed Estai
Address 94068 0
CSIRO's Australian eHealth Research Centre
147 Underwood Avenue, Floreat, WA 6014
Country 94068 0
Australia
Phone 94068 0
+61 8 9333 6191
Fax 94068 0
Email 94068 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Not allowed disclosing IPD to a third party.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
2321Study protocol    377752-(Uploaded-31-08-2019-10-05-26)-Study-related document.docx
11379Study protocol    377752-(Uploaded-27-03-2021-15-16-00)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseTeledentistry as a novel pathway to improve dental health in school children: a research protocol for a randomised controlled trial.2020https://dx.doi.org/10.1186/s12903-019-0992-1
N.B. These documents automatically identified may not have been verified by the study sponsor.