Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000315617p
Ethics application status
Submitted, not yet approved
Date submitted
3/03/2023
Date registered
23/03/2023
Date last updated
23/03/2023
Date data sharing statement initially provided
23/03/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Teleorthodontics & Artificial Intelligence in Orthodontic Screening and Treatment (Part 1)
Scientific title
The effectiveness of Teledentistry & Artificial Intelligence in orthodontic referral screening and treatment of Australian adolescents and adults: a randomised controlled trial (Part 1: Screening)
Secondary ID [1] 309050 0
Nil
Universal Trial Number (UTN)
Trial acronym
TAIS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malocclusion 329205 0
Condition category
Condition code
Oral and Gastrointestinal 326165 326165 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Part 1: Orthodontic eligibility and screening
Patients in the intervention group will be assessed for eligibility using teleorthodontics by sumitting intra-oral and extra-oral photographs using the Dental Monitoring(TM) platform. This system uses a smartphone application that allows patients to take accurate intraoral photos, software that measures individual tooth movements and an internet-based interface where the clinician can monitor patient records and correspond with the patient. The process of taking photographs and completing the patient questionnaire will take between 30-45 minutes, which is comparable to the time taken for a face-to-face screening appointment. The researchers (orthodontic registrars) will review the submitted photographs and if any images are non-diagnostic, participants will be asked to perform a new "scan" using the DM system.

This trial is a randomized crossover trial, whereby all participants are screen for eligibility using the teleorthodontic AND conventional face-to-face method. Participants randomised to Group 1 will undergo teleorthodontic assessment first, followed by conventional assessment. Group 2 will undergo conventional assessment first, followed by teleorthodontic assessment. There will be a minimum washout period of 2 months between the two assessment methods.
Intervention code [1] 325566 0
Early detection / Screening
Comparator / control treatment
Patients in the control group will be assessed for elgibility using conventional face-to-face methods. For a patient to be eligible for public orthodontic services in NSW, the patient's malocclusion (relationship between teeth) severity must equate to an Index of Orthodontic Treatment Need (IOTN) Dental Health Component score of 3 or more. This is a standardised assessment tool which will be used to determine if a patient is eligible or ineligible. The conventional face-to-face method of assessment appointment involves an intra and extra-oral examination, review of relevant radiographs and patient history information.
Control group
Active

Outcomes
Primary outcome [1] 334038 0
Outcome 1. Eligibility status assigned via teleorthodontic assessment compared with status assigned via conventional assessment method. Following the assessment (conventional or teleorthdontic), eligibility status will be recorded. For the conventonal method, this will be based on the findings from the patient examinaton and review of patient history and radiographs. For the teleorthdontic method, this will be based on intra-oral and extra-oral photographs, patient history form and available radiographs submitted electronically. The two outcomes will be compared for agreement.
Timepoint [1] 334038 0
Following teleorthodontic and conventional assessment
Primary outcome [2] 334039 0
Outcome 2. Index of Orthodontic Treatment Need (IOTN) score assigned with teleorthodontics compared with conventional assessment method. For the teleorthodontic method, this will be based on the intraoral photographs submitted with the DM system. For the conventional assessment, this will be based on the clinical examination intra-oral findings.
Timepoint [2] 334039 0
Following teleorthodontic and conventional assessment
Secondary outcome [1] 419152 0
Oral hygiene status assigned via teleorthodontic assessment compared with status assigned via conventional assessment method. Status will be assigned as "noticeably insufficient", "slightly insufficient" or "good" by the DM system for the teleorthodontic method and by the researcher (orthodontics registrar) for the conventional assessment method.
Timepoint [1] 419152 0
Following teleorthodontic and conventional assessment
Secondary outcome [2] 419155 0
Patient satisfaction with teleorthodontic screening compared with conventional eligibility assessment. 5-point Likert scale, questionnaire designed specifically for this study. Participants/carers will also provide data on time off work/school and method of transport for travel.
Timepoint [2] 419155 0
Following teleorthodontic and conventional assessment
Secondary outcome [3] 419157 0
Change in eligibility assessment wait time. Time of each face-to-face eligibility assessment appointment recorded and average calculated. Time of each teleorthodontics eligibility assessment recorded and average calculated. Reduction in wait time calculated based on reduction in number of unnecessary face-to-face screening appointments.
Timepoint [3] 419157 0
Following teleorthodontic and conventional assessment
Secondary outcome [4] 419819 0
Gingival health status assigned via teleorthodontic assessment compared with status assigned via conventional assessment method. Status will be assigned as "gingivitis" or "none" by the DM system for the teleorthodontic method and by the researcher (orthodontics registrar) for the conventional assessment method.
Timepoint [4] 419819 0
Following teleorthodontic and conventional assessment.

Eligibility
Key inclusion criteria
• Sex: Male, female, non-binary, unspecified
• Access to smartphone: Routine access to smartphone capable of running the DM™ application with camera functionality
• Access to email account
• Consent: Willingness to provide informed consent (or parental consent) and to participate and comply with the study requirements
• Age range: equal to or older than 6 to 29 years of age
• Referral status: Due for orthodontic eligibility assessment in 2023
Minimum age
6 Years
Maximum age
29 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Participants known to the investigators
• Patients living >100km from SDH

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 randomisation to crossover Group 1 & 2
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Minimum two month washout period between conventional and teleorthdontic elgibility assessments
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size calculation was based on an expected sensitivity of 0.80 and specificity of 0.73 for teleorthodontic eligibility assessment (Mandall et al 2005). In the United Kingdom, an IOTN of 3 or more renders one eligible for orthodontic treatment under the NHS. Disease prevalence was therefore set at 50% as reported by Christopherson et al (2009) (51) and Ajwa et al (2022)(52), based on a population an IOTN prevalence of 3 or more. Using the method described by Buderer (1996) with an alpha of 0.05, precision of 0.1 and 30% drop-out rate, the sample size was calculated as n=208.

Statistical analysis plan to be finalised with input of biostatistician.
Cohen’s kappa sensitivity and specificity analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/04/2023
Actual
Date of last participant enrolment
Anticipated
31/05/2023
Actual
Date of last data collection
Anticipated
29/09/2023
Actual
Sample size
Target
208
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 24174 0
Sydney Dental Hospital - Surry Hills
Recruitment postcode(s) [1] 39706 0
2010 - Surry Hills

Funding & Sponsors
Funding source category [1] 313253 0
Government body
Name [1] 313253 0
Sydney Local Health District
Country [1] 313253 0
Australia
Primary sponsor type
Other
Name
Sydney Local Health District
Address
King George Building V, RPA
83/117 Missenden Rd, Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 315143 0
None
Name [1] 315143 0
Address [1] 315143 0
Country [1] 315143 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 312485 0
RPA HREC - Clinical Trials Sub-Committee
Ethics committee address [1] 312485 0
Research Ethics and Governance Office (REGO)
Royal Prince Alfred Hospital
Missenden Road
CAMPERDOWN NSW 2050
Ethics committee country [1] 312485 0
Australia
Date submitted for ethics approval [1] 312485 0
20/02/2023
Approval date [1] 312485 0
Ethics approval number [1] 312485 0

Summary
Brief summary
This study evaluates teledentistry and artificial intelligence (AI) in the screening of new orthodontic referrals as well as during braces treatment in Australian adolescents and adults. Its goal is to improve access to public orthodontic services. 208 participants will submit photos using a smartphone-compatible platform called Dental Monitoring (DM). Based on these, patients will have their elgibility status assigned according to NSW Health Policy. Participants will also be assessed at a face-to-face appointment. The outcome of these two methods will be compared to determine the validity of teleorthodontics. Patient satisfaction, oral hygiene status, gingival health status, reduction in waiting lists and the cost-effectiveness will also be assessed.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 124826 0
Dr Oyku Dalci
Address 124826 0
Orthodontics Department, Sydney Dental Hospital
2 Chalmers St
SURRY HILLS
2010 NSW
Country 124826 0
Australia
Phone 124826 0
+61 2 9351 8321
Fax 124826 0
Email 124826 0
oyku.dalci@sydney.edu.au
Contact person for public queries
Name 124827 0
Dr Maxim Milosevic
Address 124827 0
Orthodontics Department, Sydney Dental Hospital
2 Chalmers St
SURRY HILLS
2010 NSW
Country 124827 0
Australia
Phone 124827 0
+61292933389
Fax 124827 0
Email 124827 0
mmil8904@uni.sydney.edu.au
Contact person for scientific queries
Name 124828 0
Dr Maxim Milosevic
Address 124828 0
Orthodontics Department, Sydney Dental Hospital
2 Chalmers St
SURRY HILLS
2010 NSW
Country 124828 0
Australia
Phone 124828 0
+61422862924
Fax 124828 0
Email 124828 0
mmil8904@uni.sydney.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?

No Supporting Document Provided



Results publications and other study-related documents

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

Documents added automatically
No additional documents have been identified.