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Trial registered on ANZCTR


Registration number
ACTRN12623000327684p
Ethics application status
Submitted, not yet approved
Date submitted
11/03/2023
Date registered
28/03/2023
Date last updated
28/03/2023
Date data sharing statement initially provided
28/03/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Teleorthodontics & Artificial Intelligence in Orthodontic Screening and Treatment (Part 2)
Scientific title
The effectiveness of Teledentistry & Artificial Intelligence in orthodontic referral screening and treatment of Australian adolescents and adults: a randomised controlled trial (Part 2: treatment)
Secondary ID [1] 309181 0
Nil
Universal Trial Number (UTN)
Trial acronym
TAIT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malocclusion 329313 0
Condition category
Condition code
Oral and Gastrointestinal 326257 326257 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
Participants in the intervention group will have treatment with braces and be recalled based on the recommendations of the AI-guided Dental Monitoring(TM) system. 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. Participants will provide intraoral photographs once weekly, with each "scan" taking approximately 5 minutes. Participants will be provided standardised instructions on how to use the DM system. Participants will use the DM system until the levelling and alignment stage of treatment is completed. On average, this takes 6 to 8 months. Reminders for the patient to submit their scans will be sent via the DM application, and the researchers will be notified if participants fail to submit their intraoral photos.

The DM system assesses when an orthodontic archwire is passive, indicating that the patient is ready to be recalled for the placement of the next archwrie.
Intervention code [1] 325624 0
Treatment: Devices
Comparator / control treatment
Patients in the control group will be recalled for braces adjustment appointments following a conventional recall schedule (every 6 weeks).
Control group
Active

Outcomes
Primary outcome [1] 334134 0
Number of appointments required and time to levelling and alignment compared between AI-guided and conventional scheduling groups. This is a composite outcome. The data will be collected using a specifically designed data collection form. Additionally, appointment dates and number of appointments are automatically recorded in the Sydney Dental Hospital electronic patient management system, Titanium Web. This will be cross-checked with the data collection form to ensure accuracy in number of appointments and duration of treatment recorded in the data collection form.
Timepoint [1] 334134 0
At the end of the levelling and alignment stage of orthodontic treatment
Secondary outcome [1] 419443 0
Patient satisfaction with AI-guided compared with conventional scheduling orthodontic treatment. 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 [1] 419443 0
At the end of the levelling and alignment stage of orthodontic treatment
Secondary outcome [2] 419444 0
Change in waiting time for orthodontic treatment appointment. Using the specifically designed data collection form, the time taken for each face-to-face eligibility assessment and teleorthodontic assessment will be recorded and the average calculated. The change in wait time will calculated based on the change in number of unnecessary face-to-face screening appointments and the average duration of each assessment type.
Timepoint [2] 419444 0
At the end of the levelling and alignment stage of orthodontic treatment
Secondary outcome [3] 419445 0
Cost effectiveness of AI-guided compared to conventional scheduling orthodontic treatment. This will be calculated based on: clinician and ancillary staff time per patient, diagnostic and treatment costs, PPE usage, patient/carer travel time and time off work). These parameters will be recorded for each patient appointment, estimated based on standard diagnostic/treatment costs, and patient/carer time will form part of the patient satisfaction survey.
Timepoint [3] 419445 0
At the end of the levelling and alignment stage of orthodontic treatment

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: greater than or equal to 11 to 29 years of age
• Dental status: Permanent dentition
• Treatment plan: Planned for non-extraction treatment in the upper and lower arches
• Incisor relationship: Class I or Class II Division 1/2 incisor relationship (upper tooth which is in crossbite accepted provided orthodontic bracket can be bonded to the tooth and no additional space opening mechanics required to align the tooth)
• Crowding: Mandibular and maxillary anterior Little’s Irregularity Index (LII) 1-7
Minimum age
11 Years
Maximum age
29 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Participants known to the investigators
• Severely ectopic/displaced teeth
• Impacted canines requiring mechanical eruption
• Significant medical history or medication that would adversely affect the development or structure of teeth or jaws and any subsequent tooth movement
• Previous or current orthodontic or orthopaedic treatment
• Orthopaedic treatment and/or maxillary expansion required
• Craniofacial anomaly present
• Hyperdontia or hypodontia
• History of trauma, bruxism or parafunction
• Past and/or present signs and symptoms of periodontal disease

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation to experimental and control groups
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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size calculation was based on data from Hansa et al (2020), who found clear aligner patients monitored with DM™ had 2.26 (23%) fewer visits compared to the control (7.56 vs 9.82; P < .001). A two-tailed independent t-test using an alpha of 0.05 and 80% power determined a total sample size of 40 was required (GPower 3.1 Software). To allow for a 30% drop-out rate, the total sample size was increased to n=60

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
29/03/2024
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 24264 0
Sydney Dental Hospital - Surry Hills
Recruitment postcode(s) [1] 39803 0
2010 - Surry Hills

Funding & Sponsors
Funding source category [1] 313379 0
Government body
Name [1] 313379 0
Sydney Local Health District
Country [1] 313379 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] 315142 0
None
Name [1] 315142 0
Address [1] 315142 0
Country [1] 315142 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 312596 0
RPA HREC - Clinical Trials Sub-Committee
Ethics committee address [1] 312596 0
Ethics committee country [1] 312596 0
Australia
Date submitted for ethics approval [1] 312596 0
20/02/2023
Approval date [1] 312596 0
Ethics approval number [1] 312596 0
Research Ethics and Governance Office

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

Contacts
Principal investigator
Name 125230 0
Dr Oyku Dalci
Address 125230 0
Orthodontics Department, Sydney Dental Hospital
2 Chalmers St
SURRY HILLS
2010 NSW
Country 125230 0
Australia
Phone 125230 0
+61 2 9351 8321
Fax 125230 0
Email 125230 0
oyku.dalci@sydney.edu.au
Contact person for public queries
Name 125231 0
Maxim Milosevic
Address 125231 0
Orthodontics Department, Sydney Dental Hospital
2 Chalmers St
SURRY HILLS
2010 NSW
Country 125231 0
Australia
Phone 125231 0
+61292933389
Fax 125231 0
Email 125231 0
mmil8904@uni.sydney.edu.au
Contact person for scientific queries
Name 125232 0
Maxim Milosevic
Address 125232 0
Orthodontics Department, Sydney Dental Hospital
2 Chalmers St
SURRY HILLS
2010 NSW
Country 125232 0
Australia
Phone 125232 0
+61292933389
Fax 125232 0
Email 125232 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.