Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000789662p
Ethics application status
Submitted, not yet approved
Date submitted
26/06/2023
Date registered
20/07/2023
Date last updated
20/07/2023
Date data sharing statement initially provided
20/07/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the patient experience of orthodontic treatment using virtual monitoring and digital technology for rural and metropolitan public patients in NSW.
Scientific title
Evaluating the patient experience of orthodontic treatment using virtual monitoring and digital technology for rural and metropolitan public patients in NSW.
Secondary ID [1] 309979 0
Nil
Universal Trial Number (UTN)
Trial acronym
DM study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malocclusion 330469 0
Condition category
Condition code
Oral and Gastrointestinal 327321 327321 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Public Health 327442 327442 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Up to 30 Participants in the intervention group will have treatment with aligners 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 treatment is completed. On average, this takes 12 to 18 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.
Participants will be recalled to return to the clinic for attachment placement, interproximal reduction as required. Orthodontic treatment will be provided by general dentist supervised remotely by orthodontists.
Instructions will be provided via a pamphlet with illustrations. Instructions have been designed specifically for the study.
The orthodontist will determine if treatment is complete.
Intervention code [1] 326397 0
Treatment: Devices
Comparator / control treatment
Up to 60 patients who meet the selection criteria and are able/willing to be seen face-to-face at SDH will be selected from the orthodontic waiting list and form the control groups (Up to 30 per group). These patients will be treated by the orthodontic specialist student cohort and consent to have face-to-face appointments at Sydney Dental Hospital (SDH). Positive and Negative Control Groups will be based on the use aligners or braces (respectively) for treatment.
Participants will be booked in for their next appointment based on recommendations from their treatment team like in usual orthodontic treatment with braces or aligners. Controls will not use DM system.
Control group
Active

Outcomes
Primary outcome [1] 335189 0
Completion of orthodontic treatment measured using 1) an internationally validated scoring system (Peer Assessment Rating (PAR) score & Objective Grading System (OGS)) and routinely collected clinical data. 2) Patient centred care outcomes: patient perception of improvement in appearance and Quality of life assessment in relation to experience of care using validated questionnaires (Oral Health related Quality of Life Questionnaire).
this will be assessed as a composite outcome.

Data to be collected:
Age
Postcode
Gender
Australia born
Treatment completed as expected
Attendance to follow up appointment
Missed scans to check compliance
Missed appointments to check compliance
Number/duration of visits
Time spent monitoring via DM
Costs to the health system
Travel and waiting time/cost
Cost savings due to avoiding complex/surgical orthodontic treatment
Treatment commencement date
Treatment completion date
Height and weight

Peer Assessment Rating (PAR) Index (Pre and Post treatment):

Upper and lower anterior segments contact displacements; clinical assessment
Buccal Occlusion: clinical assessment
Overjet: will be assessed using a ruler
Overbite; will be assessed using a ruler
Centreline; will be assessed using a ruler

Objective Grading Score (OGS) (Pre and post treatment)

Alignment
Marginal ridges: clinical assessment
Buccolingual inclination; will be assessed using a ruler
Occlusal contact: clinical assessment
Occlusal relationship: will be assessed using the Angle's relationship
Overjet; will be assessed using a ruler
Interproximal contact; clinical assessment
Timepoint [1] 335189 0

Clinical data will be routinely collected at each appointment until completion of orthodontic treatment.
At the end of treatment: Completion of orthodontic treatment will be measured using 1) an internationally validated scoring system (PAR score & OGS).2) Patient centred care outcomes: patient perception of improvement in appearance and Quality of life assessment in relation to experience of care using validated questionnaires (Oral Health related Quality of Life Questionnaire).
Primary outcome [2] 335190 0
This will be assessed as a composite outcome.
Process outcomes (3, 12, 24 months): Patient compliance and patient and clinician fidelity will be compared in relation to outcomes. Quantification of patient compliance in the DM and Control groups will be assessed by checking missed scans and appointments respectively. Data will be collected via audit of patient records. Compliance with treatment procedures will be checked via patient questionnaires and the total number of successfully completed treatments. To assess if the intervention was delivered as intended, checklists will be used. These questionnaires have been designed specifically for the study.
Timepoint [2] 335190 0
3, 12 & 24 post commencement of treatment.
Primary outcome [3] 335191 0
This will be assessed as a composite outcome.
Acceptability/Experience of care (3, 12, 24 months): measures will include satisfaction/experience of patients.
Uptake of proposed intervention, impact of travel time and time off work/school.
These composite outcome data will be collected via a specific questionnaire designed for this study.
Timepoint [3] 335191 0
3, 12 & 24 months post commencement of treatment
Secondary outcome [1] 423421 0
Economic evaluation to compare remote specialist orthodontic treatment with conventional orthodontic treatment. The cost of treatment in the three arms will be compared.
Data of cost of treatment will be collected via audit of patient records.
Timepoint [1] 423421 0
End of study

Eligibility
Key inclusion criteria
1. SDH Patients on orthodontic waiting list from the participating rural and metropolitan LHDs
2. 8-18 years of age
3. Class I and II malocclusion (maximum ½ unit Class II)
4. Permanent Dentition
5. Severe crowding (Greater than or equal to 7 mm per arch)
6. No need for rapid maxillary expansion
7. Good oral hygiene and no periodontal problems
8. No congenital anomalies
9. Must have a smart phone
10. Willingness to provide informed consent and willingness to participate and comply with the study requirements.
Inclusion criteria Positive and Negative Control Groups (Non-DM):
1. SDH Patients on orthodontic waiting list
2. 8-18 years of age
3. Class I and II malocclusion (maximum ½ unit Class II)
4. Permanent Dentition
5. Severe crowding (Greater than or equal to 7 mm per arch)
6. No need for rapid maxillary expansion
7. Good oral hygiene and no periodontal problems
8. No missing teeth
9. No congenital anomalies
10. Must have a smart phone.
11. Willingness to provide informed consent and willingness to participate and comply with the study requirements.
Minimum age
8 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Not available for follow-up
2. Severely ectopic/displaced teeth
3. Impacted canines requiring mechanical eruption
4. Significant medical history or medication that would adversely affect the development or structure of teeth or jaws and any subsequent tooth movement
5. Previous or current orthodontic or orthopaedic treatment
6. Orthopaedic treatment and/or maxillary expansion required
7. Craniofacial anomaly present
8. Hyperdontia or hypodontia
9. History of trauma, bruxism or parafunction
10. Past and/or present signs and symptoms of periodontal disease

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2023
Actual
Date of last participant enrolment
Anticipated
1/04/2024
Actual
Date of last data collection
Anticipated
1/05/2026
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 24981 0
Sydney Dental Hospital - Surry Hills
Recruitment hospital [2] 24982 0
Tresillian in Murrumbidgee - Wagga Wagga - Wagga Wagga
Recruitment hospital [3] 24983 0
The Sutherland Hospital - Caringbah
Recruitment hospital [4] 24985 0
Goulburn Base Hospital - Goulburn
Recruitment postcode(s) [1] 40635 0
2010 - Surry Hills
Recruitment postcode(s) [2] 40637 0
2229 - Caringbah
Recruitment postcode(s) [3] 40639 0
2580 - Goulburn
Recruitment postcode(s) [4] 40636 0
2650 - Wagga Wagga

Funding & Sponsors
Funding source category [1] 314153 0
Government body
Name [1] 314153 0
Ministry of Health
Country [1] 314153 0
Australia
Primary sponsor type
Government body
Name
Sydney Local Health District
Address
King George Building V, RPA
83/117 Missenden Rd, Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 316072 0
None
Name [1] 316072 0
Address [1] 316072 0
Country [1] 316072 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 313288 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 313288 0
Research Ethics and Governance Office (REGO)
Royal Prince Alfred Hospital
Missenden Road
CAMPERDOWN NSW 2050
Ethics committee country [1] 313288 0
Australia
Date submitted for ethics approval [1] 313288 0
26/06/2023
Approval date [1] 313288 0
Ethics approval number [1] 313288 0
Research Ethics and Governance Office

Summary
Brief summary
The study aims to trial a remote care model which should give remote patients earlier and better access to orthodontic care using their local dentist and an application, supported by an orthodontist remotely.

This is a Quasi-Experimental trial to investigate the efficacy of a virtual care model, using artificial intelligence (AI) to provide orthodontic treatment by dentists to public rural and metropolitan NSW patients, while under the remote supervision of orthodontists, in comparison to conventional face-to-face treatment provided by specialists. Participants: Up to 90 patients, aged 8-18 years, who are eligible to receive orthodontic treatment in the public system and meet the orthodontic treatment severity criteria will be selected. Treatment will be done using aligners with Dental Monitoring (DM Group) and compared to treatment using aligners without DM (Positive Control Group) and conventional braces treatment without DM (Negative Control Group).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 127614 0
Dr Oyku Dalci
Address 127614 0
Dr Oyku Dalci
Sydney Dental Hospital
2 Chalmers St
Surry Hills
2010 NSW
Country 127614 0
Australia
Phone 127614 0
+61 2 9351 8321
Fax 127614 0
Email 127614 0
oyku.dalci@sydney.edu.au
Contact person for public queries
Name 127615 0
Dr Oyku Dalci
Address 127615 0
Dr Oyku Dalci
Sydney Dental Hospital
2 Chalmers St
Surry Hills
2010 NSW
Country 127615 0
Australia
Phone 127615 0
+61 2 9351 8321
Fax 127615 0
Email 127615 0
oyku.dalci@sydney.edu.au
Contact person for scientific queries
Name 127616 0
Dr Oyku Dalci
Address 127616 0
Dr Oyku Dalci
Sydney Dental Hospital
2 Chalmers St
Surry Hills
2010 NSW
Country 127616 0
Australia
Phone 127616 0
+61 2 9351 8321
Fax 127616 0
Email 127616 0
oyku.dalci@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.