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Trial registered on ANZCTR


Registration number
ACTRN12620000475943
Ethics application status
Approved
Date submitted
16/03/2020
Date registered
15/04/2020
Date last updated
13/10/2020
Date data sharing statement initially provided
15/04/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of Dental Monitoring on the efficiency of Invisalign orthodontic treatment
Scientific title
Evaluation of Dental Monitoring on the efficiency of Invisalign orthodontic treatment: a randomised controlled trial
Secondary ID [1] 300721 0
None
Universal Trial Number (UTN)
U1111-1249-2766
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dental malocclusion. 316555 0
Condition category
Condition code
Oral and Gastrointestinal 314793 314793 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
The intervention in this randomised controlled trial is called Dental Monitoring. Dental Monitoring is a software-based program that allows orthodontic practitioners to remotely monitor patients' treatment progress.

- Arm 1: The intervention group will consist of patients undergoing Invisalign orthodontic treatment, whose treatment will be monitored remotely using Dental Monitoring. Participants in this group will be required to take a series of photos of their teeth using their Dental Monitoring application on their smartphones with the aid of a 'Scanbox' (a mouth retractor and positioning device) at 1-week intervals. The photos are processed by Dental Monitoring's clinical team and processed using patented AI algorithms to notify the patient whether they can proceed to the next aligner. The investigators will be able to review patients' treatment progress remotely on the Dental Monitoring doctor's website. Participants in this group will be notified by the application within 12 hours to proceed to the aligner. If the application gives a "No Go" notification, the investigator (orthodontist) will be notified and will contact the patient to inform them of whether or not to continue wearing the current aligner for a longer period of time or to continue to proceed to the next aligner.
- Arm 2: The control group will be will consists of patients undergoing Invisalign orthodontic treatment, who treatment will be monitored conventionally via clinical appointments at 8-week intervals with the investigators. Participants in the control group will progress the aligners at 1-week intervals.

The study will follow participant's Invisalign treatment over 20 aligners, which should approximately be 20 weeks.

Data collection will be undertaken by Dr Peter Miles at Newwave Orthodontics, 10 Mayes Ave, Caloundra QLD 4551. Data analysis and reporting will be undertaken by Dr Jonathan Lam at the School of Dentistry, The University of Queensland, 288 Herston Rd, Herston QLD 4006.
Intervention code [1] 317053 0
Treatment: Other
Comparator / control treatment
The control group will be patients undergoing Invisalign orthodontic treatment, whose treatment will be monitored by clinical appointments. This is the standard practice protocol for patients undergoing Invisalign orthodontic treatment.

The control group will be scheduled to have clinical appointments every 8 weeks. They will be issued 8 aligners at each visit and instructed to wear each aligner for 1 week before proceeding to the next aligner. Thus, over the duration of the study (20 aligners; 20 weeks) we expect the control group to require 3 clinical appointments (i.e. 1x appointment before issuing the first 8 aligners, 1x appointment after aligner 8, 1x appointment after aligner 16) with a duration of 20-30min per appointment.
Control group
Active

Outcomes
Primary outcome [1] 323151 0
A comparison of the number of clinical appointments required by the intervention and control groups.
Timepoint [1] 323151 0
20 weeks.
Secondary outcome [1] 380962 0
A comparison of the number if Invisalign "refinements" required in the intervention and control group.

A refinement refers to an additional series of aligners that is required to provide further orthodontic tooth movement in order to achieve the desired orthodontic outcome. This outcome is an indirect measure of the accuracy of the intervention in tracking whether the progression of the aligners has been optimal.

This outcome is assessed in the same manner in both the intervention and control groups. It is a clinical judgement based on whether or not the positions of the teeth during treatment coincide with the Invisalign's predicted movments, i.e. whether the teeth are tracking with the aligners. If the teeth are not tracking (i.e. not fitting in the aligners), then a refinement is required, which involves rescanning the teeth and ordering a new set of aligners to correct the dental malocclusion.
Timepoint [1] 380962 0
20 weeks.

Eligibility
Key inclusion criteria
- Permanent dentition, including permanent second molars erupted sufficiently for aligners
- Minimum of 16 aligners (Clear Aligner Therapy)
- Treatment of both upper and lower arches with Clear Aligner Therapy
Minimum age
12 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Orthodontic treatment requiring premolar extractions
- Active periodontal disease
- High caries risk

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 305167 0
University
Name [1] 305167 0
School of Dentistry, University of Queensland
Address [1] 305167 0
288 Herston Road
Herston, QLD 4006
Country [1] 305167 0
Australia
Primary sponsor type
Individual
Name
Jonathan Lam
Address
School of Dentistry, University of Queensland
288 Herston Road
Herston, QLD 4006
Country
Australia
Secondary sponsor category [1] 305529 0
University
Name [1] 305529 0
School of Dentistry, University of Queensland
Address [1] 305529 0
288 Herston Road
Herston, QLD 4006
Country [1] 305529 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305532 0
The University of Queensland Human Research Ethics Committee
Ethics committee address [1] 305532 0
Level 3, Brian Wilson Chancellery
The University of Queensland
St Lucia QLD 4072, Australia
Ethics committee country [1] 305532 0
Australia
Date submitted for ethics approval [1] 305532 0
23/03/2020
Approval date [1] 305532 0
14/04/2020
Ethics approval number [1] 305532 0
Ethics approval has been obtained.

Summary
Brief summary
This quantitative clinical trial will investigate the impact of Dental Monitoring (DM) on the efficiency of Invisalign orthodontic treatment. DM is a software-based program that allows orthodontists to remotely monitor patients' treatment progress. DM claims that it will increase treatment efficiency through shorter treatment times and reduced number of appointments, by notifying the patient when the optimum time to change over to the next aligner is.
This research project aims to evaluate these claims by conducting a randomised controlled trial comparing a control group of patients undergoing Invisalign treatment only to an intervention group of patients undergoing Invisalign treatment with Dental Monitoring GoLive over 140 days. Participants will be from Newwave Orthodontics, a private orthodonitc practice in Caloundra. We expect DM will reduce the number of appointments by 1 over this time frame.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 100694 0
Dr Jonathan Lam
Address 100694 0
School of Dentistry, The University of Queensland
288 Herston Rd
Herston QLD 4006
Country 100694 0
Australia
Phone 100694 0
+61 424542890
Fax 100694 0
Email 100694 0
jonathan.lam@uqconnect.edu.au
Contact person for public queries
Name 100695 0
Dr Jonathan Lam
Address 100695 0
School of Dentistry, The University of Queensland
288 Herston Rd
Herston QLD 4006
Country 100695 0
Australia
Phone 100695 0
+61 424542890
Fax 100695 0
Email 100695 0
jonathan.lam@uqconnect.edu.au
Contact person for scientific queries
Name 100696 0
Dr Jonathan Lam
Address 100696 0
School of Dentistry, The University of Queensland
288 Herston Rd
Herston QLD 4006
Country 100696 0
Australia
Phone 100696 0
+61 424542890
Fax 100696 0
Email 100696 0
jonathan.lam@uqconnect.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 other documents available
Summary results
No Results