ANZCTR - Registration

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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

7/02/2023

Date data sharing statement initially provided

15/04/2020

Type of registration

Prospectively registered

Titles & IDs

Public title

Comparative assessment of treatment efficiency and patient experience between Dental Monitoring and conventional monitoring of clear aligner therapy: A single-center randomized controlled trial

Scientific title

Comparative assessment of treatment efficiency and patient experience between Dental Monitoring and conventional monitoring of clear aligner therapy: A single-center randomized controlled trial

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1249-2766

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Dental malocclusion.

Condition category

Condition code

Oral and Gastrointestinal

Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Each eligible patient was randomly allocated to either a group remotely monitored with DM GoLive or a group monitored conventionally via regularly scheduled clinical visits. All patients were treated with the Invisalign appliance (Align Technology, San Jose, Calif). They were instructed to wear their aligners for a minimum of 22 hours per day. The study followed all participants to completion of orthodontic treatment.

Participants in Dental Monitoring (DM) group were required to take a DM scan at 1-week intervals using the DM app on their smartphones and a ScanBox (a proprietary mouth retractor and positioning device). The DM scan consists of a series of calibrated photos based on instructions provided via the DM app. The photos are processed by DM patented artificial intelligence algorithms that crop the photos, segment the teeth, and conduct a number of clinical observations. The treating investigator (PM) was able to remotely monitor patients’ treatment progress via the Doctor Dashboard and provide patients with appropriate clinical instructions via the DM app’s instant messaging (IM) service to manage non-tracking issues or organise an in-person appointment if clinical intervention was required. DM subjects only attended clinical appointments as required. All DM patients were on the same aligner progression protocol based upon those used by an experienced DM practitioner. Patients were notified via the DM app that they could progress to the next aligner with a “Go” notification or to continue wearing the current aligner with a “No Go” notification. For a “slight unseat” or “slight unseat still present” notification, there was a silent alert and the patient continued with aligner treatment as normal. For a “noticeable unseat” there was a patient warning, and a message was sent to the patient prompting the continued use of chewies. For a “noticeable unseat still present”, there was a patient red alert, and a message was sent to the patient prompting improvement in aligner wear to 22 hours per day. If the DM app informed the patient of a “No Go”, the treating investigator was notified via the cloud-based DM Doctor Dashboard, and a clinical decision was made to “force go”, exclude teeth within the protocol, or schedule a clinical appointment for appropriate intervention. After a “No Go” patients were asked to re-scan after 3 days.

Intervention code [1]

Treatment: Other

Comparator / control treatment

The Conventional Monitoring (CM) control group consisted of patients undergoing CAT, whose treatment was monitored by regularly scheduled clinical appointments at 8-week intervals. Each clinical appointment was scheduled for 15min. The CM group were instructed to wear each aligner for 1 week, before progressing to the next aligner. Tracking problems were managed at clinical appointments. The management protocol of poor fitting aligners for the CM group was similar to the DM group. Chewies were prescribed for slightly unseated aligners, and a clinical decision to prolong aligner wear intervals or to recover later with refinement aligners was made by the treating investigator for noticeably unseated aligners.

Control group

Active

Outcomes

Primary outcome [1]

The primary outcome of the study was the number of clinical appointments required during overall treatment period.

Timepoint [1]

Timepoint: end of clear aligner treatment

Secondary outcome [1]

The secondary outcomes were the time taken to reach first refinement, the number of refinements, the total number of aligners, and the overall treatment duration recorded. The number of appointments and number of refinements were considered as count data. The time taken to reach first refinement, total number of aligners and overall treatment duration were considered as continuous quantitative data.

Timepoint [1]

Timepoint: end of clear aligner treatment

Eligibility

Key inclusion criteria

Participants were included if they had (1) a full permanent dentition with erupted or erupting second molars, (2) no missing or previously extracted permanent teeth, (3) undergoing comprehensive orthodontic treatment with CAT and (4) did not require premolar extractions or (5) auxiliary appliances as part of orthodontic treatment.

Minimum age

12 Years

Maximum age

No limit

Sex

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)

The numbers were placed in sealed opaque envelopes and shuffled by a clinical assistant. During the clinical appointment where the initial set of aligners were given to participants, the envelopes were opened for group assignment and routine instructions were provided in a closed consultation room to ensure that the treating investigator was blinded.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Randomization was performed using 7 permutated blocks of 8 randomly generated numbers with the random generation function in Excel (Microsoft, Redmond, Wash).

Masking / blinding

Open (masking not used)

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

1/05/2020

Actual

27/04/2020

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]

University

Name [1]

School of Dentistry, University of Queensland

Address [1]

288 Herston Road
Herston, QLD 4006

Country [1]

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]

University

Name [1]

School of Dentistry, University of Queensland

Address [1]

288 Herston Road
Herston, QLD 4006

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The University of Queensland Human Research Ethics Committee

Ethics committee address [1]

Level 3, Brian Wilson Chancellery
The University of Queensland
St Lucia QLD 4072, Australia

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

23/03/2020

Approval date [1]

14/04/2020

Ethics approval number [1]

Ethics approval has been obtained.

Summary

Brief summary

Introduction: The aim of this 2-arm randomized controlled clinical trial (RCT) was to assess the effect of Dental Monitoring (DM) on the efficiency of clear aligner therapy (CAT) as well as the patient experience, compared to the conventional monitoring (CM) protocol of regularly scheduled clinical appointments.  
Methods: 56 patients with a full permanent dentition and treated with CAT participated in this RCT. They were recruited from a single private practice and treated by 1 experienced orthodontist. Randomization was performed with permutated blocks of 8 patients assigned to either a (CM) or DM group with allocations concealed in opaque, sealed envelopes. It was not feasible to blind the subjects or investigators. The primary treatment efficiency outcome assessed was the number of appointments. Secondary outcomes included time to reach first refinement, number of refinements, total number of aligners, and treatment duration. The patient experience was assessed using a visual analogue scale (VAS) questionnaire administered at the end of CAT. 
Results: No patients were lost to follow-up. There was no significant difference in the number of refinements (mean 0.1; 95% CI, -0.2, 0.5; p = 0.43) and number of total aligners (median 5; 95% CI, -1, 13; p = 0.09). There was a significant difference in the number of appointments, with the DM group requiring 1.5 fewer visits (95% CI, -3.3, -0.7; p = 0.02) as well as overall treatment duration, with the DM group taking 1.9 months longer (95% CI, 0.0, 3.6; p = 0.04). There was a difference between study groups regarding the importance of face-to-face appointments, with the DM group not perceiving face-to-face appointments as important (p = 0.030). 
Conclusions: The use of DM with CAT resulted in 1.5 fewer clinical appointments and a longer treatment duration by 1.9 months. There were no significant intergroup differences with the number of refinements or total aligners. Both CM & DM groups had similarly high levels of satisfaction with CAT. 

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

Dr Jonathan Lam

Address

School of Dentistry, The University of Queensland
288 Herston Rd
Herston QLD 4006

Country

Australia

Phone

+61 424542890

Fax

jonathan.lam@uqconnect.edu.au

Contact person for public queries

Name

Jonathan Lam

Address

School of Dentistry, The University of Queensland
288 Herston Rd
Herston QLD 4006

Country

Australia

Phone

+61 424542890

Fax

jonathan.lam@uqconnect.edu.au

Contact person for scientific queries

Name

Jonathan Lam

Address

School of Dentistry, The University of Queensland
288 Herston Rd
Herston QLD 4006

Country

Australia

Phone

+61 424542890

Fax

jonathan.lam@uqconnect.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.

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