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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12620000475943
Enrollment
23
Registered
2020-04-15
Start date
2020-04-27
Completion date
Unknown
Last updated
2023-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

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.

Sponsors

Jonathan Lam
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
12 Years to No maximum
Healthy volunteers
Yes

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.

Exclusion criteria

- Orthodontic treatment requiring premolar extractions - Active periodontal disease - High caries risk

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 11, 2026