The Use of Remote Monitoring for Orthodontic Retention Review

The Use of Remote Monitoring for Orthodontic Retention Review: A Randomised Controlled Trial

To assess whether using retainers and an artificial intelligence supported remote monitoring system maintains a more stable orthodontic treatment result than using retainers with in-office review appointments.

Study Overview

• Status: Active, not recruiting
• Conditions: Orthodontic Relapse
• Intervention / Treatment: Device: Dental Monitoring; Other: Clinic Review

Detailed Description

The amount and nature of relapse are unpredictable and natural changes in the dentition are life-long. Although some patients were shown to remain stable despite not wearing retainers, research is unable to provide predictors for identifying those patients and therefore we have to treat all patients as if they have the potential to relapse long term.

Following the results of long-term retrospective studies, there has been a gradual change of practice from prescribing retainers for 1-2 years to long-term retention. This is a significant burden on patients, clinicians and the health system as long term review and maintenance of retainers are required from both parties.

Although some studies showed compliance with the use of orthodontic retainers correlated with factors such as gender, age and type of retainer, one of the main reasons for non-compliance with removable retainers was shown to be just forgetting to wear them. Patient compliance is also needed in attending follow-up appointments for review of fit and intactness of retainers as well as calculus build-up that may be present around fixed lingual wires.

Long term review is also needed to protect patients from any side effects from broken or distorted fixed retainers. This is not common, yet when it happens its side effects can be deleterious. Since patients do not always realise these side effects on time, damage may range from simple malalignment of teeth to having roots of teeth come out of bone creating periodontal and aesthetic consequences.

Attending review appointments could be inconvenient for both patients and parents as they need to take time off of school and work.

There are currently no studies on the efficacy of DM as a tool to monitor orthodontic retention patients. Therefore, this project can shed light on whether the use of DM is an acceptable or more effective way of monitoring patients wearing retainers than traditional in-office orthodontic visits. The results of this study could also help guide clinicians regarding the most effective retention regime using remote monitoring systems. The study will also compare the costs of in-office retainer checks and remote monitoring of retainers, If the results of this study show DM is better, or comparable to, clinical review appointments and it less costly and more convenient, DM may be utilised for patients in the public system freeing chair-time for patients waiting for treatment on the public orthodontic waiting list.

• Study Type: Interventional
• Enrollment (Estimated): 82
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Surry Hills, New South Wales, Australia, 2010
      • Sydney Dental Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Consent to participate in the trial and comply with the retention regime and able to follow instructions
• Permanent dentition
• Good general health
• Good oral hygiene and good periodontal health
• Owning or having access to a mobile/smart phone compatible with Dental monitoring application (DM app is available for use on all iOS and Android devices)

Exclusion Criteria:

• Patients with

  • Congenital anomalies or craniofacial syndromes
  • Poor oral hygiene and poor periodontal health
  • Missing teeth & teeth with poor enamel quality
• Patients that were treated with orthognathic surgery
• Patients that are unwilling or unable to follow the instructions provided

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dental Monitoring; Orthodontic retention review via dental monitoring only	Device: Dental Monitoring; Patients in this arm are not required to attend in-office retention appointments except if they have any problems with their retainers and when data collection is necessary. Instead they are required to submit scans of their teeth through the DM mobile application at the designated intervals.
Active Comparator: Clinic Review; Orthodontic retention review via in-office visits as per routine care	Other: Clinic Review; Patients in this arm are required to attend in clinic appointments for their retention review

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Orthodontic treatment stability - Little's Irregularity Index	The sum of the linear displacements of five labial segment contact point in a labiolingual direction	4 years
Orthodontic treatment stability - Spacing if present	The sum of the linear distances between contact points of teeth that have space between them	4 years
Orthodontic treatment stability - Inter-canine width	Distance between the cusp tips of right and left canines	4 years
Orthodontic treatment stability - Inter-molar width	Distance between the mesiobuccal cusp tips of the right and left first permanent molars	4 years
Orthodontic treatment stability - Overjet	The maximum distance between the upper incisors edge and the lower incisal labial surface	4 years
Orthodontic treatment stability - Overbite	The maximum vertical overlap between the upper and lower incisors with the models in maximal intercuspation	4 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retainer failure	Retainer failure identification, yes or no	4 years
Retainer failure identification time	Retainer failure identification duration, in number of days	4 years
Retainer problems - compliance	Retainer compliance measured with fit of retainer - space in mm between retainer and teeth	4 years
Oral Health Assessment - Cavity presence if any	Identification of cavities	4 years
Oral health assessment - Gingivitis if any	Identification of gingivitis	4 years
Patient satisfaction	Satisfaction with the 2 protocols of retention review using Likert scale questionnaires that have 5 answer options ranging from "strongly agree" to "strongly disagree". Different questions have positive/negative outcomes with either end of the scale.	4 years
Cost effectiveness	Total cost of both systems	4 years

Collaborators and Investigators

• Sponsor: Sydney Local Health District
• Investigators: Principal Investigator: Oyku Dalci, DDS, PhD, Sydney Local Health District, The University of Sydney

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): September 22, 2026

Study Registration Dates

• First Submitted: July 29, 2021
• First Submitted That Met QC Criteria: August 6, 2021
• First Posted (Actual): August 16, 2021

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Orthodontic retention; Orthodontic relapse; Dental monitoring; Remote monitoring; AI supported remote orthodontic monitoring
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Recurrence
• Other Study ID Numbers: X20-0358

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No