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NCT Number: NCT05006339

The Use of Remote Monitoring for Orthodontic Retention Review

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sydney Dental Hospital

Surry Hills, New South Wales, 2010, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dental Monitoring

Device

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.

Clinic Review

Other

Patients in this arm are required to attend in clinic appointments for their retention review

Primary outcomes

  1. Orthodontic treatment stability - Little's Irregularity Index

    Time frame: 4 years

    The sum of the linear displacements of five labial segment contact point in a labiolingual direction

  2. Orthodontic treatment stability - Spacing if present

    Time frame: 4 years

    The sum of the linear distances between contact points of teeth that have space between them

  3. Orthodontic treatment stability - Inter-canine width

    Time frame: 4 years

    Distance between the cusp tips of right and left canines

  4. Orthodontic treatment stability - Inter-molar width

    Time frame: 4 years

    Distance between the mesiobuccal cusp tips of the right and left first permanent molars

  5. Orthodontic treatment stability - Overjet

    Time frame: 4 years

    The maximum distance between the upper incisors edge and the lower incisal labial surface

  6. Orthodontic treatment stability - Overbite

    Time frame: 4 years

    The maximum vertical overlap between the upper and lower incisors with the models in maximal intercuspation

Secondary outcomes

  1. Retainer failure

    Time frame: 4 years

    Retainer failure identification, yes or no

  2. Retainer failure identification time

    Time frame: 4 years

    Retainer failure identification duration, in number of days

  3. Retainer problems - compliance

    Time frame: 4 years

    Retainer compliance measured with fit of retainer - space in mm between retainer and teeth

  4. Oral Health Assessment - Cavity presence if any

    Time frame: 4 years

    Identification of cavities

  5. Oral health assessment - Gingivitis if any

    Time frame: 4 years

    Identification of gingivitis

  6. Patient satisfaction

    Time frame: 4 years

    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.

  7. Cost effectiveness

    Time frame: 4 years

    Total cost of both systems

Sponsors and collaborators

Lead sponsor

Sydney Local Health District

Other Gov

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Aug 16, 2021
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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