The Use of Remote Monitoring for Orthodontic Retention Review

RECRUITING

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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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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
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    Eligibility

    Age eligible for study : 12 and older

    Healthy volunteers accepted : Yes

    Gender eligible for study: All

    Things to know

    Study dates

    Study start: 2021-12-01

    Primary completion: 2025-09-22

    Study completion finish: 2025-09-22

    study type

    Study type

    PREVENTION

    phase

    Phase

      NA

    trial

    Trial ID

    NCT05006339

    Intervention or treatment

    DEVICE: Dental Monitoring

    OTHER: Clinic Review

    Conditions

    • Orthodontic Relapse

    Find a site

    Closest Location:

    Sydney Dental Hospital

    Research sites nearby

    Select from list below to view details:

    • Sydney Dental Hospital

      Surry Hills, New South Wales, Australia

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    Study Plan

    This section provides details of the study plan, including how the study is designed and what the study is measuring.

    How is the study designed?

    Participant Group/ArmIntervention/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

    Primary Outcome MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    Orthodontic treatment stability - Little's Irregularity IndexThe sum of the linear displacements of five labial segment contact point in a labiolingual direction4 years
    Orthodontic treatment stability - Spacing if presentThe sum of the linear distances between contact points of teeth that have space between them4 years
    Orthodontic treatment stability - Inter-canine widthDistance between the cusp tips of right and left canines4 years
    Orthodontic treatment stability - Inter-molar widthDistance between the mesiobuccal cusp tips of the right and left first permanent molars4 years
    Orthodontic treatment stability - OverjetThe maximum distance between the upper incisors edge and the lower incisal labial surface4 years
    Orthodontic treatment stability - OverbiteThe maximum vertical overlap between the upper and lower incisors with the models in maximal intercuspation4 years

    Secondary outcome

    Secondary Outcome MeasureSecondary Outcome DescriptionSecondary Outcome Time Frame
    Retainer failureRetainer failure identification, yes or no4 years
    Retainer failure identification timeRetainer failure identification duration, in number of days4 years
    Retainer problems - complianceRetainer compliance measured with fit of retainer - space in mm between retainer and teeth4 years
    Oral Health Assessment - Cavity presence if anyIdentification of cavities4 years
    Oral health assessment - Gingivitis if anyIdentification of gingivitis4 years
    Patient satisfactionSatisfaction 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 effectivenessTotal cost of both systems4 years

    Frequently Asked Questions

    Please note: some questions and answers are submitted by anonymous patients or using AI, and have not been verified by Clinrol

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    References

    Clinical Trials Gov: The Use of Remote Monitoring for Orthodontic Retention Review

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