Clinical trial NCT05006339: The Use of Remote Monitoring for Orthodontic Retention Review
Official title: The Use of Remote Monitoring for Orthodontic Retention Review: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Orthodontic Relapse
Keywords: Orthodontic retention
Orthodontic relapse
Dental monitoring
Remote monitoring
AI supported remote orthodontic monitoring
Lead sponsor: Sydney Local Health District
Sponsor class: OTHER_GOV
First posted: 2021-08-16
Enrollment: 82
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Orthodontic treatment stability - Little's Irregularity Index
timeFrame: 4 years
measure: Orthodontic treatment stability - Spacing if present
timeFrame: 4 years
measure: Orthodontic treatment stability - Inter-canine width
timeFrame: 4 years
measure: Orthodontic treatment stability - Inter-molar width
timeFrame: 4 years
measure: Orthodontic treatment stability - Overjet
timeFrame: 4 years
measure: Orthodontic treatment stability - Overbite
timeFrame: 4 years
Secondary outcomes:
measure: Retainer failure
timeFrame: 4 years
measure: Retainer failure identification time
timeFrame: 4 years
measure: Retainer problems - compliance
timeFrame: 4 years
measure: Oral Health Assessment - Cavity presence if any
timeFrame: 4 years
measure: Oral health assessment - Gingivitis if any
timeFrame: 4 years
measure: Patient satisfaction
timeFrame: 4 years
measure: Cost effectiveness
timeFrame: 4 years
Other outcomes:
Locations:
city: Surry Hills
country: Australia
facility: Sydney Dental Hospital
state: New South Wales
Study officials:
affiliation: Sydney Local Health District, The University of Sydney
name: Oyku Dalci, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References: