The Use of Remote Monitoring for Orthodontic Retention Review

NCT ID: NCT05006339

Last Updated: 2024-05-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-01
• Study Completion Date: 2025-09-22

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.

Conditions

Orthodontic Relapse

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Dental Monitoring

Orthodontic retention review via dental monitoring only

Group Type: EXPERIMENTAL

Dental Monitoring

Intervention Type: 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

Orthodontic retention review via in-office visits as per routine care

Group Type: ACTIVE_COMPARATOR

Clinic Review

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: DEVICE

Clinic Review

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sydney Local Health District

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Oyku Dalci, DDS, PhD

Role: PRINCIPAL_INVESTIGATOR

Sydney Local Health District, The University of Sydney

Locations

Sydney Dental Hospital

Surry Hills, New South Wales, Australia

Site Status: RECRUITING

Countries

Australia

Central Contacts

Oyku Dalci, DDS, PhD

Role: CONTACT

oyku.dalci@sydney.edu.au

+61293518328

Facility Contacts

Oyku Dalci, DDS, PhD

Role: primary

Oyku.dalci@sydney.edu.au

+61293518328

Other Identifiers

X20-0358

Identifier Type: -

Identifier Source: org_study_id