The Use of Remote Monitoring for Orthodontic Retention Review: A Randomised Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Sydney Local Health District
- Enrollment
- 82
- Locations
- 2
- Primary Endpoint
- Orthodontic treatment stability - Inter-molar width
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 12 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Dental Monitoring
Orthodontic retention review via dental monitoring only
Intervention: Dental Monitoring (Device)
Clinic Review
Orthodontic retention review via in-office visits as per routine care
Intervention: Clinic Review (Other)
Outcomes
Primary Outcomes
Orthodontic treatment stability - Inter-molar width
Time Frame: 4 years
Distance between the mesiobuccal cusp tips of the right and left first permanent molars
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
Orthodontic treatment stability - Inter-canine width
Time Frame: 4 years
Distance between the cusp tips of right and left canines
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
Orthodontic treatment stability - Overjet
Time Frame: 4 years
The maximum distance between the upper incisors edge and the lower incisal labial surface
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
- Oral Health Assessment - Cavity presence if any(4 years)
- Cost effectiveness(4 years)
- Retainer problems - compliance(4 years)
- Oral health assessment - Gingivitis if any(4 years)
- Retainer failure identification time(4 years)
- Retainer failure(4 years)
- Patient satisfaction(4 years)