Orthodontic RelapseNCT05006339
The Use of Remote Monitoring for Orthodontic Retention Review
A study testing Dental Monitoring and Clinic Review in people with Orthodontic Relapse, run by Sydney Local Health District at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Orthodontic Relapse
- What is being tested?
- Dental Monitoring and Clinic Review
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteAustralia
- Study dates
- 1 Dec 2021to 22 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use of Remote Monitoring for Orthodontic Retention Review: A Randomised Controlled Trial
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.
Read the 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
- Being tested
- Dental Monitoring, Clinic Review
- Keywords
- Orthodontic retention, Orthodontic relapse, Dental monitoring, Remote monitoring, AI supported remote orthodontic monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental MonitoringDevice
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 ReviewOther
Patients in this arm are required to attend in clinic appointments for their retention review
| Study group | Role | What they receive |
|---|---|---|
| Dental Monitoring | Experimental | Orthodontic retention review via dental monitoring only Receives: Device: Dental Monitoring |
| Clinic Review | Active comparator | Orthodontic retention review via in-office visits as per routine care Receives: Other: Clinic Review |
What is being measured
The primary outcome is the main question the study is designed to answer.
Orthodontic treatment stability - Little's Irregularity Index
The sum of the linear displacements of five labial segment contact point in a labiolingual direction
Measured: 4 years
Orthodontic treatment stability - Spacing if present
The sum of the linear distances between contact points of teeth that have space between them
Measured: 4 years
Orthodontic treatment stability - Inter-canine width
Distance between the cusp tips of right and left canines
Measured: 4 years
Orthodontic treatment stability - Inter-molar width
Distance between the mesiobuccal cusp tips of the right and left first permanent molars
Measured: 4 years
Orthodontic treatment stability - Overjet
The maximum distance between the upper incisors edge and the lower incisal labial surface
Measured: 4 years
Orthodontic treatment stability - Overbite
The maximum vertical overlap between the upper and lower incisors with the models in maximal intercuspation
Measured: 4 years
Secondary outcomes (7)
Retainer failure
Retainer failure identification, yes or no
Measured: 4 years
Retainer failure identification time
Retainer failure identification duration, in number of days
Measured: 4 years
Retainer problems - compliance
Retainer compliance measured with fit of retainer - space in mm between retainer and teeth
Measured: 4 years
Oral Health Assessment - Cavity presence if any
Identification of cavities
Measured: 4 years
Oral health assessment - Gingivitis if any
Identification of gingivitis
Measured: 4 years
Patient satisfaction
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.
Measured: 4 years
Cost effectiveness
Total cost of both systems
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2021
- Study start1 Dec 2021
- Primary completion1 May 2026 (estimated)
- Study completion22 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthodontic RelapseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sydney Local Health District
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Oyku Dalci, DDS, PhD, Principal investigator, Sydney Local Health District, The University of Sydney
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05006339
- Sponsor's protocol ID
- X20-0358
- Status last verified
- May 2026
- First submitted
- 29 Jul 2021
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Remote Monitoring for Orthodontic Retention Review: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05006339
- Acronym / sponsor ID
- X20-0358
- Conditions
- Orthodontic Relapse
- Keywords
- Orthodontic retention, Orthodontic relapse, Dental monitoring, Remote monitoring, AI supported remote orthodontic monitoring
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Sydney Local Health DistrictOther government
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 22 Sep 2026 (estimated)
- First posted
- 16 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dental Monitoring | Experimental | Device: Dental MonitoringOrthodontic retention review via dental monitoring only |
| Clinic Review | Active comparator | Other: Clinic ReviewOrthodontic retention review via in-office visits as per routine care |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (6 listed)
- Patients with
- Patients that were treated with orthognathic surgery
- Patients that are unwilling or unable to follow the instructions provided
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dental MonitoringPatients 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. | Device | Dental Monitoring |
| Clinic ReviewPatients in this arm are required to attend in clinic appointments for their retention review | Other | Clinic Review |
Primary outcome
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 - 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 - Inter-canine width
Time frame: 4 years
Distance between the cusp tips of right and left canines
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 - 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
7 secondary outcomes
Retainer failure
Time frame: 4 years
Retainer failure identification time
Time frame: 4 years
Retainer problems - compliance
Time frame: 4 years
Oral Health Assessment - Cavity presence if any
Time frame: 4 years
Oral health assessment - Gingivitis if any
Time frame: 4 years
Patient satisfaction
Time frame: 4 years
Cost effectiveness
Time frame: 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Individual participant dataSharing planned: No
Related trials for Orthodontic Relapse
Not yet recruiting
3D-Printed vs Conventional Fixed Retainers After Orthodontic Treatment
Orthodontic Relapse, Malocclusion
Not yet recruiting
Effectiveness, Patient Acceptance, and Cost Estimation of 3D-printed Retainer Compared to Hawley Retainer in Expansion Case: a Randomized Controlled Trial
Orthodontic Relapse, Retention in Orthodontic
Recruiting
Effectiveness of Gold Fixed Retainers Compared to Conventional Stainless Steel Retainers
Orthodontic Retention Appliance, Orthodontic Relapse
Active, not recruiting
The Effectiveness of 3 Orthodontic Fixed Retention Schemes on Post-treatment Stability and Gingival Recession
Relapse, Orthodontic Retention
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oyku Dalci, DDS, PhD principal investigator
Sydney Local Health District, The University of Sydney
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dental Monitoring and Clinic Review in people with Orthodontic Relapse, run by Sydney Local Health District at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Orthodontic treatment stability - Little's Irregularity Index (time frame: 4 years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.