Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05006339




Registration number
NCT05006339
Ethics application status
Date submitted
29/07/2021
Date registered
16/08/2021
Date last updated
17/05/2024

Titles & IDs
Public title
The Use of Remote Monitoring for Orthodontic Retention Review
Scientific title
The Use of Remote Monitoring for Orthodontic Retention Review: A Randomised Controlled Trial
Secondary ID [1] 0 0
X20-0358
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Orthodontic Relapse 0 0
Condition category
Condition code
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Dental Monitoring
Other interventions - Clinic Review

Experimental: Dental Monitoring - Orthodontic retention review via dental monitoring only

Active Comparator: Clinic Review - Orthodontic retention review via in-office visits as per routine care


Treatment: Devices: 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.

Other interventions: Clinic Review
Patients in this arm are required to attend in clinic appointments for their retention review
Intervention code [1] 0 0
Treatment: Devices
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Orthodontic treatment stability - Little's Irregularity Index
Timepoint [1] 0 0
4 years
Primary outcome [2] 0 0
Orthodontic treatment stability - Spacing if present
Timepoint [2] 0 0
4 years
Primary outcome [3] 0 0
Orthodontic treatment stability - Inter-canine width
Timepoint [3] 0 0
4 years
Primary outcome [4] 0 0
Orthodontic treatment stability - Inter-molar width
Timepoint [4] 0 0
4 years
Primary outcome [5] 0 0
Orthodontic treatment stability - Overjet
Timepoint [5] 0 0
4 years
Primary outcome [6] 0 0
Orthodontic treatment stability - Overbite
Timepoint [6] 0 0
4 years
Secondary outcome [1] 0 0
Retainer failure
Timepoint [1] 0 0
4 years
Secondary outcome [2] 0 0
Retainer failure identification time
Timepoint [2] 0 0
4 years
Secondary outcome [3] 0 0
Retainer problems - compliance
Timepoint [3] 0 0
4 years
Secondary outcome [4] 0 0
Oral Health Assessment - Cavity presence if any
Timepoint [4] 0 0
4 years
Secondary outcome [5] 0 0
Oral health assessment - Gingivitis if any
Timepoint [5] 0 0
4 years
Secondary outcome [6] 0 0
Patient satisfaction
Timepoint [6] 0 0
4 years
Secondary outcome [7] 0 0
Cost effectiveness
Timepoint [7] 0 0
4 years

Eligibility
Key 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)
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
22/09/2025
Actual
Sample size
Target
82
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Sydney Dental Hospital - Surry Hills
Recruitment postcode(s) [1] 0 0
2010 - Surry Hills

Funding & Sponsors
Primary sponsor type
Other
Name
Sydney Local Health District
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05006339
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Oyku Dalci, DDS, PhD
Address 0 0
Sydney Local Health District, The University of Sydney
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Oyku Dalci, DDS, PhD
Address 0 0
Country 0 0
Phone 0 0
+61293518328
Fax 0 0
Email 0 0
oyku.dalci@sydney.edu.au
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05006339