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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05006339
Registration number
NCT05006339
Ethics application status
Date submitted
29/07/2021
Date registered
16/08/2021
Titles & IDs
Public title
The Use of Remote Monitoring for Orthodontic Retention Review
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Scientific title
The Use of Remote Monitoring for Orthodontic Retention Review: A Randomised Controlled Trial
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Secondary ID [1]
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X20-0358
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Orthodontic Relapse
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Condition category
Condition code
Other
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Research that is not of generic health relevance and not applicable to specific health categories listed above
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Devices
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Orthodontic treatment stability - Little's Irregularity Index
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Assessment method [1]
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The sum of the linear displacements of five labial segment contact point in a labiolingual direction
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Timepoint [1]
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4 years
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Primary outcome [2]
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Orthodontic treatment stability - Spacing if present
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Assessment method [2]
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The sum of the linear distances between contact points of teeth that have space between them
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Timepoint [2]
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4 years
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Primary outcome [3]
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Orthodontic treatment stability - Inter-canine width
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Assessment method [3]
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Distance between the cusp tips of right and left canines
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Timepoint [3]
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4 years
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Primary outcome [4]
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Orthodontic treatment stability - Inter-molar width
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Assessment method [4]
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Distance between the mesiobuccal cusp tips of the right and left first permanent molars
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Timepoint [4]
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4 years
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Primary outcome [5]
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Orthodontic treatment stability - Overjet
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Assessment method [5]
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The maximum distance between the upper incisors edge and the lower incisal labial surface
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Timepoint [5]
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4 years
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Primary outcome [6]
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Orthodontic treatment stability - Overbite
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Assessment method [6]
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The maximum vertical overlap between the upper and lower incisors with the models in maximal intercuspation
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Timepoint [6]
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4 years
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Secondary outcome [1]
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Retainer failure
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Assessment method [1]
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Retainer failure identification, yes or no
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Timepoint [1]
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4 years
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Secondary outcome [2]
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Retainer failure identification time
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Assessment method [2]
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Retainer failure identification duration, in number of days
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Timepoint [2]
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4 years
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Secondary outcome [3]
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Retainer problems - compliance
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Assessment method [3]
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Retainer compliance measured with fit of retainer - space in mm between retainer and teeth
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Timepoint [3]
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4 years
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Secondary outcome [4]
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Oral Health Assessment - Cavity presence if any
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Assessment method [4]
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Identification of cavities
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Timepoint [4]
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4 years
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Secondary outcome [5]
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Oral health assessment - Gingivitis if any
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Assessment method [5]
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Identification of gingivitis
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Timepoint [5]
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4 years
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Secondary outcome [6]
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Patient satisfaction
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Assessment method [6]
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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.
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Timepoint [6]
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4 years
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Secondary outcome [7]
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Cost effectiveness
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Assessment method [7]
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Total cost of both systems
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Timepoint [7]
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4 years
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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)
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Minimum age
12
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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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
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/12/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
22/09/2025
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Actual
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Sample size
Target
82
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Sydney Dental Hospital - Surry Hills
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Recruitment postcode(s) [1]
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2010 - Surry Hills
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Funding & Sponsors
Primary sponsor type
Government body
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Name
Sydney Local Health District
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Address
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Country
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/study/NCT05006339
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Oyku Dalci, DDS, PhD
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Address
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Sydney Local Health District, The University of Sydney
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Oyku Dalci, DDS, PhD
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Address
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Country
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Phone
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+61293518328
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05006339