NCT05006339

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 Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2021

Completed
18 days until next milestone

First Posted

Study publicly available on registry

August 16, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

December 1, 2021

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 22, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 22, 2025

Completed
Last Updated

May 17, 2024

Status Verified

May 1, 2024

Enrollment Period

3.8 years

First QC Date

July 29, 2021

Last Update Submit

May 16, 2024

Conditions

Orthodontic Relapse

Keywords

Orthodontic retentionOrthodontic relapseDental monitoringRemote monitoringAI supported remote orthodontic monitoring

Outcome Measures

Primary Outcomes (6)

  • Orthodontic treatment stability - Little's Irregularity Index

    The sum of the linear displacements of five labial segment contact point in a labiolingual direction

    4 years

  • Orthodontic treatment stability - Spacing if present

    The sum of the linear distances between contact points of teeth that have space between them

    4 years

  • Orthodontic treatment stability - Inter-canine width

    Distance between the cusp tips of right and left canines

    4 years

  • Orthodontic treatment stability - Inter-molar width

    Distance between the mesiobuccal cusp tips of the right and left first permanent molars

    4 years

  • Orthodontic treatment stability - Overjet

    The maximum distance between the upper incisors edge and the lower incisal labial surface

    4 years

  • Orthodontic treatment stability - Overbite

    The maximum vertical overlap between the upper and lower incisors with the models in maximal intercuspation

    4 years

Secondary Outcomes (7)

  • Retainer failure

    4 years

  • Retainer failure identification time

    4 years

  • Retainer problems - compliance

    4 years

  • Oral Health Assessment - Cavity presence if any

    4 years

  • Oral health assessment - Gingivitis if any

    4 years

  • +2 more secondary outcomes

Study Arms (2)

Dental Monitoring

EXPERIMENTAL

Orthodontic retention review via dental monitoring only

Device: Dental Monitoring

Clinic Review

ACTIVE COMPARATOR

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

Other: Clinic Review

Interventions

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.

Dental Monitoring
Clinic ReviewOTHER

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

Clinic Review

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sydney Dental Hospital

Surry Hills, New South Wales, 2010, Australia

RECRUITING

Study Officials

  • Oyku Dalci, DDS, PhD

    Sydney Local Health District, The University of Sydney

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Oyku Dalci, DDS, PhD

CONTACT

+61293518328oyku.dalci@sydney.edu.au

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2021

First Posted

August 16, 2021

Study Start

December 1, 2021

Primary Completion

September 22, 2025

Study Completion

September 22, 2025

Last Updated

May 17, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)