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The Use of Remote Monitoring for Orthodontic Retention Review

Primary Purpose

Orthodontic Relapse

Status
Recruiting
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Dental Monitoring
Clinic Review
Sponsored by
Sydney Local Health District
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Orthodontic Relapse focused on measuring Orthodontic retention, Orthodontic relapse, Dental monitoring, Remote monitoring, AI supported remote orthodontic monitoring

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Sydney Dental HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dental Monitoring

Clinic Review

Arm Description

Orthodontic retention review via dental monitoring only

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

Outcomes

Primary Outcome Measures

Orthodontic treatment stability - Little's Irregularity Index
The sum of the linear displacements of five labial segment contact point in a labiolingual direction
Orthodontic treatment stability - Spacing if present
The sum of the linear distances between contact points of teeth that have space between them
Orthodontic treatment stability - Inter-canine width
Distance between the cusp tips of right and left canines
Orthodontic treatment stability - Inter-molar width
Distance between the mesiobuccal cusp tips of the right and left first permanent molars
Orthodontic treatment stability - Overjet
The maximum distance between the upper incisors edge and the lower incisal labial surface
Orthodontic treatment stability - Overbite
The maximum vertical overlap between the upper and lower incisors with the models in maximal intercuspation

Secondary Outcome Measures

Retainer failure
Retainer failure identification, yes or no
Retainer failure identification time
Retainer failure identification duration, in number of days
Retainer problems - compliance
Retainer compliance measured with fit of retainer - space in mm between retainer and teeth
Oral Health Assessment - Cavity presence if any
Identification of cavities
Oral health assessment - Gingivitis if any
Identification of gingivitis
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.
Cost effectiveness
Total cost of both systems

Full Information

First Posted
July 29, 2021
Last Updated
May 22, 2023
Sponsor
Sydney Local Health District
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1. Study Identification

Unique Protocol Identification Number
NCT05006339
Brief Title
The Use of Remote Monitoring for Orthodontic Retention Review
Official Title
The Use of Remote Monitoring for Orthodontic Retention Review: A Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
September 22, 2023 (Anticipated)
Study Completion Date
September 22, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sydney Local Health District

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Orthodontic Relapse
Keywords
Orthodontic retention, Orthodontic relapse, Dental monitoring, Remote monitoring, AI supported remote orthodontic monitoring

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
82 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dental Monitoring
Arm Type
Experimental
Arm Description
Orthodontic retention review via dental monitoring only
Arm Title
Clinic Review
Arm Type
Active Comparator
Arm Description
Orthodontic retention review via in-office visits as per routine care
Intervention Type
Device
Intervention Name(s)
Dental Monitoring
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Clinic Review
Intervention Description
Patients in this arm are required to attend in clinic appointments for their retention review
Primary Outcome Measure Information:
Title
Orthodontic treatment stability - Little's Irregularity Index
Description
The sum of the linear displacements of five labial segment contact point in a labiolingual direction
Time Frame
4 years
Title
Orthodontic treatment stability - Spacing if present
Description
The sum of the linear distances between contact points of teeth that have space between them
Time Frame
4 years
Title
Orthodontic treatment stability - Inter-canine width
Description
Distance between the cusp tips of right and left canines
Time Frame
4 years
Title
Orthodontic treatment stability - Inter-molar width
Description
Distance between the mesiobuccal cusp tips of the right and left first permanent molars
Time Frame
4 years
Title
Orthodontic treatment stability - Overjet
Description
The maximum distance between the upper incisors edge and the lower incisal labial surface
Time Frame
4 years
Title
Orthodontic treatment stability - Overbite
Description
The maximum vertical overlap between the upper and lower incisors with the models in maximal intercuspation
Time Frame
4 years
Secondary Outcome Measure Information:
Title
Retainer failure
Description
Retainer failure identification, yes or no
Time Frame
4 years
Title
Retainer failure identification time
Description
Retainer failure identification duration, in number of days
Time Frame
4 years
Title
Retainer problems - compliance
Description
Retainer compliance measured with fit of retainer - space in mm between retainer and teeth
Time Frame
4 years
Title
Oral Health Assessment - Cavity presence if any
Description
Identification of cavities
Time Frame
4 years
Title
Oral health assessment - Gingivitis if any
Description
Identification of gingivitis
Time Frame
4 years
Title
Patient satisfaction
Description
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.
Time Frame
4 years
Title
Cost effectiveness
Description
Total cost of both systems
Time Frame
4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Oyku Dalci, DDS, PhD
Phone
+61293518328
Email
oyku.dalci@sydney.edu.au
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oyku Dalci, DDS, PhD
Organizational Affiliation
Sydney Local Health District, The University of Sydney
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sydney Dental Hospital
City
Surry Hills
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oyku Dalci, DDS, PhD
Phone
+61293518328
Email
Oyku.dalci@sydney.edu.au

12. IPD Sharing Statement

Plan to Share IPD
No

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The Use of Remote Monitoring for Orthodontic Retention Review

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