Evaluation of Tailored Electronic Reminders on Compliance With Removable Orthodontic Retention

NCT ID: NCT03224481

Last Updated: 2025-04-30

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-02

Study Completion Date

2021-09-30

Brief Summary

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Participants will be recruited for inclusion at a routine adjustment appointment prior to planned removal of the appliances. Following removal of the appliances, consenting participants will be randomly allocated to one of two groups by computer-generated random allocation. Allocation will be concealed from the treating clinician using of an opaque sealed envelope system. Standard stone model records will be available for all participants following removal of the appliances (T0).

Participants in both groups will have follow-up scheduled for 3 (T1), 6 (T2) and 12 (T3) months following removal of the braces. All participants will be instructed to wear standard clear, plastic (Essix-type) retainers on a full-time basis for 6 months, followed by night-time wear for a further 6 months. A micro-electronic timer will be integrated within the upper Essix-type retainer. All participants will be given standard advice at each recall visit.

Participants in the intervention group will receive tailored electronic reminders in the form of a mobile application. The frequency and content of the reminders will be informed by qualitative interviews involving participants from an allied trial, and from posts related to orthodontic retainers shared on social media. Instructions on the necessary duration of retention, maintenance of retainers, departmental details, allied to advice on appropriate management for appliance breakages, and delineation of the implication of suboptimal retainer wear will be included. Also, information related the debond visit and maintenance of optimal oral hygiene levels will be incorporated in the mobile application. Participants in the control group will not receive additional reminders. Treating clinicians will be kept blind to the study group.

All patients failing an appointment will be sent another. Those wishing to withdraw from the trial may do so at any point without affecting continuing care with records taken at the point of withdrawal from the study with data analysis on an intention to treat basis.

Thereafter, patient experiences with electronic reminders will be evaluated on a subset of participants using one-to-one interviews.

Detailed Description

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Details related to the intervention:

Participants in the intervention group will receive access to the 'My Retainers' mobile application via a unique identification code. The researcher will demonstrate the use of the mobile application with a brief description of its features. Participants in the control group will not have access to the mobile application.

Conditions

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Retention Compliance Orthodontic Periodontal Health

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Receive electronic reminder

Participants in the intervention group will receive tailored electronic reminders. The frequency and content of the reminders will be informed by the qualitative findings of an ongoing trial, but are likely to include an intra-oral photograph taken pre-treatment and following removal of the active appliances, instructions on the necessary duration of retention, advice on maintenance of retainers, departmental details, advice on appropriate management for appliance breakages, and delineation of the implication of suboptimal retainer wear. Also, information related to the debond visit and maintenance of optimal oral hygiene levels will be incorporated in the mobile application.

Group Type EXPERIMENTAL

Electronic reminder

Intervention Type OTHER

The frequency and content of the reminders will be informed by the qualitative findings of an ongoing trial, but are likely to include an intra-oral photograph taken pre-treatment and following removal of the active appliances, instructions on the necessary duration of retention, advice on maintenance of retainers, departmental details, advice on appropriate management for appliance breakages, and delineation of the implication of suboptimal retainer wear. Also, information related to the debond visit and maintenance of optimal oral hygiene levels will be incorporated in the mobile application.

Control group

Participants in the control group will not receive additional reminders.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Electronic reminder

The frequency and content of the reminders will be informed by the qualitative findings of an ongoing trial, but are likely to include an intra-oral photograph taken pre-treatment and following removal of the active appliances, instructions on the necessary duration of retention, advice on maintenance of retainers, departmental details, advice on appropriate management for appliance breakages, and delineation of the implication of suboptimal retainer wear. Also, information related to the debond visit and maintenance of optimal oral hygiene levels will be incorporated in the mobile application.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Aged 12 to 21 years
* Planned for removable retention with Essix-type vacuum-formed retainers
* In the permanent dentition

Exclusion Criteria

* Inability to access or peruse electronic mail
* Cleft lip and palate and other craniofacial anomalies
Minimum Eligible Age

12 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Queen Mary University of London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Padhraig Fleming

Role: STUDY_CHAIR

Queen Mary University of London

Locations

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The Royal London Hospital Barts Health NHS Trust

London, , United Kingdom

Site Status

Countries

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United Kingdom

References

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Zhang X, Al-Moghrabi D, Pandis N, Shah S, Fleming PS. The effectiveness of a bespoke mobile application in improving adherence with removable orthodontic retention over 12 months: A randomized controlled trial. Am J Orthod Dentofacial Orthop. 2022 Mar;161(3):327-337. doi: 10.1016/j.ajodo.2021.09.010. Epub 2021 Nov 17.

Reference Type DERIVED
PMID: 34801348 (View on PubMed)

Al-Moghrabi D, Pandis N, McLaughlin K, Johal A, Donos N, Fleming PS. Evaluation of the effectiveness of a tailored mobile application in increasing the duration of wear of thermoplastic retainers: a randomized controlled trial. Eur J Orthod. 2020 Nov 3;42(5):571-579. doi: 10.1093/ejo/cjz088.

Reference Type DERIVED
PMID: 31799628 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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11153

Identifier Type: -

Identifier Source: org_study_id

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