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Completed

NCT Number: NCT03224481

Evaluation of Tailored Electronic Reminders on Compliance With Removable Orthodontic Retention

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.

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Key information

Conditions

Retention Behavior Compliance Health Behavior Orthodontic Patient Acceptance of Health Care Patient Compliance Periodontal Health Treatment Adherence and Compliance

Age range

12 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Royal London Hospital Barts Health NHS Trust

London, E1 1BB, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Electronic reminder

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.

Primary outcomes

  1. Wear of Removable Retainer Per Day (Hours) in the Intervention and the Control Groups

    Time frame: 3 months - 6 months - 12 months

    Objective levels of retainer wear will be recorded from an integrated micro-electronic sensor in the retainer

Secondary outcomes

  1. Self-reported Hours of Retainer Wear Per Day

    Time frame: 3 months - 6 months - 12 months

    Subjective levels of retainer wear as reported by participants using retainer wear chart

  2. Study Model Based Outcomes

    Time frame: 3 months - 6 months - 12 months

    Stability of teeth following orthodontic treatment measured from study models (in millimetres)

  3. Patients' Experience With Electronic Reminders in a Related Qualitative Element (Positive and Negative Experiences, in Addition to Feedback From Participants in Relation to Tailored Electronic Reminders Based on One-to-one Interviews)

    Time frame: 6 months

    Questionnaire

  4. Assessment of Oral Hygiene Levels and Periodontal Outcomes Including: Plaque Scores, Bleeding on Probing, and Clinical Attachment Level

    Time frame: Baseline - 3 months - 6 months

    Clinical assessment

  5. Knowledge With Orthodontic Retainers

    Time frame: 3 months

    Questionnaire

  6. Experience With Orthodontic Retainers

    Time frame: 3 months - 6 months

    Questionnaire

  7. Anxiety Levels on the Day of Debond

    Time frame: Baseline

    Questionnaire

Sponsors and collaborators

Lead sponsor

Queen Mary University of London

Other

Registry information

Official study title

Evaluation of the Effect of Tailored Electronic Reminders on Compliance With Removable Orthodontic Retention: A Randomised Controlled Trial

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Jul 21, 2017
Registry last updated
Apr 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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