Evaluation of Tailored Electronic Reminders on Compliance With Removable Orthodontic Retention

NCT03224481 | Completed Results DMC

• 1 other identifier: 11153
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Retention; Compliance; Orthodontic; Periodontal Health

Outcome Measures

Primary Outcomes (1)

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

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

  3 months - 6 months - 12 months

Secondary Outcomes (7)

• Self-reported Hours of Retainer Wear Per Day

  3 months - 6 months - 12 months

• Study Model Based Outcomes

  3 months - 6 months - 12 months

• 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)

  6 months

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

  Baseline - 3 months - 6 months

• Knowledge With Orthodontic Retainers

  3 months

Study Arms (2)

Receive electronic reminder

EXPERIMENTAL

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.

Other: Electronic reminder

Control group

NO INTERVENTION

Participants in the control group will not receive additional reminders.

Interventions

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.

Receive electronic reminder

Eligibility Criteria

• Age: 12 Years - 21 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Inability to access or peruse electronic mail
• Cleft lip and palate and other craniofacial anomalies

Sponsors & Collaborators

• Queen Mary University of London: lead

Study Sites (1)

The Royal London Hospital Barts Health NHS Trust

London, E1 1BB, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 34801348 DERIVED

• 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.

  PMID: 31799628 DERIVED

MeSH Terms

Conditions

Patient Compliance

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Results Point of Contact

• Title: Professor Padhraig Fleming
• Organization: Queen Mary University of London

padhraig.fleming@qmul.ac.uk

02073777397

Study Officials

• Padhraig Fleming

  Queen Mary University of London

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2016
• First Posted: July 21, 2017
• Study Start: March 2, 2018
• Primary Completion: December 31, 2020
• Study Completion: September 30, 2021
• Last Updated: April 30, 2025
• Results First Posted: April 30, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)