Evaluation of Tailored Electronic Reminders on Compliance With Removable Orthodontic Retention

Compliance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03224481
• Other study ID #: 11153
• Status: Completed
• Phase: N/A
• Start date: March 2, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: February 2022
• Source: Queen Mary University of London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Compliance
• Orthodontic
• Periodontal Health
• Retention

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United Kingdom	The Royal London Hospital Barts Health NHS Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
Queen Mary University of London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Self-reported hours of retainer wear per day	Subjective levels of retainer wear as reported by participants using retainer wear chart	3 months - 6 months - 12 months
Secondary	Study model based outcomes	Stability of teeth following orthodontic treatment measured from study models (in millimetres)	3 months - 6 months - 12 months
Secondary	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)	Questionnaire	6 months
Secondary	Assessment of oral hygiene levels and periodontal outcomes including: plaque scores, bleeding on probing, and clinical attachment level	Clinical assessment	Baseline - 3 months - 6 months
Secondary	Knowledge with orthodontic retainers	Questionnaire	3 months
Secondary	Experience with orthodontic retainers	Questionnaire	3 months - 6 months
Secondary	Anxiety levels on the day of debond	Questionnaire	Baseline