Clinical trial NCT03224481: Evaluation of Tailored Electronic Reminders on Compliance With Removable Orthodontic Retention
Official title: Evaluation of the Effect of Tailored Electronic Reminders on Compliance With Removable Orthodontic Retention: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Retention
Compliance
Orthodontic
Periodontal Health
Lead sponsor: Queen Mary University of London
Sponsor class: OTHER
First posted: 2017-07-21
Enrollment: 84
Sex: ALL
Minimum age (years): 12
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Wear of Removable Retainer Per Day (Hours) in the Intervention and the Control Groups
timeFrame: 3 months - 6 months - 12 months
Secondary outcomes:
measure: Self-reported Hours of Retainer Wear Per Day
timeFrame: 3 months - 6 months - 12 months
measure: Study Model Based Outcomes
timeFrame: 3 months - 6 months - 12 months
measure: 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)
timeFrame: 6 months
measure: Assessment of Oral Hygiene Levels and Periodontal Outcomes Including: Plaque Scores, Bleeding on Probing, and Clinical Attachment Level
timeFrame: Baseline - 3 months - 6 months
measure: Knowledge With Orthodontic Retainers
timeFrame: 3 months
measure: Experience With Orthodontic Retainers
timeFrame: 3 months - 6 months
measure: Anxiety Levels on the Day of Debond
timeFrame: Baseline
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: The Royal London Hospital Barts Health NHS Trust
Study officials:
affiliation: Queen Mary University of London
name: Padhraig Fleming
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.