Compliance Clinical Trial
Official title:
Evaluation of the Effect of Tailored Electronic Reminders on Compliance With Removable Orthodontic Retention: A Randomised Controlled Trial
NCT number | NCT03224481 |
Other study ID # | 11153 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 2, 2018 |
Est. completion date | December 31, 2020 |
Verified date | February 2022 |
Source | Queen Mary University of London |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | The Royal London Hospital Barts Health NHS Trust | London |
Lead Sponsor | Collaborator |
---|---|
Queen Mary University of London |
United Kingdom,
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 |
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