Retention, Compliance, Orthodontic, Periodontal Health
Conditions
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.
Interventions
OTHERElectronic 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.
Sponsors
Queen Mary University of London
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 21 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wear of Removable Retainer Per Day (Hours) in the Intervention and the Control Groups | 3 months - 6 months - 12 months | Objective levels of retainer wear will be recorded from an integrated micro-electronic sensor in the retainer |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Study Model Based Outcomes | 3 months - 6 months - 12 months | Stability of teeth following orthodontic treatment measured from study models (in millimetres) |
| 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 | Questionnaire |
| Assessment of Oral Hygiene Levels and Periodontal Outcomes Including: Plaque Scores, Bleeding on Probing, and Clinical Attachment Level | Baseline - 3 months - 6 months | Clinical assessment |
| Self-reported Hours of Retainer Wear Per Day | 3 months - 6 months - 12 months | Subjective levels of retainer wear as reported by participants using retainer wear chart |
| Experience With Orthodontic Retainers | 3 months - 6 months | Questionnaire |
| Anxiety Levels on the Day of Debond | Baseline | Questionnaire |
| Knowledge With Orthodontic Retainers | 3 months | Questionnaire |
Countries
United Kingdom
Participant flow
Pre-assignment details
Events that occurred after enrollment, but prior to assignment of participants to the treatment groups: failure to collect retainers (n= 2); mobile application did not work (n= 1); and sensor deactivated in error (n= 1).
Participants by arm
| Arm | Count |
|---|---|
| Receive Electronic Reminder 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.
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. | 42 |
| Control Group Participants in the control group will not receive additional reminders. | 42 |
| Total | 84 |
Baseline characteristics
| Characteristic | Control Group | Total | Receive Electronic Reminder |
|---|---|---|---|
| Age, Continuous | 17.2 years STANDARD_DEVIATION 1.89 | 17.23 years STANDARD_DEVIATION 1.9 | 17.24 years STANDARD_DEVIATION 2 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United Kingdom | 42 participants | 84 participants | 42 participants |
| Sex: Female, Male Female | 21 Participants | 42 Participants | 21 Participants |
| Sex: Female, Male Male | 21 Participants | 42 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 29 | 0 / 25 |
| other Total, other adverse events | 0 / 29 | 0 / 25 |
| serious Total, serious adverse events | 0 / 29 | 0 / 25 |
Outcome results
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
Time frame: 3 months - 6 months - 12 months
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Receive Electronic Reminder | Wear of Removable Retainer Per Day (Hours) in the Intervention and the Control Groups | 3.09 hours/day | Standard Error 8.1 |
| Control Group | Wear of Removable Retainer Per Day (Hours) in the Intervention and the Control Groups | 1.44 hours/day | Standard Error 9.22 |
Secondary
Anxiety Levels on the Day of Debond
Questionnaire
Time frame: Baseline
Secondary
Assessment of Oral Hygiene Levels and Periodontal Outcomes Including: Plaque Scores, Bleeding on Probing, and Clinical Attachment Level
Clinical assessment
Time frame: Baseline - 3 months - 6 months
Secondary
Experience With Orthodontic Retainers
Questionnaire
Time frame: 3 months - 6 months
Secondary
Knowledge With Orthodontic Retainers
Questionnaire
Time frame: 3 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
Time frame: 6 months
Secondary
Self-reported Hours of Retainer Wear Per Day
Subjective levels of retainer wear as reported by participants using retainer wear chart
Time frame: 3 months - 6 months - 12 months
Secondary
Study Model Based Outcomes
Stability of teeth following orthodontic treatment measured from study models (in millimetres)
Time frame: 3 months - 6 months - 12 months