RetentionNCT03224481
Evaluation of Tailored Electronic Reminders on Compliance With Removable Orthodontic Retention
A study testing Electronic reminder in people with Retention and Compliance, run by Queen Mary University of London at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 12 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Retention, Compliance, Orthodontic
- What is being tested?
- Electronic reminder
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Mar 2018to 30 Sep 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Aged 12 to 21 years
- Planned for removable retention with Essix-type vacuum-formed retainers
- In the permanent dentition
Who cannot join
- Inability to access or peruse electronic mail
- Cleft lip and palate and other craniofacial anomalies
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Royal London Hospital Barts Health NHS Trust
London, E1 1BB
About this study
Official title: Evaluation of the Effect of Tailored Electronic Reminders on Compliance With Removable Orthodontic Retention: A Randomised Controlled Trial
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.
Read more
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.
Read the 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.
- Conditions
- Retention, Compliance, Orthodontic, Periodontal Health
- Being tested
- Electronic reminder
- Medical subject headings
- Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic reminderOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Electronic reminder |
| Control group | No intervention | Participants in the control group will not receive additional reminders. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months - 6 months - 12 months
Secondary outcomes (7)
Self-reported Hours of Retainer Wear Per Day
Subjective levels of retainer wear as reported by participants using retainer wear chart
Measured: 3 months - 6 months - 12 months
Study Model Based Outcomes
Stability of teeth following orthodontic treatment measured from study models (in millimetres)
Measured: 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)
Questionnaire
Measured: 6 months
Assessment of Oral Hygiene Levels and Periodontal Outcomes Including: Plaque Scores, Bleeding on Probing, and Clinical Attachment Level
Clinical assessment
Measured: Baseline - 3 months - 6 months
Knowledge With Orthodontic Retainers
Questionnaire
Measured: 3 months
Experience With Orthodontic Retainers
Questionnaire
Measured: 3 months - 6 months
Anxiety Levels on the Day of Debond
Questionnaire
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start2 Mar 2018
- Primary completion31 Dec 2020
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for RetentionStudies of the same condition, open and under way.
- More trials run by Queen Mary University of LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Padhraig Fleming, Study chair, Queen Mary University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03224481
- Sponsor's protocol ID
- 11153
- Status last verified
- Apr 2025
- First submitted
- 24 Oct 2016
- Last updated
- 30 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be freely available to reviewers in future and may be made available on a public database
Publications
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.
PubMed 34801348Al-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.
PubMed 31799628
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Tailored Electronic Reminders on Compliance With Removable Orthodontic Retention: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03224481
- Acronym / sponsor ID
- 11153
- Conditions
- Retention, Compliance, Orthodontic, Periodontal Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Study start
- 2 Mar 2018 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 21 Jul 2017 (actual)
- Results
- Posted 30 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Receive electronic reminder | Experimental | Other: Electronic reminderParticipants 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. |
| Control group | No intervention | –Participants in the control group will not receive additional reminders. |
Who may qualify
- Ages
- 12 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Aged 12 to 21 years
- Planned for removable retention with Essix-type vacuum-formed retainers
- In the permanent dentition
Key exclusion criteria (2 listed)
- Inability to access or peruse electronic mail
- Cleft lip and palate and other craniofacial anomalies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electronic reminderThe 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 | Receive electronic reminder |
Primary outcome
Wear of Removable Retainer Per Day (Hours) in the Intervention and the Control Groups
Time frame: 3 months - 6 months - 12 months
Objective levels of retainer wear will be recorded from an integrated micro-electronic sensor in the retainer
7 secondary outcomes
Self-reported Hours of Retainer Wear Per Day
Time frame: 3 months - 6 months - 12 months
Study Model Based Outcomes
Time frame: 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)
Time frame: 6 months
Assessment of Oral Hygiene Levels and Periodontal Outcomes Including: Plaque Scores, Bleeding on Probing, and Clinical Attachment Level
Time frame: Baseline - 3 months - 6 months
Knowledge With Orthodontic Retainers
Time frame: 3 months
Experience With Orthodontic Retainers
Time frame: 3 months - 6 months
Anxiety Levels on the Day of Debond
Time frame: Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34801348Zhang 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.
- Derived from this study: PubMed 31799628Al-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.
- Individual participant dataSharing planned: Yes. Data will be freely available to reviewers in future and may be made available on a public database
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Padhraig Fleming study chair
Queen Mary University of London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electronic reminder in people with Retention and Compliance, run by Queen Mary University of London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wear of Removable Retainer Per Day (Hours) in the Intervention and the Control Groups (time frame: 3 months - 6 months - 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03224481, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2025.