MalocclusionNCT03144323
The Effectiveness of Electronic Reminders in Improving Elastic Compliance in Orthodontic Patients
A study testing Reminders in people with Malocclusion and Compliance, Patient, run by Guy's and St Thomas' NHS Foundation Trust at 2 sites in United Kingdom.
Trial summary
Fixed orthodontic appliances in combination with intraoral elastics are a common and effective method use in the orthodontic correction of malocclusions. However, their success is largely dependent on the patient's compliance. Read more about this study
- Who is it for?
- Ages 10 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Malocclusion, Compliance, Patient
- What is being tested?
- Reminders
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 1 Jul 2017to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 10 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Full fixed appliances with intraoral class II elastics full-time
- Wearing class II elastics for between 6 weeks \& 3 months
- Have smartphone with calendar-type app
Who cannot join
- Orthognathic surgery planned
- Craniofacial disorders
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites, 2 recruiting
- Recruiting
Guy's Hospital
London
Dirk Bister, dirk.bister@kcl.ac.uk
Catherine Liu, 07443870265, catherine.liu@kcl.ac.uk
- Not yet recruiting
King's College Hospital
London
Jadbinder Seehra, jadbinder.seehra@nhs.net
Catherine Liu, 07443870265, catherine.liu@kcl.ac.uk
About this study
Official title: The Effectiveness of Electronic Reminders in Improving Intra-oral Elastic Compliance in Orthodontic Patients: A Randomised Clinical Trial
Fixed orthodontic appliances in combination with intraoral elastics are a common and effective method use in the orthodontic correction of malocclusions. However, their success is largely dependent on the patient's compliance. Failure to wear the elastics as instructed will reduce efficacy of treatment, ultimately increasing treatment time and potentially producing imperfect alignment of teeth.
The hypothesis tested is that daily electronic reminders via a mobile application can significantly increase patient compliance, thus effectively improving treatment outcomes.
Read the detailed description
Despite advancements in various aspects of orthodontic treatment, patient compliance remains a critical factor in attaining a successful treatment outcome. More specifically, patient compliance in the use of intraoral elastics is an important component of the treatment plan of certain patients. Failure to wear elastics as directed will ultimately result in increased treatment time, and imperfect alignment of the teeth.
Persuading adolescent orthodontic patients to wear intraoral elastics consistently is difficult in the short appointment times of a typical practice. Studies have shown that adolescents respond at a higher level to a more constant form of communication, as well as a method more closely associated with their generation. As smartphones have become an everyday appliance for most of the general public, mobile applications (apps) have the capability to serve as an effective avenue for communication between doctor and patient. Recent studies in both dentistry and medicine have reported that active reminders via mobile phone improve appointment attendance, adherence to medication schedules, and positive behaviour changes.
The investigators will utilise the "Calendar" app to communicate via daily reminders with patients undergoing orthodontic treatment with fixed appliances and Class II intraoral elastics, and they will measure the improvement in the malocclusion. This will allow study of whether or not electronic reminders can significantly increase compliance.
As more apps are developed, this communication method may have the potential to greatly impact the way orthodontists and patients interact outside of the office. If effective, these apps could become a cornerstone of the compliance efforts of many orthodontic practices. This would benefit both the orthodontist and the patient, as it would decrease time and money spent for both parties as well as reduce the overall sense of frustration felt during extended orthodontic treatment.
- Conditions
- Malocclusion, Compliance, Patient
- Being tested
- Reminders
- Keywords
- Intraoral elastics
- Medical subject headings
- Malocclusion, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemindersBehavioural
Four reminders will be set on the patient's mobile phone's Calendar-type app, saying "Don't forget to wear your elastics", at 08:00, 13:00, 17:00 and 22:00.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | This group will receive 4 daily electronic reminders via the Calendar app on their mobile phones, reminding them to wear their elastics. Receives: Behavioral: Reminders |
| Control group | No intervention | This group will receive their orthodontic treatment and elastics instructions as normal, without reminders. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in number of elastics used and collected by the participant
Participants from both arms will collect their used elastics in a plastic bag provided, which will be collected at each recall appointment and counted.
Measured: 6 weeks, 12 weeks
Secondary outcomes (3)
Patient's self-reported duration of time spent wearing intraoral elastics
Participants will fill out duration journals between appointments, on which they tick boxes to record how many hours a day they have worn their elastics
Measured: 6 weeks and 12 weeks
Change in participant's jaw relationship, measured on mm scale by difference in overbite, overjet and molar relationship
Clinicians will record these occlusal measurements at each appointment
Measured: Baseline, 6 weeks, and 12 weeks
Clinician-perceived level of compliance of the participant at each appointment, using discrete qualitative scale
Clinicians will record whether they think the patient has been highly, somewhat, or not at all compliant
Measured: Baseline, 6 weeks, and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2017
- Study start1 Jul 2017
- Primary completion1 Oct 2024 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalocclusionStudies of the same condition, open and under way.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- King's College Hospital NHS Trust
- Responsible party
- Sponsor
- Investigators
- Dirk Bister, Study director, Guy's and St Thomas's Hospital NHS Foundation TrustJadbinder Seehra, Principal investigator, King's College Hospital NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03144323
- Sponsor's protocol ID
- 209439
- Status last verified
- Oct 2023
- First submitted
- 30 Jan 2017
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Electronic Reminders in Improving Intra-oral Elastic Compliance in Orthodontic Patients: A Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT03144323
- Acronym / sponsor ID
- 209439
- Conditions
- Malocclusion, Compliance, Patient
- Keywords
- Intraoral elastics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Collaborators
- King's College Hospital NHS Trust
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 8 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Fixed orthodontic appliances in combination with intraoral elastics are a common and effective method use in the orthodontic correction of malocclusions. However, their success is largely dependent on the patient's compliance. Failure to wear the elastics as instructed will reduce efficacy of treatment, ultimately increasing treatment time and potentially producing imperfect alignment of teeth.
The hypothesis tested is that daily electronic reminders via a mobile application can significantly increase patient compliance, thus effectively improving treatment outcomes.
Detailed description
Despite advancements in various aspects of orthodontic treatment, patient compliance remains a critical factor in attaining a successful treatment outcome. More specifically, patient compliance in the use of intraoral elastics is an important component of the treatment plan of certain patients. Failure to wear elastics as directed will ultimately result in increased treatment time, and imperfect alignment of the teeth.
Persuading adolescent orthodontic patients to wear intraoral elastics consistently is difficult in the short appointment times of a typical practice. Studies have shown that adolescents respond at a higher level to a more constant form of communication, as well as a method more closely associated with their generation. As smartphones have become an everyday appliance for most of the general public, mobile applications (apps) have the capability to serve as an effective avenue for communication between doctor and patient. Recent studies in both dentistry and medicine have reported that active reminders via mobile phone improve appointment attendance, adherence to medication schedules, and positive behaviour changes.
The investigators will utilise the "Calendar" app to communicate via daily reminders with patients undergoing orthodontic treatment with fixed appliances and Class II intraoral elastics, and they will measure the improvement in the malocclusion. This will allow study of whether or not electronic reminders can significantly increase compliance.
As more apps are developed, this communication method may have the potential to greatly impact the way orthodontists and patients interact outside of the office. If effective, these apps could become a cornerstone of the compliance efforts of many orthodontic practices. This would benefit both the orthodontist and the patient, as it would decrease time and money spent for both parties as well as reduce the overall sense of frustration felt during extended orthodontic treatment.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Behavioral: RemindersThis group will receive 4 daily electronic reminders via the Calendar app on their mobile phones, reminding them to wear their elastics. |
| Control group | No intervention | –This group will receive their orthodontic treatment and elastics instructions as normal, without reminders. |
Who may qualify
- Ages
- 10 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Full fixed appliances with intraoral class II elastics full-time
- Wearing class II elastics for between 6 weeks \& 3 months
- Have smartphone with calendar-type app
Key exclusion criteria (2 listed)
- Orthognathic surgery planned
- Craniofacial disorders
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 |
|---|---|---|
| RemindersFour reminders will be set on the patient's mobile phone's Calendar-type app, saying "Don't forget to wear your elastics", at 08:00, 13:00, 17:00 and 22:00. | Behavioural | Study group |
Primary outcome
Change in number of elastics used and collected by the participant
Time frame: 6 weeks, 12 weeks
Participants from both arms will collect their used elastics in a plastic bag provided, which will be collected at each recall appointment and counted.
3 secondary outcomes
Patient's self-reported duration of time spent wearing intraoral elastics
Time frame: 6 weeks and 12 weeks
Change in participant's jaw relationship, measured on mm scale by difference in overbite, overjet and molar relationship
Time frame: Baseline, 6 weeks, and 12 weeks
Clinician-perceived level of compliance of the participant at each appointment, using discrete qualitative scale
Time frame: Baseline, 6 weeks, and 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Individual participant dataSharing planned: No
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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.
Dirk Bister study director
Guy's and St Thomas's Hospital NHS Foundation Trust
Jadbinder Seehra principal investigator
King's College Hospital NHS Trust
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reminders in people with Malocclusion and Compliance, Patient, run by Guy's and St Thomas' NHS Foundation Trust at 2 sites 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: status not confirmed, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dirk Bister (020 7188 4415, dirk.bister@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in number of elastics used and collected by the participant (time frame: 6 weeks, 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Mar 2024.