The Effectiveness of Electronic Reminders in Improving Elastic Compliance in Orthodontic Patients

NCT ID: NCT03144323

Last Updated: 2024-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-01

Study Completion Date

2025-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Malocclusion Compliance, Patient

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Study group

This group will receive 4 daily electronic reminders via the Calendar app on their mobile phones, reminding them to wear their elastics.

Group Type EXPERIMENTAL

Reminders

Intervention Type BEHAVIORAL

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.

Control group

This group will receive their orthodontic treatment and elastics instructions as normal, without reminders.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Reminders

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* Orthognathic surgery planned
* Craniofacial disorders
Minimum Eligible Age

10 Years

Maximum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

King's College Hospital NHS Trust

OTHER

Sponsor Role collaborator

Guy's and St Thomas' NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Dirk Bister

Role: STUDY_DIRECTOR

Guy's and St Thomas's Hospital NHS Foundation Trust

Jadbinder Seehra

Role: PRINCIPAL_INVESTIGATOR

King's College Hospital NHS Trust

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Guy's Hospital

London, , United Kingdom

Site Status RECRUITING

King's College Hospital

London, , United Kingdom

Site Status NOT_YET_RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Dirk Bister

Role: CONTACT

020 7188 4415

Jadbinder Seehra

Role: CONTACT

07334870265

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Dirk Bister

Role: primary

Catherine Liu

Role: backup

07443870265

Jadbinder Seehra

Role: primary

Catherine Liu

Role: backup

07443870265

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

209439

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.