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

Malocclusion Clinical Trial

Official title:

The Effectiveness of Electronic Reminders in Improving Intra-oral Elastic Compliance in Orthodontic Patients: A Randomised Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03144323
• Other study ID #: 209439
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2017
• Est. completion date: September 30, 2025

Study information

• Verified date: October 2023
• Source: Guy's and St Thomas' NHS Foundation Trust
• Contact: Dirk Bister
• Phone: 020 7188 4415
• Email: dirk.bister[@]kcl.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 128
• Est. completion date: September 30, 2025
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 20 Years

Eligibility

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

Related Conditions & MeSH terms

• Compliance, Patient
• Malocclusion

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United Kingdom	Guy's Hospital	London
United Kingdom	King's College Hospital	London

Sponsors (2)

Lead Sponsor	Collaborator
Guy's and St Thomas' NHS Foundation Trust	King's College Hospital NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 weeks, 12 weeks
Secondary	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	6 weeks and 12 weeks
Secondary	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	Baseline, 6 weeks, and 12 weeks
Secondary	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	Baseline, 6 weeks, and 12 weeks