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

NCT03144323 | Unknown

• 1 other identifier: 209439
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Malocclusion; Compliance, Patient

Keywords

Intraoral elastics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Patient's self-reported duration of time spent wearing intraoral elastics

  6 weeks and 12 weeks

• Change in participant's jaw relationship, measured on mm scale by difference in overbite, overjet and molar relationship

  Baseline, 6 weeks, and 12 weeks

• Clinician-perceived level of compliance of the participant at each appointment, using discrete qualitative scale

  Baseline, 6 weeks, and 12 weeks

Study Arms (2)

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.

Behavioral: Reminders

Control group

NO INTERVENTION

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

Interventions

Reminders 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.

Study group

Eligibility Criteria

• Age: 10 Years - 20 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Orthognathic surgery planned
• Craniofacial disorders

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead
• King's College Hospital NHS Trust: collaborator

Study Sites (2)

Guy's Hospital

London, United Kingdom

RECRUITING

King's College Hospital

London, United Kingdom

NOT YET RECRUITING

MeSH Terms

Conditions

Malocclusion; Patient Compliance

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Dirk Bister

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

  STUDY DIRECTOR

• Jadbinder Seehra

  King's College Hospital NHS Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dirk Bister

CONTACT

020 7188 4415; dirk.bister@kcl.ac.uk

Jadbinder Seehra

CONTACT

07334870265; jadbinder.seehra@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2017
• First Posted: May 8, 2017
• Study Start: July 1, 2017
• Primary Completion: October 1, 2024
• Study Completion: September 30, 2025
• Last Updated: March 12, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)