ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03144323
Recruitment Status : Recruiting
First Posted : May 8, 2017
Last Update Posted : August 2, 2017
Sponsor:
Collaborator:
King's College Hospital NHS Trust
Information provided by (Responsible Party):
Guy's and St Thomas' NHS Foundation Trust

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.


Condition or disease Intervention/treatment Phase
Malocclusion Compliance, Patient Behavioral: Reminders Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: The Effectiveness of Electronic Reminders in Improving Intra-oral Elastic Compliance in Orthodontic Patients: A Randomised Clinical Trial
Actual Study Start Date : July 1, 2017
Estimated Primary Completion Date : July 30, 2018
Estimated Study Completion Date : July 30, 2018

Arm Intervention/treatment
Experimental: Study group
This group will receive 4 daily electronic reminders via the Calendar app on their mobile phones, reminding them to wear their elastics.
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.

No Intervention: Control group
This group will receive their orthodontic treatment and elastics instructions as normal, without reminders.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Patient's self-reported duration of time spent wearing intraoral elastics [ Time Frame: 6 weeks and 12 weeks ]
    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

  2. 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 ]
    Clinicians will record these occlusal measurements at each appointment

  3. Clinician-perceived level of compliance of the participant at each appointment, using discrete qualitative scale [ Time Frame: Baseline, 6 weeks, and 12 weeks ]
    Clinicians will record whether they think the patient has been highly, somewhat, or not at all compliant



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   10 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03144323


Contacts
Contact: Dirk Bister 020 7188 4415 dirk.bister@kcl.ac.uk
Contact: Jadbinder Seehra 07334870265 jadbinder.seehra@nhs.net

Locations
United Kingdom
Guy's Hospital Recruiting
London, United Kingdom
Contact: Dirk Bister       dirk.bister@kcl.ac.uk   
Contact: Catherine Liu    07443870265    catherine.liu@kcl.ac.uk   
King's College Hospital Not yet recruiting
London, United Kingdom
Contact: Jadbinder Seehra       jadbinder.seehra@nhs.net   
Contact: Catherine Liu    07443870265    catherine.liu@kcl.ac.uk   
Dentalcare Langley Not yet recruiting
Slough, United Kingdom
Contact: Jadbinder Seehra       jadbinder.seehra@nhs.net   
Sponsors and Collaborators
Guy's and St Thomas' NHS Foundation Trust
King's College Hospital NHS Trust
Investigators
Study Director: Dirk Bister Guy's and St Thomas's Hospital NHS Foundation Trust
Principal Investigator: Jadbinder Seehra King's College Hospital NHS Trust

Responsible Party: Guy's and St Thomas' NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03144323     History of Changes
Other Study ID Numbers: 209439
First Posted: May 8, 2017    Key Record Dates
Last Update Posted: August 2, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Guy's and St Thomas' NHS Foundation Trust:
Intraoral elastics

Additional relevant MeSH terms:
Malocclusion
Tooth Diseases
Stomatognathic Diseases