Clinical trial NCT03144323: The Effectiveness of Electronic Reminders in Improving Elastic Compliance in Orthodontic Patients
Official title: The Effectiveness of Electronic Reminders in Improving Intra-oral Elastic Compliance in Orthodontic Patients: A Randomised Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Malocclusion
Compliance, Patient
Keywords: Intraoral elastics
Lead sponsor: Guy's and St Thomas' NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: King's College Hospital NHS Trust
First posted: 2017-05-08
Enrollment: 128
Sex: ALL
Minimum age (years): 10
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Eligibility 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

Primary outcomes:
measure: Change in number of elastics used and collected by the participant
timeFrame: 6 weeks, 12 weeks
Secondary outcomes:
measure: Patient's self-reported duration of time spent wearing intraoral elastics
timeFrame: 6 weeks and 12 weeks
measure: Change in participant's jaw relationship, measured on mm scale by difference in overbite, overjet and molar relationship
timeFrame: Baseline, 6 weeks, and 12 weeks
measure: Clinician-perceived level of compliance of the participant at each appointment, using discrete qualitative scale
timeFrame: Baseline, 6 weeks, and 12 weeks
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Guy's Hospital
city: London
country: United Kingdom
facility: King's College Hospital
Study officials:
affiliation: Guy's and St Thomas's Hospital NHS Foundation Trust
name: Dirk Bister
role: STUDY_DIRECTOR
affiliation: King's College Hospital NHS Trust
name: Jadbinder Seehra
role: PRINCIPAL_INVESTIGATOR
References: