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临床试验/NCT03144323
NCT03144323招募中不适用

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

Guy's and St Thomas' NHS Foundation Trust2 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2017年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
128
试验地点
2
主要终点
Change in number of elastics used and collected by the participant

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
10 Years 至 20 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Orthognathic surgery planned
  • Craniofacial disorders

研究组 & 干预措施

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.

干预措施: Reminders (Behavioral)

Control group

No Intervention

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

结局指标

主要结局

Change in number of elastics used and collected by the participant

时间窗: 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.

次要结局

  • 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)
  • Patient's self-reported duration of time spent wearing intraoral elastics(6 weeks and 12 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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