Evaluation of the Effect of Tailored Electronic Reminders on Compliance With Removable Orthodontic Retention: A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Wear of Removable Retainer Per Day (Hours) in the Intervention and the Control Groups
研究概览
简要总结
Participants will be recruited for inclusion at a routine adjustment appointment prior to planned removal of the appliances. Following removal of the appliances, consenting participants will be randomly allocated to one of two groups by computer-generated random allocation. Allocation will be concealed from the treating clinician using of an opaque sealed envelope system. Standard stone model records will be available for all participants following removal of the appliances (T0).
Participants in both groups will have follow-up scheduled for 3 (T1), 6 (T2) and 12 (T3) months following removal of the braces. All participants will be instructed to wear standard clear, plastic (Essix-type) retainers on a full-time basis for 6 months, followed by night-time wear for a further 6 months. A micro-electronic timer will be integrated within the upper Essix-type retainer. All participants will be given standard advice at each recall visit.
Participants in the intervention group will receive tailored electronic reminders in the form of a mobile application. The frequency and content of the reminders will be informed by qualitative interviews involving participants from an allied trial, and from posts related to orthodontic retainers shared on social media. Instructions on the necessary duration of retention, maintenance of retainers, departmental details, allied to advice on appropriate management for appliance breakages, and delineation of the implication of suboptimal retainer wear will be included. Also, information related the debond visit and maintenance of optimal oral hygiene levels will be incorporated in the mobile application. Participants in the control group will not receive additional reminders. Treating clinicians will be kept blind to the study group.
All patients failing an appointment will be sent another. Those wishing to withdraw from the trial may do so at any point without affecting continuing care with records taken at the point of withdrawal from the study with data analysis on an intention to treat basis.
Thereafter, patient experiences with electronic reminders will be evaluated on a subset of participants using one-to-one interviews.
详细描述
Details related to the intervention:
Participants in the intervention group will receive access to the 'My Retainers' mobile application via a unique identification code. The researcher will demonstrate the use of the mobile application with a brief description of its features. Participants in the control group will not have access to the mobile application.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 12 to 21 years
- •Planned for removable retention with Essix-type vacuum-formed retainers
- •In the permanent dentition
排除标准
- •Inability to access or peruse electronic mail
- •Cleft lip and palate and other craniofacial anomalies
结局指标
主要结局
Wear of Removable Retainer Per Day (Hours) in the Intervention and the Control Groups
时间窗: 3 months - 6 months - 12 months
Objective levels of retainer wear will be recorded from an integrated micro-electronic sensor in the retainer
次要结局
- Study Model Based Outcomes(3 months - 6 months - 12 months)
- Self-reported Hours of Retainer Wear Per Day(3 months - 6 months - 12 months)
- Patients' Experience With Electronic Reminders in a Related Qualitative Element (Positive and Negative Experiences, in Addition to Feedback From Participants in Relation to Tailored Electronic Reminders Based on One-to-one Interviews)(6 months)
- Assessment of Oral Hygiene Levels and Periodontal Outcomes Including: Plaque Scores, Bleeding on Probing, and Clinical Attachment Level(Baseline - 3 months - 6 months)
- Knowledge With Orthodontic Retainers(3 months)
- Experience With Orthodontic Retainers(3 months - 6 months)
- Anxiety Levels on the Day of Debond(Baseline)