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临床试验/NCT05006339
NCT05006339进行中(未招募)不适用

The Use of Remote Monitoring for Orthodontic Retention Review: A Randomised Controlled Trial

Sydney Local Health District2 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2021年12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
进行中(未招募)
入组人数
82
试验地点
2
主要终点
Orthodontic treatment stability - Inter-molar width

研究概览

简要总结

To assess whether using retainers and an artificial intelligence supported remote monitoring system maintains a more stable orthodontic treatment result than using retainers with in-office review appointments.

详细描述

The amount and nature of relapse are unpredictable and natural changes in the dentition are life-long. Although some patients were shown to remain stable despite not wearing retainers, research is unable to provide predictors for identifying those patients and therefore we have to treat all patients as if they have the potential to relapse long term.

Following the results of long-term retrospective studies, there has been a gradual change of practice from prescribing retainers for 1-2 years to long-term retention. This is a significant burden on patients, clinicians and the health system as long term review and maintenance of retainers are required from both parties.

Although some studies showed compliance with the use of orthodontic retainers correlated with factors such as gender, age and type of retainer, one of the main reasons for non-compliance with removable retainers was shown to be just forgetting to wear them. Patient compliance is also needed in attending follow-up appointments for review of fit and intactness of retainers as well as calculus build-up that may be present around fixed lingual wires.

Long term review is also needed to protect patients from any side effects from broken or distorted fixed retainers. This is not common, yet when it happens its side effects can be deleterious. Since patients do not always realise these side effects on time, damage may range from simple malalignment of teeth to having roots of teeth come out of bone creating periodontal and aesthetic consequences.

Attending review appointments could be inconvenient for both patients and parents as they need to take time off of school and work.

研究设计

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

入排标准

年龄范围
12 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Consent to participate in the trial and comply with the retention regime and able to follow instructions
  • Permanent dentition
  • Good general health
  • Good oral hygiene and good periodontal health
  • Owning or having access to a mobile/smart phone compatible with Dental monitoring application (DM app is available for use on all iOS and Android devices)

排除标准

  • Patients with
  • Congenital anomalies or craniofacial syndromes
  • Poor oral hygiene and poor periodontal health
  • Missing teeth & teeth with poor enamel quality
  • Patients that were treated with orthognathic surgery
  • Patients that are unwilling or unable to follow the instructions provided

研究组 & 干预措施

Dental Monitoring

Experimental

Orthodontic retention review via dental monitoring only

干预措施: Dental Monitoring (Device)

Clinic Review

Active Comparator

Orthodontic retention review via in-office visits as per routine care

干预措施: Clinic Review (Other)

结局指标

主要结局

Orthodontic treatment stability - Inter-molar width

时间窗: 4 years

Distance between the mesiobuccal cusp tips of the right and left first permanent molars

Orthodontic treatment stability - Little's Irregularity Index

时间窗: 4 years

The sum of the linear displacements of five labial segment contact point in a labiolingual direction

Orthodontic treatment stability - Inter-canine width

时间窗: 4 years

Distance between the cusp tips of right and left canines

Orthodontic treatment stability - Spacing if present

时间窗: 4 years

The sum of the linear distances between contact points of teeth that have space between them

Orthodontic treatment stability - Overjet

时间窗: 4 years

The maximum distance between the upper incisors edge and the lower incisal labial surface

Orthodontic treatment stability - Overbite

时间窗: 4 years

The maximum vertical overlap between the upper and lower incisors with the models in maximal intercuspation

次要结局

  • Oral Health Assessment - Cavity presence if any(4 years)
  • Cost effectiveness(4 years)
  • Retainer problems - compliance(4 years)
  • Oral health assessment - Gingivitis if any(4 years)
  • Retainer failure identification time(4 years)
  • Retainer failure(4 years)
  • Patient satisfaction(4 years)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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