A Clinical Trial on the Use of a Commercial Available Tooth Positioner for the Treatment of Simple Orthodontic Relapse
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- The Little's Index
研究概览
简要总结
Orthodontic relapse occurs in almost 80% of Orthodontic Treatment. The only prevention to phenomenon is the use of fixed retainers or life time active retention. Unfortunately, patients do not comply and after a year of treatment, many stop wearing their retainers and Orthodontic relapse occurs.
The aim of this project is to prospectively analyze the treatment result of consecutive treated patients who have had active orthodontic relapse. 20 patients will be recruited through advertisement to the Department of Orthodontics at the University of Alabama at Birmingham (UAB). The sample will comprise of 20 patients with Class I malocclusions. The records to be collected will comprise of clinical pictures and pre and post study casts. The 3D study casts will be evaluated using the Little's Index. The results will be analyzed with the paired t-test and ANOVA, using the Statistical Analysis System (SAS/STAT®) software.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Permanent dentition
- •Class I malocclusion with crowding or spacing of less than 6 mm for mandibular or maxillary incisors, lower number 1's through 3's
- •Predicted compliance with device use, as determined by the investigator orthodontist
- •Good oral hygiene, as determined by the investigator orthodontist
- •At least average intelligence, as determined by investigator orthodontist
排除标准
- •Any medical or dental condition that in the opinion of the investigator could impact study results during the expected length of the study
- •Patient is currently using any investigational drug or any other investigational device
- •Patient plans to relocate or move within six months of enrollment
- •Allergic to acetaminophen (use of aspirin or non-steroidal anti-inflammatory drugs is excluded for patients while on the study)
- •Use of bisphosphonates, such as osteoporosis drugs, during the study
研究组 & 干预措施
Tooth positioner treatment group
The participants that meet the inclusion criteria will be treated with tooth positioner.
干预措施: Tooth positioner (Procedure)
结局指标
主要结局
The Little's Index
时间窗: Movement will be recorded by capturing the start and end point of the 6 anterior teeth before and at the completion of the treatment respectively. The duration of the treatment will be up to 10 months.
The Little's Index of Displacement score will be the primary clinical endpoint used to judge patient success (i.e., effectiveness).
次要结局
未报告次要终点
研究者
Chung How Kau
Professor and Chair
University of Alabama at Birmingham