Analysis of Orthodontic Tooth Movement Using 3D Imaging
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 4
- 主要终点
- Change in Little's Index From Baseline to 6 Weeks
研究概览
简要总结
Purpose: This project aims to study the effects of wire dimension and ligation method (bracket type) on the first stage of orthodontic treatment using 3D imaging.
Participants: Up to 80 patients at UNC School of Dentistry or Selden Orthodontics between the ages of 10 and 45, inclusive, who have been previously diagnosed with malocclusion requiring orthodontic treatment (braces) and are otherwise healthy.
Procedures (methods): Subjects receiving standard of care (SOC) orthodontic treatment will be randomized to one of two commonly used orthodontic archwires (.014" or .016" diameter). Subjects will be further subdivided for analysis based on the type of bracket (twin or self-ligating) that their clinician uses in their treatment. We will review the 3D digital images of each subject's dentition recorded as part of SOC at the 0-, 6- and 12-week visits. We will retrieve the archwires when they are removed per SOC by the clinician at the 12-week time point.
详细描述
Many archwire dimensions and two main bracket types (twin and self-ligating) are available to orthodontists for the first stage of orthodontic treatment, but little objective clinical evidence is available to indicate which archwire dimension and bracket type is ideal for a given patient with an individual type and degree of malalignment during this stage. A limited clinical trial will be conducted to collect and analyze this data.
The aim of this study is to study the effect of wire dimension, timing and ligation method on leveling and aligning in orthodontic treatment using 3D imaging.
The study's specific aims are as follows:
-
To analyze the effect of wire dimension (.014" vs. .016") and time-course (first six weeks or second six weeks) on Stage I treatment
-
To correlate clinical tooth movements with bench data for four types of malalignment
-
In-out
-
Rotation
-
Tip
-
Vertical step
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To analyze the effect of ligation method (twin vs. self-ligating) on Stage I treatment
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Neither subjects nor the treating orthodontists will know whether a .014" or 0.16" dimension wire is being used. The investigator will assign wire dimensions using a random number generator and distribute the wires to the treating orthodontists with the archwire dimension number removed from the package. The outcomes assessor will be blinded as to which patients were treated with which archwires while analyzing the digital models of the teeth.
Because there is a clear visual difference between twin and self-ligating brackets, there will be no blinding with regard to ligation method (bracket type).
入排标准
- 年龄范围
- 10 Years 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •In the initial stage of active treatment at the University of North Carolina graduate orthodontic clinic or Selden Orthodontics
- •Non-extraction treatment
- •Maxillary and mandibular Little Index between 1-15 mm (this is a measurement of crowding)
- •Presence of all permanent anterior teeth
- •Age 10-45 years
- •Consent to participate in the study
排除标准
- •Systemic diseases such as diabetes, hypertension, temporomandibular disorders (TMD), craniofacial syndrome, etc.
- •Any spacing between anterior teeth
- •Subjects who have incisor mandibular plane angle (IMPA) greater than or equal to 100 degrees
- •Anterior tooth completely blocked from the arch form
- •Periodontal pocketing of any teeth greater than 4 mm
- •Maxillary and mandibular Little Index >15 mm (This is a measurement of crowding. A Little Index of >15 mm indicates a need for a smaller dimension arch wire)
结局指标
主要结局
Change in Little's Index From Baseline to 6 Weeks
时间窗: Baseline and 6 weeks
Little's Index measures the distance between contact points on adjacent teeth. Little's Index will be measured at two time points (0 weeks and 6 weeks).
Change in Little's Index From 6 Weeks to 12 Weeks
时间窗: 6 weeks and 12 weeks
Little's Index measures the distance between contact points on adjacent teeth. Little's Index will be measured at two time points (6 weeks and 12 weeks).
次要结局
- Linear Change in Tooth Position From Baseline to 6 Weeks (Translation)(Baseline and 6 weeks)
- Linear Change in Tooth Position From 6 Weeks to 12 Weeks (Translation)(6 weeks and 12 weeks)
- Angular Change in Tooth Position From Baseline to 6 Weeks (Rotation)(Baseline and 6 weeks)
- Angular Change in Tooth Position From 6 Weeks to 12 Weeks (Rotation)(6 weeks and 12 weeks)
- Correlation Between Degrees of Malalignment and Rate of Tooth Movement(Baseline and 12 weeks)