A Prospective Clinical Trial on the Outcomes of Invisalign First Palatal Expander
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- molar inclination
研究概览
简要总结
Malocclusions with narrow upper arches are usually treated in the mixed dentition with a traditional bonded maxillary expander. Most recently, a new design of a removable expander by Align was brought to our attention. In this prospective clinical study, the investigators will compare the patient-reported treatment outcomes and the dental-skeletal treatment effects on palatal dimensions. With this study, the investigators will have a better understanding of this newly developed appliance and its application in early orthodontic treatment.
详细描述
Purpose:
This prospective study is aimed to investigate the patient-reported treatment outcomes and the dental-skeletal treatment effects on palatal dimensions and to compare them with those of traditional maxillary expansion.
Hypothesis:
The null hypothesis will be:
- 1: There are no differences in the inter-canine, inter-molar width, and molar inclination between IFPE and RME groups.
- 2: There are no differences in the arch width, length, size and shape, palatal surface area and volume, plaque index, and white spot lesion formation between IFPE and RME groups.
- 3: There are no differences in patients' experience of perceived pain intensity and discomfort during the first two weeks of treatment between IFPE and RME groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients in mixed dentition with 6 present on both Right and Left in the upper arch
- •Patients with transverse maxillary deficiency (presence of unilateral or bilateral crossbite, or intermolar width (as measured where the palatal groove meets the gingival margin of the first molar) of 33 mm or less)
排除标准
- •multiple and/or advanced caries,
- •missing teeth due to aplasia, trauma, or deep caries,
- •supernumerary teeth,
- •congenital craniofacial malformations or congenital or acquired systematic disease,
- •previous orthodontic treatment
结局指标
主要结局
molar inclination
时间窗: one year
measured by using Rhino3D v5.0 software in degrees
noncavitated carious lesions
时间窗: one year
The buccal surfaces of the maxillary molars will be assessed for noncavitated carious lesions (white spot lesions) using the International Caries Detection and Assessment System (ICDAS) index. The higher the score the worse condition: 0 Sound 1. First visual change in enamel (seen only after prolonged air drying or restricted to the confines of a pit or fissure) 2. Distinct visual change in enamel 3. Localized enamel breakdown (without clinical visual signs of dentinal involvement) 4. Underlying dark shadow from dentin 5. Distinct cavity with visible dentin 6. Extensive distinct cavity with visible dentin
volume
时间窗: one year
measured by using Rhino3D v5.0 software in millimeters cubed
Plaque
时间窗: one year
Plaque index was assessed using color-based plaque staining. 0 - no visible plaque, 1-plaque visible only by scraping on the denture base with a blunt instrument, 2-moderate accumulation of visible plaque, and 3-abundance of plaque. By summing up the scores from the five areas, the plaque was recorded on a scale from 0 to 15 points.
inter-canine, inter-molar, and palatal width
时间窗: one year
measured by using Rhino3D v5.0 software in millimeters
Qualitative measurements from questionnaire- level of pain and discomfort
时间窗: one year
VAS = visual analogue scale, ranges from minimum score 0% (extremely uncomfortable) to 100% (very comfortable). Higher score is good (comfortable).
surface area
时间窗: one year
measured by using Rhino3D v5.0 software in millimeters squared
次要结局
未报告次要终点
研究者
Bingshuang Zou
Principal Investigator
University of British Columbia