Alignment and Discomfort Using Non-Sliding Lingual Orthodontic Technique (BRIUS) and Conventional Bracket Systems: A Single-Center Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Overall 3D Movement
研究概览
简要总结
The purpose of this study is to compare the Full Fixed Preadjusted appliances (regular braces) when to the BRIUS system.
详细描述
This is a randomized controlled trial which aims to identify the effectiveness of alignment in the BRIUS group when compared to the full fixed appliance group.
The secondary aim of the study is to identify any difference in discomfort experienced by the patients when undergoing treatment using the two appliances
The investigators also aim to quantify the extent of tooth movement that is achieved through each appliance within a given time frame
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •10 to 18 years old
- •Angle Class I and Cl II (up to half cusp) molar and canine relationship.
- •Fully erupted permanent dentition (excluding third molars).
- •Crowding of 7 mm or less.
- •Must be able to maintain good oral hygiene assessed by the orthodontist during their visits.
排除标准
- •Previous history of orthodontic treatment or orthognathic surgery
- •Subjects who require extractions or orthognathic surgery
- •Multiple missed appointments
- •Deteriorating oral hygiene and craniofacial syndromes or disorders
- •Severe gag reflex resulting from the use of intra-oral scanners
结局指标
主要结局
Overall 3D Movement
时间窗: 18 weeks
absoluate measurement of extent of movement of teeth
Little's Irregularity Index
时间窗: 18 weeks
Little's irregularity index. The index measures the alignment discrepancy in the five contact points of the lower anterior region in millimeteres. The minimum score is zero and the maximum is 10 or above. The greater the score the worse the outcome
Discomfort
时间窗: 18 weeks
Online survey will evaluate discomfort arising from the orthodontic brackets between patients in the two groups. A visual analog scale from 0-10 millimeter will be applied. The greater the score the worse the discomfort level.
次要结局
未报告次要终点
研究者
Mohammed H Al-Zainal
Orthodontic Resident
State University of New York at Buffalo