Comparison of Subjective Experiences Between Patients Receiving Clear Aligners or Fixed Appliances During the Initial Stage of Orthodontic Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 主要终点
- The chronological changes in pain perception
研究概览
简要总结
This study aimed to compare experiences between adult patients receiving clear aligners and fixed appliances during the initial stage of orthodontic treatments.
详细描述
Patients receiving either clear aligner treatments were enrolled in this study. During the same time period, patients receiving fixed orthodontic treatments well-matched with clear-aligner patients by similar ages (difference < 3 years), same gender and similar levels of severity of malocclusion [similar Index of Complexity Outcome and Need (ICON) level] were enrolled.The two groups were well-matched with ages, gender and levels of malocclusion severity. Pain perception, anxiety and quality of life were assessed through visual analogue scale (VAS), state-trait anxiety inventory (STAI) and oral health impact profile-14 (OHIP-14), respectively.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must be 18 years of age or older;
- •Must be in good general health;
- •Upper and lower arches were both involved in two groups;
- •The fixed appliances group must be treated with wires and brackets only with the initial arch wire of 0.012 NiTi ;
- •Must be willing to sign and give written informed consent in accordance with institutional and federal guidelines.
排除标准
- •Once been undergoing with orthodontic treatment;
- •Experienced tooth ache recently;
- •Been diagnosed with contagious and/or systematical diseases;
- •Have taken any kind of painkillers three days before the initial treatment;
- •When Trait Anxiety Inventory (T-AI) shows a score believed to define a psychological state of over anxiety (male over 53 points and female over 55 points).
结局指标
主要结局
The chronological changes in pain perception
时间窗: Baseline, Day 1, Day 2，Day 3，Day 4，Day 5，Day 6，Day 7,and Day 14
The chronological changes in pain perception during the fortnight of orthodontic treatment were assessed through visual analogue scale (VAS). Participant is asked to place a line perpendicular to the VAS line.The score is determined by measuring the distance (mm) on the 10-cm line between the "no pain"anchor and the patients' mask,providing a range of scores from 0-100. A higher score indicates greater pain.
次要结局
- The chronological changes of anxiety level(Baseline, Day 1,Day 3,Day 5,Day 7 and Day 14)
- The chronological changes in quality of life(Baseline,Day 1 ,Day 7 and Day 14)
研究者
Meiya Gao
Principal Investigator
West China Hospital