Comparison of Self-reported and Experimental Pain Outcomes Between Clear Aligners and Fixed Appliances in Patients Undergoing Orthodontic Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Self-reported pain intensity
研究概览
简要总结
Pressure Pain Threshold (PPT) is defined as the minimum force applied to an area that is perceived as pain. PPT is considered an objective measurement tool to assess pain levels. Studies have assessed the difference in pain levels between clear aligners and fixed appliances using subjective pain scales. No study has utilized PPT to evaluate the difference in pain between aligners and fixed braces at different time points. This study will aim to compare the self- reported and experimental pain perception between the clear aligner and fixed appliance therapies during the phase of crown alignment and to assess how long pain is perceived in the following five days from the adjustment of the appliance.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •consecutive consented patients (> 14 years old) beginning an orthodontic treatment on both arches, either with aligners or fixed appliance at the Midwestern University, Multidisciplinary Clinic;
- •patients in possession of an email address and Internet connection.
排除标准
- •patients with generalized systemic conditions known to affect the overall body pain and pressure pain threshold assessment (e.g., fibromyalgia, autoimmune conditions such as multiple sclerosis, rheumatoid arthritis),
- •untreated dental caries.
结局指标
主要结局
Self-reported pain intensity
时间窗: At three timepoints through study completion: at baseline, at 4-6 weeks, and at 8-12 weeks
Self-reported pain will be assessed using a Visual Analogue Scale with anchors from 0 (=no pain) to 10 (=worst imaginable pain)
Pressure Pain Threshold
时间窗: At three timepoints through study completion: at baseline, at 4-6 weeks, and at 8-12 weeks
Pressure Pain Threshold will be measured through an algometer on masseter and temporals muscles
次要结局
- Past pain experience(At T0: Baseline (pre-intervention))
- Anxiety and depression symptoms(At two timepoints through study completion: at baseline, and at 8-12 weeks)
- Pain catastrophizing(At two timepoints through study completion: at baseline, and at 8-12 weeks)